Promoting Integrity in Clinical Research - Individual-Case-Studies

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Promoting Integrity as an Integral Dimension

Ref. Ares(2017)5647585 - 20/11/2017


of Excellence in Research

Promoting Integrity as an Integral Dimension


of Excellence in Research

***
Individual Case Studies

DOCUMENT DESCRIPTION

Deliverable Number D3.5

Work Package WP III – What Happens in Practice? Institutional Responses to


Misconduct.

Task T III.3 – Inventory: in-depth misconduct case studies

Type Report

Version Final

Number of Pages 176

Due Date of Deliverable Month 18, 02/017

Actual Submission Date Month 27, 20/11/2017

Dissemination Level Public

This project has received funding from the European Union’s Horizon 2020 research
and innovation programme under grant agreement No. 665926.

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Table of Contents
Radboud University – Case Study 1 ................................................................................................... 7
Highlights ............................................................................................................................................. 7
The accused ......................................................................................................................................... 7
The allegations .................................................................................................................................... 9
Processing the allegations ................................................................................................................. 10
Defence by the accused .................................................................................................................... 16
The consequences ............................................................................................................................. 17
For the accused ............................................................................................................................. 17
For the whistleblower ................................................................................................................... 17
For colleagues of the accused ....................................................................................................... 18
For the department/Faculty .......................................................................................................... 19
For the research area .................................................................................................................... 20
For the research system ................................................................................................................ 21
The responses .................................................................................................................................... 22
References ......................................................................................................................................... 22
Radboud University – Case Study 2 ................................................................................................. 24
Highlights ........................................................................................................................................... 24
The accused ....................................................................................................................................... 24
The allegations .................................................................................................................................. 25
Processing the allegations ................................................................................................................. 26
The defence by the accused .............................................................................................................. 31
The consequences ............................................................................................................................. 32
The responses .................................................................................................................................... 35
References ......................................................................................................................................... 35
University of Tartu – Case Study 1................................................................................................... 37
Description of the case ...................................................................................................................... 37
Context of the case............................................................................................................................ 41
Academic culture and safeguards ................................................................................................. 41
Supervisor’s role ............................................................................................................................ 41
The role of the Institute ................................................................................................................ 42
Continuity of researching the theme of the doctoral dissertation ............................................... 42
Reverberations of the case ............................................................................................................ 42

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Impact of the case ......................................................................................................................... 42


Case analysis sources ........................................................................................................................ 42
University of Tartu – Case Study 2................................................................................................... 44
Description of the case ...................................................................................................................... 44
Context of the case............................................................................................................................ 47
Formal criteria of the publisher vs the quality of publications ..................................................... 47
Personal level ................................................................................................................................ 48
Researchers’ career and publishing .............................................................................................. 49
Research integrity.......................................................................................................................... 49
Impact of the case ......................................................................................................................... 49
Case analysis sources ........................................................................................................................ 50
Acknowledgement................................................................................................................................. 50
Vrije Universiteit Brussel – Case Study 1......................................................................................... 51
Vrije Universiteit Brussel – Case Study 2......................................................................................... 52
Vrije Universiteit Brussel – Case Study 3......................................................................................... 53
Oslo and Akershus University College – Case Study 1 .................................................................. 54
Summary ........................................................................................................................................... 54
Persons involved, scientific field and institutional context ............................................................... 54
The Whistleblowers ....................................................................................................................... 54
The Accused................................................................................................................................... 54
Scientific field and institutional context ........................................................................................ 54
Data & Methods ................................................................................................................................ 54
Document analysis ........................................................................................................................ 55
The allegations .................................................................................................................................. 55
Form and origin ............................................................................................................................. 55
Processing the allegations ................................................................................................................. 56
The local management .................................................................................................................. 56
Investigation committee ............................................................................................................... 56
The Norwegian Board of health ........................................................................................................ 57
How did the actors interpret the case? ............................................................................................. 57
Consequences ................................................................................................................................... 58
For the accused ............................................................................................................................. 58
For patients ................................................................................................................................... 58
For the whistleblower ................................................................................................................... 58

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For the institution .......................................................................................................................... 58


For the research system ................................................................................................................ 59
Conclusions and learning points........................................................................................................ 59
References ......................................................................................................................................... 59
Oslo and Akershus University College – Case Study 2 .................................................................. 62
Summary ........................................................................................................................................... 62
Persons involved, scientific field and institutional context ............................................................... 62
The Accuser ................................................................................................................................... 62
The Accused................................................................................................................................... 62
Scientific field and institutional context ............................................................................................ 62
Data & Methods ................................................................................................................................ 63
Document analysis ........................................................................................................................ 63
Telephone interviews .................................................................................................................... 63
The allegations .................................................................................................................................. 64
Form and origin ............................................................................................................................. 64
Processing the allegations ..................................................................................................................... 64
The local management .................................................................................................................. 64
Local integrity committee ............................................................................................................. 64
Local follow-up .............................................................................................................................. 64
National Research Ethics committes ............................................................................................. 65
How did the actors interpret the case? ......................................................................................... 66
Consequences ................................................................................................................................... 66
For the accused ............................................................................................................................. 66
For the accuser/whistleblower ..................................................................................................... 66
For the colleagues/work environment .......................................................................................... 66
For the Institution.......................................................................................................................... 67
For the research system ................................................................................................................ 68
Conclusions ........................................................................................................................................ 68
Some learning points ..................................................................................................................... 68
Literature ........................................................................................................................................... 68
University of Bristol – Case Study 1 ................................................................................................. 69
Summary ........................................................................................................................................... 69
Methods ............................................................................................................................................ 69
Types of alleged misconduct: ............................................................................................................ 70

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Background information of the Accused ........................................................................................... 71


Background information about the whistle-blower .......................................................................... 71
The Institutional context ................................................................................................................... 72
The research context ......................................................................................................................... 72
Timeline and discovery and accusation of misconduct ..................................................................... 73
Resolutions & conclusions ..................................................................................................................... 85
University of Bristol – Case Study 2 ................................................................................................. 87
Summary ........................................................................................................................................... 87
Methods ............................................................................................................................................ 87
Types of alleged misconduct: ............................................................................................................ 88
Background information of the Accused ........................................................................................... 88
Background information about the whistle-blower .......................................................................... 90
The Institutional context ................................................................................................................... 91
The research context ......................................................................................................................... 91
Discovery and accusation of misconduct .......................................................................................... 93
Resolution........................................................................................................................................ 112
Institutional: ................................................................................................................................ 112
Funder: ........................................................................................................................................ 112
JBMR: ........................................................................................................................................... 112
GMC fitness to practice hearing: ................................................................................................. 112
UK Government: .......................................................................................................................... 112
Conclusions.......................................................................................................................................... 112
University of Trento – Case Study 1 .............................................................................................. 114
Resume ............................................................................................................................................ 114
1. Personal, organisational and field levels ..................................................................................... 114
2. Description of the case: main aspects ......................................................................................... 115
3. Highlights and conclusive considerations ................................................................................... 125
4. Chronology .................................................................................................................................. 126
5. Data sources and methods .......................................................................................................... 128
University of Trento – Case Study 2 .............................................................................................. 133
Resume ............................................................................................................................................ 133
1. Personal, organisational and field levels ..................................................................................... 133
2. Description of the case: main aspects ......................................................................................... 134
3. Highlights and conclusive considerations ................................................................................... 138

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4. Chronology .................................................................................................................................. 139


5. Data sources and methods .......................................................................................................... 139
Leiden University – Case Study 1 ................................................................................................... 142
1. Summary...................................................................................................................................... 142
2. Introduction ................................................................................................................................. 142
3. Gaming the system ...................................................................................................................... 143
4. Qui bono? .................................................................................................................................... 144
5. Conclusion ................................................................................................................................... 145
References ....................................................................................................................................... 146
Leiden University – Case Study 2 ................................................................................................... 148
1. Summary...................................................................................................................................... 148
2. Introduction ................................................................................................................................. 148
3. Methods and data ....................................................................................................................... 149
4. Results ......................................................................................................................................... 150
5. Conclusions .................................................................................................................................. 172
References ....................................................................................................................................... 174

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Radboud University – Case Study 1


Case Study Report Prof. N.
Highlights
 Case of alleged misconduct involving star-status researcher prof. N., with (anonymous)
allegations of plagiarism, self-plagiarism and data manipulation. After investigation of four
university based integrity committees and two LOWI-committees Prof. N. was cleared of
all official allegations. In the end, only an investigation in Prof. N.’s entire oeuvre leaves
allegations of self-plagiarism standing. No official sanctions are put up against Prof. N.
 His star-status (and particularly his period as chair of NWO) is repeatedly identified as
potential source of questionable practices or the lack of resistance against this from his
surroundings. After his NWO-period he returned to the VU and sets up a group within the
department that works autonomously within much interaction (on professional level) with
the rest of the department.
 Prof. N. is indicated as a scholar that focused on quantity, being prepared to make
concessions with regard to quality. Nevertheless, within his department he was officially
judged based on indicators that mainly take quality into account. Therefore, his citation
and publication practices were indicated as a personal strategy based on personal
preferences.
 The Prof. N.-case led to various changes in official policy regarding self-plagiarism (e.g.
KNAW letter on correct citation practices). However, the common practices both within
the department/among colleagues and within the research discipline have undergone
little changes. The main reason indicated for this is based on the ‘rotten-apple argument’:
The practices exposed by prof. N. were very uncommon and not similar to those of other
members of the community.
 Prof. N.-Dr. K. case led to novel policy on the acceptability of anonymous allegations. In
addition, the anonymous whistleblower is charged for slander and an investigation into his
identity is demanded by a Dutch judge.

The accused
Biographical information

Prof. N. (born February 26, 1946, Dalfsen, The Netherlands) is an Emeritus Professor in Regional
Economics and Economic Geography at the Faculty of Economics of the Vrije Universiteit (VU) in
Amsterdam. He graduated from the Erasmus University Rotterdam in the field of econometrics (1970)
and holds a PhD in regional economics from the same university (1972). Since 1975 he is professor in
the field of regional and urban economics, and the field of economic geography at VU. In his career,
Prof. N. has widely become known as one of the most productive scholars in his field. From 1975
onwards he published over 2300 scientific articles and more than 100 edited volumes. In addition, his
work is highly cited. Prof. N.’s publications obtained a total of nearly 40.000 citations, giving him an h-
index of 88 and an i10-index of 752 (obtained from Google-scholar on 08-09-2016).

His enormous productivity and influence on the scientific community was rewarded with the Spinoza
Award (the most prestigious scientific award in The Netherlands) in 1996. In addition, he was president
of the governing board of the Netherlands Research Council (NWO) from 2002 till 2009, chairman of

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the Dutch Social Science Council (SWR) and vice-president of the Royal Netherlands Academy of
Sciences (KNAW). As a scientist, he held guest professorships at about twenty, mainly European,
universities and was a member of about thirty editorial or advisory boards of scientific journals.

Undoubtedly, Prof. N. was an extremely productive scientist, which was considered one of the
Netherlands’ most influential scientists for several decades (Science Guide etc.)

Organisational structure

Prof. N. was a full professor at the department of Spatial Economics at VU. The department holds 60
staff members who are involved in both fundamental research as well as in national and international
commissioned research. RePEc ranks the Department in the top 5% of the world in multiple domains
of spatial economics. In addition, eight professors from the department are ranked by RePEc in the top
5% of Economics authors of the world. (http://www.feweb.vu.nl/nl/afdelingen-en-instituten/spatial-
economics/index.aspx)

The Department of Spatial Economics is part of the faculty of Economics and Business Administration.
On the faculty’s webpage there is explicit mention of the importance of scientific integrity. In addition,
it makes explicit mention of the codes of conduct that faculty members are to adhere. These are the
codes of conduct designed by VSNU (VSNU, 2012) and ALLEA (ESF/ALLEA, 2011). Furthermore, it has a
reference to a university wide ‘Academic Integrity Complaints Procedure’ (although the document
cannot be found on the universities webpage), to faculty specific confidants and it mentions the
university-wide committee on scientific integrity. (http://www.feweb.vu.nl/en/research/research-
ethics-integrity/index.aspx)
The allegations against Prof. N. were handled according to the complaints mechanism dating from
2010. In July 2014, amongst other due to the complaints by Prof. N., the mechanism was revised and
the procedure of handling anonymous complaints was altered. For further discussion of this topic see
chapter ‘consequences’. In first instance, allegations should be directed to the university’s rector, in
case of the VU prof. dr. Van der Duijn-Schouten. He was installed as rector of the VU just two weeks
before the arrival of the first allegations in the Prof. N.-Dr. K-case.

Within the department there is, officially, a clear focus on the quality of research, rather than the
quantity. This shows for example in the fact that research time is distributed over the department
members on the basis of their top-5 publications from the past 5 years, rather than their total amount
of publications (Zwemmer, Gunning, & Grobbee, 2015) (Interviewee 2,3). This system was
implemented prior to the start of the Prof. N.-case and is still in place. Contrary to this, Prof. N.’s
colleagues indicate that some members of the department, including Prof. N. himself, had a clear focus
on quantity anyway: “prof. N. was a good professor and a good scientist. He completely dedicated
himself to his research, but he particularly focussed on its quantity, rather than its quality. This mainly
showed when he participated in large European projects. […] In such cases he was very eager and
clever in forming as many journal articles as possible from one project report. In case one would focus
on quality, one would probably write one or two very strong articles on this subject. Prof. N., however,
was very talented in dividing this research into many papers. In such cases there would clearly be some
overlap in the resulting papers; not in their results and conclusions, but mainly in the introduction,
methodological descriptions or literature review.” (Interviewee 2). This focus on quantity over quality
was indicated in more detail by Prof. N.’s (former) colleagues: “He (Prof. N.) was quickly content with
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our work. Where others would probably have advised me to have another look at my paper for several
times, prof. N. would more easily announce that ‘it is good enough, let’s just send it in.’” (Interviewee
2) And in another case: “I had two supervisors during my doctoral studies, one of which was prof. N.
While both supervisors had their strengths, it seems fair to say that if Prof. N. would have been my
only supervisor, my thesis would have been of poorer quality.” (Interviewee 3)

The allegations

The accuser

In the Prof. N.-case there are several parties who have published allegations against Prof. N. Multiple
formal allegations (in May 2013, November 2013 and June 2014) were made to the ombudsperson of
the VU by an anonymous whistleblower, who works under the pseudonym ‘N.N.’. To date, the identity
of N.N. is still unknown, although a Dutch judge has demanded that national authorities will investigate
and publicise the name of the anonymous whistleblower (see section 6.2 for more details).

From January 2014 onwards, the media got hold of the Prof. N.-case and subsequently public
allegations in the form of various newspaper articles, analyses and blog posts were published by,
amongst others, Frank van Kolfschooten (NRC and blog posts), Prof. dr. Harrie Verbon (blog posts,
news items) and Prof. dr. Richard Gill. The latter intended to provoke an international debate about
the content of the Prof. N.-case (‘are the practices noticed here acceptable?’, ‘should they be allowed?’
etc.). In order to do so, he translated the original allegations by N.N., which were in Dutch, and put
them on his personal webpage.

The content

In the subsequent paragraphs we will focus on the official allegations made against Prof. N. and his co-
authors / students. The content of the informal allegations via newspapers and blog posts are to a
large extent similar to the allegations published by N.N. The anonymous whistleblower has made three
allegations against Prof. N. and his colleagues:

Allegation 1 – May 21st 2013

The first allegation by N.N. was made in May 2013 and targeted the PhD-thesis of Dr. K., a student of
Prof. N. This allegation concerned plagiarism in Dr. K.’s PhD-thesis. Hence, the allegation was not made
directly towards Prof. N., but since he is co-author of the vast majority of the chapters in Dr. K.’s thesis,
the allegation does concern Prof. N.’s work.

Allegation 2 – November 22nd 2013

In November 2013, short after the presentation of the findings of the integrity committee handling
Allegation 1, N.N. provided a second allegation to the VU ombudsperson concerning plagiarism in
sixteen publications by Dr. K., largely co-authored by Prof. N.

Allegation 3 – June 12th 2014

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In June 2014 a third allegation was presented by N.N. to the ombudsperson of the VU. Allegation 3
concerned data fraud in the work by Prof. N., Dr. K. and Turkish economist prof. B. In his allegation,
N.N. provides detailed accounts of work by Prof. N., Dr. K. and prof. B. in which he states suspicions
about the fact that data were either fabricated, manipulated or that old data sets where extended with
non-existing data. N.N. comes to these suspicions because of the fact that: labels are used
inconsistently; values in tables do not add up; manipulations were performed inconsistently; identical
or integer values occur at a rate that greatly exceeds chance; and reference is made to data sets used
in previous articles, while the novel article reports on data that was not reported in previous articles.

Processing the allegations


Since the publication of the first allegation, the VU installed several official integrity committees to
handle the various allegations (Committee 1 to 3). In addition, two committees were installed, not as
a response to a specific allegation, but to investigate Prof. N.’s entire oeuvre (Committee 4) and the
citation practices in Prof. N.’s field (Committee 5). Hereafter we will for every committee discuss their
composition, the conducted research and the official findings.

Committee 1

The committee handling Allegation 1 was chaired by prof. Dr. Pieter Drenth and has become known in
the literature as ‘Commission Drenth I’. The full-report containing the specific findings of the
committee was never published. Only the summary of the report was available for the researchers
(VSNU, 2013). From the summary it is clear that the committee based its conclusions on close study of
Dr. K.’s thesis as well as interviews with the authors. The investigation of the thesis was solely directed
towards the potential inclusion of plagiarised materials.
Concluding from this summary, the findings of the committee were as follows:

1. One chapter of the thesis, that had previously been published, contains work from other
authors that was obtained during a workshop with Prof. N. and Dr. K. During this workshop,
the participants drew from their own work or cited from other publications. In her thesis, Dr.
K. does not mention the employed strategy of obtaining her data. Therefore, according to the
committee, the reader gets the impression that the content of the thesis is due to Dr. K. and
Prof. N., while in some cases it is not.
2. Two other chapters from the thesis contain material that was published prior to the thesis.
This concerns work both from Dr. K. /Prof. N., as well as from other authors. According to the
committee re-use of earlier material was due to a process which they call ‘self-citation’. The
process runs as follows: Author A and B write an article. Together with author C, author A later
publishes a novel article in which, without reference, he uses material from the first article.
Subsequently, in some later stage, author C writes a thesis using passages from the article
authored by A and C, again without reference. According to the committee this is unjust
behaviour, among others because author B is not rewarded for his work on the original paper.

The committee decides that, under the applicable rules (referring to the code of conduct for Dutch
universities, VSNU), the above mentioned behaviour is an act of plagiarism. (Based on summary
of Drenth-I(VSNU, 2013)

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Committee 2

The committee handling Allegation 2 was again chaired by prof. Dr. Pieter Drenth and has become
known in the literature as ‘Commission Drenth II’. The full report containing the specific findings of the
committee was never published. An anonymized version of the summary of the report, including the
response to it by the VU directory board was published at the webpage of VSNU (VSNU, 2015).
The subsequent section will be based on the information in this summary and the report on this case
by LOWI (LOWI, 2015).

Committee 2 based its decisions on the definition of plagiarism in The Netherlands code of conduct for
Scientific Practices (VSNU, 2012) and the European Code of Conduct for Research Integrity(ESF/ALLEA,
2011). In addition, it incorporated (after request of the accused) the jurisprudence on copyright by the
European Court of Justice (Infopaq-arrest, Hof van Justitie van de Europese Unie, 16 juli 2009, C-5/08).
Based on these documents, the Committee finds plagiarism in three of the sixteen investigated
publications. In two of those, the Committee finds ‘less extensive’ forms of plagiarism compared to the
third publication. In one of the publications (hereafter ‘Publication 1), the Committee decides that
extensive passages have been copied and used without specific citations. Herewith the authors have
contravened the copyright of other scientists, according to the Committee. In addition, the use of
fragments from papers of third parties form a breach of scientific integrity, since it is not clear “what
passages and ideas should be credited to the authors and which are taken from other scientists”. The
defence of the accused, mentioning that they used a ‘collective reference system’ which according to
them is ‘clear in their field of research’, was not accepted by the Committee. The Committee beliefs
that it should be clear, to any person and at every moment, who should be credited for a specific part
of an article. Committee 2 decides that, regarding the extensiveness of plagiarism, the authors should
retract Publication 1. In addition, it advices the VU and the department of regional economics to decide
on manners to avoid similar behaviour in future research.

LOWI – committee

Because Prof. N. and Dr. K. did not agree with the findings of Committee 2 they decided to hand their
case to the National Integrity Office (LOWI). The office took the case under consideration by a
committee that hereafter will be called ‘LOWI-committee’ (LOWI, 2015).

Dr. K. and Prof. N. decided to appeal their case at LOWI because of several matters concerning the
procedure employed by Committee 2: the composition and impartiality of the Committee (having the
university’s ombudsman as a member), the acceptance of an anonymous allegation; and the
infringement of the right to be heard. The LOWI-committee decides that the complaints are grounded
with respect to (i) the double function of the ombudsperson, (ii) the negligent manner in which the
directory board of VU brought the case to publicity and (iii) the inaccurate preliminary investigation of
the ombudsperson into the anonymous allegation. The other complaints, in addition to complaints by
Dr. K. and Prof. N. on the employed definition of plagiarism, were found ungrounded.

Lastly, Dr. K. and Prof. N. appealed their case on the basis of charge of extensive plagiarism in
Publication 1 and minor plagiarism in two other publications, which in their opinion is incorrect.
Regarding this decision, the LOWI-committee states: “In order to qualify a piece of text as plagiarism,
there should be more evidence than merely literally or conceptually copied pieces of text without
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citations.” It claims that in qualifying a text as plagiarism, the context in which the authors wrote their
text and the intention of the authors, should be considered. Because plagiarism is understood as
‘strutting with borrowed plumes’ without attribution, a clear intention to deceive should be visible to
deem a text as plagiarism. With this in mind, the LOWI-committee decides that Dr. K. and Prof. N. did
not breach with scientific integrity in Publication 1. Even though extensive parts of the publication are
exact copies of previously published articles of other authors, Dr. K. and Prof. N. did not show a clear
intention to deceive. On the contrary, as the LOWI-committee states, Dr. K. and Prof. N. have
frequently made clear that their article provides a literature review and they incorporated a list of all
employed sources. Thereby they clearly did not try to leave the impression that the published ideas
were theirs, even though citations within the body of the text were absent. Concerning the other
publications in which Committee 2 found minor forms of plagiarism, the LOWI-committee decides that
the authors did not breach with integrity, although there was a question of negligence. The LOWI-
committee comes to this decision based on the fact that one of the publications was a book review, in
which it could be expected that several fragments were literally copied from the book. Citations would
have been appropriate here, but again the authors did not try to ‘strut with borrowed plumes’. In the
last alleged publication, the plagiarised text was limited to only two sentences, which were copied
from “not commonly accepted learning books or authorities”. For these two publications the LOWI-
committee decides that Dr. K. and Prof. N. did not meet the required diligence, but they did not breach
with scientific integrity.

Committee 3

Allegation 3 was handled by a commission chaired by prof. dr. Struikema, with prof. dr. Van Mill and
prof. dr. Widdershoven as members (Struiksma, van Mil, & Widdershoven, 2015). The commission
reported its findings in a publicly available report on November 12th 2015. In handling the allegation,
Committee 3 has followed the following procedure:

After exploratory meetings, Dr. K. and Prof. N. received a letter specifying which parts of the allegation
would be part of the investigation and how the Committee would investigate them. Subsequently, the
Committee asked all accused for a written response to the allegations. The Committee then studied
the allegations and responses. The findings of this study were presented to Dr. K. and Prof. N. After
giving all accused the opportunity to check and comment on a preliminary version of the investigation
report, the final report was published on November 12th 2015.

The Committee decided to leave the allegations concerning plagiarism, as well as allegations
concerning the quality of scientific work, out of the scope of their investigation. Therefore, the
Committee could focus on allegations concerning data fraud. The Committee defines fraud as
“intentional misleading to obtain an advantage”. Therefore, to qualify certain behaviour as fraud there
should be a clear intention to deceive and the researcher should obtain a certain advantage of this
behaviour.

From the investigation, Committee 3 concludes that none of the allegations is grounded. The
allegations were dismissed because: the Committee did not find clear evidence that data had
intentionally be manipulated or fabricated; the allegations can be classified as a difference in opinion
on scientific methodology; the allegation refer to honest-error in the publications; and employed
datasets were accidentally wrongfully referred to, but conclusion were based on computations on the
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correct dataset. Even though the Committee decides that in none of the alleged publications there is
a question of scientific misconduct, it does approve of the fact that the accused acted ‘inaccurate’ in
interpreting or reporting their data. In addition, the Committee finds multiple examples of cases in
which descriptions were ‘vague and general’ and therefore ‘inadequate to serve as common property
of the studied objects’. Nonetheless, the Committee does not believe these acts were committed in
order to intentionally deceive and does not find any indication of an advantage that the accused might
have obtained. Therefore the acts cannot be qualified as fraud. Concerning the role of Prof. N. in the
alleged cases, the Committee reports that Prof. N. only had a supporting and supervising role and was
not involved in data acquisition. Therefore, the Committee judges, Prof. N. could not have been
charged for data fraud. If fraud would have been found in the publications, this would at most mean
that he had fallen short in his task of supervision. According to the Committee this ‘has nothing to do
a breach of scientific integrity’.

The case of self-plagiarism: Committee 4

Besides the committees described above, that were formed as a response to official allegations made
to Prof. N. and his co-authors, the VU introduced an additional committees, Committee 4, charged
with the investigation into citation practices in the work of Prof. N. This committee was formed as a
response to newspaper articles in which Prof. N. was accused of committing self-plagiarism
(Kolfschooten, 2014; Remmie, 2014). The employed investigation strategies and the resulting findings
of these Committees will be discussed in the subsequent sections.

Committee 4 was chaired by prof. dr. Zwemmer (University of Amsterdam) and has become known in
the literature as ‘Commissie Zwemmer’ (Zwemmer et al., 2015). The Committee further consisted of
Prof. Dr. Gunning (VU) and Prof. Dr. Grobbee (UMC Utrecht). The directory board of the VU formed
this Committee after publication of an article in NRC Handelsblad (Kolfschooten, 2014), reporting on
several cases of self-plagiarism in Prof. N.’s work. The implicit allegation of scientific misconduct made
in the article was of sufficient severity for the directory board to launch an investigation into the
citation practices in the entire work of Prof. N. This decision was made after a conversation between
the directory board and prof. N. Contrary to Prof. N.’s desire, the VU felt that it could not disassociate
itself from the allegations without a thorough investigation of Prof. N.’s work (Interviewee 1). In her
study, the Committee based itself on the codes of conduct by VSNU (2012), ALLEA (2011) and KNAW
(2001).

For their research the Committee sampled all publications by Prof. N. since 1970 using the Metis
database. This yielded a list of 2330 publications. Due to this enormous amount of articles, the
Committee decided to restrict itself to a selection of the publications. In this selection the Committee
incorporated only:

1. Articles published in peer-reviewed journals. Hence, working papers, congress proceedings


and the like were not studied.
2. Articles that were digitally available (in order to study them using plagiarism-detection
software tools)
3. Articles that were published from January 1995 onwards. Older publications were not
incorporated in the studied sample, though they might be present in the reference list of the

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plagiarism software and were as such used to verify whether articles from the selection
contain plagiarised material.

These criteria led to a list of 364 publications which were studied. With plagiarism-detection software
these articles were compared to a reference list of over 46 trillion webpages (including scientific
articles). The Committee used the criterion that only passages overlapping in more than 50 words were
checked on relevant citations. Overlapping passages of fewer words were not considered as plagiarism.
With this the Committee intended to only make highly significant cases come to light.

From the list of selected publications, the Committee found 103 publications that they were not able
to analyse (due to various reasons). From the other 261 articles that were analysed, 60 were found to
have significant overlap with other publications, without relevant citations.
In all cases that the detection software indicated overlap between different articles the Committee
checked this overlap by hand. In this way it was able to filter the overlap that resulted from similar
literature references, address information etc. In addition, overlap in which correct citations were used
could be filtered. The sixty cases of significant overlap without correct citation are described as
‘relevant, overlapping passages in which it is not clear that the text is not original’.
The Committee judges that the amount of overlapping passages gives the impression of ‘systematic
copy-pasting’. In this, it regularly occurs that some words in the copied text have been deleted, added
or changed. However, the Committee argues that, even in case of these minor alterations, this is a case
of literally citing another publications and thus that a proper reference should be made.

The overlapping passages occur mostly within the work of Prof. N. himself, i.e. the copied passages are
usually from articles that were published by Prof. N. (possibly with co-authors). This gives the
Committee the impression that ‘the copy-pasting serves as a strategy that should lead to a high
number of publications, rather than an original oeuvre’. The report states that there might be several
reasons for not properly adding references to all passages not due to the author. However, it states
that the investigated publications by Prof. N. ‘pass well beyond this line’. The Committee finds it proven
that Prof. N. used a strategy of copying his own work, whether or not with minimal alterations, to
obtain new publications. The committee members present this as a reason for the enormous amount
of publications by Prof. N. and qualify the behaviour of Prof. N. as ‘Questionable Research Practices’.

The directory board of the VU consents with the findings of the Committee. However, it does not
approve of the judgement that Prof. N. committed ‘Questionable Research Practices’, because this,
according to the directory board, can only apply to individual publications and because no clear
regulations and norms regarding self-plagiarism were articulated at the time of publication of the
alleged articles. In addition, the list of articles that were judged to contain self-plagiarised material
involved many co-authors. The directory board thought that, also in respect to these co-authors that
were not yet formally involved in the case, the term ‘Questionable Research Practices’, would be
disproportionate. In addition, the focus of the investigation was on prof. N., including the other co-
authors (more than 50), would be ‘an immense operation’, which was deemed undesirable
(Interviewee 1). The directory board specifically focussed on prof. N., because the allegations in the
newspaper did so. The investigation was aimed as clarification of the adopted practices by prof. N. and,
in case the results of the investigation allowed for this, to clear prof. N.’s name. Because no other co-
authors were accused of committing any undue practices, the directory board did not feel the need to
clear their names and did not intend to raise any discussion on them. (Interviewee 1)
Succeeding the publication of Committee 4’s final report, the co-authors affiliated to the VU were
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individually informed about the Committee’s findings by the Rector (Interviewee 1 and 2). One of the
involved co-authors describes this as: “We were ordered to visit prof. Van der Duijn Schouten. He gave
a sermon of ten minutes and then asked: ‘do you have any questions, but please be quick because the
next visitor is waiting?’[…] This all felt very unpleasant. Yes, we were informed but in a very unpleasant
manner. […] In first instance, the board intending to handle the case in a specific way, we (red. the co-
authors) disagreed, we thought this was unacceptable. We took action and eventually the board
handled the case differently.” (Interviewee 2) (The interviewee could not tell us about the details of
this intervention.) “All in all, we as co-authors felt that the VU was not there to protect us. It did not
feel as a safe environment and my confidence in the institute has dropped dramatically.” (Interviewee
2)

The VU decided not to take any measures against Prof. N. and did not further investigate the individual
publications on plagiarism.

LOWI-Committee 2

As after the conclusion of Committee 2, Prof. N. appealed his case at the LOWI. Prof. N. appealed his
case for multiple reasons. According to Prof. N. (LOWI, 2016):

1. The directory board should not have published the report by Committee 4.
2. The directory board should have been more specific about which parts of the report by
Committee 4 it consents with.
3. The report by Committee 4 holds many mistakes.
4. Many of the reused sentences did not claim originality but were rather ‘known expressions to
experts, descriptions of data or technicalities’.
5. The Committee should have contacted his co-authors to ask for their share in the published
work.
6. The Committee should have incorporated the statement by 81 foreign colleagues, in which
they claim that there are no clear rules concerning reuse of text.
7. The practices conducted by Prof. N. are common in his field of research.

The LOWI-Committee (hereafter called ‘LOWI-Committee 2’) presented an anonymized report on their
findings concerning Prof. N.’s claims in early 2016. In their report they state that claims 1 and 3 are
ungrounded. However, LOWI-Committee 2 states that, concerning claim 1 and 2, the report was
published too early and should have been published in summary only.
Concerning claims 4 till 7, LOWI-Committee 2 makes two important statements:

First, the report by Committee 4 focuses too much on the extent of reused passages and too little on
the nature of the reused texts. According to LOWI-Committee 2 it is of crucial importance whether
passages had the intention to be presented as novel contributions to the scholarly literature or
whether they merely serve as descriptions of the research methods or the field of research. It states
that the report by Committee 4 does not show that this difference is properly considered.
Second, LOWI-Committee 2 states that the report does not properly compare Prof. N.’s practices with
the common practices in his field of research. According to LOWI-Committee 2, Committee 4 has
performed ‘uncontrolled research’: ‘only Prof. N.’s oeuvre has been studied without any verification
on the citation practices of comparable scientists.’ According to LOWI-Committee 2, Committee 4
should have involved peers judging on the content of the reused passages and the citation practices in
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the field of research. Therefore, LOWI-Committee 2 advices the directory board of the VU to perform
a novel study on the set of selected publications paying more attention to the content of the reused
fragments and to perform a study on the citation practices in Prof. N.’s field of research.

Committee 5

Following the advice of LOWI-Committee 2 the directory board of the VU announced on May 7th 2016
that it will start a new investigation into the citation practices within Prof. N.’s field of research. This
research should give insight in the common practices within this research field and provide clarity on
the extent in which Prof. N.’s practices deviated from this. After consultation with the chair of
Committee 4 and the subsequent announcement that the contextual information of Prof. N.’s practices
was in fact already taken into account in the investigation by Committee 4, the VU’s directory board
refrained from further preceding a novel investigation. Thereby, the Prof. N.-case has come to an end.

Defence by the accused


During the case, Prof. N. harshly defended himself and continuously argued that he was not guilty of
any form of scientific misconduct. His defence consists of various individual points:

- First, Prof. N. argued that he did not deviate from the common practices and behaviours in his
research area. If any of his publication practices or strategies were not appropriate, then it
would not only be him to blame, but many of his colleagues as well. This argument was
endorsed by his fellow economists in an open letter to the VU’s Rector, in which they claim
that any of them would be guilty if the norms put on Prof. N., were put on them (Westlund,
Martin, & Stough, 2014).
- Second, Prof. N. responded to the allegations of self-plagiarism by stating that it is his aim to
reach an as broad as possible audience. Therefore, he writes to multiple audiences via diverse
media and journals. In these practices he admits to have reused previously published material
but only with the goal of providing insight to his research to as many readers as possible. This,
as Prof. N. argues, should be the goal of any scientist. The latter argument was endorsed in the
interviews that we conducted: “Prof. N. was really passionate about his research and I believe
he genuinely tried to reach an as broad as possible audience. In that respect there are two
sides to this story: On the one hand there is the eager scientist trying to achieve the highest
and being proud of his achievements, but on the other hand there is the scientists trying to
support science and particular journals. Prof. N. was frequently asked to write an article for a
particular journal, also for journals of which he closely knew the editors. These editors knew
that it was in their benefit to have a paper by prof. N. published in their journal and prof. N.
was very willing to support them. His strategy of focussing on large outputs was therefore not
only for personal gain, he really tried to help others and to contribute to science.” (Interviewee
2)
On the other hand, this strategy was also criticized: “prof. N. defended his practices with the
argument of knowledge dissemination. I disagreed with him on this point. Knowledge
dissemination does not work like this, by first publishing articles in low quality journals and
later in higher quality journals. This does not work, for instance, because these lower quality

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journals might have pay walls. If you would like to reach a large audience it would be much
more beneficial to publish a working paper that is accessible to everyone.” (Interviewee 3)

The consequences

For the accused


- After the report by Committee 1, Prof. N. was requested to step back from his function as
promotor of Dr. K. Prof. N. consented with this request. Furthermore, no official measures
or sanctions were taken against Prof. N. Allegations 2 and 3 were (albeit after decision by
the LOWI) found ungrounded. In addition, the VU decided not to sanction Prof. N. after
the findings of Committee 4, because in the VU’s opinion Prof. N. did not commit any
Questionable Research Practices or scientific misconduct. During the case, Prof. N. reached
the age of retirement and was made an emeritus professor in January 2015. In this role,
he is still able to work at the VU and continue his scientific career.

- One of the major consequences of the Prof. N.-case for Prof. N. himself is that he suffered
from severe reputational damage. Prior to the case he was an extremely well-respected
scientist, possessing a high degree of ‘star-status’. However, the case obtained a lot of
(media) attention (judging by the 280 newspaper articles and multiple blogs about the
case) and created large public outcry about the scientist (as well as the person) Prof. N.
Judging by the responses from Prof. N.’s (former) colleagues, the main consequences of
the case come in the form of emotional and personal damage, in addition to the enormous
amount of time and energy that it took him to defend himself from various allegations
(Interviewee 2 and 3)

- The Review of Economic Analysis (RoEA) retracted two of Prof. N.’s articles for self-
plagiarism. The notices by the RoEA are as follows (Retraction Watch, 2014):

“The paper “An Agent-Based Decision Support Model for the Development of E-Services in
the Tourist Sector “ by Dr. Br, dr. K. and Prof. N. published in vol 2(3), 2010, has been
withdrawn by the editors because significant parts of the paper appeared in other
publications of the co-authors without proper citation.”

“The paper “Migration Impact Assessment: A Review of Evidence-Based Findings “ by Prof.


N. published in vol. 4(2), 2012, has been withdrawn by the editors because significant parts
of the paper appeared in other publications of the author without proper citation.”

For the whistleblower


- A Dutch court has ordered the state prosecutor to identify the anonymous whistleblower
N.N. and to prosecute him/her for defamation, libel and slander.
After claims by Dr. K., Dutch police has made previous attempts to identify N.N. (amongst
others by means of the IP-address used to send the anonymous allegations) but did not
succeed. The Dutch court, however, believes that there is sufficient basis for a new
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investigation towards N.N.’s identity. Dr. K. claims that the allegations by N.N. are based
on discriminative motives and jealousy. Dutch court has found sufficient evidence for this
and therefore the anonymous whistleblower will be prosecuted under Dutch criminal law.
(Gerechtshof Arnhem Leeuwarden, 2015)

For colleagues of the accused


- After Allegation 1 and the conclusions of the investigation by Committee 1, Dr. K. had to
postpone her PhD-defence. In addition, the directory board of the VU ordered her to
rewrite the chapters of her thesis that were labelled unjust by Committee 1. Proper
citations and an account of the methods to obtain research data had to be added to the
thesis.

- The Netherlands Institute for Human Rights decides that the Vrije Universiteit has treated
Dr. K. unjustly by not properly protecting her privacy rights (College voor de Rechten van
de Mens, 2015). The Institute ascertained that Dr. K. was put in a vulnerable position due
to media publications in which she was, unnecessarily, described as ‘Moroccan woman’.
The publications in the media, insinuating on her having a relation with her promotor,
were particularly harmful given Dr. K.’s cultural-religious background. The Netherlands
Institute for Human Rights concludes that the VU did not properly investigate whether it
could protect Dr. K. Therefore, the VU did not meet its responsibility as employer. The
Institute judges that hereby the VU has discriminated Dr. K. on the basis of race and
religion.
In contrast, the Institute decided that the VU did not discriminate Dr. K. by accepting
anonymous allegations against her.

- “The Court of Justice in Amsterdam has recently passed sentence on the treatment of their
case by the VU University. The Court has concluded that the University has violated the
Civil Law and the Administrative Law of the Netherlands, (i) by failing the protect its
employees (i.e., Prof. N. and Dr. K.) against unjustified and false anonymous complaints,
(ii) by leaking confidential information to the press, and (iii) by having even committed an
unlawful act against Prof. N. and Dr. K.. As a consequence, the University has been
condemned to pay a financial compensation.” (Chawla, 2016)

- Within the discussion about the Prof. N.-case, the colleagues of Prof. N., except for Dr. K.,
have been remarkably absent in official documents. Especially Prof. N.’s co-authors were
hardly touched. The allegations raised against Dr. K. and Prof. N. involved work by multiple
co-authors, but these were only obliquely mentioned in the investigation reports. The
investigations focus specifically on Prof. N. and Dr. K. (with the exception of the
investigation of Committee 3, which also takes the share of prof. B. into consideration). In
the majority of the investigation reports, it is mentioned that the co-authors of Prof. N.
were informed about the allegation and the subsequent investigation, but that they would
not be part of this. In the case of allegation 2 and the conclusion of Committee 2 that one
of the studied articles contained major forms of plagiarism and therefore should be
retracted, the involved co-authors (Dr. L. and Dr. Br.) accepted this conclusion. They were
willing to retract the article and did not support the appealing of the case by Prof. N. and
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Dr. K. to the LOWI. The choice to focus the investigations particularly on Prof. N. was made
very consciously. Because the allegations focused on prof. N., the investigation was
targeted at his work and aimed, among others, to clear him of the charges in case the
investigation’s results allowed for this. Prof. N.’s colleagues to whom no allegations were
made, were deliberately held out of the spotlights also in cases were the investigation
included their work (for instance in the work of Committee 4).

- Despite their absence in the formal documents, several co-authors and colleagues did
suffer from the case. These consequences are mainly in the personal and emotional
domain. In one case, the stress resulting from the case has caused chronic illness to one of
Prof. N.’s colleagues. Two years after the beginning of the case, this colleague was
assessed as unfit for work. (Interviewee 2, Interviewee 4)

- Apart from emotional damage, the consequences for colleagues and co-authors are
demonstrated in a greater awareness of issues regarding self-plagiarism and text recycling
and scientific integrity in general (Interviewee 3).

For the department/Faculty


- Within the department of Spatial Economics only few changes have taken place as a result
of the Prof. N. case. First of all, due to prof. N. leaving the department, the focus on quality,
rather than quantity, has become stronger. Even though formally the focus has always
been on quality (in regard of assessment criteria), there has now been a turn in the more
informal focus as well (Interviewee 2). Second, there have been taken several measures to
stimulate exchange of department member’s work in the form of seminars and working
papers announced via internal newsletters. Though these practices were already in place
prior to the Prof. N.-case, they have been intensified afterwards to increase awareness of
each other’s work.

- The fact that no further measures were taken had multiple reasons: first, “the publication
and citation practices of department members were already in line with the existing and
newly formed guidelines and codes of conduct. Therefore, there was no reason to
formulate novel rules or regulations or to put more emphasis on the commitment to the
existing guidelines. If it ain’t broken… ” (Interviewee 3). Second, the need for further
measures was diminished by the rotten-apple argument: “prof. N. was a special case. The
methods of prof. N. were very distinct from the methods employed by other members of
the department. His way of working, with many co-authors, a huge network, also
internationally, and accordingly his great productivity, were not representative for the rest
of the department. Therefore, setting up novel policies specifically adapted at the strategy
and methods of prof. N. is not very useful.” (Interviewee 3)

- By some, the lack of changes taking place after the Prof. N.-case was deemed
“disappointing”. “I had hoped that more would have changed afterwards.” “I am not so
much disappointed because of a lack of official sanctions, but because of a lack of
discussion. In my opinion, too little discussion has been going on. This could have been
much more elaborate. […] As far as I can see, several people seem to be just moving on in
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the way they did, without altering their methods or practices. I would have hoped that
they did change, but perhaps this just needs some more time. I might just be too
impatient.” (Interviewee 2)

- In addition, the lack of change might be deemed surprising, because by some the
conditions at the department were actually considered as one of the potential
circumstances that lead to this case. In particular the status of Prof. N., as a former
president of NWO, was criticized: “I think that one should ask himself whether it is
desirable for someone to return to his former working place after having been in such
prestigious positions. When returning, there is the danger of such person to be inviolable
and allowing very little resistance. […] This might lead to an unhealthy situation.”
(Interviewee 1) Accordingly, other interviewee’s confessed that the practices of which
prof. N. was accused mainly became evident after his period as a president of NWO. Prof.
N.’s strategies changed after this period, leading to a greater focus on productivity and
setting up the conditions under which this productivity became possible (Interviewee 3).

For the research area


- For the research area in which prof. N. was active, Spatial and Regional Economics, similar
comments apply as in Prof. N.’s department: not many (official) changes were made,
neither to policy nor to the common practice. The arguments for this resemble those
presented in the previous paragraph: Prof. N.’s practices and methods were not
representative for the practices of the research area (Interviewee 3) and (most) scholars
considered there was no need to make alteration because the norms and standards that
most members of the research domain adhere to are in line with the formal guidelines and
codes of conduct (Interviewee 3). As an additional argument, it was posed that most
members of the (international) research community were not so much aware of the
specific content of (the allegations in) the Prof. N.-case (Interviewee 2 and 3).

- Similar to the comments made with regard to the department, some aspects of the culture
in the research area were considered as potential triggers for unjust behaviour. As one of
the members of the research community points out: “At a certain moment, lots of
meetings were organised amongst well established members of the community. During
these meetings, the participants always decided to publish a special issue in a journal,
usually with low quality articles. Because the participants were well established scientists,
or because the editor of such a journal was among them, such a special issue was always
published. I have been a referee for some of the papers in such issues and sometimes a
thought: ‘this cannot be true, this is of much too poor quality’. I therefore rejected those
papers but in the end, they always got published.” (Interviewee 2) The interviewee
described these practices as a form of “cronyism” and sees a clear role for journals and
journal editors in potentially facilitating or initialising practices that fall into the grey areas
of academic publishing (Interviewee 2).

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For the research system


- After the publication of the findings by Committee 2 and the study of Committee 4, the
KNAW published an advice on correct citation practices (KNAW, 2014). In their advice they
particularly comment on the act of plagiarism and more specifically on the act of self-
plagiarism. Following the KNAW advice on correct citation practices, the VSNU
incorporated the following paragraph in their code of conduct for responsible research
practices:

“Een wetenschapsbeoefenaar zal geen (delen uit) eerder gepubliceerd eigen werk opnieuw
publiceren als ware dit een nieuwe bijdrage aan de wetenschappelijke literatuur. Wanneer
hij eerder gepubliceerde bevindingen opnieuw publiceert, zal hij dat door correcte
bronvermelding of op andere in zijn vakgebied aanvaarde wijze duidelijk maken.
Hergebruik zonder bronvermelding van korte teksten die al dan niet samen met co-auteurs
zijn gepubliceerd is binnen veel wetenschapsgebieden geoorloofd en zelfs gebruikelijk
indien het gaat om korte passages in inleiding, theorievorming en methodebeschrijving.”

“Academic practitioners do not republish their own previously published work or parts
thereof as though it constituted a new contribution to the academic literature. When
republishing previously published findings, they indicate this with a correct reference to the
source or by another means accepted within the discipline. In many disciplines it is
permissible and even customary to reprint short texts from works published with or without
coauthors without a source reference when it concerns brief passages of introductory,
theoretical or methodological explanation.” (VSNU, 2014)

- After complaints by Prof. N. and Dr. K., the LOWI made a statement about the acceptability
of anonymous allegations (LOWI, 2015). The LOWI states that: “fully anonymous
allegations, meaning that the identity of the whistleblower is unknown to all parties, is
undesirable”. If the policy of an institute allows anonymous complaints, the institute
should be very careful in applying this policy. In general, the LOWI advices to adopt forms
of allegations in which the identity of the whistleblower is unknown to the accused and
the integrity committee investigating the case, but in which the directory board of the
institute is aware of the whistleblower’s identity. This allows for making the whistleblower
responsible for his duty of secrecy and hearing the whistleblower on his intentions to make
the allegation. According to the LOWI, only under ‘very particular circumstances’ can an
institute accept the desire of the whistleblower to stay fully anonymous. In this case, the
whistleblower should be able to justify and motivate this desire and the directory board
should justify their reasons for complying with the whistleblower’s motivation. As a
response to this statement by the LOWI, the VU decided to alter its policy concerning
anonymous allegations. By means of a spokesperson they announced: “Our policy on
scientific integrity has been altered last year, if people want to pose an anonymous
complaint they have to make themselves known to at least one person within the
university.” (Chawla, 2016)

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The responses

Politics
- On June 25th, 2014, a member of Dutch parliament, Beertema (PVV) asked questions in
parliament to the minister of Education, Culture and Science (Jet Bussemaker) about the
PhD-defence of Dr. K. Beertema asked the minister whether she aware of the fact that
allegations were made against Dr. K., while she will defend her thesis shortly. Beertema
stated that providing a PhD to someone whose scientific integrity is in question is
undesirable.
The minister responded that she was aware of the situation and that she had the directory
board of the VU inform her about it. From the response of the VU she concluded that the
VU extensively considered this case and finally made a diligent decision to allow the PhD-
defence to take place.

Scientific community
- Following the first and second allegation by N.N. and the responses to this by the media,
a group of eighty economists wrote an open letter to the VU’s Rector supporting Prof. N.
(Westlund et al., 2014). In their letter the scientists state that:
“From the information we have about the accusations against Prof. N., we can only
conclude that we would all be “guilty” if the standards some people are trying to apply to
him, were applied to any one of us.”
Subsequently, they focus on the work of Prof. N., which they refer to as “… intellectual and
original contributions [that] have been a guide for an entire generation of young scientists
in the field.” The scientists call up on the VU to “stand up and defend the good name of
one of the true scientific leaders in our field.”
- On the contrary, multiple scientists have been very critical on Prof. N.’s work and
publication practices. In several blogs or responses to news items they have shown to fully
support N.N.’s vision and allegations (e.g. Breedveld, 2014; Verbon, 2016).
- One of the early criticists of Prof. N.’s work, professor in statistics at Leiden University
Richard Gill, started a crowd-funding project to translate the original allegations by N.N.
(which were in Dutch) in English. Hereby he aimed to enable an (international) scientific
debate about the publication practices employed by Prof. N. (Breedveld, 2015).
-

References
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http://www.advalvas.vu.nl/nieuws/leidse-hoogleraar-wil-internationale-discussie-over-
nijkamp
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VSNU. (2014). The Netherlands Code of Conduct for Academic Practice, revised version.
VSNU. (2015). VU Plagiaat - ongegrond 2. from http://www.vsnu.nl/wi-2015.html
Westlund, H., Martin, J. C., & Stough, R. R. (2014). Letter of support for Professor Peter Nijkamp.
Zwemmer, J., Gunning, J. W., & Grobbee, R. (2015, 11-02-2015). Rapport over verwijzingen in het
werk van prof. dr. P. Nijkamp.

Interviewee 1, Rotterdam, 3-4-2017

Interviewee 2, Utrecht, 13-4-2017

Interviewee 3, Amsterdam, 20-4-2017

Interviewee 4, Nijmegen, written communication, 24-3-2017

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Radboud University – Case Study 2


Case Study Report Doctoral Student A.
Highlights
 External doctoral student at EUR is sanctioned for committing plagiarism in her doctoral
thesis. Allegations arrive only after the public defence of the dissertation, and hence after
rewarding the doctoral student her doctoral degree. Several committees (including LOWI)
recommend the EUR to repeal the doctoral degree, but EUR in the end decides not to do
this, among others because of the fact that no legal measures to do so are known in the
Netherlands. Instead, EUR asks the doctoral student to voluntarily return her degree, but
she decides not to do this.
 Unless all integrity committees came to harsh conclusions with respect to the doctoral
student and her dissertation, the eventual sanctions against her are relatively mild.
Contrarily, her supervisor/promotor is sanctioned relatively severe, amongst others by no
longer allowing him to act as promotor of doctoral students nor to be a member of a
doctoral committee.
 Discussions about scientific integrity end up being entangled with discussion about
scientific quality. The final judgement on the doctoral student’s dissertation reads that it
does no longer contain plagiarised material, but that it is of too poor quality to be accepted
as dissertation.
 The case initiated a discussion in the Dutch research community about the possibility of
repealing someone’s doctoral degree. To date, such a decision has never been taken, but
it was prominently suggested to take this measure in the case at hand. Despite the EUR
eventually refraining from this decision, LOWI sketched out some concrete ways in which
such a procedure could be started and indicated which specific rules and legislation might
both form the basis of success in such a procedure as well as which might form the most
significant hurdles.

The accused

Biographical information

Doctoral student A. was born in 1957 in Jakarta, Indonesia. She studied psychology at Leiden University
and subsequently worked for several organisations. As a consultant she advised directory boards of
multiple institutions and organisations on processes of change in their organisation. During the case
under description in this report, she was an external doctoral student at the Rotterdam School of
Management, where she wrote her thesis about models of leadership, with a focus on the process of
becoming a leader (Ass, 2013).

Promotor H. was Doctoral student A.’s supervisor during the second half of her PhD-project. He is
professor in quality management and certification at the Rotterdam School of Management. Besides
that he works as director of CSR Academy, a business and knowledge institute aiming at contributing
to the development of society with respect to corporate social responsibility. Promotor H. started his
career as a consultant, after which he specialised in corporate social responsibility and advised
organisations on the implementation of these practises in their business line. In his academic career
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he acted as the supervisor of ten PhD-students, the majority of which were external PhD-students. As
a consequence, he always held strong connections to the work environment outside of academia, in
particular to business. In addition, promotor H. was president of the exam committee at the Rotterdam
School of Management. He held this position for 16 years and as such was responsible for signing
certificates of graduated students. In this position he came across several instances of plagiarism
among students and repeatedly sanctioned them for this (interviewee 2 and 3).

Organisational structure

Doctoral student A. was part of the Erasmus Research Institute of Management (ERIM) at the Erasmus
University in Rotterdam. Within this institute she was one of the external doctoral students supervised
by Dr. E. and Promotor H. In this, the daily supervision was in hands of Dr. E., while Promotor H. acted
as the official promotor (Interviewee 4). The process of writing and performing the research was mainly
supervised by Dr. E, while all results were subsequently shared with Promotor H. to allow him to give
feedback on all produced material (Interviewee 4). Together, Dr. E. and Promotor H. supervised
between 25 and 30 external doctoral students (interviewee 2), while feeling very little support from
their surroundings: “I always felt that people considered external doctoral students as useless.
According to them, they costs lots of time, while the success rates are low and they do not generate
much output in the sense of publications or grants” (interviewee 2, endorsed by interviewee 4).
As external doctoral student, doctoral student A. was only limited embedded within the department.
She did not physically spend time at the department, nor did she cooperate with members of the
department, other than her supervisors. (Interviewee 1, 2 and 3) Because she was not enrolled in any
of the training activities at Erasmus University, rules and regulations regarding scientific integrity were
expected to reach doctoral student A. via her supervisor.

The allegations
 The accuser

The case of Doctoral student A. was stirred into motion after an allegation by Dr. B. Dr. B. studied
French literature and Sociology at the Radboud University. She obtained her PhD from the same
university in 2000 for a thesis on a novel form of analysing documents in a systematic and qualitative
manner. In 2003 Dr. B. started as an independent scholar in narrative sociology. In this role she advises
clients on a variety of sociological, societal and educational aspects. Dr. B. made her allegation after
reading Doctoral student A.’s thesis and being astonished by the ‘poor quality and writing style’. She
obtained Doctoral student A.’s thesis from doctoral student A. herself, as Doctoral student A. attended
a course on narrative research given by Dr. B. When she noticed that some parts of the thesis were
written in a much more fluent style she started an investigation on the origin of different parts of
Doctoral student A.’s thesis. In first instance, Dr. B. considered the poor quality of the thesis not to
form any reason to take action, which she also did not believe to be her responsibility. However, after
several months, she changed opinion and believed it to be her duty to signal instances of scientific
misconduct as a matter of justice. When finishing her investigation, and concluding that a substantive
part of the thesis contained plagiarised material, she felt that her findings should be reported to
Doctoral student A.’s university. Eventually, three weeks after the PhD-defence of Doctoral student A.
on October 31st,Dr. B. presented her findings in a letter to the Rector of Erasmus university (Basten,
2013b) (interviewee 3).

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 The content

On November 22nd 2013 Dr. B. sent her analysis of Doctoral student A.’s dissertation to prof. dr. Pols,
Rector of Erasmus University Rotterdam. In the letter accompanying her analysis, Dr. B. alleges
Doctoral student A. of committing plagiarism in her thesis (Basten, 2013b). According to Dr. B. large
parts of the thesis have been copied from other sources without proper reference to them. Dr. B. finds
at least thirteen sources ranging from Wikipedia articles to other PhD-theses. In several cases, Doctoral
student A. does mention the use of a source in the beginning of a paragraph, but later copies large
parts of the source without showing that the text was not her own. In addition, Dr. B. mentions that
two members of the doctoral committee and Doctoral student A.’s promotor, Promotor H., were
involved in the supervision of two theses from which material was plagiarised. She wonders whether
the committee members looked over this reuse of material by accident or whether purpose was in
play (Basten, 2013b). Based on this, she recommends EUR to reconsider Doctoral student A.’s
dissertation and to take appropriate measures against her. Repealing Doctoral student A.’s doctoral
degree is one of the measures that Dr. B. considers appropriate. In addition, she asserts that other
dissertations written under the supervision of Promotor H. and doctoral committee members should
be investigated to check whether ‘ Doctoral student A.’s dissertation is an incident or whether this has
happened more frequently” (Basten, 2013a). The daily supervisor, Dr. E., was not in any way
mentioned in the allegation.In the last paragraph of her letter, Dr. B. announces that: “In two weeks I
will send my analysis to the media. Before that time, I would like to hear from you what measures you
have taken or are planning to take soon. I will include this in my letter to the media, such that is clear
that you and Erasmus University Rotterdam takes this case seriously.” (Basten, 2013a)
In addition to finding plagiarism in Doctoral student A.’s thesis, Dr. B. considers the thesis to be of
extremely low scientific quality. However, she decides not to include statements on this subject in her
allegations because she did not feel like having discussions on the content of the thesis and considered
the amount of plagiarism so overwhelming that discussion on quality were no longer needed in the
light of rules on scientific integrity so flagrantly being broken (interviewee 3).

Processing the allegations


After the publication of the allegation by Dr. B., there were several official integrity committees (by
the EUR and the LOWI) involved in handling the allegation. Hereafter we will for every committee
discuss their composition, the conducted research and the official findings.

 Committee 1

After the arrival of allegations at EUR, the rector had a meeting with Dr. B. In this meeting the content
of the allegations was discussed. In addition, intentions for further action were discussed: Baster made
it clear that, given the nature and severity of her findings, she did not expect anything less of EUR than
to seriously investigate the findings and to take proper action (Interviewee 3) In addition, she
announced that in case EUR would not take appropriate measures, the allegations would be handed
to the press (interviewee 1 and 2). At the moment the allegation was presented to Rector Prof. Dr.
Pols, the Rector had been installed at EUR only several weeks ago.On December 11th 2013 the EUR
installed a committee, hereafter ‘Committee 1’, to handle the allegation by Dr. B.. The committee was
chaired by prof. dr. de Doelder and further contained members prof. Dr. Bensing and prof. dr. ing. Van
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den Bosch. In April 2014 the commission reported its findings to the directory board of the EUR,
followed by the board’s response and decision on June 12th 2014 (Doelder, Bensing, & Bosch, 2014).
Committee 1 based its findings on the document ‘Klachtenregeling Wetenschappelijke Integriteit’
(Complaints procedure Scientific Integrity) (EUR, 2013) by the EUR. Notably, the following definition of
plagiarism was adopted:

“Wetenschap functioneert slechts met de eerlijke erkenning van de intellectuele eigendom van ieders
eigen bijdrage aan de kennis. Dat geldt voor de hele range van studentenwerkstukken en scripties tot
wetenschappelijke publicaties en dissertaties. Het gaat niet alleen om letterlijk overschrijven, maar ook
om parafraseringen, het weglaten van noten of bronvermelding, het heimelijk gebruik van door
anderen vergaarde data, ontwerpen of tabellen. Het auteursrecht biedt gedupeerden de mogelijkheid
tot genoegdoening via de rechter, maar ook als er geen direct gedupeerde (meer) is, kan een
onderzoeker worden aangeklaagd wegens plagiaat.”(EUR, 2013)

“Science only functions by the honest recognition of the intellectual property of everyone’s contribution
to scientific knowledge. This applies to the entire spectrum of student papers and theses to scientific
publications and dissertations. It does not only concern literal copying, but also paraphrasing, leaving
out citations and unjust usage of data collected by others. The copyright provides affected parties the
opportunity for reparation via court, but also in case of lack of a directly affected party, a researcher
can be prosecuted on the basis of plagiarism.”(Translation by authors)

In addition, Committee 1 took notion of the documents by the VSNU (2012), ALLEA (2011) and KNAW
(2014).

Committee 1 studied the analysis of Doctoral student A.’s thesis provided by Dr. B. and, after various
checks, concluded that the analysis adequately describes the plagiarism in the thesis. Within this
process the committee consulted Doctoral student A., Promotor H. and dr. R, one of the former
doctoral students of Promotor H. from who’s dissertation several parts were copied into the
dissertation of Doctoral student A. In the process of investigation, other members of the doctoral
committee and the daily supervisor of Doctoral student A., Dr. E., were not informed, nor were they
asked to provide information on the case (Interviewee 4). Committee 1 concludes that the allegation
by Dr. B. is grounded and that the thesis indeed contains a case of plagiarism. The amount of copied
text without proper citation is of such extent that one cannot speak of honest error or negligence.
Therefore, according to Committee 1, the EUR has unjustly provided the doctor-degree to Doctoral
student A.
Concerning the supervision, Committee 1 concludes that the promotor, Promotor H., has provided
insufficient support to his student and has been imputably inadequate. In addition, the thesis-
committee members have insufficiently considered the adopted manners of citation in Doctoral
student A.’s thesis. Committee 1 states that, because of the fact that several of the members of the
thesis-committee were involved in supervising some of the plagiarised documents, it is likely that the
members would have noticed the plagiarism by close reading of the thesis.

These conclusions led Committee 1 to advice the EUR directory board to repeal the decision to reward
Doctoral student A. a PhD-degree. In addition, it advices the directory board to investigate the other
theses written under supervision by promotor H. Apart from that, Committee 1 makes several
recommendations on policy adjustments to prevent similar cases of fraud in future projects. These
recommendations range from increasing the use of plagiarism detection software, adding a second

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supervisor to each PhD-project and increasing the awareness of EUR policy to external doctoral
candidates.

Commenting on the report by Committee 1, the directory board of the EUR states that it does not fully
consent with the findings of the committee (College van Bestuur EUR, 2014). According to the directory
board, clear rules are lacking about what should be considered as plagiarism. Therefore, in making any
judgements, one should consider the contextual information of the case at hand.
The directory board agrees with Committee 1 that the project by Doctoral student A. shows imputable
shortcomings. Relatively large pieces of text have been copied from other sources without proper
citation. Therefore the accused has committed plagiarism, according to the directory board. However,
the directory board feels that the supervision of Doctoral student A. was insufficient. In addition,
Doctoral student A. performed a plagiarism-check by detection software and discussed the results with
her supervisor and her promotor. This, according to the directory board, shows that she did not
plagiarise intentionally, but rather had the intention to detect potential overlapping text. Finally, the
majority of the plagiarised text concerns parts of the introduction, theoretical framework and
methodology sections, rather than the core of the results or conclusions. Given these contextual
circumstances, the directory board feels that repealing the decision to provide Doctoral student A. a
PhD-degree would be too grave of a sanction. Instead, the directory board decided to reprimand
Doctoral student A. and to demand her to rewrite the plagiarised parts of her thesis and provide proper
citations.
The directory board consents with the advice of Committee 1 to investigate the other PhD-theses
written under promotor H.’s supervision.

 LOWI Committee

After the decision by the EUR’s directory board to provide Doctoral student A. a second chance to
rewrite her thesis and not to repeal her PhD-degree, thereby ignoring the advice of Committee 1, Dr.
B. made a complaint to the LOWI. Besides these two specific decisions of the EUR, Dr. B.’s complaint
consists of three items (LOWI, 2014):

- She asks the LOWI to judge about the thesis’ supervision and review by promotor and thesis-
committee;
- She asks the LOWI to make a judgement about the quality of the thesis, which she believes is
very low, also when one ignores the plagiarised parts;
- She asks the LOWI to judge about the quality and scientific standards in the other theses
supervised by promotor H.

The LOWI decided that it cannot take the last three items into account since it is not commissioned to
judge about quality of scientific work, nor about any aspects that were not part of the original
allegation (LOWI, 2014). Based on a study of Doctoral student A.’s thesis and several of the plagiarised
documents, the LOWI Committee judges that Doctoral student A. committed a severe form of
plagiarism. Due to its extent of plagiarism, the fact that minor modifications were made to plagiarised
passages to make them fit in the thesis and the fact that several citations to primary sources were
altered to secondary sources, the LOWI Committee decides that the plagiarism cannot have been
performed unintentionally. The LOWI Committee therefore does not approve of the EUR directory
board’s statement that Doctoral student A. might not have been aware of the plagiarism in her thesis.
In addition, the LOWI does not approve of the notion that the plagiarised passages do not occur in the

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core parts of the results or conclusion sections of the thesis and therefore are deemed less harmful by
the EUR’s directory board. According to the LOWI, plagiarism is plagiarism, no matter in what part of
a thesis or article it occurs.

However, the LOWI recognises the fact that it is difficult to repeal the decision of providing Doctoral
student A. her PhD-degree. There is no legislation that provides means to take such a measure and
there is no precedent of it. In addition, Committee 1 did not sufficiently motivate its advice to take this
measure. However, the LOWI Committee does sketch out scenarios of how such a sanction could be
imposed and paths that could be taken.

This leads the LOWI to the following conclusions and advices:

- Doctoral student A. has committed a form of severe plagiarism that cannot be attributed to
negligence or mistake. Such a form of plagiarism demands proportionate sanctions.
- Because of a lack of motivation by Committee 1 in advising the directory board to repeal
Doctoral student A.’s PhD-degree, the LOWI Committee advices the directory board not to
follow this advice.
- The contextual circumstances provided by the directory board, serving to demonstrate why
less severe sanctions should be taken, are not approved of by the LOWI Committee. In
addition, the LOWI Committee advices to take into account the harm imposed on the
institution and society as a whole by providing a PhD-degree to someone who clearly breached
with scientific integrity. Therefore, the LOWI Committee advices the directory board to
reconsider the imposed sanctions on Doctoral student A. (LOWI, 2014).

 Committee 2

The directory board of the EUR responded to the findings by Committee 1 by demanding:

- Doctoral student A. to rewrite parts of her thesis and resubmit it to an independent committee
- The other theses written under supervision of Promotor H. to be tested on plagiarism.

After initial anger and frustration about the conclusions of Committee 1, doctoral student A. agreed to
rewrite her thesis and to denude it of plagiarism. She and promotor H. asked prof. Alexander Maas,
initially member of the thesis-committee, to assist Doctoral student A. in the rewriting process.
(Interviewee 2)

The committee responsible for the two tasks outlined by the directory board, hereafter called
‘Committee 2’, was chaired by prof. dr. P.S.H. Leeflang and further contained the members prof. dr.
H.K. van Dijk and prof. dr. H.G. van de Bunt (Leeflang, Dijk, & Bunt, 2015). Studying the revised thesis
resulted in major questions about the thesis’ scientific quality. Therefore, Committee 2 decided to
incorporate this aspect of the thesis in its investigation, even though it was not part of their original
task.
For her conclusions, Committee 2 based itself on the code of conduct by the VSNU (VSNU, 2012) and
a report by prof. dr. Kees Schuyt on scientific integrity (Schuyt, 2014).

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Regarding the plagiarism in the resubmitted thesis, Committee 2 asks itself the following question:
“Does the resubmitted version of the thesis still contain plagiarism or are the previously plagiarised
parts properly rewritten?”

After studying the resubmitted version of the thesis and the erratum that Doctoral student A. provided,
Committee 2 judges that the resubmitted thesis does no longer contain plagiarism in the sense of
copied passages without citation. However, the resubmitted thesis does still contain too many cases
of reference to secondary sources, without proper reference to primary sources. In addition,
Committee 2 concludes that Doctoral student A. did not properly rewrite the plagiarised parts in her
first thesis. Rather, she simply deleted the plagiarised parts or added a (primary or secondary) citation,
instead of putting the passages in her own words or properly paraphrasing them. Committee 2
therefore decides that Doctoral student A. has fallen short on her task to rewrite the primary version
of her thesis.

Concerning the quality of the resubmitted thesis, Committee 2 states that the resubmitted thesis does
not meet the scientific standards of a PhD-thesis. According to Committee 2 the thesis:

- lacks a proper research question and empirical analysis;


- does not clarify which (if any) method is used;
- contains too many literal citations and too little work by the student herself;
- does not show how the thesis makes a contribution to the scientific literature (Committee 2
actually doubts whether the thesis makes a genuine contribution);
- employs methods of data collection and reporting that do not meet the academic standards;
- does not allow for validation of the research findings.

Lastly, Committee 2 investigated the other theses written under supervision of promotor H. To this
end, the committee compared the results of three plagiarism scans of the ten theses written under
promotor H. to 104 other theses written at Erasmus University Rotterdam. From this analysis,
Committee 2 concludes that the theses written under supervision of promotor H. do not contain
significantly more overlap with other work, than the theses in the control group.
In addition, some in-depth studies were performed, resulting in the conclusion that all studied theses
meet the standards that can be expected from academic publications.

Directory board EUR

Basing itself on the report by Committee 2 and the LOWI Committee, the EUR directory board made a
final decision in the Doctoral student A.-case on June 25th 2015 (College van Bestuur EUR, 2015). The
final decision targets Doctoral student A., her promotor and general aspects of EUR policy for doctoral
students.

With respect to Doctoral student A. the directory board judges that she has fallen short on her task to
rewrite her thesis. Merely deleting large parts of the original thesis does, according to the board, not
meet the academic standards of revision. Having her PhD-degree gives Doctoral student A. the
responsibility to respond to allegations in a proper manner and to make sure that her thesis meets all
academic standards. According to the directory board, Doctoral student A. did not sufficiently take her
responsibility. Therefore, the directory board decides to:

- Make the (anonymised version of the) final report by Committee 2 publicly available;

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- Repay the government subsidy obtained after the PhD-defence of Doctoral student A.;
- Not store any hardcopy or digital version of Doctoral student A.’s thesis in the university
library;
- Advice other universities to remove (the original version of) Doctoral student A.’s thesis from
their libraries.

Moreover, the directory board follows the advice by the LOWI Committee and Committee 1 regarding
Doctoral student A.’s doctoral-degree. Because there are no set means to repeal Doctoral student A.’s
degree, the directory board decided to request Doctoral student A. to voluntarily renounce her degree,
but to not take any legal steps in demanding her to do so.

With respect to Doctoral student A.’s promotor, Promotor H., the directory board decides that he has
failed to properly perform his task of supervision. Therefore the board decides that, in the future, he
cannot act as promotor of a doctoral candidate, nor can he become member of a doctoral committee
judging the quality of a PhD-thesis. In addition, the board decides that (given the fact promotor H. is
soon retiring) Promotor H. will not be allowed to have an official farewell ceremony or lecture at EUR.

Lastly, the directory board follows the advices of Committee 1 and 2 and advices by the EUR’s doctoral
board to take several measures aiming to prevent similar cases to happen in the future. Amongst
others, the directory board modified the doctoral regulations by stating that:

- Every internal and external doctoral candidate should write an educational and supervision
plan for his/her doctoral study;
- Every doctoral student should be supervised by at least two staff members;
- More severe demands will be set on the composition of doctoral committees judging the
quality of a thesis;
- Every doctoral thesis should be subject to a plagiarism detection scan and the results of the
scan should be analysed in context;
- Every doctoral student should acknowledge to be aware of the code of conduct for scientific
practices at the EUR (College van Bestuur EUR, 2015).

The defence by the accused


The defence of Doctoral student A. regarding the plagiarism in the first version of her thesis, comprised
mainly of the argument that she was unaware of it. According to Doctoral student A. it was in all cases
clear whether a passage was original, and if not, whose work it concerned. In addition, she used
plagiarism detection software to scan her thesis. The results of this scan were discussed with her
supervisor, which resulted in the conclusion that there was no need for alterations to the thesis
(College van Bestuur EUR, 2014). The defence of promotor H. comprised the fact that the employed
definition of plagiarism was ‘new to him’ and that it was ‘never written down’ (Interviewee 2).
According to him, the thesis did not contain passages from other texts that were not cited. He did
agree that the thesis contains significant overlap with other texts (including other theses written under
his supervision) but that in all cases it was clear what the origin of the passages were (Interviewee 2
and 4). The fact that several instances of reference to secondary sources instead of primary sources
occur in the thesis, are, according to promotor H., due to the fact that the thesis refers to Augustine,
whose primary sources are in Latin. Because doctoral student A. cannot read Latin she used secondary
sources (Interviewee 2 and 4). Promotor H. states that he has no reason to doubt Doctoral student A.’s

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integrity (Interviewee 2 and 4) According to him, the only thing you could blame her of is using a way
of referring to other sources that was deemed inappropriate by others (Interviewee 2). Concerning his
own position, Promotor H. feels that “people have been looking for stick with which they could hit me
for 16 years, now they finally found one.” (Interviewee 2) The fact that he felt resistance against his
work with external doctoral students and against his social-constructivist research methods were
indicated as signs of colleagues trying to oppose him (Interviewee 2).

Last, the defence of the accused targeted the critique on the composition of the doctoral committee.
According to the accused, the committee was “a fine committee”, which was deliberately chosen to
cover all subjects touched upon in the dissertation (Interviewee 4). They consider the allegation that
members of the committee did not properly verify or read the dissertation ungrounded: “six professors
need to sign for such a dissertation. […] They do not just put down their signature for no reason,
especially when it concerns a topic of their interest.” (Interviewee 4)

The consequences
 For the accused

- Doctoral student A. suffered reputational damage. Even though her case was not heavily
reported in (national) newspapers (only few articles were written about it (Kolfschooten,
2015)) her chances of obtaining an academic position are minimal.
- Several official sanctions were imposed on her (see section 4.2). These sanctions comprise the
directory board to:
o Make the (anonymized version of the) final report by Committee 2 publicly available;
o Not store any hardcopy or digital version of Doctoral student A.’s thesis in the
university library;
o Advice other universities to remove (the original version of) Doctoral student A.’s
thesis from their libraries.
- Doctoral student A. was requested to voluntarily renounce her doctoral degree. She decided
not to do this.
- In general, the involved actors feel that the sanctions for Doctoral student A. were relatively
limited. Her chances of preceding a career in academia might be minimal, but this was never
ambition. In addition, the EUR did not take legal actions with regard to repealing her doctor-
degree, which she therefore still uses. The other sanctions, such as removing copies of her
thesis from university libraries, are considered to have very little practical impact (Interviewee
1, 2, 3). Therefore, even though actors consent that the emotional damage might be
substantial, they feel that in the end, the sanctions against Doctoral student A. were relatively
mild.
- The fact that not more sanctions were taken, was explained in several ways: first, as external
doctoral student, Doctoral student A. had no labour contract at EUR, therefore the possibilities
of sanctioning her were limited (Interviewee 1, 2, 3). Second, it was put forward that Doctoral
student A. was not solely responsible for the plagiarism in her thesis, her promotor, the
members of the doctoral committee and the dean should have noticed and corrected this in
an earlier stage (Interviewee 1 and 3). Lastly it was put forward that “the doctoral student was
punished enough by everything that already happened. For the university it therefore became
more import to focus on the future and to try to prevent similar things from happening in the
future instead of keeping focussed on this specific case.” (Interviewee 1)

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 For the whistleblower

- There were no negative consequences for the whistleblower. Her allegations were decided to
be grounded and Committee 1 thanked her for her efforts to investigate this case. The main
impact that the case had for Dr. B. were the time and energy that it took her to put her
allegation forward, and the frustration that came along with the, in her opinion, weak
responses from EUR. Besides this, she was accused by some of starting a witch-hunt against
doctoral student A. and persisting this, also when the case was finished and Doctoral student
A. was, according to these people, appropriately punished. Dr. B. does not feel that these
consequences are particularly negative and in addition does not feel that Doctoral student A.
was appropriately punished (Interviewee 3).

 For colleagues of the accused

i. Promotor H.
- Promotor H. was officially sanctioned for his involvement in the case. He was sanctioned for
failing to perform his role as promotor by:
o Not getting the opportunity to have an official farewell lecture or ceremony at his
retirement;
o Not having the right to act as promotor of future (doctoral) students.
o Not having the permission to be a member of a doctoral committee, judging the
quality of a doctoral thesis.
- To some extent it seems to be reasonable to conclude that the sanctions for promotor H. were
more severe than for doctoral student A. (Interviewee 1, 2, 3). On top of the official sanctions,
Promotor H. suffered from various forms of reputational damage, which he deems to be more
severe than the official sanctions (although they evidently result from them). This reputational
damage can be witnessed in his political occupations and his professional and academic
occupations. They mainly come in the form of not be asked for certain positions, tasks or
honours which he would previously certainly be asked for (Interviewee 2).
- The fact that Doctoral student A.’s promotor became such a central point of focus in the
proceeding of the case by the integrity committees might be deemed surprising, judging from
the fact that he was not part of the official allegation (though he is mentioned in the letter
accompanying the allegation). Only during the investigation of Committee 1 he became a
central point of attention in the case (Interviewee 1, 2, 3).
- Several actors labelled the sanctions against Promotor H. (partly) as symbolic. Especially the
fact that he was not allowed to have an official farewell ceremony or lecture was classified as
symbolic, because it was not directly linked to the case itself or the practices for which
Promotor H. was sanctioned (Interviewee 3). As such, the sanctions were thought to serve the
prevention of reputational damage for EUR (Interviewee 2 and 3).

ii. Dr. E.
- For Dr. E, the daily supervisor of Doctoral student A., the consequences of the case were very
limited. He was not mentioned in any of the official reports on the case, nor has he been part
of any of the investigations neither as object of research, nor as informant of the committees.

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Hence, no formal sanctions against him were taken, nor did he suffer from reputational
damage.
The reason for not making him part of the investigations was not entirely clear. It was deemed
‘Very surprising’ (Interviewee 4), that he was not part of the allegation, nor of any
investigation. In addition, it was deemed even more surprising that none of the committees
asked Dr. E. for any information regarding the case (Interviewee 4).

iii. Members of doctoral committee


- The members of the doctoral committee judging whether Doctoral student A.’s thesis was
permissible for defense were blamed for not noticing the poor quality of and plagiarism in the
original version of Doctoral student A.’s thesis. However, no official sanctions were imposed
on the committee members and they remained relatively out of picture in the official
correspondence on the case.Considering the fact that the members of this committee were
named in the allegation by Dr. B. (Basten, 2013a) in exactly the same manner as promotor H.,
the doctoral committee members relatively kept out of focus in this case.

iv. Doctoral students of Promotor H.


- During the case, four doctoral students were writing their thesis under supervision of
promotor H. Due to the sanctions against him, most importantly the fact that he was no longer
allowed to act as promotor, these students became involved in the case. They all had to find a
new promotor. For some of them this caused delay, which in turn had several consequences
ranging from emotional damage to issues with potential future jobs (Interviewee 2). The
doctoral students received support from the faculty’s dean in searching a novel promotor
(Interviewee 1 and 2), but this support was deemed insufficient (Interviewee 2).
- In addition, all finished dissertations under the supervision of promotor H. were subjected to
an investigation on plagiarism. The authors of these dissertations were not notified of this
procedure and only via the media, official statements on the EUR webpage or personal
contacts became aware of this decision (Interviewee 2). Because Committee 2 judged that
these dissertations did not contain higher levels of textual overlap than other dissertations
written at EUR, no other consequences for these authors arrived.

 For the research system

The Doctoral student A.-case had several consequences for the policy regarding doctoral students at
Erasmus University and it had a specific consequence for the status of doctoral degrees in general.

- The directory board of the EUR made several adjustments to the doctoral regulations at her
university:

o Every internal and external doctoral candidate should write an educational and
supervision plan for his/her doctoral study;
o Every doctoral student should be supervised by at least two staff members;
o More severe demands will be set on the composition of doctoral committees judging
the quality of a thesis;
o Every doctoral thesis should be subject to a plagiarism detection scan and the results
of the scan should be analysed in context;

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o Every doctoral student should acknowledge being aware of the code of conduct for
scientific practices at the EUR.
It is noted that, in practice, the majority of these changes has little influence (Interviewee 4).

- In addition, the program at RSM specifically aimed at external doctoral students, mainly
directed by Dr. E. and promotor H., was terminated (Interviewee 3 and 4). A new program for
external doctoral students is yet to be installed.

- EUR announced not to take any further measures, partly because the circumstances in the
Doctoral student A. case were rather specific (Interviewee 1). It was mentioned that the case
concerned an external doctoral student, with a promotor who did not have a full-time
appointment at the university and hence that there was significant difference between this
case and the common practices in academia and EUR. “This should be taken into account when
implementing measures based on this case.” (Interviewee 1)

- Lastly, the LOWI investigated the opportunities for Dutch universities to repeal the decision of
providing someone a doctoral degree. To date, there is no regulation to take such a measure
and no precedent has occurred. Therefore, the LOWI sketched out a scenario for repealing a
PhD-degree:
According to the LOWI the PhD-degree is a ‘favourable decision’ rewarded by the Doctoral
board (or the board of deans) of a university. Such a favourable decision can be retracted on
the basis of the ‘obligation to inform’, which the PhD-candidate holds. If it turns out that the
doctoral student did not meet this obligation to inform (for example in case of severe scientific
misconduct), than the Doctoral board can in principle retract the PhD-degree, regarding it as
a favourable decision. However, there will be several impediments in such a procedure. For
example, the Doctoral board will be required to show that they met their obligation to
investigate whether the PhD-candidate has met her obligation to inform (which, in this case,
the LOWI beliefs will not be possible). In addition, the proportionality principle and the balance
of interest will form impediments in a procedure to repeal a doctoral degree.
Despite the evident difficulties with such a procedure, the LOWI beliefs that the success of
such a procedure is feasible and advices institutions to set a precedent in case they belief that
repealing someone’s doctoral degree is a proportionate sanction in a case at hand.

The responses
No particular responses were provided outside of those commented on in the previous sections of this
report. In particular, (national) politicians did not get involved in this case, nor did the media report
extensively on it. Also, no responses from within the scientific community were registered.

References
Ass, A. v. (2013). Het triple A model voor leiderschap: Analyse van wording en verwording van de
persoon van de leider. (Doctor), Erasmus University, 's Hertogenbosch.
Basten, F. (2013a). Letter to Rector Pols (pp. 1-2). Nijmegen.
Basten, F. (2013b). Sorry, wetenschap, ik heb verzaakt #plagiaat. from
https://www.floorbasten.nl/sorry-wetenschap-ik-heb-verzaakt-plagiaat
College van Bestuur EUR. (2014). Besluit CvB naar aanleiding van melding plagiaat – 12 juni 2014.

35
Promoting Integrity as an Integral Dimension
of Excellence in Research

College van Bestuur EUR. (2015). Definitief besluit College van Bestuur naar aanleiding van melding
plagiaat. from
http://www.eur.nl/fileadmin/ASSETS/press/2015/Juli/Besluit_CvB_plagiaat_proefschrift_290
62015.pdf
Doelder, H. d., Bensing, J. M., & Bosch, F. A. J. v. d. (2014). Rapport Commissie Wetenschappelijke
Integriteit: Melding plagiaat in proefschrift - april 2014.
ESF/ALLEA. (2011). The European Code of Conduct for Research Integrity.
EUR. (2013). Klachtenregeling Wetenschappelijke Integriteit EUR (KWI-EUR). from
http://www.eur.nl/fileadmin/ASSETS/abd/Integriteitscode/KWI_EUR_121210_NL.pdf
KNAW. (2014). CORRECT CITATION PRACTICE, Academy Advisory Memorandum. from
https://www.knaw.nl/en/news/publications/correct-citation-practice?set_language=en
Kolfschooten, F. v. (2015, 30-06-2015). Erasmus Universiteit in Rotterdam vraagt psycholoog
doctorsbul terug. NRC Handelsblad.
Leeflang, P. S. H., Dijk, H. K. v., & Bunt, H. G. v. d. (2015). Rapportage adviescommissie beoordeling
plagiaat. from
http://www.eur.nl/fileadmin/ASSETS/press/2015/Juli/Geanonimiseerd_Eindrapport_adviesc
ommissie_plagiaat_RSM_24_april_2015_02.pdf
LOWI. (2014, 28-11-2014). LOWI Advies 2014, nr. 10.
Schuyt, K. (2014). Tussen fout en fraude - integriteit en oneerlijk gedrag in wetenschappelijk
onderzoek.
VSNU. (2012). De Nederlandse Gedragscode Wetenschapsbeoefening: Principes van goed
wetenschappelijk onderwijs en onderzoek. from
http://www.vsnu.nl/files/documenten/Domeinen/Onderzoek/Code_wetenschapsbeoefening
_2004_(2012).pdf

Interviewee 1, Rotterdam, 24-4-2017

Interviewee 2, Gouda, 8-5-2017

Interviewee 3, Nijmegen, 10-5-2017

Interviewee 4, Rotterdam, 19-5-2017

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University of Tartu – Case Study 1


Suspicion of plagiarism in a doctoral dissertation
Description of the case1

PhD applicant A submitted her doctoral dissertation together with the necessary accompanying
documents to the Council of the Institute in spring 2013. The Council had to decide whether to allow
the doctoral dissertation to be defended. It is essential to note that, according to the University’s
Statutes of Research Degrees,2 the doctoral dissertation of this Institute can be presented (1) as a series
of publications on the theme of the dissertation supplied with a summary survey or (2) a monograph
or (3) a summary survey together with a monograph. The dissertation of PhD applicant A complied
with point 1 – she submitted a summary survey along with four pre-reviewed research publications
that had been published earlier.
The case deals with accusations of plagiarism in her doctoral dissertation. To understand the case, it is
essential to know the procedural requirements of the University and the Institute for defences of
doctoral dissertations. These are regulated by the Procedure for Awarding Doctorates3, the Institute’s
Regulations for Defences of Doctoral Dissertations4 and Guidelines for Opponents of PhD Dissertations
of the Institute.5 The Procedure describes the requirements for a doctoral degree. The applicant for a
doctorate submits to the Council the documents described in Section V. Thereafter, the Council will,
within three working days of receipt of the documents specified in section 19, send them to the
Academic Secretary who will assess the formal compliance of the submitted materials with the
requirements of the Procedure, involving experts if necessary. The Academic Secretary of the
University will check the completion of doctoral studies and the compliance of the doctoral
dissertation with the formal requirements. The Academic Secretary of the University will submit his
written opinion to the Council within five working days. Within six weeks of receipt of the documents
submitted by the applicant, the Council will make one of the following decisions, which will be minuted:
21.1. allow the dissertation to be defended;
21.2. reject the dissertation;
21.3. submit the dissertation for a pre-review;
21.4. in the event of deficiencies, demand that the dissertation be reformulated and corrected and,
after corrections have been made, make a new decision to allow the dissertation to be defended or to
reject the dissertation.

1 Document analysis and interviews were used to analyse the case. It is essential to note that the case was
not openly covered in the media, and the persons associated with the case were not prone provide their
own input. Official documents related to the defence of the dissertation have not been added to the
treatment of the case to guarantee the anonymity of the persons involved in the case.
2 Statutes of Research Degrees http://www.zooloogia.ut.ee/en/study-department-zoology/statutes-

research-degrees-university-tartu (accessed 19 October 2017) and


https://www.ut.ee/sites/default/files/ut_files/Applying%20for%20a%20Doctoral%20degree.pdf
(accessed 19 October 2017).
3 http://www.ut.ee/sites/default/files/www_ut/oppimine/procedure_for_awarding_doctorates.pdf

(accessed 19 October 2017).


4 Available only in Estonian at

https://www.flfi.ut.ee/sites/default/files/fl/hvfi_doktoritoode_kaitsmise_kodukord_02-2016.pdf
(accessed 19 October 2017).
5 https://www.flfi.ut.ee/sites/default/files/fl/guidelines_for_opponents_flfi.pdf (accessed 19 October

2017).
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If the dissertation has been submitted for pre-reviewing according to clause 21.3, and the pre-reviews
have been received, the Council will make one of the following decisions, which will be minuted:
22.1. allow the dissertation to be defended;
22.2. in the event of deficiencies, demand that the dissertation be reformulated and corrected and,
after corrections have been made, make a new decision to allow the dissertation to be defended or to
reject the dissertation;
22.3. reject the dissertation.

According to the Good Practice of Doctoral Studies,6 clause 13, “The decision of the defence council to
“allow to be defended” or “not to allow to be defended” respectively means the assessment “deserves
a doctorate in the event of the successful defence of the thesis” or “does not deserve a doctorate for
this thesis”. By allowing the thesis to be defended, the defence council certifies that it declares the
doctoral thesis to be compliance with the substantive and formal requirements established for a
research paper and the applicant for a doctorate to be worthy of the doctorate, unless the defence
council must revise its initial assessment due to circumstances that become evident in the defence
(e.g. a creative theft or fraud or very poor defence).”

If the Council decides to allow a dissertation to be defended, the Council simultaneously appoints the
opponent(s) of the dissertation, the time and place of defence and, if necessary, additional members
of the Council. To be appointed as an opponent or a pre-reviewer of a dissertation, one must be an
internationally recognised researcher of the respective specialisation who holds a doctorate or
equivalent qualifications and does not have a conflict of interests when performing the task. At least
one of the opponents of the dissertation must come from outside Estonia, unless the Rector decides
otherwise based on a proposal of the Council.

When the dissertation has reached the process of defence, the Defence Council has the right,
according to clause 34.3 of the Procedure for Awarding Doctorates, not to make a decision due to
suspicion of plagiarism or academic fraud and to send the dissertation to experts for assessment. The
probability that plagiarism is discovered as late as at the defence is rare (interview 1), as the earlier
check-up is sufficiently thorough.

The case focuses on the accusation of plagiarism in the doctoral dissertation of PhD applicant A.

Based on the documents submitted by the PhD applicant, the Academic Secretary of the University
gave on 7 June 2013 his assessment on the components of the dissertation and found that the
requirements for publishing the results of the dissertations, as stipulated in clause 17.1 of the Statutes
of Research Degrees, had been met. All the four publications on which the dissertation was based met
the requirements of clause 18 of the Statutes of Research Degrees, and the credit points required by
the curriculum had been collected.

On 1 July 2013, the Institute Council discussed the question of allowing the doctoral dissertation of
applicant A to be defended. Having listened to the applicant’s report on her work and the oral opinion
of supervisor B and the written opinion of supervisor C of 23 May 2013 and the discussion between
the applicant and the Council members, the Council decided unanimously to allow the dissertation to

6 http://www.ut.ee/sites/default/files/www_ut/oppimine/doktorioppe_hea_tava-en.pdf (accessed 19
October 2017).
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be defended and appointed its defence to 25 September 2013. The Council also appointed researchers
D and F as opponents.

The Institute’s guidelines to the opponents of dissertations provide criteria for assessment and ethical
guidelines, which refer to the need to avoid a conflict of interests. The Guidelines include an additional
clause that, to avoid legal problems, the opponent communicates during the decision-making process
only with the Head of the Institute or with his/her appointed representative, i.e. the opponent does
not pass his/her comments to the PhD candidate, his/her supervisor, or any third persons. During the
reviewing process, the opponent does not consult with the PhD applicant, his/her supervisor, or any
third persons, nor give them information about the contents of the review.

On 16 September 2013, opponent D submitted his opinion where he considered the dissertation
worthy of a doctoral degree. Opponent F submitted her opinion on 19 September. She made critical
remarks about the empirical study, the methodology of the work and its theoretical framework. The
opponent’s most severe reproach was that, in the summary survey, the applicant had used the sources
carelessly, arbitrarily and academically inadequately. The summary survey had at least three pages of
material that was, in its essence, plagiarism where the text had been translated into Estonian word for
word without any references from a doctoral dissertation defended in a university of another country.
In addition, the opponent reproached her for dubious ways of referencing, leaving out references, and
compilation, which was close to plagiarism. Reviewer F did not consider the doctoral dissertation
worthy of a doctoral degree.

The further description of events is based on interviews. The leaders of the Institute received the
critical review of opponent F on 19 September 2013, after which the case was dealt with within the
Institute. The chairperson of the Defence Council talked in private to the applicant and both of her
supervisors to understand the essence of criticism. In addition, the lawyer of the University was
consulted to be aware of further strategies of action if plagiarism was ascertained. Information
exchange continued with opponent F. In further cooperation, she was constructive and searched for
solutions (interview 1).

The chairperson acquainted himself with the source of plagiarism, compared the two texts and found
that the reproach might be disproportionate. The problem primarily concerned different cultures of
referencing where, in the case of a postmodern approach, the requirement for precision cannot be
fully met.

The Institute decided to include opponent F into the Defence Council to facilitate comprehensive
analysis of the dissertation at the defence (interview 1). In addition, opponent D was asked to express
his opinion on the suspicion of plagiarism; he submitted it on 24 September 2013. He was of the
opinion that this kind of references were not decisive from the viewpoint of the content of the paper.
“Social science texts are filled with such statements, they have no direct bearing upon the claims made
in the papers, and are rather an editorially useless "baggage" that, as editor, you try to overlook to get
to the major points made.” As another circumstance essential from the viewpoint of research ethics,
opponent D pointed out that “Researchers write their papers to communicate what new they have
found – yet, by tradition, need to embed it in the context of "background knowledge" that is to be
demonstrated to be there, and not necessary shown to be bearing upon the new findings. Publication
becomes a social game of acting in "morally upright" ways, rather than communicating the usually
limited new knowledge that emerges from the given study.” The opponent points out in his assessment

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that “The problem – of writing many pages about others' written work, before the few pages that
illustrate the novelty of one's own, is increasing in the contemporary social sciences.”

Applicant A was asked to submit her counterargument where she stated that the criticism did not
concern the main body of her work – the academic articles – and, as her doctoral dissertation and the
doctoral dissertation referred to dealt with the same subject, some of the authors they relied on were
the same. Therefore, the generalisations of viewpoints could have a similar wording.

In the further discussion of the case, the opponent agreed to allow the dissertation to be defended.

On 25 September 2013, the defence of the doctoral dissertation was on the agenda of the meeting of
the Defence Council. The Defence Council consisted of ten people, including opponent F. The applicant
made a presentation on her dissertation; this was followed by an academic debate between the
opponent and the applicant. Opponent F worded her suspicion of plagiarism in her last question,
“When reading the paper, the reviewer had a number of doubts about the sources (...) there are close
paraphrases in the paper without appropriate references. This is associated with the broader questions
about the function and level of the introductory chapter. (...) In this subsection of the paper, in a cluster
of quotations, there are two references to the doctoral dissertation of Z on a similar theme. Here, there
would have been an excellent opportunity to enter into the dialogue with this source; instead, there
are close paraphrases, the reference to which is at the end of clustered references. Similar problems
occur on pages 24–26. I presented a serious reproach for plagiarism in my written review once; the
other cases are on the borderline. I ask you to answer a general question – what will happen if the
author’s authority as a researcher begins to crumble in the introductory chapter? If the reader
experiences signals of threat from the first page, what is associated with the foundations of the paper
and your own credibility as a researcher?”

The applicant answered to the question of the opponent, “Writing of this paper has been a complicated
process of study and my superficial attitude to referencing certainly is a lesson for the future. I
definitely accept the train of thought that warning signs in the first chapter cast doubt on the whole
paper.”

The opponent was satisfied with the answers of the applicant, “Indirect referencing, clustered
references and close paraphrasing are definitely threats in academic writing, particularly in doctoral
dissertations based on articles. If there is a lot of them, the question arises – where are the applicant’s
own ideas, analysis and synthesis. The responsibility for allowing the applicant to defend her
dissertation paper also lies with the supervisor and the Council; the problems of this dissertation could
have been avoided by the preliminary defence. There is actually no mechanism for correcting the
printed version of this dissertation. I am satisfied with your answers.” This was the end of the debate
between the opponent and the applicant.

Thereafter, the applicant answered the questions of the Council members. None of the Council
members or researchers participating in the defence asked any questions about the suspicion of
plagiarism. This was followed by a discussion between the Defence Council members. Excerpt from
the minutes:

The Council emphasised in the discussion that the dissertation had shortcomings, but refusal
to award a doctoral degree would have been a disproportionate response. Resulting from the
experience of the defence of this dissertation, the Council considers it necessary to initiate
concretisation of procedural rules (requirements for supervisors, requirement of preliminary
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defence for all papers, printing of papers after the defence). The applicant was obligated to
write a post factum correction (errata) to both paper and electronic versions of the doctoral
dissertation. This would give the applicant an opportunity to openly correct the errors against
the academic tradition of referencing and would prevent the situation that the paper in its
current form would become a model for future doctoral dissertations.

Thereafter, the committee for counting the votes handed out ten ballots and a secret ballot was
conducted. All the ten Council members, including the critical opponent, voted for awarding the
doctoral degree. Thus, the applicant received her doctoral degree (PhD).

Context of the case

Academic culture and safeguards


All the interviewees were of the opinion that there was no plagiarism in the paper but problems with
academic precision and correctness, particularly in the summary survey. As a cause, pressure to submit
the paper for defence was mentioned, and this led to haste in writing the introductory text (interviews
1 and 3). The applicant had been very precise and thorough in her earlier studies and assignments
(interview 3).

Another problem mentioned was different cultures of writing doctoral dissertations (interviews 1 and
3), where the monographic text is presumed to have a more profound introduction which creates a
framework for understanding the following chapters. In the dissertation based on pre-reviewed
articles, however, the articles comprise the main part of the work, and the role of the introductory
article is to provide a background for understanding the following articles. The two opponents had
different expectations to the dissertation. Researcher 1: “Opponent F represents a different culture
where very great precision is required; she represents the monographic culture where a dissertation
consisting of articles is a more dubious thing. In a dissertation consisting of articles, the introductory
article is a frame that is created later, and often it is relatively artificial. In the case of a monograph,
the introduction is an organic part that is essential for understanding the rest.”

In addition, opponent F concentrated her attention on one detail and amplified its impact; this could
have distracted her attention from the whole (interview 3).

Supervisor’s role
As an annex to a resolution of the Senate, the University adopted the Good Practice of Doctoral
Studies.7 Section 2 in Part III of the Good Practice gives advisory guidelines for the supervisor. Clause
9.10 says that the supervisor immediately reacts to a suspicion of a creative threat, informing the dean
and the head of the institute thereof, where necessary, and Clause 9.15 stipulates that if the doctoral
candidate has (a) co-supervisor(s), the supervisor agrees on the division of work with the co-
supervisor(s). The applicant’s supervisors did not consider clustered references a problem (interview
3).

The dissertation had two supervisors, one of whom appeared later and was a researcher of a different
speciality. This created questions about the area that the doctoral dissertation belonged to and about
the supervisors’ responsibility. Supervisor B was the supervisor from the Institute, and she bore the

7http://www.ut.ee/sites/default/files/www_ut/oppimine/doktorioppe_hea_tava-en.pdf (accessed 19
October 2017).
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responsibility before the Institute. Supervisor C was from another institute, and as the applicant
changed her theme, supervisor C became the main supervisor of the dissertation. In this situation, the
question arose about the supervisor’s responsibility, as the supervisor from the Institute was not the
principal one from the viewpoint of the theme, but the responsibility fell mostly on her. So, the Head
of the Institute considered supervisor B the culprit for the negative attention the Institute received
and did not pay her the fee for supervising (interview 3), while supervisor C received the fee.

The role of the Institute


The general convention, confirmed by the document of Good Practice, is that the Defence Council, by
allowing the doctoral dissertation to be defended, admits that the dissertation meets the requirements
of content and form, and the PhD applicant deserves a doctoral degree. Thus, the Defence Council had
considered the doctoral dissertation appropriate. When opponent F presented her suspicions, the
leaders of the Institute had doubts about the applicant and the appropriateness of her dissertation,
and applied all means to secure that the responsibility would not fall on the Institute Council (interview
3). Researcher 2 was of the opinion that the Institute should have held its stance more firmly.
Considering that all the Defence Council members voted for awarding the applicant the doctoral
degree, the prior measures towards the applicant may seem disproportionate.

Continuity of researching the theme of the doctoral dissertation


From the viewpoint of the doctoral dissertation, it is essential to study one theme continuously and
profoundly throughout doctoral studies. In this case, the doctoral student changed her theme in the
middle of her studies and acquired a co-supervisor. This may have caused some shortcomings in the
introductory article to which the opponent referred as plagiarism of secondary literature (interview 1).
Nonetheless, a great deal work was done on the introductory text (interview 3).

Reverberations of the case


The case did not receive any formal treatment, but searching for solutions at the informal,
interpersonal level was intense and constructive (interview 1). The question arose why the Institute
took the accusation of plagiarism so seriously while, in conclusion, no plagiarism was proved. One of
the reasons could be fear of possible media coverage where earlier analogous cases had received
excessive, often disproportionate coverage (interview 3). Talk about the potentially problematic
doctoral dissertation had spread in the University, and several members of the University
administration were present at the defence (interview 1).

Impact of the case


The existing order of checking the quality of doctoral dissertations was considered sufficient, as the
case was an isolated instance that was influenced by different expectations to the academic text.
Therefore, no procedural changes were considered necessary (interview 1).

PhD applicant A did not continue her academic career after the defence of the doctoral dissertation.

Case analysis sources

Documents

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Procedure for Awarding Doctorates


http://www.ut.ee/sites/default/files/www_ut/oppimine/procedure_for_awarding_doctorates.pdf
(accessed 19 October 2017).

Institute’s Regulations for Defending Doctoral Dissertations (in Estonian)


https://www.flfi.ut.ee/sites/default/files/fl/hvfi_doktoritoode_kaitsmise_kodukord_02-2016.pdf
(accessed 19 October 2017).

Institute’s Guidelines for Opponents of PhD Dissertations


https://www.flfi.ut.ee/sites/default/files/fl/guidelines_for_opponents_flfi.pdf (accessed 19 October
2017).

Good Practice of Doctoral Studies


http://www.ut.ee/sites/default/files/www_ut/oppimine/doktorioppe_hea_tava-en.pdf (accessed 19
October 2017).

Statutes of Research Degrees at the University of Tartu

http://www.zooloogia.ut.ee/en/study-department-zoology/statutes-research-degrees-university-
tartu (accessed 19.10.2017).

Documents related to the defence of the doctoral dissertation:


1. Opinion of supervisor B, 17 May 2013
2. Opinion of supervisor C, 23 May 2013
3. Assessment by the Academic Secretary of the University, 07 May 2013
4. Minutes of the meeting of the Institute Council, 1 July 2013
5. Review by opponent D, 16 September 2013
6. Review by opponent F, 19 September 2013
7. Applicant’s answers, September 2013
8. Opinion of opponent D on plagiarism, 24 September 2013
9. Speech of opponent F at the defence, 25 September 2013
10. Minutes of the Defence Council, 25 September 2013

Interviews
Researcher 1 – interview 1, conducted in Tartu on 26 September 2017 (59 min)
Researcher 2 – interview 3, conducted in Tallinn on 5 October 2017 (51 min)
Member of University administration – interview 2, conducted in Tartu on 26 September 2017 (1 h 5
min)

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University of Tartu – Case Study 2


Publishing of research articles in predatory journals for a fee
Description of the case8

On 26 January 2016, the Estonian national newspaper Postimees published an article with the title
“Estonian researchers’ shady life: bought articles in predatory journals”9. The article reproaches some
Estonian researchers for publishing research articles in seemingly trustworthy research journals the
research value of which is, at closer observation, dubious.

The Estonian Research Information System measures the research value of publications by means of
classifiers.10 The present case deals with journal articles and leaves out other types of research
publications. Journal articles are divided between three classifiers. 1.1. Scholarly articles indexed by
Web of Science Citation Index Expanded, Social Sciences Citation Index, Arts & Humanities Citation
Index and/or indexed by Scopus (excluding chapters in books). These articles are most highly
appreciated. The list of acknowledged publishing houses is given on the homepage of the Estonian
Research Information System11.

1.2. Peer-reviewed articles in other international research journals with an ISSN code and international
editorial board, which are circulated internationally and open to international contributions. From the
viewpoint of the case under observation, these are the most essential.

The last classifier includes articles in journals of national significance. 1.3. Scholarly articles in Estonian
and other peer-reviewed research journals with a local editorial board; peer-reviewed scientific articles
in journals important for Estonian culture or scholarly articles in Akadeemia, Looming, Vikerkaar.

As the newspaper article said, articles in journals with a dubious background had been published by
researchers from different educational institutions – from a professional higher education institution
and from several universities. Particularly noticeable were two researchers who worked at the same
professional higher education institution as the person who had hinted at the problem. While other
schools were represented in dubious journals by several researchers, this institution was represented
by these two authors who had published most articles in co-authorship.

The staff member of the professional higher education institution who discovered the problem acted
in this case deliberately as a whistleblower. He also confirmed this in his interview (interview 3).
Lecturing to his students on the fundamentals of research philosophy and research ethics, he also
analysed the questions of research integrity and measurability of research. The students were given
an assignment to find the best researchers of their school. One of the measurable criteria was the
number of published articles, and here it was revealed that the total number of articles published by
the two authors was several times higher than the number of articles published by other staff members
of the same school. Next, the journals where the articles were published were regarded, and it was
found that most of them could be classified as predatory open access journals, which, at that time, had
been entered into the list of the American Jeffrey Beall. One of the characteristics of the journals in

8 To analyse the case, document analysis, opinion articles from the press and interviews were used.
9 https://pluss.postimees.ee/3483435/eesti-teadlaste-varjuelu-ostetud-artiklid-prugiajakirjades
(accessed 19 October 2017)
10 https://www.etis.ee/Portal/Classifiers/Index (accessed 19 October 2017)
11 https://www.etis.ee/Portal/Classifiers/PublishingHouseDetails?lang=ENG (accessed 19 October 2017)

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Beall’s database is that often they are published only on the web. Often, the international editorial
board is a mere illusion. Pre-reviewing – if it exists at all – is done in a few days, not weeks.

The staff member approached the school administration early in December 2015 to draw attention to
the fact and to find a solution (interview 3). The administration was familiar with the problem
(interview 1), but it seemed to the staff member that the administration did not deal with the problem,
and early in January 2016, he decided to approach a journalist he knew. In mid-January, he met the
journalist and gave him the findings of his study. The article on predatory journals was published on
26 January 2016.

In this newspaper article, the staff member referred to the circumstance that, in cooperation with his
students, he discovered 71 research articles that, at first sight, seemed to belong to category 1.2, but
their credibility was questionable. Fifty-nine of these articles had been published in research journals
that are considered predatory open access journals. The staff member compared all the 5000 articles
entered into the Estonian Research Information System during the last five years with Beall’s list and
found that 450 of them had been published in blacklisted publications. The researchers of Tallinn
University of Technology had published in these journals 226 times, of the University of Tartu – 103
times, of Tallinn University of Applied Sciences –59 times, of Tallinn University – 32 times, and of the
Estonian University of Life Sciences – 22 times.

The essence of the accusation of breach of research ethics was that researchers had published research
articles in journals with a dubious research value which publish articles without appropriate pre-
reviewing and for a fee. The case analysis focuses on the two researchers mentioned in the newspaper
article. They are close relatives and, together, they have published 66 problematic articles in predatory
open access journals. One of them is a member of a board of experts of similar research journals – a
publisher of research journals registered in Nigeria issues 23 research journals and claims that their
international editorial office is situated in a private house, which is the residence of the researchers
concerned.

The publication of the article in the newspaper was followed by statements in the media by several
researchers and persons responsible for research policy. According to the stance of the Ministry of
Education and Research, published on the following day (27 January 2016),12 the problem does not lie
in open access journals. “OA journals with a publishing fee is a publication model used by very different
journals – better and less known, with top and lower quality, new and old – no generalisations can be
drawn purely on the business model. For example, by paying the publishing fee, one can publish an
article in the top-quality journal Nature that is fully readable to the reader from the moment of
publication,” and “Each journal that asks for a fee is not a predatory journal. In the case of publishing
in a predatory journal, the question lies in the ethic and credibility of the researcher. Researchers must
proceed from ethical principles of research in their work and practice of publishing.” The Ministry is of
the opinion that it does not direct Estonian researchers in the selection of ways of publishing and leaves
room for academic freedom in deciding on the channels of publishing of articles. The responsibility is
seen to lie with the individual researcher and the research institution, “To ensure the society’s trust in
research, all researchers should understand the importance of ethical conduct. Ensuring the

http://www.postimees.ee/3484435/ministeerium-teadlaste-ostetud-artiklite-probleem-pole-eesti-
12

omapara (accessed 19 October 2017).


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researchers’ credibility and good reputation is primarily the responsibility of researchers themselves
and research institutions.”

On 28 January, a disapproving opinion by the Rector of the University of Tartu on publishing in


predatory journals is published.13 On 2 February, the Chairman of the Board of the Estonian Research
Council explains the impact of publishing in predatory journals on the credibility of research and the
essence of the Research Information System as a tool.14

On 10 February, the same newspaper publishes a researcher’s opinion on circumstances related to


publishing and on predatory journals, which is also a response to the article published at the end of
January15. On 12 February and 4 March, a national cultural newspaper publishes articles that also deal
with accreditation of research and research publications. In the first article, President of the Academy
of Sciences and Vice-Rector for Research of Tallinn University of Technology analyse various aspects of
research publishing, including different ratings of publications and questions of accreditation of
research.16 In the other article, a researcher analyses the possibilities of publishing in so-called
predatory journals from a personal perspective.17 Thus, we can say that the problem found relatively
broad coverage in public. These opinion articles, however, did not add new information to clarifying
the circumstances of the case.

In issue 7 of the journal Akadeemia, the researcher who had drawn attention to the problem published
the article “Production of Estonian researchers in predatory open-access journals”. He refers to the
circumstance that there are research journals that lack the values characteristic of research journals
(e.g. credibility, originality of articles, impact on future research papers). Half a year after publicising
the problem, the researcher finds that the condemnation of publishing in predatory journals has
remained purely formal, and concrete measures to prevent the problem have not been taken
(interview 3).

The central figures of the case analysis, the researchers who were mentioned by names in the first
article and who were reproached for breaches of research ethics, do not see that they are guilty. As
no personal contact could be made with them, the analysis is based on the publications in the media
and the statements of other interviewees.

Author 1 and author 2 are close relatives and have published many research articles in co-authorship.
Author 1 gave a comment to the journalist who had made the problem public, but he did not share the
opinion that he was writing for predatory journals. “If I were writing for one journal that is dubious...
But if there are 50 of them, on all the five continents, it is somewhat strange to say that all of them are
dubious. Who claims this is incompetent” (Postimees, 26 January 2016).

Author 1 substantiates publishing in large numbers with the fact that the level of the researcher is
assessed by the number of publications and citations. “We were cited twice a week on average during

13 http://www.postimees.ee/3485313/tartu-ulikool-taunib-prugiajakirjades-publitseerimist (accessed 19
October 2017).
14 http://arvamus.postimees.ee/3561469/andres-koppel-kas-kahtlaste-teadusartiklite-avaldamine-

rampsajakirjades-on-kahjutu (accessed 19 October 2017).


15 http://arvamus.postimees.ee/3577845/riho-paramonov-rampsajakirjades-peegeldub-teaduse-

tagatuba (accessed 19 October 2017).


16 http://www.sirp.ee/s1-artiklid/c21-teadus/akadeemiline-sullerlus-kui-akadeemilise-vabaduse-

kuritarvitamine/ (accessed 19 October 2017).


17 http://www.sirp.ee/s1-artiklid/c21-teadus/teaduse-diskreetne-dustoopia/ (accessed 19 October

2017).
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the last three years. Whether I am known in Estonia or not has no importance – this is the level of a
village. It is important how well I am known in the world” (Postimees, 26 January 2016). The article
draws attention to the fact that neither of the authors can be found in the research data base ISI Web
of Science. Citability is visible in Google Scholar, but there the researchers have mainly cited their own
earlier works, which increases the researchers’ H-index.

The incident was not formally dealt with by the institution; therefore, no document analysis can be
done. In the institution where the whistleblower as well as author 1 and 2 worked, the question was
discussed at the level of the administration. In 2016 a change took place in teaching staff members’
labour relations as fixed-term work contracts were revised, and staff members could contest for
contracts for an unspecified term. No new contracts were concluded with any of the three staff
members and they left the school. Author 2 had earlier had a small teaching load; author 1 was
reproached for poor quality of teaching, which was confirmed by students’ feedback. None of the three
are known to continue teaching at an institution of higher education. While in 2015, author 1 had 15
entries with classifier 1.2 in the Research Information System, in 2016 he had only one. The public
discussion of the case influenced mainly the researchers related to the professional higher education
institution. The staff member who brought the problem to public attention, however, has acquired the
reputation of an expert who can give advice on breaches related to publishing (e.g. interview 3).

Publishing in open access journals is known to have been briefly discussed at the university where the
greatest number of problematic articles had been published. A member of the university
administration asked bibliographers to make a list of research publications and talked to a few
researchers whose names most often occurred in open access predatory journals (interview 2).

As from the viewpoints of higher educational institutions and the ministry coordinating research
(interviews 1, 2, 4) the problem was not typical of Estonian research, it was not considered necessary
to undertake systematic changes in the assessment of publications or researchers’ work.

Context of the case

Formal criteria of the publisher vs the quality of publications


It was the first time that the problem of publishing in predatory journals received so great attention in
the media. Both the higher education institutions and the Ministry consider the problem relatively
marginal in the Estonian context (interviews 1, 2, 4). According to the information of the Estonian
Research Council (interview 5), the problem is not new. The administrators of the Estonian Research
Information System have drawn attention to the questions of classifying of research publications at
public events since 2014 (interview 5). The professional higher educational institution that had
employed author 1 confirmed that they had been aware of the problem for a few years. At least from
this time, the administrators of the Estonian Research Information System have been aware of
problematic publishers and researchers who most often use open access journals.

Entries into the Estonian Research Information System are made by the researchers themselves.
Research Information System administrators and confirmers from the universities check the
conformity of the publication to the formal criteria of the classifier. Neither the administrators of the
Estonian Research Information System nor the confirmers from the research institutions assess the
content or quality of articles. While the criteria for 1.1 publications are very clearly fixed, the criteria
for 1.2 are such that the articles published in predatory open access journals usually meet them. The
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of Excellence in Research

confirmers have no right to reject applications for entering the publication into the Research
Information System if there are no sufficient formal criteria to substantiate the rejection.

The stance of both the university and the Ministry (interviews 2, 4) was that, primarily, the researchers
themselves are responsible for the quality of articles, and checking should be done either by the
research group or the researchers of the given speciality more broadly. The Ministry and the
universities do not consider additional quality check of publications necessary, and the Estonian
Research Council does not consider it possible. Additionally, open access does not automatically mean
predatory journals. An employee of the Estonian Research Council (interview 5) commented that in
the 1990s it was necessary to integrate quickly with the western research system, and one of the
indicators was the number of publications. By today, however, indicators of quality and assessments
by international assessors are more significant for financing decisions of projects. Thus, applications
for research financing are an essential filter for assessing the quality of publications.

For professional higher education institutions, applying for research financing is not topical, as they do
not apply for grants. Therefore, professional higher education institutions have no research groups.
Often, there are very few experts in one speciality, and there is no sufficient competence to assess the
quality of publications (interview 1). Publications are still one of the assessment criteria when teaching
staff members are elected to their posts. Therefore, professional higher education institutions, which
have no additional check-up mechanisms of research financing, expect the Estonian Research
Information System classification for publications also to give feedback on the value of publications.
Moreover, the articles by teaching staff members and researchers from professional higher education
institutions which have no research and development departments are confirmed by the
administrators of the Estonian Research Information System. Both the Ministry and the Estonian
Research Council say that the system is functioning primarily for universities and other research
institutions, but in the case of professional higher education institution, there may be defects in the
present system.

Personal level
The staff member who was mentioned in the national newspaper as one of the authors who most
often published in open access journals is an aged researcher. He had defended a research degree in
the automobile and road-building faculty of a higher educational institution in the former Soviet Union
in 1979 and upgraded his education at the Business College of Stockholm University. After defending
his research degree, he worked at different private and public institutions of higher education as an
associate professor or visiting lecturer. In 1997, he was Head of the Institute of Economic Law and
Politics, which gave applied higher education in economic policy, economic law, and business
management. As associate professor of economics, he repeatedly appeared in the media, particularly
in the national newspaper that raised the topic of predatory articles, as an expert on questions of
economy. He has published several books on international economy, the European Union and energy
questions. Some books were written in co-authorship with a close relative.

The interviewees (interviews 1, 3, 5) referred to the circumstance that this researcher deliberately
used the strategies of mass publication. As the school where he worked half-time as an associate
professor specialised in technology, it did not consider itself competent to assess the quality of articles
on economics (interview 1). The researcher presented the publications as one of the proofs of his
qualifications when he contested for an academic position. The institution payed the publication fees.

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The whistleblower commented (interview 3) that the school uses publication statistics in overviews of
its activities.

Researchers’ career and publishing


All interviewees referred to the significance of publications in building the career of a researcher. The
head of the professional higher education institution says in the newspaper article, “We have
overestimated publications. The train has been set in motion, and now they publish wherever and
whatever. We have received exactly what we wanted to produce, referring to the circumstance that,
if publications are valued, ways are found to get them” (Postimees, 26 January 2016). In the case of
the researcher in question, it was mentioned that the great number of publications was an essential
indicator in his self-image as a researcher (interview 1), and he repeatedly referred to this. The
interviewees also said (interviews 1 and 5) that, at the professional higher education institution, there
was no pressure to publish so much, and this was the researcher’s personal choice and a matter of
pride.

Research integrity
One of the themes in all interviews was the standard and mechanisms of research integrity in Estonian
research institutions. Research integrity is not systematically developed at the level of organisations.
Relying on interviews 1, 2 and 3, it can be said that the problem is dealt with ad hoc. So, the employer
solved the question of open-access publishing by not concluding a new work contract with the
researcher. Previously, the researcher had been talked to regarding publishing, but there was no
official procedure for dealing with such cases.

The head of the second institution of higher education (interview 2) asked for an overview of
publications in his university and talked to the staff members who had most often used open-access
publishing. No sanctions followed.

The whistleblower was most reproachful about the treatment of research ethics. When the problem
became evident, he approached a member of the school administration, but their meeting ended in a
conflict, and the situation did not change. He refers to the circumstance that, when a case of research
integrity does not find a solution in the organisation, the researcher or the person who informs about
the breach research integrity has no next instance to apply to. The Study Regulations prescribe what
to do with students who have violated the rules, but there are no similar rules for teaching staff or
researchers. The viewpoint of the Ministry is that dealing with research integrity is the problem of
educational institutions, which should create the mechanisms that meet their needs (interview 4).

Impact of the case


The case influenced directly the careers of the two authors under discussion and of the whistleblower.
None of them continue to work at the institution of higher education where they worked when the
case took place. Authors 1 and 2 are not known to occupy an academic position at any institution of
higher education. As of October 2017, the researchers’ database in the Estonian Research Information
System does not reflect the activities of either author. The work contract of author 1 with the
professional higher education institution was not prolonged. The problem of publishing was not the
only reason but an additional factor rather. The whistleblower’s contract was not prolonged either. He
continues studies in another speciality.
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Promoting Integrity as an Integral Dimension
of Excellence in Research

In a broader context, all the interviewees admitted that great public attention increased awareness of
problems related to publishing. As the problem has been considered marginal, concrete measures have
not been taken.

Case analysis sources


Documents
Estonian Research Information System, Publication classification
https://www.etis.ee/Portal/Classifiers/Details/81e52bde-a1a1-490a-a9c4-2df9f3fc3a70?lang=ENG
Estonian Research Information System, Acknowledged publishers
https://www.etis.ee/Portal/Classifiers/PublishingHouseDetails?lang=ENG
Newspaper articles (in chronological order)
Postimees, 26 January 2016 https://pluss.postimees.ee/3483435/eesti-teadlaste-varjuelu-ostetud-
artiklid-prugiajakirjades (accessed 19 October 2017).
Postimees, 27 January 2016 https://www.postimees.ee/3484435/ministeerium-teadlaste-ostetud-
artiklite-probleem-pole-eesti-omapara (accessed 19 October 2017).
Postimees, 28 January 2016 https://www.postimees.ee/3485313/tartu-ulikool-taunib-
prugiajakirjades-publitseerimist (accessed 19 October 2017).
Postimees, 2 February 2016 https://arvamus.postimees.ee/3561469/andres-koppel-kas-kahtlaste-
teadusartiklite-avaldamine-rampsajakirjades-on-kahjutu (accessed 19 October 2017).
Postimees, 10 February 2016 https://arvamus.postimees.ee/3577845/riho-paramonov-
rampsajakirjades-peegeldub-teaduse-tagatuba (accessed 19 October 2017).
Sirp, 12 February 2016 http://www.sirp.ee/s1-artiklid/c21-teadus/akadeemiline-sullerlus-kui-
akadeemilise-vabaduse-kuritarvitamine/ (accessed 19 October 2017).
Sirp, 4 March 2016 http://www.sirp.ee/s1-articles/c21-research/academic-sullerlus-than-academic-
freedom-kuritarvitamine/ (accessed 19 October 2017).

Interviews
Interview 1 – head of institution 1, conducted in Tallinn on 24 August 2017 (1 h 8 min)
Interview 2 – head of institution 2, conducted in Tallinn on 31 August 2017 (56 min)
Interview 3 – researcher 1, conducted in Tartu on 12 September 2017 (1 h 23 min)
Interview 4 – official 1, conducted in Tartu on 12 September 2017 (1 h 8 min)
Interview 5 – official 2, conducted in Tartu on 12 September 2017 (57 min)
Acknowledgement
Case analysis was written in Estonian. English translation by Ilmar Anvelt.

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Vrije Universiteit Brussel – Case Study 1


Case 1
Authors individual case studies:
Van Buggenhout, M.
Christiaens, J.
Gutwirth, S.

In this case the Commission for Scientific Integrity (CWI) was informed by a journal editor of a breach
of publication ethics. More precisely, the alleged breach of scientific integrity concerns “dual
publication”. The plaintiff argues that the submitted paper is based on research data already used in a
former publication in another journal. It was argued that the author had not referenced the (former)
paper and had changed the wording so that similarity was not picked up by the automated program
(that checks for plagiarism). The plaintiff additionally expressed more suspicions of “dual” or
“redundant publication” concerning other publications of the same author(s). The preliminary
investigation of the CWI concluded that the complaint was admissible. An ad hoc commission was
installed to investigate the alleged breach of integrity. The Commission concludes that the alleged dual
use or redundant publication is in conformity with the scientific and publication practices in this specific
the field of research domain and cannot be considered as a breach of scientific integrity. The CWI
concludes that the absence of reference to the prior publication represents a serious negligence of the
authors, but that it does not amount to a breach of scientific integrity.

NB
The information for these cases was available only to researchers, under very strict conditions of
confidentiality. Hence the information here is extremely concise. Longer reports were made available
to the coordinator for analysis. (note by Willem Halffman)

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Vrije Universiteit Brussel – Case Study 2


Case 2
Authors individual case studies:
Van Buggenhout, M.
Christiaens, J.
Gutwirth, S.

This case constitutes an allegation of plagiarism brought to the attention of a Commission for Scientific
Integrity (CWI)18. The complaint was made by a third party who noticed multiple passages taken over
from syllabi and other sources without appropriate accreditation. The allegation was found grounded
and after a formal investigation, which included a comparison between the sources and a hearing of
the authors of the original work and the accused, the CWI found the allegation of plagiarism to be
upheld. After receiving the formal conclusions, the accused instigated a second procedure at the
Flemish Commission for Scientific Integrity, who provided a second advice. This second investigation
led to the same conclusion: the case was found proven, plagiarism has been formally established in the
work of professor X.

NB
The information for these cases was available only to researchers, under very strict conditions of
confidentiality. Hence the information here is extremely concise. Longer reports were made available
to the coordinator for analysis. (note by Willem Halffman)

18
Hereafter referred to as the Commission.
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Vrije Universiteit Brussel – Case Study 3


Case 3
Authors individual case studies:
Van Buggenhout, M.
Christiaens, J.
Gutwirth, S.

This case consists an investigation by the Commission for Scientific integrity (CWI) 19, to alleged
infringements of scientific integrity under the form of fabrication (fabricated research design, data and
research output) in two scientific papers (one published, one in the reviewing process). A formal
complaint was made, and afterwards withdrawn. The investigation went on, however, and after
hearings with the involved parties and a comparison between the two articles, the commission found
the allegations to be grounded. A final report was made and sent to the rector of the institution and
the editor of the journals. The further proceedings in form of resignations, sanctions, or a second advice
of the Flemish Commission for Scientific Integrity are unknown to us.

NB
The information for these cases was available only to researchers, under very strict conditions of
confidentiality. Hence the information here is extremely concise. Longer reports were made available
to the coordinator for analysis. (note by Willem Halffman)

19
Always referred to as ‘the Commission’
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of Excellence in Research

Oslo and Akershus University College – Case Study 1


Black Case
Summary
Svenn-Erik

Jon Sudbø was an academic super-star until a whistleblower suggested that the patient data used in
his 2005 Lancet article did not yet exist. An investigation into Sudbø’s record of accomplishment,
showed that he had fabricated data in at least half of his scientific articles including his PhD. Sudbø lost
his job and was revoked his PhD and authorizations as a doctor and a dentist. Both Individual and
institutional factors explains why he was able to carry on with fraudulent behavior without questions
for more than a decade.

Persons involved, scientific field and institutional context

The Whistleblowers
Camilla Stoltenberg read Sudbø’s most recent article in the Oct. 7, 2005, issue of the Lancet, which
supposedly used data from patients listed in the Cohort of Norway (CONOR), an epidemiological
database. The problem was that this database did not exist at the time of the supposed data collection.

Camilla Stoltenberg, M.D., was a researcher and Director at the time for the Division of Epidemiology
at the Norwegian Institute of Public Health.

Stoltenberg set the fraud investigation in motion when she contacted the Cancer Registry who further
contacted Professor Lars Vetten at the University of Trondheim and asked him to evaluate her
discoveries. On January 5 2006, Vetten contacted Sudbø via e-mail and confronted him with his
concern that Sudbø’s data did not exist, and that he had not applied to the Norwegian Data
inspectorate for the permission to use sensitive health data.

The Accused
Jon Sudbø was relatively young (45 years) and a good-looking medical doctor (1985) and a dentist
(1994) when he was accused of scientific fraud in 2006. He had top grades (best in his odontology
class), was a lover of risk sports and had an impressive CV and several large research grants. One of his
last grants were from the National Cancer Institute in the USA, which he got in March 2004 together
with distinguished American cancer researchers. In an interview in this connection with the Norwegian
newspaper Aftenposten, Sudbø tells “about periods of intense engagement where work is all-
embracing and that the research gives the same kick as paragliding and diving. I'm probably a risk-taker
and curious person” (1). Sudbø was a Norwegian academic super-star in 2005 (2).

Scientific field and institutional context


Sudbø’s scientific disciplines were medicine and odontology. He was an oral cancer researcher at the
Rikshospitalet-Radiumhospitalet.

Data & Methods


The analysis is based on a selection of a larger number of documents from various databases. We have
asked the dean of faculty of medicine at the University of Oslo and heads of respectively department
of pathology and digital pathology at Rikshospitalet-Radiumhospitalet in 2006 for interviews but got

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Promoting Integrity as an Integral Dimension
of Excellence in Research

no reply. We also asked for interviews with the current dean of faculty of medicine and the current
head of department of clinical medicine at the University of Oslo but got no reply.

Document analysis
Our analysis is mainly relying on the investigation report on the Sudbø-case of 30th June 2006 (3). Other
documents include the letter of 21st November 2006 from the Norwegian Board of health to Jon Sudbø,
with decision to revoke his authorization as a physician and dentist (4).

We have searched the following databases for articles on the Sudbø-case. First, we used Atekst
(Retriver) to search for Norwegian newspaper articles on the Sudø-case. We found 315 matches 2006-
2017 searching for “Jon Sudbø”. As most of these articles were mainly commenting on the allegations
and the conclusions from the Investigation report from 2006, we are for the most part not citing them
here. However, the number of matches shows that this was a high media profile case. Second, we
searched for “Jon Sudbø” and “Jon Sudbo” in a database named “Oria” which includes several
Norwegian and international journal databases. Here we got 63 matches. A similar search in the
EBSCO-database gave 16 matches. After deleting doublets and other non-relevant articles, we ended
up with 63 articles. Finally, we made a Google search. When excluding newspaper articles found in the
Atekst-search, we found 28 matches. In our analysis, we have only used documents (internet, journal
or newspaper articles) that brings in new facts or perspectives not found in the investigation report on
the Sudbø-case.

The allegations

Form and origin


The allegations came after Camilla Stoltenberg, a researcher at The Norwegian institute of Public
Health, over Christmas 2005 had read a new article by Sudbø in the October issue of Lancet (5). The
research was on how non-Cox2 Nsaids (Ibuprofen-like substances) could reduce risk of oral cancer in
smokers. Furthermore, it was indicated that overall mortality would not decline because Nsaids would
have cardiovascular side-effects. In other words, the study showed that the number of cardiovascular
deaths increased by the same number of decreasing deaths from cancer. The problem was that the
data used was from an epidemiological database (CONOR) that did not exist at the time of the
supposed data collection. Another problem was that the Health authorities in the US (FDA) had warned
about the cardiovascular side-effects already 7 April 2005, based on preliminary analysis from the later
published Lancet article. European and Norwegian health authorities did not change their
recommendations accordingly, but the news that FDA warned about Ibuprofen-like substances were
widely covered in Norwegian media (3).

On the 10th of January 2006, Sudbø and his PhD advisor met with the Cancer registry, where also
Professor Vatten from the University of Trondheim was present. Sudbø verbally admitted to his
employer on 12th of January 2006 that he had fabricated the patient data (3). The Radium hospital
informed the Lancet and the press that Sudbø had manipulated the data in his article the day after.
The Lancet itself first expressed a concern about the article on January 21st (6) and retracted the article
on February 4th (7) after Anders Ekbom, the leader of the investigation committee, confirmed in a letter
to the Lancet that it contained fabricated data. The New England Journal of Medicine expressed a

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similar concern on two other papers by Sudbø on February 9th (8), but awaited the results from the
investigation committee before they retracted both papers on November 2nd 2006 (9-11).

Processing the allegations

The local management


On the 18th of January 2006, an independent investigation commission was appointed by
Rikshospitalet – Radiumhospitalet Medical Center and the University of Oslo to investigate the
admitted fraud and determine, among other things, the role of the co-authors (among others Sudbø’s
wife and twin brother, and prominent cancer researchers from the USA and Finland) and also whether
Sudbø’s prior work was fraudulent. The commission was led by the Swedish epidemiology professor
Anders Ekbom, at Karolinska hospital in Stockholm, Sweden (3). The committee also included
statisticians, researchers and staff at the Norwegian Institute of Public Health, the Norwegian Research
Council, Cancer Registry of Norway, and the Cancer Clinic at the Radium Hospital.

Investigation committee
All of Sudbø’s scientific work from 1993-2006 was investigated in a report of almost 150 pages (3). In
total 60 scientists from 6 different countries, and 38 scientific papers, were investigated. 15 of Sudbø’s
38 articles, including parts of his doctoral work as well as articles in Lancet, New England Journal of
Medicine and Journal of Clinical Oncology were considered fraudulent based on manipulation and
fabrication of patient data.

Most of Sudbøs research was on the part of his PhD-thesis (2001) dealing with the characterization of
the early stages of oral cancer. It was only this part, and not another part in the PhD on theoretical and
applied works on tissue architecture in cancerous tumors and normal tissue, that was fraudulent. The
research question in the “early stages of oral cancer”-part of the thesis was whether and, if so, to what
extent, different types of classifications of white patches in the oral cavity (Leukoplaika) were indicative
of a high risk for developing oral cancer. The doctoral dissertation and related publications give an
affirmative response to this question, asserting that a classification based on DNA content can with
great accuracy predict the subsequent development of cancer.

His sensational results first appeared in two articles in New England Journal of Medicine in 2001 and
2004 based on the DNA analyses of 150 patients (10, 11). The investigation committee documented
that large part of the patient data were manipulated, for example: 1) several were fictious persons with
inserted birth dates; 2) two pictures of Leukoplaika were from the same patient; 3) some patients
appeared several times; and 4) half of the patients had already been diagnosed with oral cancer before
or at the same time as the leukoplakia was diagnosed. These latter patients could not be studied for
later development of cancer, since they already had cancer. Sudbø explained that these data was
initially meant for a simulated database. Sudbø, however, seemed to continue simulating data. In his
October 2005 Lancet article, he seemed to have used a database including 908 subjects (5). It turned
out that these data came from a database which was not yet existent and that the data once again
was fabricated with 250 subjects with identical birthdays (3). Sudbø also admitted partly to the
investigating commission (3) that he had fabricated data in an article in Clinical Oncology (12).

According to the Norwegian newspaper Aftenposten, someone discovered that the two photos in the
New England Journal of Medicine article from 2001 were identical. However, this was after the article

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was printed. Sudbø allegedly answered that he had done a mistake when he inserted the two photos.
No alarm bell rang. No report were sent to the journal to correct the mistake (1).

Sudbø’s Lancet article were first submitted to New England Journal of Medicine, but was refused. This
is nothing special. However, it is worth noting that Sudbø et al. published their Lancet article through
a fast-track referee-based system. One of the referees was negative to publishing the article (3), and
the Vice President of the American Cancer Institute, Michael Thun, was skeptical to the article before it
was printed. The Lancet invited Thun to write an editorial to the article. However, Lancet was under
time pressure. In the end, Thun pulls himself out and the Sudbø article was printed without an editorial
(1).

Sudbø not only acted fraudulently by fabricating data. When he got his consultant medical doctor’s
position at Rikshospitalet in 2005, he also bluffed that he had submitted his application for a specialist
approval. First, he was three months short of finishing his mandatory training. Second, the application
had not been sent (1). In his Lancet article, Sudbø also claimed funding from a Norwegian Cancer
Society grant although his proposal was rejected (13).

The Norwegian Board of health


On 4th of July 2006, the Norwegian Board of Health in Oslo and Akershus requested the Norwegian
Board of Health (NBH) to apply for prosecution on the grounds of fabrication and manipulation of
research (4). In other words, the NBH mandate was to conclude whether Sudbø was to be revoked
authorizations as a physician and dentist because of scientific fraud. This inquiry was based on
admitted circumstances in the report from the Investigation Commission (3). In a letter from NBH
dated 21st of November 2006, Sudbø was informed that he was revoked both of his authorizations (4).
This matter was not made publically before a press release came from NBH on 8 th of February 2007
(14). The press release ends by stating that “The Health services and the general public must be able
to trust the results published in internationally renowned journals. According to the assessment of the
Norwegian Board of Health, strict requirements must therefore be placed on the conduct of health
personnel in connection with research”.

How did the actors interpret the case?


Sudbø first denied the extent and the severity of the allegations, but later admitted fabrication in large
parts of his portfolio of articles, but not his PhD. Through his attorney, he said the rationale was
“accolades and professional pride” (15). In a rare interview with the Norwegian newspaper Verdens
Gang, in 2009, Sudbø said “he lost his critical sense in his drive after academic recognition. As a
scientist, the number of publications and the quality of the journal is what counts. It provides positions
in the academic environment. I was part of that culture, and that race” (16).

Ekbom said that the magnitude of this fraud was possible because Sudbø was a an independent lone
wolf ever since he started his PhD in 1993, and few had insight into his work (3). The co-authors were
innocent and had no role in the fabrication of data, but criticized for not following the Vancouver
convention; not a single of the co-authors of the Lancet article had read a draft of the paper before
submission.

Sudbø’s supervisor accepted criticism for lack of vigilance and follow-up, and his institutions for lack of
control of this project, lack of educational measures in the area of research ethics, and lack of routines
for dealing with misconduct. Neither Sudbø, nor his advisor, had applied for permission to do research

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on sensitive health data, as they are obliged to. Sudbø blamed his advisor for not doing his job as
project leader.

Consequences

For the accused


Short-term consequences. After the allegations and during the investigations, Sudbø went on a sick
leave. He was the first to have his authorizations as a physician and dentist revoked because of
scientific fraud in Norway. One month after he had lost his right to practice as a doctor and a dentist,
he also was the first to have his doctoral thesis revoked at the University of Oslo, at 19th of December
2006 (17). He also lost his job at the Rikshospitalet-Radiumhospitalet and his 20% position at the
Medical Faculty, University of Oslo.

Medium-term consequences. It did not take long before Sudbø was starting to recover his work or
future research ambitions. In May 2007, 1.5 years after Sudbø was revealed fabricating research data,
he got limited right to work as a dentist. At this time, he got a position as a dentist in Seljord, Telemark
County. May 21st 2008, he further got his authorization as a doctor back, but still without the right to
do health-related research activities (16).

Long-term consequences. How long time does it take to rehabilitate a fraudster? When can we trust
him again? Should Sudbø ever get the right to do research again? These questions were debated in the
media (Verdens Gang) and in the Norwegian Medical Journals after Sudbø, in January 2013, seven
years after the revelations of his research misconduct, applied for full authorizations with the right to
do dental research again (16, 18). In a comment in the Norwegian Medical Journal, Sudbø claimed that
he submitted this application not to do research again, as was claimed in the newspaper Verdens Gang,
but “because I now wish to be able to put some kind of sentence for this tragic case” (19). The
Norwegian Board of Health turned Sudbø’s application for being able to do clinical research down.

In 2016, at age 55, Sudbø’s work- and research life was again debated in the Norwegian media. In April
2016, Sudbø started in a new job, this time as the Head of clinic at the Dental Services Center of
Competence East. This center is publically financed and is doing clinical research on dental care. The
debate and tensions were circulating around the question whether Sudbø, as head of clinic, would not
in any way be involved in research activities at the center (20).

For patients
It could not be documented that patients have suffered as a consequence of the Lancet article (4).
However, some patients reducing their use of Nsaids might have lived under more chronic pain due to
less consumption of Nsaids due to fear from cardiovascular side-effects (1, 3).

For the whistleblower


The whistleblower is in 2017 the top director at the Norwegian Institute of Public Health.

For the institution


As an answer to the critique from the investigation Commission, Rikshospitalet-Radiumhospitalet
introduced regulatory systems for securing better institutional control over their research activities,
among other things, the introduction of larger research groups (21).

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PhD students who worked under Sudbø’s supervision got access to fabricated data as well, and had to
cancel their research.

For the research system


The Sudbø-case undoubtedly increased the awareness of research misconduct not only in the health
care sector in Norway, but also at other research institutions, colleges and universities. Several
institutions have introduced better supervisory and regulatory systems to follow up research
programmes and routines (22). Mandatory courses in research ethics have also been introduced and
several institutions have made their own local research integrity guidelines (23).

The Sudbø-case sparked an international debate on peer-review, the internal quality-control process
and co-authorship. However, the demand from several top medical journals for each author to specify
their contribution, had already been debated and introduced after the South Korean cloning scandal,
in which Woo Suk Hwang had falsified data regarding stem cell lines from cloned human embryos (15).

The Sudbø-case was an eye-opener for the Norwegian authorities. Although a discussion on research
integrity had been going on for several years, a new law on research ethics was finalized quicker than
anticipated, in 2007. The law requires institutions to bear the responsibility of regulating research
misconduct. In the wake of the new law, the National Commission for the Investigation of Research
Misconduct (“Granskningsutvalget”) and the regional ethics committees for medical research also saw
its birth and became statutory (23, 24). Moreover, scientific dishonesty was given a legal definition in
the form of "falsification, fabrication, plagiarism and other serious breaches of good scientific practice
committed intentionally or grossly negligently in planning, conducting or reporting research" (§5).

In 2009, the Health Research Act was implemented with requirements for the organization and
approval of research projects as well as research director, project manager and research protocol.
Several countries have laws on medical research ethics (including Norway with the Health Research
Act) and some countries have laws governing the treatment of issues of scientific dishonesty, but only
Norway has a law on research ethics that applies to all disciplines.

Up until the Sudbø-case, it had been denied that research misconduct was a problem in Norway. A
concomitant discussion on whether research integrity should be addressed by the State authorities or
academia itself had blocked any good progress in dealing with the topic (2).

Conclusions and learning points


 Sudbø was a lonely wolf. Individual (risk-taker, high ambitions) but also institutional factors
(lack of control about his work, competitive culture) explains why he was able to carry on
without questions
 Fast-track publishing may increase the risk of scientific fraud
 The negative individual consequences for a person accused of severe scientific misconduct are
not just immediate loss of trust, scientific position and work. Problems alike may follow
him/her for decades.
 The case sparked institutional and organizational change and public debate

References
1. Kluge L, Hafstad A, Torp IS. Jon Sudbø ble avslørt som juksemaker. Men han har selv avslørt
hvordan forskningen kan lure en hel verden. Aftenposten A-magasin. 2006, 27 January.

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2. Kaiser M. The integrity of science – Lost in translation? Best Practice & Research Clinical
Gastroenterology. 2014;28(2):339-47.
3. Ekbom A. Report from the Investigation Commision appointed by rikshospitalet -
Radiumhospitalet MC and the University of Oslo January 18, 2006. 2006.
4. The Norwegian Board of Health. Letter of 21 November 2006 from the Norwegian Board of
Health to Jon Sudbø, with the decision to revoke his authorization as physician and dentist. 2006, 21
November.
5. Sudbø J, Lee J, Lippman S, Mork J, Sagen S, Flatner N, et al. RETRACTED: Non-steroidal anti-
inflammatory drugs and the risk of oral cancer: a nested case-control study. The Lancet.
2005;366(9494 ):1359–66.
6. Horton R. Expression of concern: non-steroidal anti-inflammatory drugs and the risk of oral
cancer. The Lancet. 2006;367(9506):196-.
7. Horton R. Retraction—Non-steroidal anti-inflammatory drugs and the risk of oral cancer: a
nested case-control study. The Lancet. 2006;367(9508):382.
8. Curfman GD, Morrissey S, Drazen JM. EDITORIALS: Expression of Concern: Sudbø J et al. DNA
Content as a Prognostic Marker in Patients with Oral Leukoplakia. N Engl J Med 2001;344:1270-8 and
Sudbø J et al. The Influence of Resection and Aneuploidy on Mortality in Oral Leukoplakia. N Engl J
Med 2004;350:1405-13. The New England Journal of Medicine. 2006;354(6):638.
9. Curfman GD, Morrissey S, Drazen JM. Retraction: Sudbø J et al. DNA Content as a Prognostic
Marker in Patients with Oral Leukoplakia. N Engl J Med 2001;344:1270-8 and Sudbø J et al. The
Influence of Resection and Aneuploidy on Mortality in Oral Leukoplakia. N Engl J Med
2004;350:1405-13. The New England Journal of Medicine. 2006;355(18):1927-.
10. Sudbø J, Kildal W, Risberg B, Koppang HS, Danielsen HE, Reith A. DNA content as a prognostic
marker in patients with oral leukoplakia. New England Journal of Medicine. 2001;344(17):1270-8.
11. Sudbø J, Lippman SM, Lee JJ, Mao L, Kildal W, Sudbø A, et al. The influence of resection and
aneuploidy on mortality in oral leukoplakia. New England Journal of Medicine. 2004;350(14):1405-
13.
12. Sudbø J, Samuelsson R, Risberg Br, Heistein S, Nyhus C, Samuelsson M, et al. Risk markers of
oral cancer in clinically normal mucosa as an aid in smoking cessation counseling. Journal of clinical
oncology. 2005;23(9):1927-33.
13. Couzin J, Schirber M. Science misconduct - Fraud upends oral cancer field, casting doubt on
prevention trial. Science. 2006;311(5760):448-9.
14. The Norwegian Board of Health, . Case involving scientific fraud 2005-2006. 2007, 8 February
15. Vastag B. Cancer Fraud Case Stuns Research Community, Prompts Reflection on Peer Review
Process. Journal of the National Cancer Institute. 2006;98(6):374-6.
16. Gjerding ML, Utheim EB. Avslørt for forskningssvindel - nå vil han forske igjen. Verdens Gang
(Internet version). 2013 25.01.2013 (Accessed 04.09.2017).
17. Haug C. Erfaringer, forventninger og forsetter. Tidsskrift For Den Norske Laegeforening:
Tidsskrift For Praktisk Medicin, Ny Raekke. 2007;127(1):13.
18. Hem E. Rehabilitering av en svindler? Tidsskrift For Den Norske Laegeforening: Tidsskrift For
Praktisk Medicin, Ny Raekke. 2013;133(3):257.
19. Sudbø J. Til Erlend Hem (Comment to Erlend Hem on "Rehabilitering av en
svindler"/"Rehabilitation of a Fraudster"). Tidsskrift For Den Norske Laegeforening: Tidsskrift For
Praktisk Medicin, Ny Raekke. 2013;133(3):257.
20. Dommerud T. Tat for forskningsjuks - nå er Jon Sudbø ansatt som klinikkleder. Aftenposten
(Web). 2016 10 May.
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21. Harboe M. Dette er ikke vår medisinske etikk. Tidsskrift For Den Norske Laegeforening:
Tidsskrift For Praktisk Medicin, Ny Raekke. 2006;126(17):2283.
22. Nylenna M. Research Misconduct: lessons to be learned? Michael. 2007;4(1):7-8.
23. Nylenna M. Ti år etter Sudbø-saken. Tidsskrift For Den Norske Laegeforening: Tidsskrift For
Praktisk Medicin, Ny Raekke. 2016;136(17):1420.
24. Tavare A. Managing research misconduct: is anyone getting it right? BMJ : British Medical
Journal. 2011;343.

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Oslo and Akershus University College – Case Study 2


TITLE: Grey Case
Summary
Svenn-Erik

The third work package of the Printeger project includes a task that involves detailed case studies of
cases of misconduct. There are two objectives for these case studies

- To gather illustrative material for use in educational tools for early career scientists (in WP5).
Hence cases are not just about ‘pointing out obvious wrong behaviour’, but illustrate the
dilemmas and tensions in research that lead to dubious practices, the tensions between
different principles or guidelines, point out how misconduct cases can develop (e.g. the
dynamic of ‘scandal’), or the complications of whistle blowing.
- To look for patterns in the development of misconduct cases in terms of the personal dynamics
of fraud, in light of the tensions arising from work conditions, such as pressures or research
culture. (A specific focus in light of information gathered in the context of other work
packages.)

Some of the case studies will involve ‘hard’ misconduct cases, namely cases involving clear examples
of fabrication, falsification or plagiarization of data (FFP). Other case studies will involve so-called ‘grey
cases’ with less clear examples of FFP or other misconduct, such as questionable authorship practices,
selective use of data, etc. A protocol for the case study reports has been developed by the lead partner
and has been followed in this report from Norway.

The persons involved in this low media profile “grey case” of alleged plagiarism were all working at the
same Christian University College in Bergen, Norway. The case was “grey” for two reasons. First, the
case shows that there were tensions between using ethics guidelines and ethics legislations (norms
versus laws) to judge whether or not a case of plagiarism had occurred. Second, the case shows that
there might be diffuse distinctions between processing and handling a case of workplace conflict and
a case of research misconduct.

Persons involved, scientific field and institutional context

The Accuser
The accuser is a first lecturer in pedagogics for bachelor and master students. The accuser is a mid-
career researcher with a master’s degree in pedagogics and an unfinished PhD. The accuser has
published three book-chapters in Norwegian anthologies on the topic of pedagogic creed for teachers.

The Accused
Two lecturers in pedagogics, one for pre-school teacher students, the other for both pre-school
teacher and primary school teacher students. Both were mid-career researchers. They are co-editors
of one Norwegian anthology on pedagogic creed for kindergarten teachers, published August 2015:
two of the chapters in this anthology were included in the later search for plagiarism.

Scientific field and institutional context


During this case of alleged scientific misconduct, the accuser and the accused worked at the same
private Christian NLA University College with 2000 students and 200 employees. The College was
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founded in 1968 and has, in 2017, campuses in Bergen (1600 students), Kristiansand (200 students)
and in Oslo (300 students). The NLA is owned by seven Christian organizations.

NLA University College is the only private college in Norway offering primary school teacher education.
This education is offered in Bergen, where also the kindergarten teacher education is offered together
with bachelor and master's degrees in pedagogics, intercultural understanding and theology / practical
theology and management.

The persons involved were at the Bergen campus in the field of pedagogics. However, the accuser was
at the department for pedagogics (Sandviken) and the accused at the department for pre-school
teacher education (Breistein). The two departments are located 15 kilometers apart. The two units
merged in 2010. Sandviken hosts more staff with PhDs, professors and publish more academically than
Breistein who does more teaching and applied science.

The NLA University college is private, they are therefore not obliged to report openly to the public and
do not have a public mail journal. For this reason, it is not easy to get information or get in contact
with the institutional leaders. The rector politely refused to be interviewed.

Data & Methods

Document analysis
We have studied the local and national investigation reports as well as transcripts from interviews with
the involved parties made by the national investigation report (Norwegian National Research Ethics
committes). The case was not covered by national media. We found two newspaper reports made by
the Christian and Bergen-based newspaper “Dagen” (19 and 21 November 2015), and one online
report made by “Forskerforum”, a journal for the members of the labour union Forskerforbundet (19
November 2015). These articles are mainly describing the content of the two investigation reports. We
have been in contact with journalists from “Bergens Tidende”. They are working on a feature article
that will appear in a weekend-issue of the newspaper in September 2017.

Telephone interviews
The current rector politely declined an interview (The rector started a 5-year fixed term 1 February
2015 and came from the position as the deputy rector for R&D. It was the deputy rector who appointed
the local investigation report members). We got no response from the Labor safety representative or
from Utdanningsforbundet, the labour union with most members employed at the unit of the accused.
However, we interviewed the representative for Forskerforbundet, the labour union with most
members employed at the unit of the accuser/whistleblower. We do not know, but
Utdanningsforbundet may have had different opinions on the case than Forskerforbundet. We have
also interviewed the three members of the local investigating committee as well as the secretariat of
the national investigation committee. We have decided not to directly quote any of our informants in
order to protect their anonymity. One motivation for doing so is also the ongoing workplace tensions
following this case.

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The allegations

Form and origin


This history of this case of alleged research misconduct started on 12th of February 2014 when the
accuser/whistleblower (the same person) at Sandviken unit in Bergen accused two colleagues at
Breistein unit for plagiarism, violation of good reference practice and for “uncollegial” behavior. The
accuser claimed that the two colleagues had plagiarized the concept “pedagogic creed” in 5
unpublished drafts, including two chapters meant for a Norwegian anthology (later published in 2015),
and an abstract, paper and a power-point presentation used at an international conference.
Processing the allegations

The local management


The leadership of the NLA University College first sought to resolve the matter between the parties
internally, but this effort did not lead to a solution. Then, on April 30th 2014, it was decided to appoint
a local expert committee to assess the alleged scientific misconduct. Two of the appointed members
were employed at the University of Bergen and a third member was a retired professor still associated
with the NLA University College.

Local integrity committee


The internal committee concluded on 15th of August 2014 that the accused had plagiarized the accuser,
that they had violated good reference practices and behaved “uncollegially”. According to the local
report, the management of NLA believed that the accused had "conflicting and unfair behavior related
to the accuser". In other words, the fact that the accused were allegedly plagiarizing a colleague made
the case extra sensitive. The internal committee used the Copyright act (1961) and the National
Committee for Research Ethics guidelines in the Social Sciences and the Humanities from 2006 (NESH)
for supporting their argument that this was a case of plagiarism. Finally, the local commission stated
that the institution had a responsibility for preventing scientific research misconduct in the future; this
should be achieved in courses in research ethics, other follow-up and in establishing a sufficient
organizational culture.

Local follow-up
The management at the NLA University College decided to take note of the committee's statement
and lay the foundation for further follow-up of the case. This led to a delay of book publishing and
disciplinary warnings for the two employees. The management believed that there were grounds for
termination of the accused’s positions, but would allow them to continue if they could accept the
certain conditions. These included that the accused should relate to general standards for research
ethics in the field of pedagogics and at the institution, and follow a ban on sending e-mails or publish
any documents on the case to internal or external colleagues.

The accused disagreed in the conclusions and indicated what they considered were law suiting- and
procedural errors, but the opposition was not taken into consideration by the NLA University College
management. Subsequently, the two appealed to the National Committees for Research Ethics 13th of
October 2014. The committee started to work on 11th December 2014.

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National Research Ethics committes


The work of the National Review Committee (“Granskningsutvalget”) differed on several fronts
compared to the work by the local review committee:

First, while the local committee asked the question whether the accused had plagiarized text from the
accuser, the national committee considered both text- and idea plagiarization. Examples of the latter
type of plagiarization would be in the form of models / figures that explained the term "pedagogic
creed".

Second, the National Committee believes that the internally appointed committee has had an incorrect
starting point for the selection of documents. The review committee clarified which documents could
not be used as a basis for plagiarism accusations by specifying that the documents must be "completed
and made available to others". This is a clarification that is not stated in the Law on Research ethics,
but the committee interpreted this clarification into the statutory provision. This is a right of law with
lower rank than laws, cf. legal method. The national committee obtained inspiration from Denmark,
which has had the same clarification in regulatory form for several years. The clarification “completed
and made available to others” has in other words no basis in formal law, only in governance (through
the NLA case). Time will show if this becomes a firm practice. It is worth noting that legally the text is
not required to be published in order to count as plagiarism. In practice, the clarification means that a
researcher cannot be accused of plagiarism if she has forgotten an article draft on the Xerox machine,
nor can she be accused of plagiarism if she has sent a draft to a colleague for feedback. However, if
she sends it to a scientific journal or publisher for publication, the product will be "completed and
available to others" - although significant changes may still be made to the article or the book-chapter
in the peer-review process etc.

Some of the documents were not considered "finished and available", and then one could not proceed
with a plagiarism assessment (for example, the draft for an article in English). However, other
documents were "completed and available", such as a PowerPoint presented at a conference and the
published version of one article. For these documents, the Committee made concrete plagiarism
assessments.

Finally, according to the National Review Committee's report, only the law of Research Ethics is
applicable to such cases, and not the NESH-guidelines and the Copyright act. The NESH guidelines are
not a legal framework, the definitions of scientific dishonesty might be a bit unclear, and it says little
about legal consequences of breaches of the ethical guidelines. The local committee used the
plagiarism concept described in the Copyright Act. However, a University College should not settle
cases using the Copyright Act - only the courts can do this.

The Law on Research Ethics has two similar terms, both of which must be met in order to reach the
conclusion of scientific dishonesty: 1) objective conditions - an act must be committed which is a
serious breach of good scientific practice and 2) subjective conditions - the breach occurred
intentionally or grossly negligently.

The examination committee can only conclude whether a researcher has acted scientifically
fraudulently or not, and the assessment can only be done using the definition of the Law of Research

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Ethics. Other conclusions are not possible. On September 8th 2015, the national review committee
concluded that there was no serious breach of the subjective nor the objective condition for good
scientific practice and that the accused had not acted fraudulently according to the Law of Research
Ethics. In the cases of similarity in text (in PPT-presentations), the investigators had recited text from
the study guide at NLA Breistein, not copied the text from the colleague at Sandviken.

Setting the question of plagiarization aside, the national commission criticized the local report for
procedural errors and the NLA University College for a lack of routines for dealing with suspected cases
of scientific research misconduct and education on research ethics.

How did the actors interpret the case?


The Rector and Deputy Rector for R&D early on took side with the accuser/whistleblower. As we
described above, the accused denied plagiarizing the whistleblower and claimed procedural errors in
the local investigation report. The accused were, for example, not allowed to make their case and to
comment on the report before the conclusions were written. During this process, the accused were
also confused because they did not know exactly what they were accused of doing wrong or how
serious the allegations were (Nasjonal utvalg for granskning av redelighet i forskning 2015). Moreover,
the accused also claimed impartiality in the local investigating report; One of the committee members
was a retired professor still associated with the NLA University College.

Consequences

For the accused


The accused did not agree with the terms for continuation of their positions laid out by the
management and quit their jobs in 2015. The accused also had to delay the publishing of an anthology
on pedagogic creed for pre-school teachers in 2014. However, it was published in August 2015, one
month before the national investigating published their report.

For the accuser/whistleblower


The accuser still works at the NLA University College.

For the colleagues/work environment


The management early on understood the alleged case of misconduct as a case of work-place conflict
rather than as a case of scientific fraud. The management therefore had a strong focus on solving the
personal workplace conflicts, and had less focus on research ethics in general. As discussed above, the
management believed that there were grounds for termination of the accused’s positions, but this
conclusion must have been somewhat ad hoc as no guidelines for handling of work place conflicts were
in place at this time.

The case was tough for all parties directly involved, and it even affected the work environment and
well-being of those who were not directly involved. The management was working closely with safety
representatives and unions to solve the work-place conflict and were in the fall of 2015 in the process
of acquiring competence to solve these challenges. As part of this, in December 2015, the NLA
University College had a visit from the Norwegian Labour Inspection Authorities. The purpose was to
get help at sorting out work-environment challenges and prevent future conflicts. At this time, the
accused had already quit and found new jobs.

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The report of the National Review Committee states that the "concrete collegial challenges have
significantly escalated as a result of the way the case has been handled at the institution". For example,
the accused were not allowed to read and comment on the local investigating committee report before
it was finalized. Further, the choice of an internal local committee member may have reduced the trust
in the process and the conclusions in the local investigating report.

One of our early working hypotheses were that the merger between the unit of pedagogics at
Sandviken and the unit of teacher education in 2010 is part of the underlying reason for what
happened at the NLA Univesity College. Our document analysis as well as several of our interviews
clearly support this hypothesis. The unit where the accuser worked were traditionally more academic
with a higher number of employees with PhDs while the unit of the accused were traditionally an
applied institution educating teachers. It may be reasonable to believe that the knowledge about
research integrity was lower at the unit of the accused. Here they also have a shorter experience with
academic publishing.

For the Institution


The rector at the time when the case was first reported in February 2014 stepped down from the fixed-
term position before it ended; allegedly of own free will, on 1 st of February 2015
(https://www.nla.no/nor/om-nla/nyhetsarkiv/nyhetsvisning/?&displayitem=1778&module=news).
The new Deputy Rector for R&D who replaced the new and current rector went on a sick leave later in
2015.

The webpages of the Christian College includes a page with information on research integrity
(https://www.nla.no/nor/forskning/forskingsetikk). As a direct consequence of the case described
here, these webpages now include new ethics guidelines and new ideals and guidelines for handling
and processing of alleged scientific misconduct (both issued 16 April 2015). The webpages also include
a Scientific Misconduct Notification Form as well as links to web-sources on research integrity.
However, it is unclear when the notification form and the web sources on research integrity were
published. The institution also made new guidelines for the prevention and management of conflicts
between employees (Adopted by the NLA Board on May 13, 2015). The institution did not have
routines for handling and processing of alleged misconduct as is a requirement in the guidelines from
NESH. The case described here were the first in this institution’s history.

In 2014 and 2015, the institutional management mainly focused on solving what they considered a
workplace conflict and did not pay too much attention to research ethics, but this has reversed over
time. In January 2016, the union with the most members at the unit of the accuser (Forskerforbundet),
arranged a half-day seminar on research ethics, and in later that winter of 2016, the NLA University
held a one-day seminar on research ethics. This latter meeting was the first institutional measure of
ethics management after the case exploded in the winter of 2014. Forskerfobundet also held a 2-day
meeting in May 2016 on research ethics. In the spring of 2017, The NLA University College has also
started to offer courses in research ethics. These were given by members from the Norwegian National
Research Ethics committees. The NLA University College has never before given specific courses to
their students. However, research ethics has been part of the curriculum in classes in research method
at the master's level for pedagogics students, at least since 1988. In recent years, the NESH guidelines
has also been part on the bachelor's syllabus. One of our interviewees believed that at least one of the

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accused had also had the NESH guidelines as a curriculum, but they came the year the accused took
this part-examination. The accused therefore had a different syllabus in research ethics.

The question whether the accused had done anything wrong according to the Law on Research Ethics,
was settled in the fall of 2015. The management and the two parties did not appeal against the
conclusion of the National Review Committee. However, the indirect negative consequences on the
work environment are not over, not even in the fall of 2017. According to one of our informants, «there
is still a war at the institution» - but another of our interviewees’ impression is that this only holds for
the unit where the accused used to work.

For the research system


No national or long-reaching consequences of this case. Little media attention.

Conclusions
The case presented here shows that there are tensions between using ethics guidelines and ethics
legislations (norms versus laws) to judge whether or not a case of scientific misconduct has happened.
This is a field of major ambiguities and gray zones of regulation: law, guidelines for research ethics and
the law on research ethics (mix of law and ethics). Research ethics as interpreted in Norway is not the
same as in the rest of Europe. Several countries have laws on medical research ethics (including
Norway with the Health Research Act) and some countries have laws governing the treatment of issues
of scientific dishonesty, but only Norway has a law on research ethics that applies to all disciplines.

Our case also shows that there might be diffuse distinctions between processing and handling a case
of workplace conflict and a case of research misconduct.

Some learning points


 Allegations of misconduct may be associated with underlying work place conflicts
 Allegations of misconduct may be grounded in underlying differences in competence, work
praxis and disagreements between science fields
 Allegations of misconduct may be interpreted in completely different ways depending on what
laws and guidelines for research ethics are used to judge the case
 Judicial and bureaucratically competence about required guidelines for and handling of
research misconduct in the College and University sector may not be sufficient, especially at
small colleges
 Increased demand for more professionalism and publishing pressure might lead to more
allegations of scientific misconduct at practice-oriented colleges.

Literature
 Forskerforum (2015): anklager om plagiat på kristen høgskole. Forskerforum 19. November 2015
 Nasjonal utvalg for granskning av redelighet i forskning (2015): Uttalelse i sak om mulig
vitenskapelig uredelighet ved NLA Høgskolen AS. 8 September 2015.
 Sævik, Tore Hjamar (2015): Arbeidstilsynet til kristen høgskole etter plagiatstrid. Dagen, 21
November 2015
 Sævik, Tore Hjamar (2015): Plagiat-strid på kristen høgskole, Dagen, 19 November 2015
 Uttalelse fra komite for vurdering av klagesak ved NLA Høgskolen. 15 August 2014.

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University of Bristol – Case Study 1


The MMR Fiasco
Summary
This case study documents what is probably the most notorious and most publicised case of alleged
research misconduct in the UK which led to a global public health crisis regarding the safety of the
Measles, Mumps and Rubella (MMR) vaccination. The case follows a timeline of over 20 years, over
which allegations and investigations regarding the research and the accused, Andrew Wakefield, have
emerged. Whilst the research in this case was contentious amongst the scientific community from the
outset, the work of the investigative journalist Brian Deer, the whistle-blower in this case, exposed
more worrying issues about the integrity of the research. The outcomes of this case culminated in the
longest ever medical fitness to practise investigation conducted by the General Medical Council
(GMC)20 which resulted in Wakefield being struck-off the medical register along with one of his co-
authors Professor John Walker-Smith and the journal articles documenting this research were
retracted. Whilst Walker-Smith has gone on to successfully appeal his removal from the medical
register, Wakefield has not attempted to clear his name by appealing the GMC ruling. Nevertheless,
throughout the entire case, Wakefield has remained belligerent, standing by his research and denying
any wrong-doing. Fascinating is that he still continues his work, albeit in the US and retains a great
deal of support amongst the public despite the scientific consensus that his theories are flawed and
compelling evidence that he has committed research misconduct and acted unprofessionally and
without integrity.

Methods
Evidence for this case study consists of documents that are publicly available via the internet. The
evidence was gathered through a combination of on-line searches for relevant keywords (e.g. Dr
Andrew Wakefield, MMR, misconduct, etc) using Google and Google Scholar. Furthermore, evidence
was gathered through following a ‘paper-trail’ of citations and information from documents as they
were collected. Table 1 below details the different types of data and sources below (also see
references and bibliography for full details of sources used). Unfortunately, due to time constraints it
was not possible to conduct interviews with any actors related to this case.

Table 1: list of evidence sources

Type Source

Newspaper articles The Sunday Times, The Guardian, The Telegraph


& online news
articles

Webpages UCL, The Russell Group, Whistle-blower’s website

Official documents GMC Fitness to practice hearing, UCL Policy response, Wakefield v
Channel 4 & others Libel case decision

Press releases UCL, UKRIO

20
Deer, B. The Lancet’s two days to bury bad news. BMJ, 2011; 342:c7001.
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Personal & official Letters of complaint to GMC by whistle-blower


correspondence

TV programmes Channel 4 Dispatches documentary by the whistle-blower

BBC Panorama

BBC Horizon

Other Audio/visual Vaxxed & video recorded interviews with the accused

Academic Journal The Lancet,


Articles
BMJ,

The open Vaccine Journal,

The American Journal of Gastroenterology

Molecular Pathology

Types of alleged misconduct:


There are a number of areas of misconduct that have been alleged in this case:

First it is alleged that the research itself is flawed and there is insufficient evidence for the conclusions
drawn, this was later expanded to suggest that in fact the data was manipulated potentially including
some falsification to make the findings favourable to the hypothesis of the accused.

Later investigations lead to accusations about unethical treatment of research participants, and
deviation from the original ethical approvals obtained from Royal Free Hospital research ethics
committee.

There is also accusation of conflict of interest in terms of the funding of the accused by a lawyer
working on behalf of families seeking to take legal action against the manufacturers of the MMR
vaccine. But also that the accused had business interests and patents for a single vaccine.

The academic institution employing the accused has been criticised for the handling of the case and its
initial actions publically promoting the research and the views of the accused, leading to a media
uproar about the research which greatly affected public trust in the government MMR vaccination
programme, with public health repercussions world-wide.

Finally the Editor of The Lancet has been criticised for the role that the journal played in the case,
allegedly failing to properly peer review the original research and allowing it to remain in the public
sphere without full retraction for twelve years.

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Background information of the Accused

Andrew Wakefield

Andrew Wakefield trained in Medicine at St Mary’s Hospital Medical School where he qualified in 1981,
later becoming a fellow of the Royal College of Surgeons in 1985 and specialising in Gastroenterology.
He worked in Canada for several years in the late 1980s, before returning to work in the UK at the
Royal Free Hospital in the 1990s, initially as a Senior Lecturer in the Departments of Medicine and
Histopathology, followed by the role of Reader in experimental Gastroenterology from May 199721. In
this role, Wakefield was an Honorary Consultant in Experimental Gastroenterology but his contract
“stipulated that he should have no involvement in the clinical management of patients” 22. Wakefield
worked at the Royal Free investigating a controversial and now known to be unsubstantiated theory
that linked the single measles vaccine to Crones Disease23. During this time, he was contacted by
parents of children with autism who believed that the MMR vaccine may have caused the disease due
to the onset of the disease post MMR, which also included intestinal problems 24. Wakefield claims
that it was these cases that triggered his interest in autism and the start of his work investigating a link
of MMR to a syndrome with symptoms of inflammatory bowel disease and autism25.

As soon as Wakefield et al’s research was published in The Lancet in 1998, it was controversial and
heavily criticised amongst the scientific community for lacking any substantiated proof of a link
between MMR and inflammatory bowel disease and autism26. Furthermore, the research had become
extremely politically charged due to the huge media attention it received. The public health
consequences of which, led to Dr Wakefield’s mutually agreed resignation from his post at the Royal
Free Hospital in 200127.

After investigations by Brian Deer commenced in 2003, accusations of misconduct regarding the ethical
conduct of the research and potential conflict of interests emerged in 2004 28; by this time Wakefield
had moved from the UK and was working in the US as Research Director of the International Child
Development Rescue Center, run by Dr Jeff Bradstreet, a controversial figure, who claims to treat
Autism with 80% success29.

Background information about the whistle-blower

21
GMC Fitness to Practise Hearing, 28th January 2010 Available online, accessed 20/9/2017:
http://briandeer.com/solved/gmc-charge-sheet.pdf
22
Ibid.
23
BBC Horizon, 2005, Does MMR Cause Autism? 2005 available online, accessed 20/9/2017:
https://www.youtube.com/watch?v=VxFIl53_qKY, https://www.youtube.com/watch?v=3I-XaxJQNyA,
https://www.youtube.com/watch?v=BUeJ7nyb_MA, https://www.youtube.com/watch?v=Dh0CwtZ2pno
24
Ibid; Wakefield, A, Dr Wakefield deals with allegations, 2016, Available online, accessed 20/9/2017:
http://vaxxedthemovie.com/dr-andrew-wakefield-deals-with-allegations/
25
Ibid.
26
BBC, Horizon, 2005
27
BBC Panorama, 2005
28
Deer, B, Revealed: MMR research scandal, 22nd February 2004, The Sunday Times, available online, accessed
20/9/2017: http://briandeer.com/mmr/lancet-deer-1.htm
29
Deer, B. Wakefield joins strange enterprise when “transfer factor” autism products fail [no date], available
online, accessed 20/9/2017: http://briandeer.com/wakefield/wakefield-quack.htm
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Brian Deer

Brian Deer is a British investigative journalist who is known for working in ‘social affairs journalism’
since the 1980s, mainly for the Times and Sunday Times newspapers30. His work has looked at a range
of social issues, and has a large medical focus with investigations into the pharmaceutical industry and
medicine where he has uncovered several cases of scientific misconduct, including Dr Andrew
Wakefield, the accused in this case31.

Deer initially conducts a four-month investigation of Wakefield’s MMR research for The Sunday Times
initiated in 2003 and culminating in the publication of an article on the 22 nd February 200432. His
investigations into Wakefield continued and he reported on further allegations of wrong-doing in a
Channel 4 Dispatches investigation aired on UK television in November 200433. Deer also wrote to the
General Medical Council (GMC) requesting them to investigate the professional conduct of Wakefield
and also his colleagues Dr Simon Murch and Prof John Walker-Smith. Deer continued to explore the
case and document the GMC hearings and finally published a feature series of articles in the BMJ in
2011 summing up the case.

The Institutional context


The Royal Free Hospital is part of the University College London (UCL) Medical School, a merger that
occurred in 199834. UCL is a prestigious UK university founded in 1826 and a member of the Russell
Group, representing the top twenty four research intensive universities in the UK35.

At the time of Wakefield’s employment at UCL and the Royal Free his boss and mentor was Professor
Roy Pounder, Professor of Medicine at the Royal Free36. In 1999, Prof Mark Pepys takes over as head
of the Medical School.

The research context


Dr Wakefield worked with other clinicians, all based at the Royal Free Hospital, part of University
College London Medical School to conduct the case series of children exploring a new syndrome of
bowel and developmental disorder, potentially linked to MMR, this research was reported in The
Lancet in 1998. The clinicians came from the Inflammatory Bowel Disease Study Group, and the
university departments of Paediatric Gastroenterology, Child and Adolescent Psychiatry, Neurology
and Radiology37 .

Prominent co-researchers of Wakefield in this case are:

30
Deer, B. Overview of website [no date] Available online, accessed 20/9/2017: http://briandeer.com/deer-
site-guide.htm
31
Ibid.
32
Deer, B, Revealed: MMR research scandal, 22nd February 2004, The Sunday Times
33
Deer, B, Dispatches, Available online, accessed 20/9/2017:
https://www.youtube.com/watch?v=7UbL8opM6TM
34
MMR and the development of UCL’s research governance framework, 13th September 2012, available online,
accessed 29/6/2017: http://www.ucl.ac.uk/news/news-articles/1209/13092012-Governance
35
Russell Group, About our Universities: UCL [no date] available online: accessed 20/9/2017:
http://russellgroup.ac.uk/about/our-universities/university-college-london/
36
37
Wakefield AJ, Murch SH, Anthony A, Linnell J, Casson DM, Malik M, Berelowitz M, Dhillon AP, Thomson MA,
Harvey P, Valentine A. RETRACTED: Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive
developmental disorder in children. 1998, The Lancet, 637-641
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Dr Simon Murch who was a Senior Lecturer in Paediatric Gastroenterology with an honorary consultant
contract with the Royal Free Hampsted NHS Trust (1995-2004)38, who investigated inflammatory bowel
disease, including the potential links to autism39.

Professor John Walker Smith who was Professor of Paediatric Gastroenterology at the Royal Free
Hospital School of Medicine with an honorary clinical contract with the Royal Free Hampsted NHS
Trust40

Prof John O’Leary Trinity College, Dublin, who collaborated with Wakefield and the Royal Free research
group during between February 1999 and 200341.

Timeline and discovery and accusation of misconduct

1998
Wakefield et al ‘Early Report’ paper was published in The Lancet42. The paper reports on a case series
of 12 children who apparently have a new syndrome linking “regressive autism” and “non-specific
colitis” potentially caused by the MMR vaccine43. However, the article makes no causal claim about a
link to the MMR vaccine and the syndrome, something that Wakefield is keen to highlight in defence
of the article to this day44.
Wakefield claims that he had been studying the safety reports of vaccines and became concerned
about the use of the MMR vaccine45. His theory was (and still is) that the MMR vaccine could be the
cause of the increase in cases of autism, and he claims that looking at the autism figures per country,
there is a correlation of an increase in autism with when the MMR vaccine was introduced46. His theory
that was proposed in The Lancet article was that in some children with low immune systems the
measles virus injected in the MMR shot stays in the body, causing a persistent infection in the gut
causing inflammatory bowel disease which prevents efficient digestion, leading to a build-up of opioids
that damages the developing brain, causing autism47

There was a great deal of critical scientific response to the paper because the evidence of a potential
link between MMR and inflammatory bowel disease and autism was highly speculative and not at all
substantiated48. Indeed, criticisms and concerns were voiced in correspondence about the article
published in The Lancet49, to which the Editor, Richard Horton replied: “the paper by Andrew Wakefield

38
GMC Fitness to Practise Hearing, 28th January 2010 Available online, accessed 20/9/2017:
http://briandeer.com/solved/gmc-charge-sheet.pdf
39
BBC, Horizon, 2005
40
GMC Fitness to Practise Hearing, 28th January 2010
41
Deer, B, O’Leary denounces collaborator Wakefield as clouds gather over Dublin pathologist [no date]
available online, accessed 20/9/2017: http://briandeer.com/mmr/oleary-statement.htm
42
Wakefield AJ, Murch SH, Anthony A et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and
pervasive developmental disorder in children. Lancet 1998; 351: 637–41.
43
BBC Horizon, 2005; Deer, B. How the case against the MMR vaccine was fixed, BMJ, 2011, 342:c5347.
44
Wakefield, A, Dr Wakefield deals with allegations, 2016
45
Ibid.
46
BBC Horizon, 2005.
47
Ibid.
48
BBC Horizon, 2005.
49
Chen RT, DeStephano, F. Vaccine adverse events: causal or coincidental? Lancet, 1998; 351: 611-12.
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and colleagues is an example of how researchers, editors, and those concerned with the public’s health
can work together to present new evidence in a scientifically balanced and careful way”50.

Indeed, it seems fair to state that what really thrust the research into the public sphere was a press
conference that was held at the Royal Free Hospital to launch the paper 51. The press conference was
organised by Professor Roy Pounder, Wakefield’s boss at the Royal Free Hospital 52. During the press
conference, Wakefield appears very confident about the results and conclusions of the research
exclaiming: “We would not have presented this paper to The Lancet had we not undertaken extensive
virological studies already,”53 and stating: “there is sufficient anxiety in my own mind about the safety
of the MMR Vaccination, and I think that it should be suspended in favour of the single vaccine” 54.
Wakefield also claimed that it is “a moral issue for me” and “I can’t support the continued use of these
three vaccines, given in combination, until this issue has been resolved” 55. Thus, the comments made
by Dr Wakefield at the press conference differed from the more tentative conclusions made in the
article itself, triggering an explosion of media interest in MMR and, creating controversy about the use
of the triple vaccination. Wakefield claims that Pounder was well aware of his views regarding MMR
and yet insisted that he attend the press conference to discuss his research56.

The media storm surrounding the research subsequently initiated a decline in uptake of MMR
vaccination across the country and demands for the single vaccine57. Nevertheless, right from the start
there was disagreement with Wakefield amongst the scientific community: Dr Liz Miller (of the UKs
Health Protection Agency) disagreed with Wakefield’s claims and raised concerns about his suggestion,
particularly since there was a scientific rationale for providing the triple vaccination, including ensuring
that full vaccination has been obtained and preventing spread of Rubella that can be damaging to
unborn children58.

2000

Wakefield et al publish a paper in the American Journal of Gastroenterology which utilises data
collected from the 12 patients from the 1998 paper published in The Lancet59.

2001

In January 2001, it is revealed that the UK government is to spend £3 Million on an advertising


campaign to inform the public and medical professionals that they deem the MMR vaccine effective

50
Horton, R. Editor’s reply. The Lancet, 1998; 351: 908.
51
Ibid
52
Wakefield, A, Dr Wakefield deals with allegations, 2016.
53
Deer, B. Hidden records show MMR truth, The Sunday Times, 8th February 2009.
54
BBC Horizon, 2005.
55
Deer, B. Hidden records show MMR truth, The Sunday Times, 8th February 2009.
56
Wakefield, A, Vaxxed, 2016
57
BBC, Horizon, 2005
58
Ibid.
59
A J Wakefield, A Anthony, S H Murch, M Thomson, S M Montgomery, S Davies, J J O'Leary, M
Berelowitz and J A Walker-Smith, Enterocolitis in children with developmental disorders Enterocolitis in
Developmentally Disabled Children, September 2000, The American Journal of Gastroenterology 95,
2285-2295.
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and safe to use, due to a decrease in uptake of the vaccine in the UK60. On the 22nd January, the Chief
Medical Officer for England, Prof Liam Donaldson called a meeting of medical professionals to appraise
the MMR evidence61. A UK government press conference is also conducted, including medical experts
aimed at reassuring people about the MMR vaccine and counter the concern raised by Wakefield 62.
Strong criticism of Wakefield et al’s research is evident at this stage amongst scientists, for example a
member of the government advisory authority Medicines Control Agency, Stephen Evans, is reported
as saying that the research was “flawed, contained errors of fact and had not been completely peer
reviewed”63. Nevertheless, there is also considerable support of Wakefield and criticism of the
government by families of autistic children convinced of a link between MMR, inflammatory bowel
disease and autism, with in excess of 500 families seeking to sue manufacturers of the vaccine64

In March 2001, at a UK parliamentary committee investigating autism Andrew Wakefield is asked to


present, and describes his current ‘double hit theory’ in which he claims that some children who have
received 2 doses of MMR may go on to develop autism, to evidence this, Wakefield uses a case study
of a child ‘Christopher Walker’65.

25th April 2001 – Wakefield attends congressional hearing into link between MMR vaccine and autism
in the US in which ‘Wakefield is seen as something of a hero’66. At this meeting, there is more sympathy
and support for Wakefield than there is for the UK government representative researcher (Dr Liz Miller)
who claims to have evidence that MMR vaccine does not increase the likelihood of developing
autism67.

In November 2001, Wakefield leaves the Royal Free Hospital ‘by mutual agreement’ 68, although it is
reported in The Telegraph that Wakefield was forced out, with him claiming “I have been asked to go
because my research results are unpopular”, stating that he agreed to leave with the hope that this
would “take the political pressure off my colleagues and allow them to get on with the job of looking
after the many sick children we have seen”69. At this point in time, despite much criticism of his
theories, there was no accusation that Wakefield had committed research misconduct, although the
UK government and World Health Organisation (WHO) did not support the findings of Wakefield’s
research and maintained that children should be vaccinated with MMR70.

2002

60
Hall, C, Campaign to persuade parents that the MMR jab is safe, 23rd January 2001, The Telegraph, available
online, accessed 20/9/2017: http://www.telegraph.co.uk/news/uknews/1319029/Campaign-to-persuade-
parents-that-the-MMR-jab-is-safe.html
61
Ibid.
62
Barclay, Sarah, BBC Panorama, MMR the debate, 2002, Available online, accessed20/9/2017:
https://www.youtube.com/watch?v=cpyjnys3Nf0
63
Hall, C, Campaign to persuade parents that the MMR jab is safe, 23rd January 2001, The Telegraph
64
Ibid.
65
BBC Panorama, 2002
66
Ibid.
67
BBC panorama, 2002
68
BBC Panorama, 2002
69
Fraser, L, Anti-MMR doctor is forced out, The Telegraph, 2nd December 2001, available online,
accessed20/9/2017: http://www.telegraph.co.uk/news/uknews/1364080/Anti-MMR-doctor-is-forced-out.html
70
Ibid.
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A BBC Panorama documentary is aired – Dr Simon Murch expresses concern about the research linking
MMR to autism, as a clinician he states that it is problematic because it threatens vaccine uptake and
there is no hard evidence about the link71.

Prof Brent Taylor at the Royal Free criticises Wakefield for not utilising rigorous methods to investigate
his hypothesis about MMR72, he has not been able to reproduce the research nor has anyone else

The Panorama programme reports on findings of Prof John O’Leary, a specialist in detecting viruses
based in Trinity College, Dublin. O’Leary collaborated with Wakefield to investigate whether the
measles virus could be detected in gut and blood samples of autistic children. In the Panorama
documentary, O’Leary states that the measles virus was detected in 82% of the autistic children: “we’ve
identified a persistent measles infection in the guts of these children, which is statistically significant as
compared to normal controls”73. The findings were subsequently published in the journal Molecular
Pathology74 and the MMR controversy is reignited75. Nevertheless, the wider scientific community
remained sceptical76, indeed Wakefield’s team had not been able to find this evidence in their earlier
investigations of the bowel tissue77.

In the Panorama documentary, Wakefield claims that the research team have investigated around 200
cases of inflammatory bowel issues in children, finding “a remarkably consistent disease”78.
Furthermore, he defends making the link between MMR and autism, stating that “Proof may be ten,
fifteen years away in terms of definitive scientific proof… the proof was there, that the questions that
the parents had raised were valid…”79

The BBC documentary also highlights that by 2002, uptake of MMR vaccine in some areas of the UK
are well below that what is needed for herd immunity80, spurring the UK government to invest in an
advertising campaign to push the message to parents that MMR is safe despite claims made by
Wakefield81.

2003

Brian Deer is employed by The Sunday Times to investigate Andrew Wakefield and the Royal Free
team’s research.

2004

On the 22nd February 2004, Deer’s investigation of Dr Wakefield’s work is published in The Sunday
Times. It is claimed that Wakefield deceived both his colleagues and The Lancet, by failing to mention

71
BBC Panorama, 2002
72
BBC Panorama, 2002
73
Ibid.
74
Uhlmann V, Martin CM, Sheils O, Pilkington L, Silva I, Killalea A, Murch SB, Walker-Smith J, Thomson M,
Wakefield AJ, O'Leary JJ. Potential viral pathogenic mechanism for new variant inflammatory bowel disease.
Molecular Pathology. 2002 Apr; 55(2):84.
75
BBC Horizon, 2005
76
Ibid; BBC Panorama, 2002
77
BBC Horizon, 2005; Deer, B, Dispatches,
78
BBC Panorama, 2002
79
Ibid.
80
BBC panorama
81
BBC panorama, 2002
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a conflict of interest, exposing that at the time of the research, he was in receipt of funds from lawyer
Richard Barr of Dawbarns Solicitors, Norfolk, to seek evidence to use against manufacturers of MMR82.
Deer made the link through reviewing an article about the MMR legal case involving Rosemary Kessick,
reported in The Independent newspaper in 1996 which highlights the research conducted at the Royal
Free Hospital, funded by Dawbarns Solicitors83.

Rather than being a random sample, several families whose children were participants reported in The
Lancet paper were clients of Lawyer Richard Barr, seeking to sue manufacturers of the MMR vaccine
or had heard about Wakefield through ‘Jabs’ an MMR campaign group84. However, unknown to the
families involved in the research, was that Wakefield had been employed by Jabs Lawyer Richard Barr,
who was utilising ‘legal aid’ funding from the UK government to bring a case against MMR
manufacturers85. Barr used some of his legal aid budget to employ Wakefield to explore any links
between MMR and autism, funding his research and paying him £435,64386. No mention of this
funding or prior research agenda are made in the paper published in The Lancet87.

In addition to the allegations of conflict of interests, Deer also questioned the validity of the ethical
approval for Wakefield et al’s research and their treatment of research participants88. Deer alleged
that the research conducted did not correspond to the approval sought from and subsequently
provided by the Royal Free Hospital research ethics committee89. Furthermore, Deer had reason to
believe that the highly invasive procedures (lumbar punctures and intubations) which were conducted
on some of the vulnerable children, were unwarranted because they were not approved by the ethics
committee, but nor were they ‘clinically indicated’ investigations90.

The Editor-in-Chief of The Lancet, Dr Richard Horton, along with five other Lancet editors were
informed about Deer’s investigation at a meeting with Deer, three days before his article was due to
be published in The Sunday Times91. During the meeting they were presented with “confidential and
embargoed material”92 about the investigation which Deer claims was breeched by journal, who
promptly issued a press release before Deer’s article was published in collaboration with Murch,
Walker-Smith, Wakefield and Professor Humphrey Hodgson, Vice-Dean at the Royal Free and
University College School of Medicine93.

The press release by The Lancet consisted of statements by Horton the editor, Murch, Walker-Smith
and Wakefield and Hodgson94. Horton explained that the statements published followed the

82
Deer, B. Revealed: MMR research scandal, The Sunday Times, 22nd February 2004.
83
Deer, B, Rosemary Kessick's son was in lawyer's project which underlay vaccine scare [no date], available
online, assessed 20/9/2017: http://briandeer.com/wakefield/dawbarns-kessick.htm
84
Ibid; Deer, B. Hidden records show MMR truth, The Sunday Times, 8th February 2009.
85
Deer, B. Hidden records show MMR truth, The Sunday Times, 8th February 2009.
86
Ibid.
87
Deer, B. Revealed: MMR research scandal, The Sunday Times, 22nd February 2004.
88
Deer, B. Letter of complaint to the GMC, 25th February 2004; Deer, B. The Lancet’s two days to bury bad
news. BMJ, 2011.
89
Ibid.
90
Deer, B. Letter of complaint to the GMC, 25th February 2004;
91
Deer, B. The Lancet’s two days to bury bad news. BMJ, 2011
92
Deer, B. Letter of complaint to the GMC, 25th February 2004.
93
Deer, B. Letter of complaint to the GMC, 25th February 2004; Deer, B. The Lancet scandal [no date] available
online, accessed 20/9/2017: http://briandeer.com/mmr-lancet.htm; Deer, B. The Lancet’s two days to bury
bad news. BMJ, 2011
94
Statement, The Lancet, 2004: 363: 820-824.
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Committee On Publication Ethics (COPE) guidelines to provide “full disclosure and transparency
concerning these allegations” and goes on to claim that the “allegations of alleged research misconduct
have been answered by clarifications provided by the senior authors of this work”95. The accusations
about improper ethical conduct of the research were strongly refuted by the authors but it was
conceded that the potential conflict of interest arising from the Legal Aid funding should have been
declared in the original article, because this could have affected appraisal of the work 96. In the
statement provided by Hodgson, representing the Royal Free and UCL, it was concluded that they were
“entirely satisfied” that the research had been subject to independent and “rigorous ethical scrutiny”97.
Needless-to-say, Deer was critical of The Lancet press release and annoyed that Horton had colluded
with the others to publish statements concerning his work that had been provided in confidence, prior
to it being published98. What resulted was another “media firestorm”, whereby Deer’s article in The
Sunday Times was one of many99.

In Deer’s report three days later, the Editor of The Lancet is reported as stating that Wakefield’s link
between MMR and autism was “entirely flawed” and should not have been published100. Indeed, the
then Editor of the BMJ, Dr Richard Smith also criticised the publication of the paper exclaiming: "That
MMR paper is the best example there has ever been of a very, very dodgy paper that has created a lot
of discomfort and misery."101. Nevertheless, Wakefield publicly denied acting unethically and
defended his research as being “conducted in good faith”102; stating that the conflict of interest was “a
matter of opinion”103.

Wakefield’s co-author, Dr Simon Murch claimed that learning about the legal aid funding was not
something that he and his colleagues knew about, making it “a very unpleasant surprise” that had
caused some anger104. But, Murch also stated that he did not see the issue as “personal corruption”,
rather it was “a clear conflict of interest — it was not declared to us and it was not declared to the
journal, and it should have been."105. However, another co-author Dr Peter Harvey defended
Wakefield, claiming that there was no conflict of interest106.

On the 25th February, Brian Deer writes a letter to the GMC (sent by email) requesting that they use
their powers to investigate the conduct of Dr Wakefield in light of his investigation 107. In the
correspondence Deer urges the GMC to investigate the conduct of Murch, Walker-Smith and
Wakefield on grounds of the potentially dubious ethical conduct of the research, the issue of conflict
of interest and scientific fraud.

95
Ibid.
96
Ibid.
97
Ibid pg.: 824.
98
Deer, B. The Lancet’s two days to bury bad news. BMJ, 2011
99
Ibid.
100
Deer, B. Revealed: MMR research scandal, The Sunday Times, 22nd February 2004
101
Ibid.
102
Ibid; BBC News, Lead researcher defends MMR study, 22nd February, 2004, available online, accessed
20/9/2017: http://news.bbc.co.uk/1/hi/health/3510721.stm
103
Deer, B. Revealed: MMR research scandal, The Sunday Times, 22nd February 2004
104
Ibid.
105
Ibid.
106
Ibid.
107
Deer, B. Letter of complaint to the GMC, 25th February 2004
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On March 6th 2004, The lancet publishes a partial retraction of the Wakefield et al, 1998 paper,
whereby a ‘retraction of interpretation’ is made by ten authors of the original paper, only Wakefield
and Peter Harvey do not support this retraction (and it was not possible to contact John Linnell) 108.
The retraction of interpretation makes it clear that the 10 authors deem the evidence reported in the
paper insufficient to make a causal link that the MMR vaccine causes autism and furthermore they
retract the interpretation that there could be any such possibility in light of the public health concerns
about the vaccine109

On the 1st July 2004, Brian Deer emails Tim Cox-Brown, Fitness to Practise Directorate at the GMC
further to his previous request that Murch, Walker-Smith and Wakefield are investigated by the
GMC110. In the email, Deer annotates his views in response to the statements written by all three
doctors published in The Lancet on the basis of the documentary evidence he has gathered in his
investigation of the research111. Again, Deer urges the GMC to investigate the professional conduct of
all three doctors112.

In November 2004, Channel 4 aired a Dispatches documentary ‘MMR: What they didn’t tell you” based
on Deer’s on-going investigations into Wakefield113. The programme exposed that Wakefield’s
laboratory had failed to find traces of the Measles virus in bowel tissue samples extracted from
children with autism114. This claim was corroborated by a former PhD student of Wakefield, Dr Nick
Chadwick, who had developed a technique to test tissue samples and who co-authored a paper with
Wakefield & Pounder regarding this method115. Chadwick informed Deer that he had used method
and found no vaccine strain measles virus in the gut samples of autistic children, and that apparently
Wakefield was aware of this116. But it is claimed that he ignores Chadwick’s findings since they are not
compatible with his hypothesis and turns to another research team in Japan to validate his theory 117.
Like the findings of the O’Leary work, it is argued that the presence of the measles virus is due to
contamination118

Another claim of the Dispatches programme is that prior to commencing the research Wakefield
patents a range of products relating to a single measles vaccine (based on the controversial scientific
ideas of Hugh Fudenberg), suggesting that Wakefield also had a commercial interest in discrediting the
triple MMR vaccine119.

2005

108
Horton, R. The lessons of MMR, The Lancet, March 2004; 363: 747; Murch, SH et al, Retraction of an
interpretation, The Lancet; 363:750.
109
Ibid.
110
Deer, B, email correspondence to Tim Cox-Brown, GMC, 1 July 2004.
111
Ibid.
112
Ibid.
113
Dispatches, MR, what they didn’t tell you, Channel 4, November 2004, Available online, accessed 20/9/2017:
https://www.youtube.com/watch?v=7UbL8opM6TM
114
Ibid.
115
Ibid.
116
Ibid.
117
Ibid.
118
Ibid.
119
Ibid.
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BBC Horizon documentary aired examining the evidence – Does MMR Cause Autism?120 The
programme explores Wakefield’s claims about the potential link between MMR and inflammatory
bowel disease and regressive autism, finding little basis for this assertion apart from anecdotal
evidence of parents of children with autism121. It also reports on dozens of epidemiological studies
that have been conducted, post-Wakefield, to explore his claims, which have found no link and
conclude that the MMR vaccine is in fact safe and not responsible for rises in cases of Autism122.

The programme debunks claims made by Wakefield, reported in the 2002 BBC Panorama programme:
that is a ‘vulnerable subset’ of children are susceptible to autism triggered by MMR, who have the new
and distinctive bowel disease identified by Dr Simon Murch (a member of the Royal Free Hospital team
and co-author of the 1998 Lancet paper)123. And, that traces of the measles virus had been found in
the bowels of a ‘vulnerable subset’ of children with autism124. It reports upon new clinical studies into
that fail to replicate O’Leary’s findings and Dr Murch is featured, stating that the evidence now clearly
demonstrates that there exists no link between MMR and Autism125. Nevertheless, the programme
highlights that Wakefield continues to believe that evidence will be found that proves his hypothesis
and furthermore, documents continued support of Wakefield’s theories amongst parents of children
with regressive autism, identifying that a lack of clinical research to investigate the issue has not helped
to convince them otherwise126.

2006

Wakefield takes Libel court action against Channel 4 Television Corporation, Twenty Twenty
Productions Ltd and Brian Deer. The case is rejected by the judge The Hon Mr Justice Eady and
Wakefield is instructed to cover legal costs.

2007

On 16th July 2007, the GMC fitness to practise tribunal against Dr Simon Murch, Prof John Walker-Smith
and Dr Andrew Wakefield begins. The focus of the investigation is that the Doctors conducted
unauthorised research upon the 12 children who were participants reported in the case series research
published in The Lancet, rather than the validity of the findings of the research127.

2009

On the 8th February 2009, Brian Deer reports in The Sunday times that none of the other twelve co-
authors of the 1998 Lancet paper, were involved in preparing the data used 128. Deer claims that the
his on-going investigation of Wakefield (including interviews with some parents of the children
involved in case series and access to their medical records), combined with the evidence presented at
the GMC hearing demonstrates that the findings of the Wakefield 1998 research were selectively

120
BBC Horizon, 2005, Does MMR Cause Autism? 2005 available online, accessed 20/9/2017:
https://www.youtube.com/watch?v=VxFIl53_qKY
121
Ibid.
122
Ibid.
123
Ibid.
124
Ibid.
125
BBC Horizon, 2005, Does MMR Cause Autism? 2005
126
Ibid.
127
Deer, B. Hidden records show MMR truth, The Sunday Times, 8th February 2009.
128
Deer, B. Hidden records show MMR truth, The Sunday Times, 8th February 2009.
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reported and altered to assert a link between MMR and autism129. Significantly, timings of onset of
symptoms reported by Wakefield et al, varied considerably from those documented in the medical
records, as did diagnoses of both gut and behavioural problems130. Indeed, Deer reports that seven
out of the eleven children reported in the paper as having bowel problems did not according to other
specialists at the Royal Free131.

Importantly, Deer reports that in June 1996, prior to any of the children involved in the case series
being examined by Wakefield and his collaborators, Wakefield and Richard Barr (the Jabs Lawyer) filed
a document with the UK government’s Legal Aid Board, claiming a ‘new syndrome’ for which they
intended to seek evidence to legally represent families132. Thus, unknown to Wakefield’s research
participants or collaborators, the ‘new syndrome’ was already conceptualised and the purpose of the
research was to retrospectively gather evidence to support his claims133.

The media report also highlights how Wakefield stands by his research, denies allegations made against
him, and still works in Austin, Texas, conducting colonoscopies in children and touring the US giving
anti-vaccination lectures, whilst still maintaining a loyal following (including several participants who
were involved in the original case series)134. It highlights exasperation amongst scientists that despite
the evidence of wrong-doing, failure to replicate Wakefield’s findings and clinical and epidemiological
work that has gone on to disprove any link to MMR and autism, the controversy and mistrust of the
vaccination among many members of the public remains135.

2010

28th January 2010, The GMC fitness to practise hearing of Murch, Walker-Smith and Wakefield finally
concludes after two and a half years, making it the longest ever GMC disciplinary hearing 136, during
which the panel examined documentary evidence, and listened to cross-examinations of the three
doctors and evidence provided by 36 witnesses137. The GMC found Wakefield guilty of 30 charges
which included dishonesty and causing children to subject to invasive procedures that were clinically
unjustified, and found Walker-Smith to be irresponsible and unethical138.

On 10th May 2010 both Wakefield and Walker-Smith were ‘struck off’ the medical register, but Murch
was cleared over his involvement by the panel139. Later, after appeal, Walker-Smith is reinstated140.

129
Ibid.
130
Ibid.
131
Ibid.
132
Ibid.
133
Ibid.
134
Ibid.
135
Ibid.
136
Deer, B. The Lancet’s two days to bury bad news. BMJ, 2011; 342:c7001
137
GMC Fitness to Practise Hearing, 28th January 2010
138
Ibid; Deer, B. How the vaccine crisis was meant to make money, BMJ, 2011; 342:c5258
139
Deer, B. Andrew Wakefield erased after tribunal rules him "dishonest", "unethical" and "callous"
[No date] available online, accessed 20/9/2017: http://briandeer.com/wakefield-deer.htm.
140
Ibid.
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The GMC Panel concluded that Wakefield committed “serious professional misconduct” and described
him as “dishonest”, “unethical” and “callous”141.

Following the findings of the GMC hearing, on 2nd February 2010, The Lancet retracts the Wakefield et
al, 1998 article in response to the concerns about the work underlying the paper raised during the
GMC hearing which contradicts the earlier investigation of the work by the Royal Free and UCL Medical
School that stated that the study had full ethical approval (reported in a statement by Prof Humphrey
Hodgson, Vice-Dean and Campus Director at the Royal Free and University College School of Medicine,
printed in the Lancet 2004)142.

In May, the American Journal of Gastroenterology follows suit and retracts the Wakefield et al 2000
paper on the basis that it contained data from the 12 patients included in the retracted 1998 paper
published by The Lancet around which there were concerns about bias of the sample, inadequate
ethical approval and potential bias in the interpretation of the data143.

In May 2010 Wakefield publishes the book: Callous Disregard: Autisms and Vaccines: The Truth Behind
a Tragedy in which he claims that his removal from the medical register was a political move to silence
his criticism of vaccine safety144. In a review of the book, Joel Harrison states that the main themes of
the book are to first, discuss the vaccine safety studies and approval process and second, to discredit
Brian Deer and the GMC fitness to practise panel hearings145.

2011

Deer publishes a feature series in the BMJ: “Secrets of the MMR scare” detailing his full investigations
regarding the work of Andrew Wakefield, supplemented by the evidence presented in the GMC fitness
to practise hearings. In a series of 3 reports in January 2011 Deer discloses allegations of data
fabrication/manipulation, unethical research practices and conflicts of interest. It is revealed that in
addition to Wakefield’s commercial interests in developing a single measles vaccine, the Medical
School at the Royal Free were also involved in the development of the single vaccine product patents,
including Prof Roy Pounder, the organiser of the press conference, launching the 1998 Lancet paper,
which Deer argues boosted the commercial plans146. Deer claims that the business scheme with the
School disintegrates when a new Head of Medicine, Prof Mark Pepys took over in 1999 and that
Wakefield was finally paid to leave UCL in 2001 and with the condition that UCL were gagged from
making any critical comments about him147.

Also mentioned in one of Deer’s reports, is that Brent Taylor (head of community child health at Royal
Free), who reputedly frequently clashed with Wakefield and Walker-Smith, claims that Wakefield’s

141
Ibid; GMC Fitness to Practise Hearing, 28th January 2010
142
The Editors of The Lancet, Retraction - Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive
developmental disorder in children, The Lancet, 6–12 February 2010, Volume 375, Issue 9713, pg.445, Available
online, accessed 20/9/2017:
http://www.sciencedirect.com/science/article/pii/S0140673610601754?via%3Dihub
143
AJG, 2010, Errata, Corrigenda and Retractions, May 2010, Vol 105, pg.: 1214, Available online, accessed
20/9/2017: https://www.nature.com/ajg/journal/v105/n5/pdf/ajg2010149a.pdf
144
Harrison, JA. Wrong about vaccine safety: A review of Andrew Wakefield’s “Callous Disregard”. The Open
Vaccine Journal, 2013; 6:9-25.
145
Ibid.
146
Deer, B. How the Vaccine crisis was meant to make money, BMJ, 2011.
147
Ibid.
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team would “talk about how they would win the Nobel Prize for this” (referring to the MMR
research)148.

2012

Wakefield is reported as filing a defamation lawsuit against Deer, Fiona Godlee and the BMJ for the
accusations of fraud made against him in the Feature series about him published in the BMJ in 2011.
The case is filed in Texas in the US and is later dismissed (3/8/2012) by the Judge Amy Clark
Meachum149.

In January 2012, the BMJ and COPE hold a meeting to discuss research misconduct, which highlighted
that the UK needs to strengthen procedures for investigating research misconduct150

UCL publish MMR and the development of a research governance framework in UCL, a document
reflecting upon the MMR fiasco and what UCL can learn from the incident151. UCL state that they learnt
a lot from the Wakefield incident and sought advice from the UK Research Integrity Office (UKRIO)
about how to conduct a full investigation and detailed review of UCL governance procedures, however,
it was concluded that such a review would not be feasible for several reasons152:

1. UCL would not have sufficient authority to require potential witnesses to contribute, UCL
would therefore be unlikely to get full co-operation from all the individuals concerned
2. There is no formal complaint or complainant to trigger the formal UCL process
3. The considerable time that has elapsed since the initial research means that there evidence
will likely be affected by failings in memory and, it is unlikely that full documentary evidence
(lab notes etc.) would still be available to scrutinise.

UCL explain that their research governance framework is encompassed in 3 documents: the code of
conduct for research, the procedure for investigating and resolving allegations of misconduct in
academic research and the declaration of interest policy153. All three documents were present in 2004
but since then have undergone considerable review, and the policy documents are now overseen by
the UCL Research Governance Committee, which did not exist in 2004154.

UCL states that as a consequence of the Wakefield case it has introduced a revised research
governance framework “that is robust and fit for purpose”155. The institution states that this

148
Ibid.
149
Meachum, A, Travis County, Texas, 201st District Court, 3rd August, 2012, available online, accessed
20/9/2017: http://briandeer.com/solved/slapp-jurisdiction-dismissed.pdf
150
UCL, MMR and the development of UCL’s research governance framework, Press Release, 13 September
2012, available online, accessed 29/6/2017: http://www.ucl.ac.uk/news/news-articles/1209/13092012-
Governance
151
UCL, MMR and the development of UCL’s research governance framework, Press Release, 13 September
2012, available online, accessed 29/6/2017: http://www.ucl.ac.uk/news/news-articles/1209/13092012-
Governance ; UKRIO, UKRIO responds to ‘MMR and the development of a research governance framework in
UCL’, 13th September 2012, available online, accessed 29/6/2017: http://ukrio.org/ukrio-responds-to-mmr-and-
the-development-of-a-research-governance-framework-in-ucl/
152
Ibid.
153
Ibid.
154
Ibid.
155
Ibid.
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framework must now be adequately embedded into management infrastructure and remain dynamic
and workable to reflect ‘best practice’156. UCL argue that institutions need to be self-reflective and
also collaborate with others to critically review their policies and procedures annually and ‘actively
raise the profile of research governance issues’157.

UKRO also made a press release, welcoming the statement by UCL and stating that other institutions
should similarly evaluate their own research governance policies to ensure that they are adequate and
‘fit-for-purpose’, in addition to promoting UKRIO as a valuable source of support and advice158.

2016

Vaxxed: From Cover-Up to Catastrophe, a documentary directed by Wakefield is released, the film
claims Autism is growing exponentially and that this increase can be attributed to the MMR vaccine,
and that there is evidence to support this159. The film is a polemic and effectively claims that there is
a conspiracy between the US Centre for Disease Control (CDC) and manufacturers of the MMR vaccine
(who have financial interests in the CDC) and that there is effectively a ‘revolving door’ between roles
in industry, academia and policy makers160. The CDC and Pharmaceutical companies are accused of
covering up that the MMR vaccine can cause autism in some vulnerable children, which is evidenced
by a ‘whistle-blower’ Bill Thompson from the CDC161. Wakefield and others in the film claim that the
evidence shows that the vaccination schedule for MMR means that it is given at an age when children
are vulnerable to developing “isolated autism” because of the vaccine, particularly amongst children
of African American decent162.

Critics of the film claim that it ignores the fact that Wakefield has been discredited and struck off the
General Medical Council register, and that his research has been disproven and heavily criticised 163.
Furthermore, the film criticised for being very biased, and going against scientific consensus by failing
to acknowledge a wealth of research into MMR and autism that has found no link164.

In an interview with Wakefield on the Vaxxed website, he attempts to explain some of the allegations
levelled at him by Deer165: Wakefield claims that involvement with the MMR litigation occurred after
his research rather than before as Deer claims166. He also states that allegations that the research was
funded for and done for the purposes of the litigation are “absolutely untrue” , rather he claims that
the legal aid funds were to pay for him acting as a medical expert on behalf of the parents bringing the

156
Ibid.
157
Ibid.
158
UKRIO, UKRIO responds to ‘MMR and the development of a research governance framework in UCL’, 13th
September 2012, available online, accessed 29/6/2017: http://ukrio.org/ukrio-responds-to-mmr-and-the-
development-of-a-research-governance-framework-in-ucl/
159
Wakefield, A. Vaxxed, 2016
160
Ibid.
161
Ibid. Interestingly this ‘whistle-blower’ does not speak openly in the film, rather his evidence is provided in
the form of audio recordings secretly obtained without his knowledge.
162
Ibid.
163
Glenza, J, Vaxxed: an expert view on controversial film about vaccines and autism, 2nd April 2016, The
Guardian, available online, accessed 20/9/2017: https://www.theguardian.com/film/2016/apr/02/vaxxed-film-
scientist-interview-vaccines-autism
164
Ibid.
165
Wakefield, A, Dr Wakefield deals with allegations, 2016.
166
Ibid.
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litigation, and that the Lancet study was paid for by the NHS.167. Furthermore, Wakefield claims that
the editor of the Lancet was told a year in advance of the paper being published that he was working
with the legal team representing children believed to be affected by MMR; but he failed or forgot to
tell this to the GMC investigation whilst under oath168.

In the interview and Vaxxed film, Wakefield portrays himself as a medical expert championing the
cause of parents and children who have been affected by the MMR vaccine; standing-up against the
powerful pharmaceutical companies who are so influential of mainstream medical opinion. He claims
that Deer has ‘come after’ him and ‘concocted a fairy tale’ framing him as an ‘evil Dr’ out to profiteer
from causing controversy169. Wakefield claims that Deer’s investigation was a ‘public relations
strategy’ to silence and discredit him170.

In response to the accusations that he planned to profit from the single vaccine market through
discrediting MMR, Wakefield claims that this is not true and that the patent held by the University that
he was linked to, was not a single vaccine product171.

Finally, Wakefield also makes some counter allegations about Brian Deer, claiming that he has a very
‘intimate’ and ‘close’ relationship with GSK the manufacturers of MMR. He also highlights that James
Murdoch (son of Rupert, owner of The Times – Deer’s funder and publisher) was on the board of GSK172

2017

Whilst MMR vaccine uptake has increased again in the UK, the controversy about MMR continues.
Wakefield remains to be supported by anti-vax groups and parents who claim a link between MMR
and autism.

Resolutions & conclusions


Wakefield was paid to leave his position at the Royal Free in 2001 with a gag on Royal Free Hospital
making any critical comment about him.

GMC removes Andrew Wakefield from the medical register after the fitness to practise hearing

In response to the GMC ruling papers in The Lancet and the American Journal of Gastroenterology are
retracted in full.

The BMJ and COPE held a meeting to discuss the research misconduct in 2012 that is attended by
institutional leaders from across the UK and highlights the need to strengthen processes for
investigating research misconduct in the UK.

Institutional response UCL publishes a press release and policy statement reflecting on the MMR
fiasco, there is recognition that research governance issues are important and that institutions should

167
Ibid.
168
Ibid.
169
Ibid.
170
Ibid.
171
Ibid.
172
Ibid.
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be periodically reflect on the adequacy of internal policies and procedures, as well as work together to
maintain best practice.

The UK government has fought a continued public information campaign to refute the link between
the MMR vaccine and Autism and counteract the drop in uptake of the vaccine. Only recently are the
numbers of people opting for the vaccine starting to get back to the pre-MMR scare levels

To this day Wakefield denies any wrong doing and remains belligerent about the accusations made
against him. He retains considerable support among parents concerned about MMR and is champion
of the ant-vax movement. Despite rejection of Wakefield’s claims by mainstream scientific opinion,
the controversy rages on in public debate.

86
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University of Bristol – Case Study 2


The Actonel / Risedronate Affair
Summary
This case concerns a collaboration between a group of academic researchers based at the University
of Sheffield (UoS) and the drugs company Procter and Gamble (P&G) investigating the effectiveness of
the drug Actonel also known as Risedronate, post licencing. The case highlights complexities, potential
conflicts of interest and differences in methodological approach between the research collaborators,
regarding work conducted during early 2000s, which is partially reported in the Journal of Bone Mineral
Research (JBMR) in 2003. Furthermore, it demonstrates in depth, the plight of Dr Aubrey Blumsohn,
the whistle-blower who was also a collaborator in the research. The case received some media
attention at the time, in part due to the relentless activity of Blumsohn to try to get issues resolved.
Blumsohn heavily criticises the actions of P&G in this research, but also managers at the UoS and his
superior, Professor Richard Eastell, who is accused of deception and acting inappropriately. The case
leads to revised analyses of the research data originally published in the JBMR, which is published in
the JBMR as a letter of response. The case also leads to a General Medical Council fitness to practise
hearing for Professor Eastell.

Methods
Evidence for this case study consists of documents that are publically available via the internet. The
evidence was gathered through a combination of on-line searches for relevant keywords (e.g.
Professor Richard Eastell/Aubrey Blumsohn/Procter & Gamble/Actonel/Risedronate/University of
Sheffield/misconduct, etc) using Google and Google Scholar. Furthermore, evidence was gathered
through following a ‘paper-trail’ of citations and information from documents as they were collected.
Table 1 below details the different types of data and sources below (also see references and
bibliography for full details of sources used). Unfortunately due to time constraints it was not possible
to conduct interviews with any actors related to this case.

Table 2: list of evidence sources

Type Source

Newspaper articles & online news Times Higher Education supplement, The observer &
articles Guardian, The Ecologist, The Slate

Scientific blog Whistle-blower’s blog & other

Official documents GMC Fitness to practice hearing,

Personal & official Emails, letters, contracts, research statistical plan


correspondence (via whistle-
blower)

Audio recording (via online blog) Recorded by whistle-blower

Webpages and Wiki UoS, Russell Group, The Jabberwock

Academic Journal Articles JBMR, BMJ

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Academic organisations CAFAS

Types of alleged misconduct:

Significant in this case is the collaboration between industry and academia, whereby, Procter &
Gamble Pharmaceuticals (P&G) were the funders of the research in question, and a UK public
educational institution the University of Sheffield (UoS) were the recipients of these funds to conduct
the research. P&G had a commercial interest in the findings of the research, but UoS also had an
interest in being in receipt of substantial funding from the company. Furthermore, this case offers an
interesting view on the way the educational institution dealt with its members of staff: the senior
clinician-researcher accused of misconduct, as well as treatment of the whistle-blower. Moreover, it
also highlights how external organisations dealt with the issue of misconduct raised, including the
General Medical Council (GMC) that regulates UK clinicians and the academic journal concerned, the
Journal of Bone Mineral Research (JBMR).
The types of misconduct at stake in this case are: conflict of interests, ghost writing, misrepresentation
of data and deception.

Background information of the Accused

Professor Richard Eastell, MD FRCP FRCPI FRCPEdin FRCPath FMedSci

Professor Eastell has a medical background. He trained in Medicine at Edinburgh University, qualifying
in 1977173. He then went on to work in Edinburgh as a junior doctor, and as an MRC research fellow
between 1978-1980 conducting work in the field of osteoporosis, developing a technique for
measuring mineral density, funded by the MRC174. Following this research post, Eastell worked as a
registrar in Edinburgh until 1982 and then moved to Northwick Park Hospital in London until 1984,
conducting clinical work, training in endocrinology and diabetes175. Eastell then moved to work in the
USA for five years at the Mayo Clinic, Rochester, Minnesota. Here he did three years of purely research
work and two years of clinical training, under the supervision of Dr B L Riggs 176. Whilst working at the
Mayo clinic he developed novel methods to study osteoporosis177. He returned to England to Sheffield
in 1989 where he took up a senior research fellowship post in the department of Human Metabolism
and Clinical Biochemistry at the University of Sheffield178. Eastell set up a metabolic bone service at

173
General Medical Council, Fitness to Practise Panel (misconduct), 2-5 November 2009: D1/43; D/59,
Accessed 31/8/2017, http://www.thejabberwock.org/doc/doc00001.pdf
174
Ibid;
Eastell, R: Staff webpage, University of Sheffield, Accessed 31/8/2017, https://www.sheffield.ac.uk/oncology-
metabolism/staff/eastell
175
Ibid.
176
Ibid.
177
Eastell, R: Staff webpage, University of Sheffield
178
Ibid; General Medical Council, Fitness to Practise Panel (misconduct), 2-5 November 2009: D1/43; D/59
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the Northern General Hospital and in 1990 he became an Honorary NHS Consultant Physician 179.
Eastell progressed to become a Senior Lecturer at the University of Sheffield, and in 1995 became a
Professor of Bone Metabolism, where he was funded by the Arthritis Research Campaign to investigate
the development of osteoporosis and susceptibility to bone fracture in older men and women using
biochemical tests180.

Professor Eastell has proceeded to have a distinguished career in the field of bone research and
osteoporosis, gaining several awards during his research career181:

1997 – Hospital Doctor of the Year (osteoporosis category)

1998- Corrigan Medal of the Royal College of Physicians of Ireland

2004 – Kohn Foundation award from the National Osteoporosis Society

2004 – Society of Endocrinology Medal

2012 – Awarded the Philippe Bordier for Excellence in Clinical Research in Bone from the
European Calcified Tissue Society.

2014 – Fredrick C Bartter Award from the American Society for Bone and Mineral Research

He has been past president of the European Calcified Tissue Society, the Bone Research Society and
past chairman of the National Osteoporosis Society182.

At the time of the alleged misconduct, Professor Eastell was Research Dean for the School of Medicine
and Biomedical Science and member of the Academic Unit of Bone Metabolism at the University of
Sheffield; as well as the Research Director of Sheffield Teaching Hospitals.183 He was the research lead
at the University for the Procter and Gamble Pharmaceuticals (P&G) funding to investigate the
osteoporosis drug Risedronate/Actonel, and between 1994 and 2004, and was responsible for trials
into this drug184 (Eastell also had some prior experience of working with P&G when he first located to
Sheffield in a trial of Risedronate in steroid induced osteoporosis (a separate study) 185). Professor
Eastell also had other involvement with P&G as Chair of their UK scientific Advisory Board186.

At the time of writing (August 2017) Professor Eastell is Head of the Academic Unit of Bone Metabolism
in the department of Oncology and Metabolism and Director of The Mellanby Centre for Bone
Research (established in 2009)187, both based at the University of Sheffield188. Professor Eastell is a
National Institutes for Health Research (NIHR) Senior Investigator since 2009 and has published over

179
Ibid.
180
Ibid.
181
The Mallenby Centre, Investigators: Richard Eastell [no date], accessed 31/8/2017,
http://mellanbycentre.org/richard-eastell/; Eastell, R: Staff webpage, University of Sheffield
182
Eastell, R: Staff webpage, University of Sheffield
183
Blumsohn, A. Events Underlying the publication of Eastell et al., JBMR 2003, 2009, Accessed 31/8/2017,
http://www.thejabberwock.org/blog/pdf/pgprport2.pdf
184
General Medical Council, Fitness to Practise Panel (misconduct), 2-5 November 2009: D1/43; D/59
185
Ibid.
186
Blumsohn, A. Events Underlying the publication of Eastell et al., JBMR 2003, 2009
187
The Mellanby Centre, Home Page [no date], accessed 31/8/2017, http://mellanbycentre.org/
188
Eastell, R: Staff webpage, University of Sheffield
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320 research papers; and conducts senior editorial work for the academic journals ‘Bone’ and
‘Osteoporosis International’189.

Background information about the whistle-blower

Dr Aubrey Blumsohn MSc MBBCh PhD MRCPath

Dr Blumsohn originates from South Africa, where he qualified as a medical doctor and went on to
specialise in Chemical Pathology190. Along with several other South African doctors, Blumsohn wrote
a letter to the South African Medical Journal to protest about conditions at a hospital in Soweto and
consequently his medical contract was not renewed after he refused to apologise for this; so he left
the country to work abroad191.

Blumsohn undertook his PhD under the supervision of Professor Eastell in the Bone Metabolism Unit
at the Medical School at UoS192. He went on to work for five years in Dundee before returning to the
UoS where he took on the role of Senior Lecturer and honorary Consultant in Metabolic Bone Disease
in Eastell’s department. Here, Blumsohn headed a laboratory, working alongside Dr Rosemary
Hannon, measuring markers of bone turnover193. Dr Blumsohn was in this role, at around the time of
the alleged misconduct. Dr Blumsohn and Professor Eastell signed a contract with P&G to conduct
further work on blood and urine samples that had been collected and stored from the clinical trials
Professor Eastell had been involved in during the 1990s194.

In 2005, Dr Blumsohn was suspended from his Senior Lecturer role, facing disciplinary charges by the
UoS for communicating his concerns about misconduct to the media195. In March 2006, the disciplinary
charges were dropped by UoS, and Blumsohn resigned from his role under mutual agreement with the
university196 . It is reported that Blumsohn received a six-figure sum pay-off by UoS197. In 2009, Dr
Blumsohn was said to be living in the UK, based in Sheffield, working in pathology for the NHS 198.
However, a later article in 2014 states that he has now left both research and the medical profession199.

189
The Mallenby Centre, Investigators: Richard Eastell [no date],
190
Dyer, C. Aubrey Blumsohn: Academic who took on industry, BMJ, 339:b5293 (2009); The University of
Sheffield, The Medical School Staff: Aubrey Blumsohn [no date], Accessed 31/8/2017,
https://www.sheffield.ac.uk/medicine/staff/blumsohn
191
Dyer, C. Aubrey Blumsohn: Academic who took on industry, BMJ
192
ibid
193
Ibid; The University of Sheffield, The Medical School Staff: Aubrey Blumsohn
194
Dyer, C. Aubrey Blumsohn: Academic who took on industry, BMJ; General Medical Council, Fitness to
Practise Panel (misconduct), 2-5 November 2009.
195
CAFAS Update No. 50, Aubrey Blumsohn, 7 April 2006, pp.2-4, Accessed online 31/8/2017:
http://wp.cafas.org.uk/wp-content/uploads/2016/11/update50.pdf
196
CAFAS Update No. 50, Aubrey Blumsohn, 7 April 2006, pp.2-4
197
Dyer, C. Aubrey Blumsohn: Academic who took on industry, BMJ; Morgan, J. Life After Whistleblowing, July
31 2014, Accessed online 2/9/2017: https://www.timeshighereducation.com/features/life-after-
whistleblowing/2014776.article
198
Dyer, C. Aubrey Blumsohn: Academic who took on industry, BMJ.
199
Morgan, J. Life After Whistleblowing, July 31 2014
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Nevertheless, a ‘Linkedin’ profile in his name states that he is presently a medical doctor working in
Sheffield Teaching Hospitals, NHS200 Therefore, Dr Blumsohn’s current occupation is inconclusive.

The Institutional context

The University of Sheffield

University of Sheffield (UoS) is a university based in Yorkshire, England, UK which received its Royal
Charter in 1905. The university has gone on to become one of the largest research institutions in the
UK, and is held in high esteem201, with an international reputation for research excellence and
impact202. The university is a member of the prestigious Russell Group, a body who represents 24
leading research-intensive universities in the UK203. At the time of writing (August 2017), the university
is reported as having nearly 7000 members of staff and a turnover in excess of £575 million, with links
to local and national business as well as multinational companies204. The current Vice Chancellor is Sir
Keith Burnett, who was appointed in 2007.

The allegation of research misconduct in this case study refers to work conducted in UoS Medical
School, Bone Metabolism Unit, thus in the field of bone research, specifically osteoporosis. In 2007,
the UoS was ranked as one of the leading institutions in the UK in this field and is currently recognised
as a world leader in osteoporosis research205. At the time of the alleged misconduct the Vice Chancellor
of the UoS was Robert Francis Boucher CBE (Bob Boucher) who worked in this role from 2001-2007206.
The Dean of the Medical School was Professor Anthony Wheetman (from 1999-2008)207 and the Head
of Human Resources was Ms Rosie Valerio208.

The research context


The accusation of misconduct in this case concerns research conducted at the Medical School at
University of Sheffield in the Bone Mineral Research Group, headed by Professor Richard Eastell. The
issues relate to two corresponding projects. First, a review of blood and urine data from two trials into

200
Linkedin: Aubrey Blumsohn, accessed online 2/9/2017: https://uk.linkedin.com/in/aubrey-blumsohn-
ab2320a
201
Russell Group, Our Universities: University of Sheffield [no date], Accessed 31/8/2017,
http://russellgroup.ac.uk/about/our-universities/university-of-sheffield/
202
The University of Sheffield, About us, 2017, Accessed 31/8/2017, https://www.sheffield.ac.uk/about
203
Russell Group, Our Universities [no date], Accessed 31/8/2017, http://russellgroup.ac.uk/about/our-
universities/
204
Russell Group, Our Universities: University of Sheffield.
205
The Mellanby Centre, About the Mellanby Centre, [no date], accessed 31/8/2017,
http://mellanbycentre.org/about/
206
Tomlinson, G. Obituary: Bob Boucher, April 27 2009. Accessed online 31/8/2017:
https://www.theguardian.com/education/2009/apr/27/obituary-bob-boucher
207
The University of Sheffield, The Medical School Staff: Weetman [no date], accessed 31/8/2017,
https://www.sheffield.ac.uk/medicine/staff/weetman
208
Blumsohn, A. Science, academic integrity and the General Medical Council, in: CAFAS Update No. 64, 30th
September 2009. Accessed online 31/8/2017: http://wp.cafas.org.uk/wp-
content/uploads/2016/11/update64.pdf
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the osteoporosis drug Risedronate/Actonel (licenced in the UK since 2002209) involving UoS and funded
by Procter & Gamble (the drug manufacturers) 210. Trial data was collected as blood and urine samples
from more than 100 centres world-wide during 1999- 2000 and further measurements of this data
from two of three randomised trials was to be conducted by the Bone Mineral Research Group at
UoS211. The second project was initiated in 2002; here Professor Eastell and Dr Blumsohn signed a
contract with P&G to conduct further research to evaluate the findings of a third trial to investigate
the effectiveness of Actonel (post-licencing) by completing further measures on the blood and urine
samples previously collected, and an aim to provide a final analysis based on all three trials 212. Thus,
the data from projects one and two were overlapping and it was anticipated that a total of three
research articles would be produced from the two projects: one from project 1 and two from project
2213.

Some of the members of the UoS research team were directly, funded by P&G through the specific
research grants, but Professor Eastell also highlights during his cross-examination in his GMC fitness to
practise tribunal that the company also provided a ‘Sheffield Centre’ grant which paid for P&G to have
a collaborative base with the university department developing evaluation technologies where the
company would benefit from the latest technology being incorporated into their trials214.

Members of the Bone Mineral Research group research team identified in the documentary evidence
are: Professor Richard Eastell, Dr Aubrey Blumsohn and Dr Rosemary Hannon. Dr Hannon was in a
junior role as a research associate and had previously completed her PhD at the UoS, and worked with
Professor Eastell on project 1 evaluating the Actonel trial data215. During project 2, she continued to
work in the UoS research group in a laboratory set up by Blumsohn. It is confirmed that for the first
project at least, Dr Hannon’s wages came directly from the funding for the trial paid to UoS by P&G216.
Furthermore, Professor Eastell would have also had a substantial amount of his staff salary funded by
P&G, as well as being in receipt of and responsible for research income from the company 217. In
addition, he may have also financially benefitted from his role as Chair of the UK Scientific Advisory
Board of P&G, but this is not confirmed218

It is possible to identify a number of external researchers, who collaborated with the UoS team on the
Actonel research. Dr Ian Barton, a statistician employed by P&G, who was involved in project 1 and

209
Revill, Jo. How the drugs giant and a lone academic went to war, Sunday 4th December 2005, The Guardian.
Accessed online 31/8/2017: https://www.theguardian.com/uk/2005/dec/04/health.businessofresearch
210
Revill, Jo. How the drugs giant and a lone academic went to war, Sunday 4th December 2005; Washburn, J.
Rent-a-researcher: Did a British university sell out to Procter & Gamble? 22nd December 2005, Accessed online
31/8/2017:
http://www.slate.com/articles/health_and_science/medical_examiner/2005/12/rentaresearcher.html;
General Medical Council, Fitness to Practise Panel (misconduct), 2-5 November 2009
211
Washburn, J. Rent-a-researcher: Did a British university sell out to Procter & Gamble? 22nd December 2005;
General Medical Council, Fitness to Practise Panel (misconduct), 2-5 November 2009
212
Washburn, J. Rent-a-researcher: Did a British university sell out to Procter & Gamble? 22nd December 2005;
Dyer, C. Aubrey Blumsohn: Academic who took on industry, BMJ; Blumsohn, A. Events underlying the
publication of Eastell et al., JBMR 2003, 2009;
213
; Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009
214
General Medical Council, Fitness to Practise Panel (misconduct), 2-5 November 2009 (D1/60).
215
Ibid.
216
Ibid.
217
Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009
218
Ibid.
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2219 and co-authors of the project 1 manuscript published in the Journal of Bone Mineral Research in
2003220: Arkadi Chines, responsible for medical information at P&G, and Patrick Garnero and Dr Pierre
Delmas who worked at the French National Institute of Health and Medical Research (INSERM)
laboratory in Lyon221. Furthermore, Dr Simon Pack, a P&G employee is acknowledged as being involved
in the data processing of project 1, as well as Lisa Bosch, a medical writer also employed by P&G,
however neither are listed as authors of the project 1 publication.222

Discovery and accusation of misconduct


Prior to Audrey Blumsohn’s involvement in P&G funded Actonel/risedronate research, Professor
Eastell and Dr Hannon in collaboration with the individuals identified above co-authored a journal
article to disseminate the results of project 1. The paper was finally printed in the Journal of Bone
Mineral Research in 2003, however the team originally hoped to get the work published in the
Lancet223. The first allegations of research misconduct arise from this publication and from this
incident, further overlapping concerns about misconduct relating to the second project are also made
by Dr Blumsohn. What follows is a description of issues and events as they occurred in chronological
order.

The P&G funding for the first project evaluating Actonel was granted to Professor Eastell, however, at
the GMC fitness to practise tribunal, Professor Eastell revealed in his evidence that both he and Dr
Delmas from INSERM, had applied to P&G for funding to do this research so the company suggested
that they collaborate on this project, meaning that Prof. Eastell and Dr Delmas were of equal footing
in this project (something that Prof. Eastell was keen to highlight in his GMC tribunal)224. The
measurements performed on the urine samples (originally collected in the multicentre randomised
trials performed for licencing Actonel) were conducted in Sheffield, UK225. Measurements on the blood
serum were conducted by Dr Garnero226. In Sheffield, due to the large numbers of samples,
measurements were outsourced to Hospital laboratories under the guidance of Dr Hannon, and she
was then responsible for checking and collating the returned measurement data (entering them into
a large database) and subsequently supplying this to Ian Barton, a statistician employed by P&G who
was responsible for holding all the raw data and carrying out all the analysis of the data for project
1227. During 2001, Ian Barton performed statistical analysis of the data following a statistical analysis
plan that had been pre-agreed with Prof. Eastell, Dr Delmas, and the other authors in May 2000228.

Although Ian Barton conducted the data analysis for project 1, Prof Eastell maintains that he and other
members of the research team had access to summaries of the data and opportunities to view data

219
Ibid.
220
Eastell, R, Barton, I, Hannon, RA, Chines, A, Garnero, P Delmas, PD. Relationship of early changes in bone
reabsorption to the reduction in fracture risk with risedronate, J Bone Miner Res. 2003 Jun:18(6): 1051-6.
221
Eastell, R, Barton, I, Hannon, RA, Chines, A, Garnero, P Delmas, PD. Relationship of early changes in bone
reabsorption to the reduction in fracture risk with risedronate, J Bone Miner Res. 2003; General Medical
Council, Fitness to Practise Panel (misconduct), 2-5 November 2009.
222
Eastell et al, JBMR, 2003.
223
Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009; General Medical Council,
Fitness to Practise Panel (misconduct), 2-5 November 2009.
224
General Medical Council, Fitness to Practise Panel (misconduct), 2-5 November 2009.
225
Ibid; Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009
226
General Medical Council, Fitness to Practise Panel (misconduct), 2-5 November 2009.
227
Ibid.
228
Ibid.
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and analyses229. A preliminary analysis document from Ian Barton was provided to Eastell in April 2001,
and in May 2001 Prof. Eastell and Dr Delmas met in Paris to discuss the analysis and further work
required230. In June 2001, Ian Barton, Dr Delmas and Prof Eastell met in Madrid to discuss further
analysis of the data, including the best ways to present the data visually231. Prof Eastell describes this
meeting as “a very lively discussion on this data trying to work out what it meant until now and whether
there were any further analyses that would be helpful to better understand what is going on.”
Highlighting the he and Dr Delmas had some input in the data analysis and presentation of the findings
from project 1.232

In October 2001, Prof Eastell presented the data from project 1 at the American Society for Bone
Mineral Research, using the results from the preliminary data analysis as well as requesting some
further data analysis from Ian Barton233. In the meantime the researchers on project 1 (outlined above)
were preparing the journal article for this project. The Journal article was written originally for
submission to the Lancet, with Prof Eastell as first and correspondence author, Ian Barton as second,
followed by Hannon, Chines and Garnero, with Dr Delmas as the last author indicating co-seniority
with Prof Eastell in the research234.

At the GMC tribunal it is revealed that on 21st November 2001, Ian Barton and Professor Eastell met
for a whole day of writing, for which a publication brief was created in advance, initially by Barton 235.
The publication brief included figures and tables to be used as well as a provisional title and plans to
structure the document, based on the earlier discussions about the research had between Eastell,
Barton and Delmas throughout 2001236. The manuscript goes through several drafts with tracked
changes being shared between the authors as the article is revised237. During the creation of the
manuscript Dr Hannon’s role concerned the methods section of the document 238. Furthermore, as
well as the named authors on the paper, P&G employed their ‘in-house’ medical writer, Lisa Bosch, to
‘ghost write’ amendments to the article239. In the fourth iteration of the manuscript, Bosch includes
as part of her amendments a statement about data access, because from the 15 th September 2001,
the Lancet had strengthened their stance on publication ethics to stipulate that the “responsible
author” (i.e. Eastell as first author) “state that he or she had full access to all the data in the study and
had final responsibility for the decision to submit for publication” 240. In March 2002 the article from
project 1 was submitted to the Lancet, but the manuscript was rejected for publication by the
journal241.

229
Ibid.
230
Ibid.
231
Ibid.
232
Ibid (D1/49)
233
Ibid; Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009
234
General Medical Council, Fitness to Practise Panel (misconduct), 2-5 November 2009.
235
Ibid.
236
Ibid.
237
Ibid; Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009
238
General Medical Council, Fitness to Practise Panel (misconduct), 2-5 November 2009.
239
Ibid; Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009.
240
Ibid; Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009 (pg.5).
241
Ibid; Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009.
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After rejection by the Lancet, it was decided by the research team that the article should be revised
and submitted to the Journal of Bone Mineral Research (JBMR). A first draft for this journal was
provided on 1st May 2002. In this submission, the statement about data access required by the Lancet
remained as part of the acknowledgements section (see below)242:

“ACKNOWLEDGMENTS
We would like to acknowledge the help of Dr Simon Pack and Lisa Bosch of Procter & Gamble
Pharmaceuticals, as well as the help of Oldham Hospital Clinical Chemistry
Department for measuring urinary CTX and creatinine. This study was supported by grants from
Procter & Gamble Pharmaceuticals, Inc. (Cincinnati, OH) and Aventis Pharma, Bridgewater, NJ.
Employees of Procter & Gamble Pharmaceuticals and Aventis Pharma participated in the design and
execution of the study, the analysis of the data, and the preparation of the manuscript. All authors
had full access to the data and analyses.”

The article was peer reviewed and revised accordingly and received by the Journal of Bone Mineral
Research on 5th November 2002. By the 12th December 2002, the article was accepted for publication
by JBMR, and in June 2003, the article was published in the journal243.

This statement of data access and the timeline of dates of submission of the manuscript from project
1 are relevant issues regarding the allegations of misconduct and threats to research integrity made
by the whistle-blower in this case. This is because, during this time period, in July 2002, Blumsohn had
embarked on his research into Actonel with P&G (in collaboration with Prof Eastell, Dr Hannon and Ian
Barton) and had started to encounter issues raising concern regarding data access and the use of
medical (ghost) writers employed by P&G. Blumsohn has kept a detailed record of events and
correspondence relating to these concerns which will be discussed below244.

2002
Some initial concerns were raised for Blumsohn in May 2002, shortly after the revised manuscript for
project 1 had been submitted to JBMR and just prior to Blumsohn’s signing the contact to work on
project 2 with P&G245. He had learned that Eastell had been asked some “difficult questions” regarding
“who had analysed the data” at the American Society of Bone Mineral Research meeting that he
attended in the autumn of 2001246, and also at an International Osteoporosis Foundation meeting he
had attended247. Blumsohn was copied into an email from Prof Eastell to Ian Barton at P&G, in which
Eastell admits that he did not have full access to the project 1 data, or conduct an independent analysis
of it248. In the email, despite expressing faith in the data management and analyses conducted by P&G
employees, Eastell displays some discomfort with this situation, since he highlights that another
researcher had expressed surprise that he worked in this manner, he suggests to Barton in the email:
“I think that to avoid criticism in the future it would be good if we could say that we had done the

242
Ibid; Eastell et al, 2003, JBMR
243
Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009.
244
Ibid; Washburn, J. Rent-a-researcher: Did a British university sell out to Procter & Gamble? 22nd December
2005.
245
Ibid.
246
Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009 (pg. 6)
247
Ibid; Washburn, J. Rent-a-researcher: Did a British university sell out to Procter & Gamble? 22nd December
2005.
248
Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009
95
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analyses independently” and proposes that Blumsohn, should be enabled to do this for both the project
1 and 2 data249. On the 14th June, Ian Barton replies to Prof Eastell’s email stating that they do not
intend to have anyone else look at the analysis, since the team are transparent with the data analysis
methods utilised, therefore rendering an independent analysis of the data “just to make a few people
happy” unnecessary250. Instead, Barton suggests that a prospective data analysis plan be drawn up for
project 2251.

Despite Ian Barton’s email, on 2nd July 2002, Blumsohn and Eastell sign the contract for project 2 to
extend the Actonel work, in which the contract stated that “academics would be able to analyse and
interpret the data and report on the findings without interference from the company” 252 However, on
July 8th 2002, Prof Eastell receives an email from Dr Mike Manhart (Director of Clinical Development at
P&G, in the US), who admits that allowing Blumsohn to conduct an independent analysis of the data
would “add an extra layer of credibility”, but arguing that this would mean that “Industry loses the
opportunity to demonstrate its ability to be a true partner in scientific endeavours” 253. Manhart goes
on to raise concerns about the “time to result” delay and data protection/ownership issues if the
company release their data to an external analysist (Blumsohn)254. Instead, Manhart suggests the team
follow Barton’s proposals for a prospective data analysis plan255.

Blumsohn states that on July 24th 2002, P&G sent the statistical analysis plan. The plan states that it
demonstrates that the statistical analysis for project 2 has been prospectively planned, prior to the
company receiving the analysed samples from the UoS team256. However, Blumsohn argues that this
plan had little in the way of meaningful statistical plans, and rather focussed on “business purpose”,
and a “brand tactic” that was to initiate an “osteoporosis paradigm shift”257. This demonstrates the
strong commercial interests that P&G have in the findings of the research.

Regarding project 1, it is clear from the correspondence collected by Blumsohn during May-July 2002,
that Prof Eastell did not have full access to the data or conduct an independent analysis (indeed, this
is something that he concedes during his GMC fitness to practice hearing in 2009 258). Moreover, Dr
Hannon, admits that she did not view all the data but also stated “neither did I request access to all the
data”259. Furthermore, P&G refuse to let Eastell or Blumsohn access the data to conduct an
independent analysis. Despite these issues, the manuscript for project 1 was re-submitted to the JBMR
after peer review in November 2002, with the statement claiming full access to data and analyses for
all the authors. The article is subsequently accepted for publication by JBMR in December 2002, with
this statement included. At the time, Blumsohn does not make a complaint about this, although he

249
Ibid (pg. 6).
250
Ibid (pg.7)
251
Ibid.
252
Ibid.
253
Ibid (pg.8)
254
Ibid.
255
Ibid.
256
Ibid
257
Ibid (pg.8)
258
General Medical Council, Fitness to Practise Panel (misconduct), 2-5 November 2009.
259
Baty, P. When access to data is a real bone of contention, 25th November 2005. Times Higher Education.
Accessed online 13/9/2017: https://www.timeshighereducation.com/news/when-access-to-data-is-a-real-
bone-of-contention/199922.article, pg. 2/6
96
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describes having some concerns about the attitude of P&G in their correspondence260. Meanwhile, in
December 2002, Blumsohn’s laboratory provided the final raw data to P&G for the project 2 work, but
in line with their earlier correspondence and statistical analysis plan, P&G did not supply the
randomisation codes to Blumsohn which would enable him to conduct an independent analysis of the
data261.

2003
During April 2003, Blumsohn was sent a range of graphs and summaries of the analysis P&G had
conducted on the data. According to email archives collected by Blumsohn, on the 1 st April 2003, Ian
Barton privately emailed Prof Eastell to ask for abstracts for the American Society for Bone and Mineral
Research (ASBMR) regarding project 2 findings to be supplied within two days.262 In this email Barton
also states that P&G will provide a medical writer (Mary Royer) for the later write up of the first project
2 manuscript263. Subsequently, two abstracts are submitted for the ASBMR meeting in which
Blumsohn is cited as the first author and Eastell as the senior (presumably last) author, however,
Blumsohn claims that he did not author these abstracts, or actually know who did; presuming that
these abstracts were written by a P&G employee or perhaps Eastell himself 264. Blumsohn claims that
at the time he “did not object, but was bewildered” and that Eastell appeared unconcerned about this
process.

A “Procter and Gamble Sheffield Centre Grant Meeting” was conducted on the 16th April 2003, where
it is recorded that Blumsohn was to write publication drafts on the project 2 data using the analysis
reports provided by P&G in the previous weeks265. It is claimed that Eastell intended to submit
manuscripts using the data ‘as it stands’ to the Journal of Clinical Endocrinology and Metabolism266. A
week later, Blumsohn and Eastell are emailed by Ian Barton to introduce them to an external medical
writer Mary Royer to be employed by P&G for the creation of the two project 2 manuscripts267. In this
email, Barton describes Royer as experienced with the “risedronate data and our key messages, in
addition to being well clued up on competitor and general osteoporosis publications”, furthermore,
Barton asks how Eastell and Blumsohn would like to utilise the medical writer who can take over early
drafts or “write from the beginning”268. Following on from this, Blumsohn claims that one draft
publication was produced by P&G stating: “key message: The relationship between early changes in
NTX and longer term fracture risk for 5mg Risedronate is non-linear (p=0.008), consistent with findings
from the VERT trial”269.

The drugs Risedronate and rival Fosamax, manufactured by Merck work to reduce the risk of bone
fractures in patients with osteoporosis by increasing bone density and decreasing bone ‘turnover’ 270.

260
Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009
261
Ibid.
262
Ibid.
263
Ibid.
264
Ibid.
265
Ibid.
266
Ibid.
267
Ibid.
268
Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009.
269
Ibid, pg. 10.
270
Baty, P. When access to data is a real bone of contention, 25th November 2005. Times Higher Education.
Accessed online 13/9/2017: https://www.timeshighereducation.com/news/when-access-to-data-is-a-real-
97
Promoting Integrity as an Integral Dimension
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Fosamax, was considered by many Drs to be more effective at doing this than Risedronate and
therefore presumed to be more effective at preventing fractures271. This meant that Merck had about
three times more sales for Fosamax (at $3 billion) compared to P&G’s Risedronate at the time of the
research272. The significance of the key messages that P&G wanted to promote about Risedronate is
that as in Eastell et al’s previous research (project 1), there was a ‘plateau/threshold effect’ with
treatment so that beyond a certain level of depleted bone density, no further benefits are produced,
challenging the assumption that the extra reduction in bone turnover that Fosamax could achieve over
Risedronate would result in fewer fractures273. Hence P&G’s talk in the project 2 statistical plan that
the findings will lead to a ‘osteoporosis paradigm shift’274. Moreover, it seems that there were time
pressures on P&G getting their key messages out since Merck were due to publish a study comparing
the two drugs the following year (2004)275.

Dr Blumsohn wanted to have the opportunity to look at the raw data and conduct independent
analyses on it prior to commencing writing draft manuscripts to publish the data, and therefore in June
2003 he emailed Ian Barton (also copying in Prof Eastell and Dr Hannon) to ask for this information. Dr
Hannon in reply contacted Dr Blumsohn individually to congratulate him on his diplomacy in the
wording of the email to Ian Barton and stated “I hope you get the desired response”276. However later,
they received a reply email from Ian Barton stating that P&G did not want to delay or distract from the
writing and submission of the manuscripts and, although open to exploring the data more, that they
would be doing this277. Furthermore, Barton expressed that they wanted the manuscripts written
quickly because they had interesting and unique data and did not want P&G’s competitors to “pip us
to the post”278.

A few days later, on 12th June 2003, P&G conveyed another draft manuscript for a third publication,
relating to the abstracts for the ASBMR meeting written in Blumsohn’s name; which again repeated
the key message (see above)279. The next day Blumsohn reports that he approached Professor Eastell
because he was concerned that they would both be accused of scientific fraud 280. On the 19th June
2003, in response to Dr Blumsohn’s conversation with Prof Eastell, Ian Barton sends an email to
Blumsohn (copying in Eastell) to state that P&G do not provide data to “external parties”, but offering
Blumsohn the opportunity to visit P&G’s research and development site to look at the data in more
detail, perform analyses and write-up the publication briefs281. Blumsohn took up this offer and visited
P&G site to meet with Ian Barton on 28th July 2003282. At this meeting Blumsohn became aware that
the data analyses conducted by P&G were incorrect and the graphical data misrepresented, meaning

bone-of-contention/199922.article; Washburn, J. Rent-a-researcher: Did a British university sell out to Procter


& Gamble? 22nd December 2005.
271
Washburn, J. Rent-a-researcher: Did a British university sell out to Procter & Gamble? 22nd December 2005.
272
Ibid.
273
Baty, P. When access to data is a real bone of contention, 25th November 2005. Times Higher Education;
Revill, Jo. How the drugs giant and a lone academic went to war, Sunday 4th December 2005.
274
Washburn, J. Rent-a-researcher: Did a British university sell out to Procter & Gamble? 22nd December 2005.
275
Washburn, J. Rent-a-researcher: Did a British university sell out to Procter & Gamble? 22nd December 2005.
276
Ibid, pg. 12.
277
Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009.
278
Ibid, pg. 12.
279
Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009.
280
Ibid.
281
Ibid, Pg. 13
282
Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009.
98
Promoting Integrity as an Integral Dimension
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that it did not support the conclusions and key message reported in the journal article from project 1
(now published in the JBMR), nor the abstracts and draft publications from project 2, written in
Blumsohn’s name283. Blumsohn did not have access to the raw data so was not able to develop any
accurate analyses for publications and was concerned about the up-coming scientific meetings where
he was expected to present the findings as reported by P&G284. Indeed, Blumsohn was concerned
again to discover that he would be presenting a third abstract at the annual meeting of the American
College of Rheumatology, only when he received an email congratulating him on his successful
submission of an abstract that he had no role in writing285

In September 2003, Blumsohn has a meeting with Prof Eastell and Dr Barton to discuss the findings of
the research which he secretly audio records286. During this meeting Blumsohn expresses concerns
about the representation of the data and the ghost writing process for the abstracts to present at three
scientific meetings, including the ASBMR287. In response to the representation of data, Barton
expresses concern that if they alter the conclusion about the threshold effect, Merck (manufacturers
of Fosamax, a rival drug to Actonel) would use this information to their commercial advantage288.
Eventually a compromise was made, so that the misleading conclusion (that there was a threshold
effect in those treated with Risedronate) was removed from the meeting presentations, and Blumsohn
went on to present at the meetings as planned289.

In hindsight, Blumsohn says that he regrets presenting at these meetings290, but at this point, he states
that he envisaged he would now be permitted access to the raw data to conduct accurate analyses for
the planned publications, and that P&G, Eastell and other authors, involved in the published article
from project 1, would be taking steps to investigate whether the analysis of this was also flawed 291.
P&G argue that Blumsohn was permitted access to the data, also requesting several extra analyses to
ensure that he was comfortable with the data292. However, Blumsohn claims that was not the case,
stating that he never had full access to the data, and that Prof Eastell took no action 293. Interestingly,
a day after the meeting with both Ian Barton and Prof Eastell, Blumsohn secretly audio records a
conversation with Prof Eastell294. In this discussion Blumsohn states that he is more comfortable
presenting posters at the scientific meetings with the amended conclusions, but expresses concern
about oral presentations having not seen the data, in response Prof Eastell states295:

283
Ibid.
284
Ibid.
285
Baty, P. When access to data is a real bone of contention, 25th November 2005. Times Higher Education.
286
Washburn, J. Rent-a-researcher: Did a British university sell out to Procter & Gamble? 22nd December 2005.
287
Transcripts of meeting between Blumsohn, Eastell & Barton, 9 September 2003, available online (accessed
13/9/2017): http://www.fraudinscience.org/PG/20030909audio.htm, cited in Washburn, J. Rent-a-researcher:
Did a British university sell out to Procter & Gamble? 22nd December 2005.
288
Ibid.
289
Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009.
290
Baty, P. When access to data is a real bone of contention, 25th November 2005. Times Higher Education
291
Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009.
292
Baty, P. When access to data is a real bone of contention, 25th November 2005. Times Higher Education
293
Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009.
294
Transcript of meeting between Blumsohn & Eastell, 10th September 2003, available online (accessed
13/9/2017): http://www.fraudinscience.org/PG/20030910audio.htm, cited in: Washburn, J. Rent-a-researcher:
Did a British university sell out to Procter & Gamble? 22nd December 2005.
295
Ibid.
99
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“The only thing that we have to watch all the time is our relationship with P&G. Because we
are ... because we have the big Sheffield Centre Grant [from P&G] which is a good source of
income, we have got to really watch it. So.... the reason why I worry is the network within P&G
is like lightening. So if Ian is unhappy it goes to Arkadi, it goes from Arkadi to Nora and before
we know it, there is an issue, there is a problem... and it has to be addressed and so forth. and
so I was getting worried that the whole thing might be activated and that would affect our
relationship.”

This evidence demonstrates that Prof Eastell was concerned about the implications that challenging
Ian Barton’s work and questioning the intentions of P&G would have for the on-going funding and
collaboration with UoS. However, when later asked about these comments, Eastell claims not to
recognise these words or remember the meeting296. In terms of P&G’s objectives, despite alterations
being made to Blumsohn’s presentations for the ASBMR and ACR, P&G continued to promote the
effectiveness of Actonel, referring to the threshold effect in their promotional and educational
materials; revealing that the company wanted to promote their key message about Actonel rather
than a new interpretation of the data proposed by Blumsohn297. Nevertheless, to deal with his
concerns, Blumsohn was informed that for the two draft publications for project 2 that he was involved
in, P&G would revise the aim of the study, altering the study hypothesis in retrospect298. Subsequently,
a new draft manuscript was created by P&G, which also introduced a new author: Dr Pierre Delmas299.

2004
On 29th February 2004, Blumsohn reports that he emailed Prof Eastell to express that he was not happy
with the situation; he highlighted his confusion regarding who should be writing the (project 2)
manuscripts, and stated that corrections with regards to the published abstracts (where a threshold
effect for risedronate was reported) needed to be made in print as soon as possible 300. In response,
Eastell stated that he believed that it was still expected that Blumsohn was to be the lead author of
these planned papers301. However, Blumsohn still did not have access to the raw data and claims
therefore, at that moment, there was nothing he could write302. In late March 2004, Blumsohn again
emailed Ian Barton to request the raw data, copying it to Prof Eastell and blind copying his Trade Union
representative at UoS (who by now keeping track of correspondence) – this correspondence was
ignored by Barton303.

At the end of May 2004, Dr Blumsohn wrote a formal complaint to Prof Eastell, also sending a copy of
the letter to Prof Tony Weetman, Dean of the Medical School304. In the letter, Blumsohn makes it clear
to Eastell that he is not happy and, from the tone of the letter, Dr Blumsohn seems exasperated and
angry with the situation, importantly, the letter highlights that Blumsohn perceives this to be an issue
of scientific integrity and research ethics, identifying a number of areas of concern including: conflicts

296
Baty, P. Gag money rejected, 16th December 2005, Times Higher Education. Available online, Accessed
31/8/2017: https://www.timeshighereducation.com/news/gag-money-rejected/200366.article
297
Washburn, J. Rent-a-researcher: Did a British university sell out to Procter & Gamble? 22nd December 2005.
298
Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009.
299
Ibid.
300
Ibid.
301
Ibid.
302
Ibid.
303
Ibid
304
Ibid.
100
Promoting Integrity as an Integral Dimension
of Excellence in Research

of interest, misleading data and poor statistical methods, all with implications for patient care and
scientific knowledge (see excerpt below)305 . Prof Eastell replies to this letter, but fails to address
anything but access to the data in his response, and states that Tony Weetman suggest that he and
Blumsohn meet “face-to-face” to discuss the other issues raised 306. In response to this Blumsohn
states that he provides an angry reply, blind copying in the UoS trade union representative and other
members of staff307.

In mid-October Blumsohn receives a letter from Ian Barton, Richard Eastell and Pierre Delmas
apparently stating that they plan to go ahead and write up the project 2 work without Blumsohn if he
did not cooperate308. Blumsohn replies to this correspondence by writing again to Prof Eastell in early
November 2004, reiterating his concerns about research integrity previously expressed and stating
that he disagrees with their suggested approach of retrospectively adjusting the aims of the
research309. In December 2004, Dr Blumsohn receives a reply from Prof Eastell as a formal letter in
which it states that to maintain position as a co-author, Blumsohn must be willing to accept the
situation as it stands and sign an author’s agreement310. In this letter, Eastell also argues that not
having full access to the original data is common practice in collaborative work with pharmaceutical
companies, in line with the “PhRMA guidelines”311, and maintains that their approach of “working
closely with the statisticians to identify the best approach to analyse the data is an example of best
practice” 312. This argument is something that Eastell later relies upon during his GMC fitness to
practise tribunal in 2009313 and, is also used by P&G defending their actions as being “standard industry
practice”314.

305
Ibid.
306
Ibid, pg. 19
307
Ibid.
308
Ibid.
309
Ibid.
310
Ibid; Baty, P. When access to data is a real bone of contention, 25th November 2005. Times Higher Education
311
PhRMA stands for Pharmaceutical Research and Manufacturers of America, a lobbying organisation
representing pharmaceutical research company interests in the US (see: http://www.phrma.org/about)
312
Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009, pg. 24; Baty, P. When
access to data is a real bone of contention, 25th November 2005. Times Higher Education
313
General Medical Council, Fitness to Practise Panel (misconduct), 2-5 November 2009.
314
Baty, P. Data row sparks research debate, 25th November 2005, Times Higher Education, Available online,
accessed 31/8/2017: https://www.timeshighereducation.com/news/data-row-sparks-research-
debate/199898.article
101
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of Excellence in Research

Excerpt of letter from Dr Blumsohn to Prof Eastell (copied to Tony Weetman), dated 26th May
2004:

“… 1) No self-respecting scientist could ever be expected to publish findings based on data to


which they do not have free and full access.

2) This is particularly so when


a) There is a preconceived desirable result which is dictating statistical analysis, b) the
results are likely to benefit a pharmaceutical company patron,
c) Results are likely to have a direct impact on patient care,
d) Results are likely to influence our scientific understanding of drug action, and
e) Where the experiment is unlikely to be repeated or refuted by subsequent work.

2) It is inappropriate for a head of a University Department to pressurise a colleague (let


alone a senior one) to get involved in such activities based on data generated by that
colleague, to accept blindly the findings of company statisticians or the use of particular
statistical techniques, or to accept other misleading aspects of the treatment of data…”

“…This obfuscating process has been going on for over a year now, and the misleading analyses
have been in the public domain for 7 months. Given the persistent attempts to a) prevent a full
and proper examination and presentation of the data, and b) to prevent correction of the
scientific record, I can only assume that you have not conveyed my views to the company…”

2005
In late May 2005, Dr Blumsohn employs a legal representative at McKay LAW to write formal
complaints to Prof Eastell, Dr Larry Games (Vice President of Research and Development at P&G) and
Barbara Slatt (Manager of R&D at P&G) asking for the raw data relating to the abstracts in his name as
well as the Eastell et al, 2003 JBMR publication315. These letters make it clear that Dr Blumsohn
believes there to be misrepresentation of data and has concerns about research integrity 316. In
response to these letters Radcliffes LeBrasseur reply on behalf of Prof Eastell stating that he does not
possess the data so cannot help317 P&G’s legal team respond to state that providing access to the data
for external researchers is not standard practice and, furthermore that since Dr Blumsohn presented
the research at scientific meetings, the company do not understand the allegation that the data was
presented incorrectly318.

In May 2005, Blumsohn also writes to Prof John Eisman, Editor-in-Chief of the Journal of Bone and
Mineral Research to inform him that he is concerned about the validity of the data published in the
two project 2 abstracts written in his name, provided to the ASBMR in 2003; and asking to be

315
Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009
316
Ibid.
317
Ibid, pg. 26.
318
Ibid, pg. 28.
102
Promoting Integrity as an Integral Dimension
of Excellence in Research

disassociated from these319. Moreover, in his letter Blumsohn also states his concerns regarding the
Eastell et al, paper published in the JBMR in 2003320. During this period, Blumsohn’s legal
representative also writes to Prof Bob Boucher, Vice Chancellor of UoS to raise “serious concerns” and
request a meeting to discuss how the UoS could “support him as an academic confronted with an
important external threat to academic freedom and integrity”, yet this meeting was declined by Prof
Boucher321.

In June 2005 Dr Blumsohn again contacts Prof Tony Weetman322. The correspondence with Prof
Weetman, contains a copy of an email (sent from Weetman to Blumsohn, dated 29 th June 2005) in
which it appears that an ‘initial inquiry’ was conducted to investigate misconduct by the institution323.
However, a later media report claims that the UoS did not start any investigation in to the matter 324.
It can only be hypothesised that the initial inquiry referred to in the email, was perhaps not a formal
process. But, it appears that there was a “grievance committee” whose outcome was not favourable
to Blumsohn, because Weetman states that Blumsohn questions his “integrity” by claiming that he lied
about the conduct of the inquiry and stating that the committee was “biased to protect those
involved”325. These claims about the process apparently cause offense to Prof Weetman, for which he
requests an apology from Blumsohn326. In Blumsohn’s letter replying to Weetman’s email it is apparent
that he has supplied documentary evidence to the Dean to report an issue of research integrity and
misconduct to the UoS regarding the P&G research collaboration327. Furthermore, Blumsohn describes
a “poor collegial relations” with Prof Eastell328.

Also during this time, Blumsohn writes to Ms Valerio, Head of Human Resources at UoS to again
request a meeting with Prof Bob Boucher to discuss his plight in relation to the Actonel research 329.
The original letter is not available, but a reply to Ms Valerio by Blumsohn reveals that he was not
granted a meeting with the Vice Chancellor330. In the letter, Blumsohn states his concerns about the
conduct of Prof Eastell and the Actonel research (use of ghost authors, denial of access to full data,
incorrect data analysis and misrepresentation of data), however, the crux of the letter is asking that
university support him by seeking advice about whether P&G have breached their contract with the
university by not permitting UoS researchers full access to the data to conduct independent
analyses331. There is no further correspondence available in reply to these letters written by Blumsohn.

319
Blumsohn, A, Correspondence documents cited in: Washburn, J. Rent-a-researcher: Did a British university
sell out to Procter & Gamble? 22nd December 2005.
320
Ibid.
321
Baty, P. Gag money rejected, 16th December 2005, Times Higher Education.
322
Blumsohn, A, Correspondence documents cited in: Washburn, J. Rent-a-researcher: Did a British university
sell out to Procter & Gamble? 22nd December 2005.
323
Ibid.
324
Baty, P. Gag money rejected, 16th December 2005, Times Higher Education.
325
Blumsohn, A, Correspondence documents cited in and available via: Washburn, J. Rent-a-researcher: Did a
British university sell out to Procter & Gamble? 22nd December 2005.
326
Ibid.
327
Ibid.
328
Ibid.
329
Ibid.
330
Ibid.
331
Ibid.
103
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of Excellence in Research

In July 2005, apparently getting nowhere by raising his concerns with senior officials at the UoS,
Blumsohn announces his intention to go public with his concerns332. In September 2005, Aubrey
Blumsohn is suspended from his role at the UoS, after a complaint is made by Prof Weetman accusing
Blumsohn of conduct that is “incompatible with the duties of office”333. It is reported that this
disciplinary action was due to Blumsohn contacting the press and professional organisations regarding
his concerns about the Actonel research334, whereby the UoS criticised his “refusal to comply with a
reasonable management instruction by briefing journalists”335. The University of Sheffield claims that
they repeatedly encouraged Dr Blumsohn to present his concerns and evidence through the ‘proper
channels’ in line with university policies, so that they could be investigated by the institution 336. In a
statement made to The Observer, the UoS state337:

“the University of Sheffield has offered Dr Blumsohn a range of procedures, including the offer of
an independent investigatory panel, and direct access to the head of the university’s Research
Office and other senior staff. Despite this, the University of Sheffield has not received any
substantive complaint from Dr Blumsohn related to the Bone Metabolism Unit’s work with the
pharmaceutical company and thus the university has not been able to investigate this matter.”

Furthermore, in the same article Prof Eastell is cited as stating that “Blumsohn’s claims are
“misleading”” and that he “would welcome the opportunity to give evidence to the correct channels”338.
Blumsohn however, is reported as stating that making complaints through the UoS internal procedures
would not have been a correct way to deal with the issue339. Instead he was apparently seeking legal
advice and confirmation of support from the UoS if he were to directly challenge P&G about their
apparent breach of contract by refusing to provide full access to the data and permit independent
analyses340. Moreover, Baty reported in the Times Higher Education that Blumsohn “had lost
confidence in Sheffield’s internal procedures after an internal investigation into a separate
complaint”341. It is not clear what this refers to and whether this is this inquiry that is discussed in the
correspondence between Blumsohn and Weetman (described above).

At some point before September 2005, Blumsohn realised that he was in possession of some of the
Actonel research data, located in a graphics file that had been supplied to him by P&G342. In September
2005, a statistician Prof Martin Bland was employed by the BBC to examine this partial data for

332
Washburn, J. Rent-a-researcher: Did a British university sell out to Procter & Gamble? 22nd December 2005.
333
Baty, P. Gag money rejected, 16th December 2005, Times Higher Education.
334
Baty, P. When access to data is a real bone of contention, 25th November 2005. Times Higher Education;
Revill, J. Whistleblower wins drugs study inquiry, 11th December 2005, The Observer, Available online, accessed
31/8/2017: https://www.theguardian.com/uk/2005/dec/11/research.highereducation
335
Washburn, J. Rent-a-researcher: Did a British university sell out to Procter & Gamble? 22nd December 2005.
336
Ibid; Revill, Jo. How the drugs giant and a lone academic went to war, Sunday 4th December 2005.
337
Revill, Jo. How the drugs giant and a lone academic went to war, Sunday 4th December 2005.
338
Ibid.
339
Baty, P. When access to data is a real bone of contention, 25th November 2005. Times Higher Education
340
Ibid.
341
Ibid, pg. 4.
342
Bland, M. Risedronate, the BBC and me, December 2007, Significance, pg.: 175-178.
104
Promoting Integrity as an Integral Dimension
of Excellence in Research

reporter Vivienne Parry for the Radio 4 series ‘File On Four’, investigating the Risedronate case,
however the programme did not air as planned343.

In October 2005, Blumsohn reports that a complaint was made to the General Medical Council about
the conduct of Prof Eastell in relation the Actonel research and specifically regarding the publication
of the article from project 1 in 2003 by Eastell et al in the JBMR, in which it is claimed that Eastell makes
a false statement of having full access to the data and analyses344 . At this stage, the GMC do not
initiate any investigation of these claims.

During November -December 2005, several media articles reporting the issues were published in the
Times Higher Education345, The Observer346 and The Slate347 (an online outlet). Prof Bland who
conducted an independent analysis of the partial data held by Blumsohn reports that he expected his
analysis to be utilised in the report by The Observer, but this had been “pulled by the lawyers at the
last minute”348. Bland also reveals that P&G threatened to sue UoS around this time, but this threat
was dropped the following year349. Blumsohn remained suspended by the UoS, but in December 2005,
it emerges that the UoS offered him £120,000 compensation for loss of employment and £25,000 for
“injury to feelings” if he agreed to leave the university350. The UoS claimed that these negotiations
were not a result of Dr Blumsohn’s concerns with the P&G research reported in the press, but rather
other ongoing matters about several different issues351. The offer made by the UoS was turned down
by Dr Blumsohn352.

A number of consequences arose from media articles highlighting the Actonel affair: publicity of the
case ignited calls for there to be a debate about the responsibilities of academics regarding authorship
of research papers, with senior researchers from the University of Oxford and London School of
Hygiene and Tropical Medicine voicing concerns about industry collaborations following PhARMA
guidelines ‘standard practice’ of restricting full access to data to external researchers as in the Actonel
research353. It was also reported that journal editors were due to meet in January 2006 to look at
bringing stronger restrictions for publications354 and address concerns raised about industry
collaborations by the Actonel case355. Moreover, due to the media attention to the case, John Eisman,
the editor-in-chief of the JBMR stated that the journal would investigate concerns raised about the

343
Ibid.
344
Blumsohn, A. Events underlying the publication of Eastell et al., JBMR 2003, 2009.
345
Baty, P. When access to data is a real bone of contention, 25th November 2005. Times Higher Education;
Baty, P. Data row sparks research debate, Times Higher Education supplement, 25 November 2005; Baty, P.
Gag money rejected, 16th December 2005, Times Higher Education.
346
Revill, Jo. How the drugs giant and a lone academic went to war, Sunday 4th December 2005; Revill, J. Dr
Accuses drugs giant of ‘unethical’ secrecy, Sunday 4th December 2005, The Observer, Available online, accessed
31/8/2017: https://www.theguardian.com/uk/2005/dec/04/health.healthandwellbeing; Revill, J.
Whistleblower wins drugs study inquiry, Sunday 11th December, The Observer.
347
Washburn, J. Rent-a-researcher: Did a British university sell out to Procter & Gamble? 22nd December 2005.
348
Bland, M. Risedronate, the BBC and me, December 2007, Significance
349
Ibid.
350
Baty, P. Gag money rejected, 16th December 2005, Times Higher Education; Washburn, J. Rent-a-researcher:
Did a British university sell out to Procter & Gamble? 22nd December 2005.
351
Ibid.
352
Ibid.
353
Baty, P. Data row sparks research debate, Times Higher Education.
354
Ibid.
355
Revill, J. Whistleblower wins drugs study inquiry, Sunday 11th December, The Observer.
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of Excellence in Research

articles they had published356. The Medicines and Healthcare Regulatory Authority (MHRA) (a UK
government agency responsible for regulating standards in medicines, including education and
research), declared that they would conduct an initial inquiry to review the documentary evidence
relating Blumsohn’s allegations357. And finally, a member of Parliament, Paul Burstow (also a member
of the Health Select Committee) had called for a Commons debate on the regulation of the
pharmaceutical industry (held on Thursday 8th December 2005358) 359.

2006
In 2006, the Actonel case was picked-up by the Council for Academic Freedom & Academic Standards
(CAFAS), where it was reported in several newsletters which included sources of documentary
evidence and accounts written by Dr Blumsohn360. The tone of the newsletters was to raise awareness
of Dr Blumsohn’s plight and offer support from fellow academics. Through the CAFAS updates in 2006,
it is possible to identify developments in the Actonel case:

On 31st March 2006, Dr Blumsohn resigned from the UoS, and the University also dropped their
disciplinary charges against Blumsohn, making a joint statement361:

“Dr Blumsohn and the University of Sheffield are pleased to announce that they have
compromised their differences upon mutually satisfactory terms which they have agreed will
remain confidential”

It is understood that Blumsohn received a six-figure sum pay-out from the University362.

In CAFAS Update No. 50, it is reported that due to growing scrutiny in the UK and US, P&G “launched
a public relations offensive” by introducing a new “Bill of Rights” for researchers, under which
collaborating researchers would be permitted access to data363. Nevertheless, the newsletter also
reports that Blumsohn was still not being granted access to the Actonel data that he had been
requesting from P&G for several years, and was therefore sceptical about the real value of these new
rights364 (Indeed, at the time of writing (August 2017), it has not been possible to locate the P&G bill
of rights through internet searches). In response to these new rights, CAFAS reported that they
contacted the Vice Chancellor of UoS to enquire how he would ensure that P&G implement these
rights for their researchers, but reported that the UoS response failed to address the question asked365.

356
Ibid.
357
Ibid.
358
Unfortunately it has not been possible to locate the transcripts from this debate in the Hansard archive.
359
Revill, J. Whistleblower wins drugs study inquiry, Sunday 11th December, The Observer.
360
CAFAS Update No. 49, 20th January 2006, available online, accessed 31/8/2017: http://wp.cafas.org.uk/wp-
content/uploads/2016/11/update49.pdf; CAFAS Update No. 50, 7th April 2006, available online, accessed
31/8/2017: http://wp.cafas.org.uk/wp-content/uploads/2016/11/update50.pdf; CAFAS Update No. 51, 3rd July
2006, available online, accessed 31/8/2017: http://wp.cafas.org.uk/wp-
content/uploads/2016/11/update51.pdf
361
CAFAS Update No. 50, 7th April 2006.
362
Dyer, C. Aubrey Blumsohn: Academic who took on industry, BMJ; Morgan, J. Life After Whistleblowing, July
31 2014,
363
CAFAS Update No. 50, 7th April 2006
364
Ibid.
365
Ibid.
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Nevertheless, in April 2006, Blumsohn was assured by the Vice President of P&G that he would be
provided with the data366.

In February 2006, news of the Actonel case including independent analysis of the partial data by Prof
Bland (confirming that the data was indeed misrepresented by P&G statisticians) was reported by the
journalist Vivienne Parry on ‘You and Yours’, a consumer news programme on BBC Radio 4367.

In April 2006, it is reported in a Times Higher Education article that despite the UK government’s Chief
Medical Officer requesting that the MHRA investigation into the Actonel research, very little progress
had been made368. Blumsohn reveals, that he has not been asked for any documentary evidence, data
or met with any MHRA officials369. Apparently correspondence between Blumsohn and the MHRA
indicates that the agency classifies the case as “low priority370” and “do not have the proper remit to
investigate the issue because it’s “priority” is to inspect clinical trials where the risk to patients is” more
apparent and immediate”” 371. MP Paul Flynn is quoted in the article as criticising the MRHA and
pharmaceutical industry stating: “their tentacles spread everywhere including deeply into the MHRA,
which is the pharmaceutical industry regulating the pharmaceutical industry”372. This further
demonstrates a high level of scepticism and lack of trust surrounding the pharmaceutical industry in
the UK amongst some individuals.

Blumsohn reports that in Spring 2006, the JBMR place a “statement of concern” on its website referring
to the Eastell et al, 2003 paper from project 1 and the two abstracts (first authored by Blumsohn, ghost
written by Mary Royer) from project 2373. Presumably this statement is in response to the letter written
by Blumsohn to the editor-in-chief of the JBMR in May 2005 and the considerable media attention
given to the case during November and December 2005.

In April 2006, Blumsohn reports that P&G finally provide him and Eastell with the data randomisation
codes so that he is now able to independently analyse the data from projects 1 and 2374. Blumsohn
states that from this he could confirm that his suspicions that the data was misrepresented, making
the conclusions made in the Eastell et al 2003 JBMR paper and two abstracts printed in the JBMR in
his name, commercially favourable to P&G375. Indeed, in the CAFAS update No. 51, After obtaining the
full data, statistician Prof Jane Hutton also examined the data, confirming Blumsohn’s suspicions376.

366
Ibid.
367
It has not been possible to locate this episode in the Radio 4 archives.
368
Baty, P. ‘Malign’ effect, 7th April 2006, Times Higher Education, reproduced in CAFAS Update No. 50, 7th April
2006
369
Ibid.
370
Note: the Actonel research in projects 1 and 2 was conducted post-licencing.
371
Ibid.
372
Ibid.
373
CAFAS Update No. 53, 10th January 2007, available online, accessed 31/8/2017: http://wp.cafas.org.uk/wp-
content/uploads/2016/11/update53_1.pdf
374
Ibid.
375
Ibid.
376
CAFAS Update No. 51, 3rd July 2006.
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On 17th May 2006, CAFAS wrote a further letter to Prof Bob Boucher, Vice Chancellor of UoS regarding
Dr Blumsohn and the new P&G ‘Bill of Rights’, attempting to obtain full answers to their questions 377.
They asked about a review set up by UoS to investigate the issues raised by Blumsohn, since he had
not been contacted to contribute to this378 . In reply, dated 21st June 2006 (reproduced in CAFAS No.
51), Prof Boucher claims that the UoS will conduct a review about how they have dealt with the matters
raised by Blumsohn, using the “outputs of this review to reflect upon action and any procedural changes
deemed necessary”, whereby the “external chair” of the review group will “determine how they choose
to investigate and whom they wish to meet”. Furthermore, Prof Boucher, states that the UoS will co-
operate with the MHRA in their investigation. Yet also in CAFAS update No. 51, Blumsohn writes that
the MHRA: “failed to properly investigate, and provided gobbledygook responses to the mounting
barrage of concern from patient support groups and public policy analysts”379. Indicating that a full and
proper investigation into the case by them was unlikely, which Blumsohn claims that UoS were aware
of380.

Reflecting on the events in a statement about his plight published in a Council for Academic Freedom
& Academic Standards (CAFAS) update, Blumsohn draws attention to troubled relationships between
members of the UoS staff stating: “Events were brought into focus by poor collegial relationships,
conflicts of interest, other misconduct, and increasingly overt and unusual attempts by the University
to ignore and to hide allegations of improper conduct involving their Research Dean” 381

2007

In January 2007, CAFCAS Update 53, Blumsohn reports on a number of Freedom of Information (FOI)
requests that he requested, that no full investigation of the case by the MHRA occurred and no report
on the matter produced382. The FOI requests reveal that the MHRA deems the investigation ‘low
priority’ and outside of the remit of the agency383.

In November 2007, the JBMR publishes an editorial discussing the concerns raised by Blumsohn
submitted to the journal regarding the Eastell et al 2003 paper, claiming that there had also been a
number of enquiries from the media384. It was stated that in the interests of transparency, Eastell and
colleagues not employed by P&G, including two new independent authors had conducted an
independent review of the data and written a letter of response in relation to the statement of
concern385. Furthermore, Eisman states that as a consequence of this case, the JBMR would be
introducing new publication procedures which would insist on authors signing that they had full access

377
Ibid.
378
Ibid.
379
Ibid.
380
Ibid.
381
Blumsohn, A. The Issue. In CAFAS update No. 49, 20 January, 2006. Accessed online 31/8/2017:
http://wp.cafas.org.uk/wp-content/uploads/2016/11/update49.pdf
382
CAFAS Update No. 53, 10th January 2007.
383
Ibid.
384
Eisman, JA. Editorial. JBMR, 2007, 22 (11): 1654-1655.
385
Ibid.
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to data for all manuscripts, with the hope that this would promote and reinforce the independence of
academic researchers collaborating with pharmaceutical companies386.

The letter of response published in the same edition of the journal is significant because it publicly
admits that Eastell and the other authors who were not P&G employees did not have full access to the
data, in contrast to the statement published in the original article, however, it is argued that this is in
line with PhRMA guidelines387. Furthermore, it is admitted that the independent analysis of the data
reveals that there were “some errors and some poor practice” in the original work388.

Following the publishing of the letter of response, Blumsohn is quoted in the Times Higher Education
as stating that the independent analysis of the data validated the concerns he raised about the paper,
however, Baty highlights that despite the re-analysis, Eastell still concluded that a threshold effect
could still be supported389. Also reported is a statement by P&G, claiming “We agree with the
corrections noted by the independent researchers… and we are pleased that the re-analysis supports
the original conclusions drawn in 2003”390.

In December 2007, a further critique of the analysis reported in Eastell et al’s 2003 paper by Martin
Bland, a statistician who conducted the independent analysis of the partial data provided by Blumsohn,
is published in the Journal of the Royal Statistical Society: Significance391.

2008

A response by Bauer & Vittinghof to Eastell et al’s 2007 letter of response is published in the JBMR
which welcomes the independent reanalysis of the data, however, concerns are raised about this new
analysis, in particular, Bauer & Vittinghof state that the results need to be considered in the context of
more recent research which do not support the conclusion of the threshold effect proposed by Eastell
et al392.

2009

In September 2005 it is reported in the media that Richard Eastell will face a fitness to practise hearing
by the GMC in relation to the ‘false’ statement made in the 2003 JBMR paper stating that he and all

386
Ibid; Baty, P. Expert admits he did not have full access to data. Times Higher Education, 12th October 2007.
387
Eastell, R. Hannon, RA. Garnero, P. Campbell, MJ & Delmas, PD. Letter of Response. JBMR, 2007, 22 (11):
1656-1660.
388
Ibid.
389
Baty, P. Expert admits he did not have full access to data. Times Higher Education, 12th October 2007.
390
Ibid.
391
Bland, M. Risedronate, the BBC and me, December 2007, Significance.
392
Bauer, DC & Vittinghof, E. Letter to the Editor, JBMR, 2008. 23(8): 1349.
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the other authors had full access to the data and analyses393. The Guardian article also highlights the
practice of ghost-writing in research collaborations with drugs companies as problematic394.

On 30th September 2009, Blumsohn also writes a critique of ghost-writing and reports upon the
upcoming GMC hearing of Eastell, expressing concern that it would only superficially examine the case
and not deal with the thorny issues regarding research integrity and academic collaboration with the
pharmaceutical industry395.

In November 2009 The GMC fitness to practise hearing for Prof Richard Eastell commences on
Monday 2nd November and lasts for four days, finishing on Thursday 5th November 2009396. The
hearing indeed focusses on the JMBR paper published in 2003 in which Eastell makes the statement
about data access, and part of this includes discussion of the role of the medical or ‘ghost’ writers
employed by P&G397. During the GMC hearing it is stated in the evidence given by Dr Hannon and
Professor Eastell that the role of the company medical writer is not to make any substantive
contribution to manuscripts submitted for publication (therefore they are not named as an author),
their role is instead to ensure that the document has correct formatting, is well written and
comprehensible and follows the correct referencing formatting and rules of the Journal398. The
editorial corrections recommended by the medical writer are highlighted and sent to authors for
approval, and in this case Eastell and Barton received the tracked changes document from Lisa Bosch,
the P&G medical writer399.

At the hearing, Eastell admits that he was fully aware of the introduction of this sentence during the
drafting of the paper400. He argues that what is meant by the term ‘full access to the data and analysis’
is an important issue401. He claims that he thought and reflected on this sentence in terms of his
collaboration with Ian Barton the P&G statistician responsible for holding the raw data and analysis,
and states that the sentence was true in that all the authors had full access to the data through Ian
Barton the statistician, who was holder of the raw data402. Eastell claims that the authors had the
analyses sent to them and when further analyses were requested these were provided. He argues that
therefore in the ‘common sense’ of the meaning, the sentence was reasonable. Nevertheless, in her
evidence Dr Rosemary Hannon admits that she did not request either the full data or analyses, and nor
did she think to403.

393
Boseley, S. British doctor faces action over claims of ‘ghost writing’ for US drug company, The Guardian,
Friday 18th September 2009; Baty, P. Bone professor faces GMC probe. Times Higher Education, 22nd
September 2009.
394
Boseley, S. British doctor faces action over claims of ‘ghost writing’ for US drug company, The Guardian,
Friday 18th September 2009
395
Blumsohn, A. Science, academic integrity and the General Medical Council. CAFAS update N0. 64, 30th
September 2009. Available online, accessed 20/9/2017: http://wp.cafas.org.uk/wp-
content/uploads/2016/11/update64.pdf
396
General Medical Council, Fitness to Practise Panel (misconduct), 2-5 November 2009.
397
Ibid
398
Ibid.
399
Ibid.
400
Ibid
401
Ibid.
402
Ibid.
403
Ibid.
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The findings of the GMC hearing conclude that Richard Eastell may have acted negligently by allowing
the false statement to be published in the 2003 JBMR article404. However, he was not deemed to have
acted dishonestly and was not guilty of misconduct so that his fitness to practice was not impaired 405.
The GMC panel concluded that there was “an evolving understanding of access to data” during the
time period between when the article was first drafted and published in the JBMR, and the letter of
response by Eastell et al, that was published four years later in 2007406. The panel accepted Eastell’s
claim that he had now amended his practice and viewed the incident as “a single episode in an
otherwise accomplished career” in which Eastell was “still highly regarded in the research
community”407. Furthermore, on the basis of arguments from Eastell’s Lawyer, the GMC panel chose
not to issue a warning to Prof Eastell in case it harmed his ability to secure future research funding408.

In response to the GMC panel decision, Eastell is reported in the BMJ as saying:

“I am pleased that the GMC has exonerated me of any intentional wrongdoing. The GMC recognised
that there was never any intention on my part when I wrote the paper along with the others in the
Journal of Bone and Mineral Research in 2002 to deliberately mislead about our access to the data used
in the study. I have spent the last 30 years conducting research into the cause, diagnosis, and treatment
of osteoporosis, and over that time I have published around 295 papers. I am committed to continuing
with medical research and to working on new treatments for osteoporosis. Hopefully, this work will
hasten the development of better treatments for patients with osteoporosis.”409

In the same report, Blumsohn made a statement saying:

“I agree with the outcome. The GMC has done an important job in helping to define the meaning of
data and the responsibilities of scientific authors. The council has determined that access to data
means proper unfettered access to raw data so that authors can check findings reported in their
names.”410

Furthermore, in a later article published by the BMJ, it was revealed that Blumsohn was critical of the
GMC, for its “apparent tolerance for indiscretions of highly placed individuals” and subsequent slow
pace it had in deciding to investigate Professor Eastell411.

This final BMJ article sums up the events and asks Blumsohn if he would do anything differently in
retrospect, to which he replies: “I might not have done it in the same way. But I have no regrets that I
prevented the two further proposed papers from being published.” 412. And despite not considering
himself as a whistle-blower, states: “It’s hard to encourage anyone to speak out about poor practice in
the current environment. This case sums up what has gone wrong with systems set in place to ensure
safety and integrity in scientific medicine. It would help if regulators put as much effort into responding

404
Ibid; Dyer, C. GMC clears research dean of dishonesty, BMJ, 2009; 339:b4617
405
Ibid.
406
Ibid.
407
Ibid.
408
Ibid.
409
Dyer, C. GMC clears research dean of dishonesty, BMJ, 2009; 339:b4617
410
Ibid.
411
Dyer, C. Aubrey Blumsohn: Academic who took on industry. BMJ, 2009; 339:b5293.
412
Ibid.
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to serious critics and whistle-blowers as they do producing glossy brochures and yet more guidance.”
413

Resolution

Institutional:
Mutual agreement between Blumsohn and the University of Sheffield regarding his resignation
including a pay-off for an undisclosed amount.

There do not appear to be any policy or procedural review conducted at the UoS in response to this
case.

Funder:
A threat to sue UoS was made, which was dropped.

Apparently P&G have drawn up a ‘Bill of rights for researchers’, however, it has not been possible to
locate a copy of this.

After denying collaborating academic authors access to the full data and analyses, the company finally
decided to provide the data to Blumsohn and Eastell.

JBMR:
Issued an initial statement of concern, followed by an editorial and letter of response by Eastell et al
which included an independent analysis of the data once it was released by P&G

In light of the case, the JBMR revised their rules for submission of journal articles.

GMC fitness to practice hearing:


Eventually decided to investigate Eastell after he publicly admitted that the statement about having
full access to the data was incorrect. The hearing explored the use of ghost writers in academic
research collaborations with pharmaceutical companies and the issue of what counts as having full
access to data in research.

Found Eastell did not deliberately deceive, but did act negligently.

UK Government:
Held a debate about the issue in the House of Commons.

Instructed MHRA to investigate, but the issue was deemed to not be within their remit, since Actonel
is already licenced.

At around the same time period, The Health Committee published an investigation into the influence
of Pharmaceutical companies, however, this does not appear to be as a direct result of this case.

Conclusions

413
Ibid.
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 Prof Eastell was at the time of the alleged misconduct (and still is) a senior academic and
clinician who is well respected and held roles with responsibility for clinical research
governance, could this have had an effect on the way that UoS and GMC assessed this case?

 The voice of the institution seems weak - there appears to be little in the way of press releases
regarding reassurances. It is as if there were no issues of concern raised by Blumsohn.

 The treatment of the Whistle-blower, Aubrey Blumsohn in this case reveals how difficult it was
for him to be listened to and get support from his institution

 The case demonstrates the might of the funder and how reliant academic institutions may be
on investment in research from the private sector

 The case also highlights differences in perceived normal or best practices (such as the use of
ghost writers and access to data) between private industry and academic research institutions

 The case highlights the role of the publishers and their responsibilities to ensure that accepted
research manuscripts are scientifically sound and meet appropriate ethical standards.

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University of Trento – Case Study 1


Paolo Macchiarini
Author: Ilaria Ampollini

Resume
Paolo Macchiarini, an Italian surgeon working at Karolinska Institutet (Sweden), is found guilty of
misconduct (falsification and fabrication of data). The papers involved reported the results of a series
of windpipe transplants, that P. Macchiarini had been practising since 2008.

1. Personal, organisational and field levels

a) Personal level: people involved

Paolo Macchiarini, super-surgeon: one of the most famous doctors in the world at the time of the
events here considered; well known since 2008, when he had saved a woman's life with the first tissue-
engineered whole windpipe transplant. In 2011, he implanted the first artificial, plastic trachea into a
patient.
Careggi Hospital (Florence, Italy)
Karolinska Institutet (Solna, Sweden)
NBC and journalist Meredith Vieira
SVT swedish television and filmaker Bosse Lindquist
Whistleblowers (researchers and doctors from Karolinska Institutet and Karolinksa Hospital): Matthias
Corbascio, MD, PhD; Thomas Fux, MD; Karl-Henrik Grinnemo, MD, PhD; Oscar Simonson, MD.
Karolinska Institutet members: Vice-chancellor Andres Hamsten (Nobel Committee); Urban Lendhal,
professor of genetics at the Karolinska and general secretary of the Nobel Committee in Physiology or
Medicine; Harriet Wallberg (Nobel Committee); Hans-Gustaf Ljunggren, KI’s Dean of Research.

b) Organisational level c) Field level


Karolinska Institutet is a one of the most important medical universities in the world. It is a leading
centre for biomedical research, particularly in the following areas: Epidemiology and Registry-Based
Research; Clinical and Translational Research; Experimental Research; Regenerative Medicine and
Ageing Research. The Nobel Assembly at KI is a body of the Institution that awards the Nobel prize in
Physiology or Medicine.
As Asplund pointed out:

«The employment of Macchiarini at KI and the hospital was a part of a coherent strategy to build a
centre for advanced airway surgery at Karolinska University Hospital and KI»414.

The level of competition and pressures has been judged by the person we interviewed (see 5.E) as very
high: «High profile research in prestigious research centres [competition] is “very high”».

414
K. Asplund, The Macchiarini Case. Investigation of the synthetic trachea transplantions at Karolinska
University Hospital, August 2016, p.6
http://www.sll.se/Global/Verksamhet/H%C3%A4lsa%20och%20v%C3%A5rd/Nyhet%20bilaga/The%20Macchiar
ini%20Case%20Summary%20(eng).pdf
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See also below (section 2, paragraph Boundaries between healthcare and clinical research).

The researches by Macchiarini received funding from several institutions, including European
Commission415.

d) Field of research
Biomedicine: experimental surgery, regenerative medicine.

2. Description of the case: main aspects

Some preliminary clarification:


As clearly explained by Karolinska Institutet itself, Karolinska Institutet and Karolinska University
Hospital have different responsibilities and different roles in Paolo Macchiarini case. Macchiarini was
in fact a researcher at KI and by Karolinska Institutet he has been investigated for misconduct in
research:

«In the matter of Paolo Macchiarini and the allegations against him of scientific misconduct, KI’s task
was to investigate whether the scientific articles that had been criticised gave a true account of the
actual circumstances surrounding patients at the time of publication»416.

But the transplantations described in the articles were performed at Karolinska University Hospital
(and in Russia). Operations were entirely Hospital's responsibility; moreover, it was not a matter of
scientific misconduct, but rather of ethical issues or similar (such as lack of informed consent, failure
to obtain ethical review, but also the CV that turned out to be falsified). The contract of P. Macchiarini
with the Hospital expired in October 2013417.
In this report, for obvious reasons we'll only consider the matter of scientific misconduct related to
Macchiarini's research activity and his papers. For questions regarding transplantations, see The
Macchiarini Case. Investigation of the synthetic trachea transplantations at Karolinska University
Hospital, freely available at
http://www.sll.se/Global/Verksamhet/H%C3%A4lsa%20och%20v%C3%A5rd/Nyhet%20bilaga/The%2
0Macchiarini%20Case%20Summary%20(eng).pdf.

Origins, antecedents and contextual info: the super-surgeon tale


In 2012, surgeon Paolo Macchiarini is famous all around the world for trachea transplants he's been
performing since 2008, when he still worked in Spain, at Barcelona Clinical Hospital. At the beginning,
Macchiarini uses dead windipipes from donors, put in a biorector together with stem cells before the
transplants. The technique seems successful, as it's described in the paper

415
See for instance https://www.ncbi.nlm.nih.gov/pubmed/22119609.
416
Karolinska Institutet, A clarification of the responsibilities relating to the surgical implantation of synthetic
tracheas in Sweden and Russia, Karolinska Institutet website, January 2016,
https://internwebben.ki.se/en/clarification-responsibilities-relating-surgical-implantation-synthetic-tracheas-
sweden-and-russia
417
Ibidem.
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Clinical transplantation of a tissue-engineered airway published in «Lancet» journal in 2008


(http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(08)61598-6/abstract ). Authors'
summary says:

«Findings: The graft immediately provided the recipient with a functional airway, improved her quality
of life, and had a normal appearance and mechanical properties at 4 months. The patient had no anti-
donor antibodies and was not on immunosuppressive drugs. Interpretation: The results show that we
can produce a cellular, tissue-engineered airway with mechanical properties that allow normal
functioning, and which is free from the risks of rejection. The findings suggest that autologous cells
combined with appropriate biomaterials might provide successful treatment for patients with serious
clinical disorders»418.

Following these excellent results, Macchiarini becomes a super-star doctor, capturing a great amount
of attention from people and international media. Specifically, in Italy public opinion starts to be
interested into Macchiarini's work419 and the will to have him back quickly increases, connected with
the well-known rhetoric of the brain drain. At the end of 2008, P. Macchiarini starts working at Careggi
Hospital, in Florence, and two years later he is recruited from Karolinska Institutet420. He also receives
permission to work at the Kuban State University in Krasnodar (Russia).
In 2011, a new paper, published in «Lancet» journal, shows a new, great breakthrough: Macchiarini
has generated a windpipe implanting stem cells on a bioartificial, synthetic trachea. The trachea was
then transplanted in a patient. The paper, titled Tracheobronchial transplantation with a stem-cell-
seeded bioartificial nanocomposite: a proof-of-concept study, says:

«Methods. A 36-year-old male patient, previously treated with debulking surgery and radiation
therapy, presented with recurrent primary cancer of the distal trachea and main bronchi. After
complete tumour resection, the airway was replaced with a tailored bioartificial nanocomposite
previously seeded with autologous bone-marrow mononuclear cells via a bioreactor for 36 h [...]
Findings. We noted an extracellular matrix-like coating and proliferating cells including a CD105+
subpopulation in the scaffold after the reseeding and bioreactor process. There were no major
complications, and the patient was asymptomatic and tumour free 5 months after transplantation [...]
Interpretation. Tailor-made bioartificial scaffolds can be used to replace complex airway defects. The

418
P. Macchiarini et al. (2008), Clinical transplantation of a tissue-engineered airway, «Lancet», 372 (9655), pp.
2023-2030. Available at http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(08)61598-
6/abstract.
419
E. g.: E. Rosaspina, Eseguito da un italiano il primo trapianto di trachea al mondo: la paziente sta bene,
«Corriere della Sera», 19 November 2008.
420
«However, it seems that some negative signals did arise at the time of his employment: «From the hospitals
he previously worked at (in Italy, Germany and Spain), there were signals of inadequacies as a surgeon other
than surgical techniques, mainly in terms of indication decisions, in other words what kinds of operations were
performed on which patients. [...] Before Macchiarini was employed, he performed a “test operation” where his
Stockholm colleagues were impressed by his technical skills. The hospital took no references of its own on
Macchiarini’s clinical qualifications until a very late stage in the recruitment process. The warning signs that arose
then were suppressed. Pressure from KI and some time pressure appear to have contributed to Macchiarini
being employed as a senior physician despite the strongly negative signals from his former clinical colleagues»,
in The County Council of Sweden, The Macchiarini Case Summary, August 2016, pp. 6-7.
http://www.sll.se/Global/Verksamhet/H%C3%A4lsa%20och%20v%C3%A5rd/Nyhet%20bilaga/The%20Macchiar
ini%20Case%20Summary%20(eng).pdf
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bioreactor reseeding process and pharmacological-induced site-specific and graft-specific


regeneration and tissue protection are key factors for successful clinical outcome»421.

But in september 2012, P. Macchiarini unexpectedly goes under house arrest in Italy, for fraud and
attempted extortion. When the house arrest is revoked, P. Macchiarini resigns from Careggi Hospital,
declaring that some major powers were trying to abstacle his carreer422 and rejecting all the
accusations, and he eventually moves to Karolinska Institutet.
Meanwhile, the paper Development and Validation of a New Outcome Score in Subglottic Stenosis 423
by A. Ganfiotti et al. (among the authors, P. Macchiarini as well), originally published in «The Annals of
Thoracic Surgery», is retracted. As the journal's website explains, the paper

«has been retracted for scientific misconduct for reproducing a table but failing to acknowledge and
cite the previous, original work from which it was taken: Nouraei SAR, Nouraei SM, Upile T, Howard
DJ and Sandhu GS. A proposed system for documenting the functional outcome of adult laryngotracheal
stenosis. Clinical Otolaryngology, 2007; 32, pp. 407-409»424.

At Karolinska Institutet, P. Macchiarini continues his researches on tracheas transplants, while his
celebrity keeps on growing.
At the beginning of 2013, the journalist Meredith Vieira interviews P. Macchiarini for a two-hour NBC
special, called A Leap of Faith. The documentary, available at
https://www.youtube.com/watch?v=bGyl5YTqono, follows doctor Macchiarini in a new, brilliant
challenge: a synthetic-trachea transplant on a two-year old child. Macchiarini is presented as a super-
surgeon, capable with his technique to solve two of the most problematic obstacles for tranplants:
organ rejection and the lack of donor organs. The NBC special is transmitted in summer 2014.
Meanwhile, in a 2014 paper published in the «Journal of Biomedical Materials Research», Macchiarini
reports that Beyene, his first patient, had an «almost normal» airway a year after the operation,
repeating the phrase from the 2011 «Lancet» article. But by the time that article appears, Beyene,
after having suffered repeated infections, dies: the autopsy reveals the synthetic trachea had come
loose425.
After Beyene's death, four doctors at Karolinska Institutet begin to have doubts about synthetic
transplants and they suspect that Macchiarini have mispresented the success of the operations,
omitting or even fabricating data in his published articles.

Processing the allegations: whistelblowers and investigations


In August 2014, a Formal Appeal for an Investigation of Scientific Misconduct, signed by Matthias
Corbascio, MD, PhD; Thomas Fux, MD (involved in the aftercare of Macchiarini's patients at the
hospital); Karl-Henrik Grinnemo, MD, PhD (who had assisted Macchiarini in Beyene's organ transplant

421
P. Jungebluth et al. (2011), Tracheobronchial transplantation with a stem-cell-seeded bioartificial
nanocomposite: a proof-of-concept study, «Lancet», 378, pp. 1997-2004.
422
«He is only very annoyed at the injustice he is being suffering and he is almost sorry to be back in Italy», said
lawyer Rosario Bevaqua [...]», S. Innocenti, Arrestato il superchirurgo Macchiarini. «Approfittava della fragilità
dei malati», «Corriere Fiorentino-Corriere della Sera», 27 settembre 2012.
423
A. Gonfiotti et al. (2012), Development and Validation of a New Outcome Score in Subglottic Stenosis, «The
Annals of Thoracic Surgery», 94 (4), pp. 1065-1072.
424
http://www.annalsthoracicsurgery.org/article/S0003-4975(12)01315-X/abstract.
425
W. Kremer, Paolo Macchiarini: a surgeon's downfall, «BBC News», 10 September 2016,
http://www.bbc.com/news/magazine-37311038
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operation in 2011) and Oscar Simonson, MD, colleagues of P. Macchiarini at Karolinska Institutet, is
sent to the President of Karolinska Institutet. The Appeal includes an Analysis of Clinical Outcome of
Synthetic Tracheal Transplantation Compared to Results Published in 6 Articles by Macchiarini et al.,
followed by an Amendment in September 2014. The authors of the Formal Appeal list inconsistencies
and inaccuracies, including serial fabrications and omissions of biopsy findings; serial fabrications
and omissions of bronchoscopic findings and fabrication and omission of clinical status. They
especially refer to the 2011 paper:

«In the article: Tracheobronchial transplantation with a stem-cell-seeded bioartificial nanocomposite:


a proof-of-concept study. Jungebluth P et al. Lancet Vol. 378 Dec 10, 2011 (Appendix 4) which is a five-
month follow-up of a 36 year-old man from Iceland transplanted at Karolinska University Hospital in
June 2011, it is stated that biopsies performed in the early follow up demonstrate evidence of
regeneration of the mucosal lining of the trachea. However, in the patient’s medical records there is
no evidence of regeneration of the airway mucosa and actually just the opposite is found. Biopsies
analysed by different pathologists and taken at different times all show a chronically necrotic and
infected airway. This is further corroborated by bronchoscopic findings which are included in this
analysis on a USB memory storage device. In our opinion, the biopsy results in the Lancet article from
2011 seem to be fabricated. The other five articles analysed use the Lancet article of 2011 as their
primary reference and serve to perpetuate the fabrications of this initial publication. Please find the
other five articles listed below, as well as an analysis of all six of the articles and documentation of
their divergence from the patients’ medical records»426.

Other issues are raised by Professor Pierre Delaere (KU Leuven-Belgium)427, who writes a letter to
Karolinska Institutet, suggesting that P. Macchiarini has engaged in scientific misconduct, including
fabricating data.
In December 2014, on the basis of the complaint of his colleagues as well as of Prof. Delaere, Karolinska
Institutet undertakes two investigations: the first one assigned to Karolinska Institutet Ethics Council;
the second one assigned to an external reviewer, Professor Emeritus Bengt Gerdin.
In April 2015, KI’s Ethics Council clears Macchiarini of accusations levelled against him by Prof. Delaere,
whom allegations of scientific misconduct are judged unfounded and of a philosophy of science kind
rather than of a research ethical kind:

«The Ethics Council's general conclusion is that apart from the clinical outcome of the transplanted
patients - whose medical records we have not examined and which are being examined in another
investigation - we find that the issues raised by Professor Delaere are of a philosophy-of-science kind
rather than of a research-ethical kind. Accordingly, the Ethics Council concludes that, on the backdrop
of the examined issues, Professor Delaere's allegations of scientific misconduct are
unfounded".Delaere also suggested The Lancet, which published the first paper describing the

426
Matthias Corbascio, MD, PhD; Thomas Fux, MD; Karl-Henrik Grinnemo, MD, PhD and Oscar Simonson, MD,
Formal Appeal for an Investigation of Scientific Misconduct, August 2014, p. 2.
427
The original letter Prof. Delaere addressed to KI is not available. Some informations may be found here: P.
Delaere, Macchiarini and the tracheal regeneration scandal, forbetterscience.com, April 2016,
https://forbetterscience.com/2016/04/02/macchiarini-and-the-tracheal-regeneration-scandal-by-pierre-
delaere/.
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synthetic trachea transplant, had issues with its peer review. The Ethics Council refuted that
accusation, as well. Professor Macchiarini has allowed the Ethics Council to see the correspondence
between the authors and The Lancet. The Ethics Council can confirm that the paper was critically
reviewed by four reviewers in The Lancet»428.

The report of Gerdin’s investigation429 is released in May 2015, when Karolinska Institutet provides an
English translation of it. The report says that Prof. Gerdin found «examples of misconduct in seven of
Macchiarini’s published papers» and that Paolo Macchiarini was guilty of scientific misconduct by
presentation of fabricated data and other type of information in some cases and omission of relevant
data in other cases. Gerdin, basing his examination on a narrow definition of scientific misconduct430,
as explained by himself, writes that:

«To explicitly state that an ethical permit exists despite the absence of one is a false claim that affects
the reliability of the research; this is a serious departure from accepted scientific practice and
therefore qualifies as misconduct (Paper 1) .
To refer to paper 1 and make out that it accounts for a longer follow-up than actually was the case is
false. This also applies to the actual description of the healing of the mucosa over the prosthesis,
which in no way matches the accounts given in the medical records. In any case, it is an act of
carelessness and a departure from accepted scientific practice and therefore qualifies as misconduct
(Paper 2).
To describe the postoperative condition of a patient in such a way that leaves readers unable to make
any other interpretation than that the postoperative conditions are good when in reality the patient
has serious problems is to deliberately dress up the results. This is inconsistent with accepted scientific
practice and therefore qualifies as misconduct, regardless of the fact that the papers main purpose
is not purely clinical (Paper 3).
To state that the circumstances 12 months after the operation were good despite the patient being in
an extremely serious clinical condition and to claim by way of excuse that no check was made of the
patient's status in the hospital records is significant; it is inconsistent with accepted scientific practice
and therefore qualifies as misconduct (Paper 4).
To omit to mention that one of the reported patients had to undergo a new operation because of
material failure was an active withholding of information and a dressing-up of the results. Such
withholding of information is inconsistent with accepted scientific practice and therefore qualifies
as misconduct (Paper 5).
To selectively describe certain minor postoperative problems while omitting the really major
problems that led to the operated patient's death is a false embellishment of the results. This
constitutes active withholding of information, which is inconsistent with accepted scientific practice
and therefore qualifies as misconduct (Paper 6)»431.

At this point, Karolinska Institutet gives Macchiarini the opportunity to answer to the allegations, in
order to defend his own work. Macchiarini rejects all the accusations:

428
Ethics Council, Letter to Vice-Chancellor Anders Hamsten, April 2015, http://retractionwatch.com/wp-
content/uploads/2015/04/2445_001.pdf .
429
http://www.circare.org/info/pm/gerdin-finalrpt-20150513.pdf
430
See B. Gerdin, Statement of opinion on assignment, May 2015, pp. 10-11.
431
Ibidem, p. 35.
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«However, I strongly disagree with the conclusions of Professor Gerdin regarding the accusations of
scientific misconduct made against me. I was, in fact, deeply shocked to read them – knowing that I
had not carried out the actions of which I am accused»432.

Due to Gerdin's report, in June 2015 the Swedish Research Council freezes grant payments to
Karolinska Institutet center run by Macchiarini. Nevertheless, in August 2015, Karolinska
Institutet’s Vice Chancellor Anders Hamsten, after analysing the evidence gathered in Gerdin's report
as well as Macchiarini's response, rules that Macchiarini's behaviour does not qualify as scientific
misconduct:

«Now that we have examined the allegations of scientific misconduct in all seven indicted articles, we
have found that they contain certain flaws but nothing that can be considered scientific
misconduct»433.

Shortly after, P. Macchiarini writes an open letter to retractionwatch.com, the website that has
followed all the phases of the case. He states that:

«[...] accusations of scientific misconduct can have many motivations, and one of them is to attempt
to destroy someone’s career. We all know how easily a reputation can be damaged, and how hard –
nearly impossible – it is to repair. The availability of a website willing to publish all and any allegations
sent to it will make false accusations an even more powerful weapon available in the deplorable
political battles of academia – something that could eventually undermine the whole nascent
framework being built to support genuine whistle-blowers and expose genuine wrongdoing. This is
why I fear that Retraction Watch has overstepped its mark in branching out from documenting facts
to providing a platform for dangerous gossip in a way that threatens to damage, rather than help
serve, the professional academic community»434.

At the end of 2015, the entire case seems to be closed and P. Macchiarini appears to be cleared from
every suspects of misconduct.

Role of the media


But in January 2016, Vanity Fair publishes a story about how Macchiarini fell in love with an NBC
producer, while she was working on the documentary A Leap of Faith, because he had promised her a

432
http://www.circare.org/info/pm/si-Paolo%20Macchiarini%20response.pdf.
433
Ki Press Office, Visiting Professor at Karolinska Institutet cleared from suspicions of scientific misconduct,
Karolinska Institutet website, August 2015, http://news.cision.com/karolinska-institutet/r/visiting-professor-at-
karolinska-institutet-cleared-from-suspicions-of-scientific-misconduct,c9820224 . Cfr. Official documents about
Vice-Chancellor Hamsten's decision are freely available online: Decision (1)
https://internwebben.ki.se/en/node/26403 and Decision (2) https://internwebben.ki.se/en/node/26404. See
also the interview to Vice.Chancellor A. Hamsten, at https://internwebben.ki.se/en/vice-chancellor-anders-
hamsten-comments-inquiry-allegations-scientific-misconduct .
434
P. Macchiarini, Where I think Retraction Watch went wrong. A guest post from Paolo Macchiarini,
retractionwatch.com, September 2015, http://retractionwatch.com/2015/10/09/where-i-think-retraction-
watch-went-wrong-a-guest-post-from-paolo-macchiarini/
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marriage celebrated by Pope Francesco II, as well as a wedding party with hosts like George Clooney
and Barack Obama. She then found out that none of the things P. Macchiarini had promised was true
and she told the story to Vanity Fair journalist. In the meantime, the Swedish Television airs a series
of documentaries about Macchiarini: the three episodes435, partially translated in English, brings to
light some concerns regarding his work436.
Macchiarini reacts negatively to the documentary, arguing that it is misrepresentative437.

A. Hamsten too reacts to SVT documentary, writing a letter to all Karolinska Institutet professors to
clarify his position:

«On 28 August 2015 I made a decision that it was not a case of misconduct, but I criticised Macchiarini
for carelessness and for the fact that sections from the publications did not live up to the high demands
that KI and the scientific community place on quality. Just before Christmas I received a letter from
Bengt Gerdin in which he presented his opinions on the decision to acquit Paolo Macchiarini of
misconduct in research. I have thoroughly reviewed this with colleagues in KI management and taken
note of Gerdin's opinions, but find no new facts that warrant a re-opening of the investigation into
misconduct in research»438.

Finally, the authors of the Formal Appeal dated August 2014 write a letter to the Swedish Medical
Association news magazine «Sjukhuslakaren» addressed to A. Hamsten and his colleagues, underling
that they had provided evidence of misconduct long before the SVT documentaries439.

Following the numerous questions raised by SVT series, the Royal Swedish Academy of Sciences asks
for a new investigation, requiring that:

«[...] the enquiry into scientific misconduct is reopened and transferred from Karolinska Institutet to
the Central Ethical Review Board. It is of the greatest importance that the case is decided in an
impartial manner that gains general acceptance and repairs the credibility of medical research»440.

In February 2016 Karolinska Institutet reopens its misconduct investigation into Macchiarini and
requests four statements from the Expert Group for Misconduct in Research at the Central Ethical
Review Board. The first statement regards a 2014 paper (Experimental orthotopic transplantation of a
tissue-engineered oesophagus in rats, «Nature Communications», 5, p. 3562):

«The Expert Group has been asked to provide a statement on whether the contents of the documents
in the case constitute misconduct in research. The Expert Group is thereby requested particularly to

435
https://www.svt.se/dokument-inifran/experimenten-stjarnkirurgen/.
436
Based on this series, BBC releases, in October 2016 , the documentary Fatal Experiments: The Downfall of a
Supersurgeon http://www.bbc.co.uk/programmes/b080xglm/episodes/guide.
437
N. Frizzell, Fatal experiments: a maverick surgeon strikes back, «The Guardian», 25 October 2016.
438
A. Hamsten, Letter from the Vice-chancellor to all KI professors, January 2016.
439
http://www.sjukhuslakaren.se/visselblasande-kirurgernas-egna-ord-om-kis-agerande/.
440
Royal Swedish Academy of Sciences, The Royal Swedish Academy of Sciences takes action against scientific
misconduct - Press release, February 2016, http://www.kva.se/en/pressroom/2016/vetenskapsakademien-
kommenterar/.
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comment on whether the descriptions of the results in the article come across as distorted and if the
co-authors are responsible for the content of the article both before and after publication»441.

The board concludes that

«The article also contains a number of references which have resulted in incorrect interpretations,
thereby misleading the ethical committee on animal research. The pictures and figures that reportedly
demonstrate the success of the experiment are also incorrect and misleading in several places. The
raw data that the Expert Group has had access to is not always consistent with the figures in the
article, which leads to incorrect conclusions. The methodology is briefly described in the article; it is
not possible to extract original from the material submitted in the case; there are no systematic records
or summaries, inter alia, of which analyses and how many were performed, and how the data has been
processed and analysed statistically [...]It is therefore, in the Expert Group's view, conclusively
established that the presentation of the results in the article is inconsistent with the outcome of the
research that was conducted, which is scientific misconduct»442.

And regarding P. Macchiarini:

«There is no doubt that the article's main author, Paolo Macchiarini, has the main responsibility for
the content of the article and that he is therefore guilty of misconduct in research»443.

Following that, Karolinska Institutet declares Macchiarini and three co-authors culpable of
misconduct in the 2014 «Nature Communications» paper. At the time of the decision, one of the co-
author is no longer employed by KI, as well as Macchiarini. The other two co-authors are junior
researchers and they are judged to have acted in a position of dependence by P. Macchiarini: for this
reason, they are issued a simple admonition. The responsible department head is asked to supervise
their future researches.
In October 2016, «Nature Communications» issues an expression of concern for the paper:

«Nature Communications is publishing an editorial expression of concern on the manuscript


‘Experimental orthotopic transplantation of a tissue-engineered oesophagus in rats’ from Sjoqvist et
al. to alert our readership to concerns regarding the integrity of the study. An investigation related to
this research has been conducted by the Expert Group for Misconduct in Research at the Swedish
Central Ethical Review Board on behalf of Karolinska Institutet. A statement on behalf of the Expert
Group summarizing the results of this investigation raises concerns regarding the extent to which the
data presented in this Article accurately report and are fully representative of the results of the
experiments that were carried out. Concerns have been raised regarding the in vitro characterization
of the oesophageal scaffold, in vivo imaging of the transplanted oesophageal scaffold and the degree
to which its transplantation into animals was successful. We are currently following our established
process to investigate these issues further».

441
Central Ethical Review Board, Statement, September 2016, http://www.circare.org/info/pm/O1-2016-
statement-expert-group-for-misconduct-in-research-160906-eng.pdf .
442
Ibidem, p. 3.
443
Ibidem.
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The paper was retracted in March 2017 at the request of the authors.

Consequences: dismissions, recommendations and new actions


In February 2016, as the new investigation starts, Urban Lendhal, the general secretary of the Nobel
Assembly, resigns, as announced by the Nobel Assembly itself:

«Today, Professor Urban Lendahl has announced that he resigns effective immediately and at his own
request, from his position as Secretary General of the Nobel Assembly and the Nobel Committee in
Physiology or Medicine at Karolinska Institutet. The Board of Karolinska Institutet has initiated an
external investigation concerning the Macchiarini case. As Professor Lendahl anticipates that he may
be involved in this investigation, he resigns from his position as Secretary General out of respect for
the integrity of the Nobel Prize work [...]»444.

Vice-chancellor Andres Hamsten and Hans-Gustaf Ljunggren, KI's Dean of Research, resign too.

In March 2016, the Staff Disciplinary Board of Karolinska Institutet decides to rescind Macchiarioni's
contract. The Board lists the following motivations:

«PM’s activities at Kuban State Medical University in Krasnodar are in breach of KI’s fundamental
values and have damaged KI’s reputation. PM failed to truthfully and fully report his extra-occupational
activities. PM supplied false or misleading information in the CV he submitted to KI. Paolo Macchiarini
demonstrated scientific negligence, according to KI’s investigation in 2015»445.

In May, Paolo Macchiarini is interviewed in The Swedish Medical Association news


magazine «Läkartidningen»: in that occasion, he claims that KI's decision to discharge him is ill-
founded and that KI's actions were media-driven.
Meanwhile, «Lancet» removes four authors, upon their request, from Paolo Macchiarini’s seminal
2011 paper, which described the first transplant of an artificial trachea seeded with autologous stem
cells. «Lancet» also issues an expression of concern for the paper.

In August 2016, Harriet Wallberg and Anders Hamsten leave the Nobel Assembly.

Boundaries between healthcare and clinical research


One of the main problem in Macchiarini case was the boundary between the clinical research and the
medical care and practice, as the Royal Swedish Academy also notes:

«The Macchiarini case also shows that the boundary between clinical research and advanced
medical care needs be clearer, and that the regulations governing the use of new treatment methods
on seriously ill patients are sometimes not respected. Therefore, the Academy and the Swedish Society

444
http://www.nobelprizemedicine.org/4696-2/ .
445
http://ki.se/en/news/karolinska-institutet-dismisses-macchiarini
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of Medicine are appointing a review panel to investigate these issues, with the task of proposing
recommendations for clinicians and scientists working at the boundary between clinical research and
medical care. The review will be led by Professor Olle Lindvall, Lund University»446.

The same consideration appears in Gerdin's report:

«The statements to this investigation, which will be mentioned later, demonstrate that the line
between research and healthcare can appear rather vague at times. Healthcare is characterised by
the treatment of individual patients and is required by the Health and Medical Services Act (HSL) to be
of “good quality”. The development of the healthcare sector is based on scientific activity and is
defined as “research”; this can also be reworded as “research forms the basis of healthcare
development”»447.

Finally, similar conclusions are also presented by the report headed by the Swedish National Council
on Medical Ethics (commissioned by Karolinska University Hospital), that highlights that in future «a
task force will work with issues in the border zone between healthcare and clinical research [...]»448.
The account also found that the environment contributed to Macchiarini’s problems, providing a
«culture of silence», a lack of respect for rules and «group thinking»449. However, the report and the
recommendations included concern more P. Macchiarini practice at Karolinska Hospital, rather than
his researches at Karolinska Institutet (and the related papers)450.

Another external inquiry, conducted by Sten Heckscher, focuses instead on misconduct allegations,
pointing out that Karolisnka Institutet did not properly deal with the case:

«Mr. Heckscher pointed out that his team had, rather than determining Macchiarini’s guilt on the
matter of scientific misconduct, examined the actual handling of the case, concluding, amongst other
things, that there were no consistent administrative procedures in place at KI for cases of this kind,
that parts of the cases were not even dealt with and that those that were contain errors. Moreover,
KI did not make sure to furnish the external investigator Bengt Gerdin with the material he requested,

446
Royal Swedish Academy of Sciences, The Royal Swedish Academy of Sciences takes action against scientific
misconduct - Press release, February 2016, http://www.kva.se/en/pressroom/2016/vetenskapsakademien-
kommenterar/.
447
B. Gerdin, Statement of opinion on assignment, May 2015, p. 7.
448
K. Asplund, The Macchiarini Case. Investigation of the synthetic trachea transplantions at Karolinska University
Hospital, August 2016, pp. 20-21,
http://www.sll.se/Global/Verksamhet/H%C3%A4lsa%20och%20v%C3%A5rd/Nyhet%20bilaga/The%20Macchiar
ini%20Case%20Summary%20(eng).pdf.
449
Ibidem.
450
E. g.: «In our investigation, we have tried to get a grasp of the environment that made the course of events in
the Macchiarini case possible. Here, we present some of our observations, well aware that there are very wide
variations in the care culture within the hospital. • In an environment as strongly competitive as Karolinska
University Hospital, culture of silence is found [...] Karolinska University Hospital has a long tradition of being
seen as Sweden’s leading university hospital in both medical care and research, which is something that entails
a risk of inadequacies and shortcomings not coming to light. There may be a need to further develop the
hospital’s work on core values», in Ibidem, pp. 20-21.
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and the decisions from 2015, in which Macchiarini was cleared of the misconduct allegations, are not
sufficiently justified»451.

The report also states that KI cannot be completely absolved of responsibility for the synthetic
trachea transplantations performed at Karolinska University Hospital, recalling the already underlined
problems of boundaries between clinical research and healthcare or clinical practice.

Grey case?
Fatal Experiments's filmaker Lindquist and Doctor Birchall opinions:

«“He was very much like other brilliant scientists I’d met previously who pursue big international
projects with high stakes,” says Lindquist. “It’s clear that in his mind he’s justified. I don’t think he’s a
bad person or an evil person. He believed he’s helping mankind and that he’ll succeed given enough
time and enough patients.” Of course, there is always risk when working at the forefront of science
and surgery. “I have a nurse in London who scrubbed for Christiaan Barnard [who performed the
world’s first successful human-to-human heart transplant] and when I described Paolo Macchiarini to
him he said Barnard was exactly the same,” says Birchall. “That’s not to say there weren’t a lot of
problems about the way Macchiarini did things, because there were... But maybe Christiaan Barnard
wasn’t much better, and yet he’s lauded for introducing cardiac transplantation, which later proved
to be so good.”»452.

However, Doctor Martin Birchall is among the co-authors of some of Macchiarini's papers. His
Institution, the UCL, launched a special investigation in March 2017, whom results are attended to be
released by the end of summer. The investigation aims to clarify the position of UCL people in
Macchiarini's works453.

3. Highlights and conclusive considerations

The case study appears to be interesting for many reasons, for instance:
 the fundamental role played by the media. KI re-opened the investigation only after SVT
documentary presented the Macchiarini case to the public opinion
 the border between a person who is risk-taking, in name of the progress of medicine and
research, and a person who commits serious misconducts, with severe consequences for
patients (even death)
 the decision of KI to hire Macchiarini, even if he had already gone under house arrest in Italy

The interview to one person close to KI also pointed out some other aspects (for the integral responses,
see 5.E.).

451
Karolinska Institutet, Information meeting with Heckscher – this is the summary, Karolinska Institutet
website, Semptember 2016, https://internwebben.ki.se/en/information-meeting-heckscher-summary
452
N. Frizzell, Fatal experiments: a maverick surgeon strikes back, «The Guardian», 25 October 2016.
453
https://www.ucl.ac.uk/news/news-articles/0916/160916-special-inquiry-regenerative-medicine.
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First of all, the interviewee underlined that Macchiarini was not the only responsible. Several
individuals in his research group, as well as in KI administration should be considered responsible of
what happened.
Secondly, he thinks that, even if KI has declared they would have changed/improved their procedures
in case of misconduct, it will take time, because the KI culture is a «repressive and cover-up culture».
Finally, the interviewee said that, in order to avoid similar cases in the future, KI «should not be allowed
to investigate them self. There has to be an “outside” independent state authority who investigates
these kinds of allegations». He also added that a «whistle blower protection legislation» is needed, «to
protect whistle blowers to be punished by the institution they work in».

4. Chronology

Spain - 2008: first transplant at Barcelona Clinical Hospital; donor trachea + stem cells before the
transplant.
Italy - 2009-2012: Macchiarini is employed at Careggi Hospital.
Sweden - End of 2010: Macchiarini is employed as professor at Karolinska Institutet and as senior
physician at Karolinska University Hospital.
Sweden - 2011: Macchiarini performs the first transplant of a synthetic trachea prepared with bone
marrow cells in the world.
Sweden - 2011-2013: Prof. Pierre Delaere files several warnings regarding Macchiarini's procedure that
is not, according to him, supported by animal data.
Sweden - November 2012 : paper published in «Annals of Thoracic Surgery» retracted for plagiarism.
Italy - September 2012: house arrest in Italy, for fraud and attempted extortion
Italy - 3 October 2012: house arrest confirmed, permission to operate patients on waiting list
Italy - 15 October 2012: house arrest revoked; Macchiarini's resigns from Careggi Hospital
End of 2012: Macchiarini moves to Karolinska Institutet
Italy - November 2013: Macchiarini and Fabio Mannini, Alessandro Gonfiotti, Pasquale Rulli, Aida Chiti
and Osvaldo Jaus are sent to trial for embezzlement, abuse of power and forgery
Sweden - March 2014: Meeting at KI with Dr. Grinnemo (who would have later on signed the Formal
Appeal), A. Hamsten and P. Macchiarini's superiors, during with all participants receive a report
showing discrepancies between medical records of the patients and the published work by
Macchiarini.
Sweden - June 2014: Delaere sends a report of suspected scientific misconduct to KI Vice-Chancellor.
Sweden - August 2014 Formal Appeal for an Investigation of Scientific Misconduct To the President
of Karolinska Institutet signed by Matthias Corbascio, MD, PhD; Thomas Fux, MD; Karl-Henrik
Grinnemo, MD, PhD; Oscar Simonson, MD: Analysis of Clinical Outcome of Synthetic Tracheal
Transplantation Compared to Results Published in 6 Articles by Macchiarini et al.
Sweden - September 2014 Amendment to the Formal Appeal for an Investigation of Scientific
Misconduct by Prof Macchiarini submitted to Karolinska Institutet on August 18, 2014.
Sweden - December 2014: Macchiarini goes under investigation by Karolinska Institutet, on the basis
of the complaint of his colleagues and of Prof. Pierre Delaere.

Sweden - April 2015: Vice-Chancellor appoints an external investigation to Professor Gerdin. P.


Macchiarini answer to the allegations and Vice-Chancellor judges Macchiarini unguilty.

Italy - May 2015: Macchiarini is sent to trial for embezzlement, abuse of power and forgery.
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Sweden - May 2015: KI releases an English translation of the report of Gerdin’s investigation. Gerdin's
report says the Paolo Macchiarini was guilty of scientific misconduct.
Sweden - June 2015: Swedish Research Council freezes grant payments to the KI center run by
Macchiarini.
Sweden - August 2015: After reviewing the evidence gathered during Gerdin’s investigation and
Macchiarini's response, KI’s Vice Chancellor Anders Hamsten rules that Macchiarini acted in some
cases without due care, but that his behaviour does not qualify as scientific misconduct. Moreover,
Vice-Chancellor of KI judges that Professor Delaere's allegations of scientific misconduct are
unfounded.

Sweden - October 2015: Post by Macchiarini to Retraction Watch

Spain - January 2016: Vanity Fair publishes a story about how Macchiarini romanced an NBC producer
while she was working on a story about him, and in the process raises the allegation he lied on his CV
when applying to the KI position.

Sweden - January 2016: Swedish Television airs a series of documentaries about Macchiarini and his
work, alleging, in part, that he operated on patients in Russia whose conditions were not life-
threatening enough to warrant such a risky procedure.

The Royal Swedish Academy of Science asks for a new investigation.


KI reopens its misconduct investigation into Macchiarini following the allegations revealed by SVT.
The four whistle-blowers release a statement arguing they had provided evidence of misconduct long
before the SVT documentary series aired.
Sweden - February 2016: KI announces it will not extend Macchiarini’s contract.
The secretary general of the Nobel Assembly Urban Lendhal resigns.
KI confirms that Macchiarini’s CV did contain inaccuracies when he applied for his adjunct position in
2010.
SVT releases additional short films comparing one patient’s medical record to what is reported in
Macchiarini’s articles.
A. Hamsten and Hans-Gustaf Ljunggren, KI's Dean of Research, resign.

Sweden - March 2016: Declaration of KI about Macchiarini dismission


http://ki.se/en/news/karolinska-institutet-dismisses-macchiarini. His contract was rescinded.
Swedish government tasks a nomination committee to submit proposals for new members of
Karolinska Institutet University Board.

The Lancet remove four authors name from Paolo Macchiarini’s seminal 2011 paper, upon their
request.
Sweden - August 2016: First external report headed by the chairperson of the Swedish National
Council on Medical Ethics and commissioned by Karolinska University Hospital.
Sweden - September 2016: Second external inquiry, conducted by Sten Heckscher.
Harriet Wallberg and Anders Hamsten leave the Nobel Assembly.
Sweden’s Central Ethical Review Board finds Paolo Macchiarini guilty of misconduct in a 2014 paper.
Italy - September 2016: Macchiarini is cleared of accusations of embezzlement, abuse of power and
forgery.

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October 2016: «Nature Communications» issues an expression of concern for the 2014 paper flagged
by the Central Ethical Review Board.
December 2016: Karolinska Institutet declares Macchiarini and three co-authors culpable of
misconduct in the 2014 «Nature Communications» paper, which it asks to retract.

5. Data sources and methods

A) Print

Newspapers

ITALY
«La Stampa»
«Repubblica»
«Corriere della Sera»
«Il Sole 24 Ore»
Total amount of articles: 134
USA
«New York Times» 21 articles
UK
«Guardian» 16 articles

Journals
«Nature»
«Science»
«Nature Communication»
«Lancet»
«Annals of Thoracic Surgery»
«Journal of Biomedical Materials Research»

B) Video
1. Primo trapianto al mondo di trachea
http://video.corriere.it/ha-realizzato-barcellona-chirurgo-paolo-macchiarini/ac85d8b2-b634-11dd-
909d-00144f02aabc (November 2008)
2. Quando il chirurgo non riesce a trapiantare sé stesso
http://video.corriere.it/quando-chirurgo-non-riesce-trapiantare-se-stesso/6e7277a0-f11f-11e0-
a040-589a4a257983 (October 2011)
3. Il pioniere delle cellule staminali, interviewd by Alice Martinelli (LUISS)
https://www.youtube.com/watch?v=GmWSMDWBha8 (March 2012)
4. Malasanità: arrestato Macchiarini, il «mago» della trachea http://video.corriere.it/malasanita-
arrestato-macchiarini-mago-trachea/555242b6-08b4-11e2-b109-0c446f94a4e2 (September 2012)
5. A Leap of Faith. A Meredith Vieira Special English Movie (NBC production)
https://www.youtube.com/watch?v=bGyl5YTqono (Summer 2014)
6. SVT documentaries The Experiments http://www.svt.se/dokument-inifran/experimenten-in-
english/ (January 2016)
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7. Short films translated in english taken from the documentaries by SVT (February 2016)
EXAMPLE 1 http://www.svtplay.se/klipp/6465549/do-the-articles-of-paolo-macchiarini-reflect-
reality-example-1-the-1-week-sample
EXAMPLE 2 http://www.svtplay.se/klipp/6465585/do-the-articles-of-paolo-macchiarini-reflect-
reality-example-2-the-2-month-sample
EXAMPLE 3 http://www.svtplay.se/klipp/6465765/do-the-articles-of-paolo-macchiarini-reflect-
reality-example-3-the-8-month-sample
EXAMPLE 4 http://www.svt.se/dokument-inifran/did-paolo-macchiarini-describe-his-experiments-
truthfully-in-his-scientific-articles
8. Press Conference with Sten Heckscher regarding the Macchiarini review (swedish)
https://www.youtube.com/watch?v=htJcfShqP5A and other contents on YouTube by
KarlonskaInstitutet channel, but all in swedish (September 2016)
9. BBC documentary (SVT documentary translated), Fatal Experiments: The Downfall of a Supersurgeon
(October 2016)

C) Websites
1. News regarding Macchiarini case on Karolinska Institutet website http://ki.se/en/news/macchiarini
2. Dossier Macchiarini + timeline http://retractionwatch.com
3. Blog http://forbetterscience.com
4. Nobel Prize website http://www.nobelprizemedicine.org/

D) Documents
1. Correspondance between KI and Careggi Hospital about Macchiarini's CV, profile and troublesome
in Italy - PDF (September 2010) http://www.circare.org/info/pm/tsai-rossi.pdf
2. Formal Appeal for an Investigation of Scientific Misconduct to the President of Karolinska
Institutet by Matthias Corbascio, MD, PhD; Thomas Fux, MD; Karl-Henrik Grinnemo, MD, PhD; Oscar
Simonson, MD (August 2014)
3. Analysis of Clinical Outcome of Synthetic Tracheal Transplantation Compared to Results Published
in 6 Articles by Macchiarini et al., signed by Matthias Corbascio, MD, PhD; Thomas Fux, MD; Karl-
Henrik Grinnemo, MD, PhD; Oscar Simonson, MD (August 2014)
4. Amendment to the Formal Appeal for an Investigation of Scientific Misconduct by Prof
Macchiarini submitted to Karolinska Institutet on August 18, 2014. To the Vice-Chancellor of
Karolinska Institutet by Matthias Corbascio, MD, PhD; Thomas Fux, MD; Karl-Henrik Grinnemo, MD,
PhD; Oscar Simonson, MD (September 2014)
5. Cengiz Gebitekin, Uludag Unversity School of Medicine, Bursa (Turkey), Letter in defense of P.
Macchiarini, regardin the condition of the Turkish patient Yesim Cetir - PDF (January 2015)
http://www.circare.org/info/pm/gebitekin-sayr-20150127.pdf
6. Letter in response to Anders Hamsten Vice-Chancellor; Hans-Gustaf Ljunggren Dean of Research;
Jan Carlstedt-Duke Senior Adviser, Rectorate to the journal Sjukhuslakaren
http://www.sjukhuslakaren.se/visselblasande-kirurgernas-egna-ord-om-kis-agerande/ signed by
Matthias Corbascio, MD, PhD; Thomas Fux, MD; Karl-Henrik Grinnemo, MD, PhD; Oscar Simonson,
MD (February 2015)
7. Response by P. Macchiarini to the allegations of misconduct raised by the four colleagues
http://www.svt.se/svts/article2971402.svt/binary/PM%20yttrande%20i%20april..pdf (April 2015)
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8. Ethics Council's decision about suspected scientific misconduct in the case of Professor Paolo
Macchiarini, in response to Professor Pierre Delaere’s letter - PDF (April 2015)
9. Professor Bengt Gerdin External review report (May 2015)
http://www.circare.org/info/pm/gerdin-finalrpt-20150513.pdf
10. Response by P. Macchiarini to Prof. Gerdin report http://www.circare.org/info/pm/si-
Paolo%20Macchiarini%20response.pdf (June 2015)
Vice-Chancellor Hamsten's decisions available online: Decision (1)
https://internwebben.ki.se/en/node/26403 and Decision (2)
https://internwebben.ki.se/en/node/26404 (August 2015)
11. Post by Macchiarini to Retraction Watch http://retractionwatch.com/2015/10/09/where-i-think-
retraction-watch-went-wrong-a-guest-post-from-paolo-macchiarini/ (October 2015)
12. Report on examination of Macchiarini's CV - PDF (January 2016)
http://ki.se/sites/default/files/investigation_of_cv.pdf
13. A. Hamsten's response to SVT documentary - PDF http://www.circare.org/info/pm/vice-
chancellors_letter_to_the_professors_160126.pdf (January 2016)
14. Declaration of KI about Macchiarini dismission http://ki.se/en/news/karolinska-institutet-
dismisses-macchiarini
BBC Radio programme, The Medical Scandal Engulfing top Swedish University,
http://www.bbc.co.uk/programmes/p03j2qdf (February 2016)
15. Press release by the Royal Swedish Academy
http://www.kva.se/en/pressroom/2016/vetenskapsakademien-kommenterar/ (February 2016)
17. Macchiarini and the tracheal regeneration scandal, by Pierre Delaere. Open letter
https://forbetterscience.com/2016/04/02/macchiarini-and-the-tracheal-regeneration-scandal-by-
pierre-delaere/ (April 2016)

18. Ola Hermanson's report (co-author of Jungebluth et al, Lancet, 2011) - PDF (June 2016)
19. Decision about Suspicion of research misconduct by KI, Vice-Chancellor Karin Dahlman-Wright
with a resume of all the main facts and people involved - PDF (December 2016)
20. Kjell Asplund, Professor Emeritus and Chairman of the Swedish Council on Medical Ethics's report
http://www.sll.se/Global/Verksamhet/H%C3%A4lsa%20och%20v%C3%A5rd/Nyhet%20bilaga/The%2
0Macchiarini%20Case%20Summary%20(eng).pdf
21. Sten Heckscher's report
22. P. Macchiarini et al. (2008), Clinical transplantation of a tissue-engineered airway, «Lancet», 372
(9655), pp. 2023-2030. Available at http://www.thelancet.com/journals/lancet/article/PIIS0140-
6736(08)61598-6/abstract
23. P. Jungebluth et al. (2011), Tracheobronchial transplantation with a stem-cell-seeded bioartificial
nanocomposite: a proof-of-concept study, «Lancet», 378, pp. 1997-2004.
24. A. Gonfiotti et al. (2012), Development and Validation of a New Outcome Score in Subglottic
Stenosis, «The Annals of Thoracic Surgery», 94 (4), pp. 1065-1072.
25. Royal Swedish Academy of Sciences, The Royal Swedish Academy of Sciences takes action against
scientific misconduct - Press release, February 2016,
http://www.kva.se/en/pressroom/2016/vetenskapsakademien-kommenterar/

E) Interviews

We interviewed one person close to KI. Here the inteview:

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1. Before the SVT documentary was transmitted, KI didn't take any measure against Macchiarini,
although your Appeal and the Amendment to the Appeal had clearly shown evidences of
misconduct. How do you explain KI's (or Prof. Hamsten) behavior?

Hamsten´s priority was to defend KI´s reputation, the responsible individuals for head hunting
their “star-recruitment” (PM) and the investments made in connection to PM. Hamsten and his
key leadership companions priority was not to “listen” and act to the horrendous alarm signals
that we presented, they did not want to meet us.

2. Regarding the field of research of transplants, would you say that the levels of competition and
pressures (for career, for funds or to publish) are a) very high b) high c) low d) very low? How would
you describe the general situation?

High profile research in prestigious research centers is “very high”.

3. Do you think that competition and the different types of pressure (within the field of research,
within KI or both) may have played an important role in Macchiarini's case? If yes, how?

Yes, researchers in general at these kind of centers most probably feel a pressure to be
successful which to a great part is measured in publish studies. However I do not have any “data”
to support this opinion which is a more general impression.

4. As far as you know, were KI people informed about the Italian investigations on Macchiarini's
conduct at Careggi Hospital? If so, how did they deal with it?

I don´t know. We are not a part of or have had any insight to the inner circles of the KI
administration which have been involved in protecting PM and where these discussions have
been taking place.

5. Would you consider some of Macchiarini's colleagues, of his group of research, responsible of
misconduct as much as him? Why?

Yes absolutely. Many clinicians and researchers have been misled and lied to by PM. But there
is a principle difference between acting in good belief (even if misled) and actively protecting
these horrendous violations on human beings after hard evidence has been presented. So
several individuals in PM:s research group (“gang”) as well in the administration and within the
Hospital carries heavy responsibility to that this tragedy could proceed for so long.

6. Did KI change/improve its procedures in case of suspect of misconduct after Macchiarini's case?
How?

I do not know. “They” say they have, but difficult to objectively verify this. This kind of repressive
and cover-up culture takes time to change, especially when several of the responsible KI
individuals still hold positions in the organization.

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7. On the basis of your experience, in order to avoid other similar cases, would you consider more
important a) to intensify controls on researchers' activities and publications b) to intensify the
prevention of misconduct (eg. training courses on research integrity for young researchers) c) to
introduce tougher sanctions?

Part of a solution to prevent these things from happen again must contain a mixture of a), b)
and c) but there is also a d): the university should not be allowed to investigate them self. There
has to be an “outside” independent state authority who investigates these kinds of allegations.
And finally e), whistle blower protection legislation to protect whistle blowers to be punished
by the institution they work in.

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University of Trento – Case Study 2


Frederico Infascelli
Author: Ilaria Ampollini

Resume
Federico Infascelli, Professor of Animal Nutrition and Feeding (Federico II, University of Naples), is
found guilty of images manipulation in some papers concerning GMOs in animal feed. The suspects
were firstly raised after a Parliamentary Auditon, during which Prof. Infascelli had presented some
results of his group of research.

1. Personal, organisational and field levels

a) Personal level: people involved

Federico Infascelli (responsible of the group of research), Professor of Animal Nutrition and Feeding
(Federico II, University of Naples)
Other authors of the papers: V. Mastellone, R. Tudisco, (corresponding author) G. Monastra, M. E.
Pero, S.Calabrò, P. Lombardi (corresponding author), M. Grossi, M. I. Cutrignelli, L. Avallone, F. Bovera,
N. Mirabella, G. Piccolo.
Elena Cattaneo, Professor of Pharmacology (University of Milan); co-founding director of the University
of Milan's Center for Stem Cell Research; Senator for life
Enrico Bucci, author of Cattivi Scienziati. La frode nella ricerca scientifica (Torino, Add, 2016); head of
the biomedical services and information consultancy firm BioDigitalValley in Aosta, Italy
Luigi Zicarelli, Director of the Department of Veterinary Medicine and Animal Science
Gaetano Manfredi, Rector of University of Naples
Tommaso Russo, responsible for coordinating the investigation

b) Organisational level; c) Field level (GMO in animal feed); d) National research system
Federico Infascelli was at the head of a group of research at the Department of Veterinary Medicine
and Animal Sciences (Federico II, University of Naples).
Among the papers considered (see below, section 2), only one paper -Genetically modified soybean in
a goat diet: Influence on kid performance- specifies that the trial was supported by regional funding454.
The other two papers do not give any information about the funding.
GMOs have been object of frequent debates between scientists, politics and public opinion since the
last 20 years.

d) Type of misconduct
Images manipulation and re-use of the same set of images related to different data.

454
POR CAMPANIA FSE 2007/2013. Sviluppo di Reti di Eccellenza tra Università – Centri di Ricerca – Imprese.
PROGETTO CARINA “Sicurezza, sostenibilità e competitività nelle produzioni agroalimentari della Campania”
CUP B25B09000080007.
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2. Description of the case: main aspects


On the 8th of July 2015, during an audition promoted by the Commission for Agriculture and Food
farming industry of Italian Parliament, Prof. Federico Infascelli, invited by Elena Fattori (M5S), displays
to the Senate the results of his studies on GMOs and animal feed, stating that his research group has
found traces of modified DNA in blood and milk of animals studied (rabbits and goats). Prof. Infascelli
particularly refers to the results shown in two of his papers.
The first one, dated 2010, is Fate of transgenic DNA and evaluation of metabolic effects in goats fed
genetically modified soybean and in their offsprings, by R. Tudisco, V. Mastellone, M. I. Cutrignelli, P.
Lombardi, F. Bovera, N. Mirabella, G. Piccolo, S. Calabrò, L. Avallone, F. Infascelli, published in «Animal»
(abstract available here https://www.ncbi.nlm.nih.gov/pubmed/22445119; paper available here
http://stopogm.net/sites/stopogm.net/files/webfm/plataforma/fatednagoattudisco.pdf).

The second one, printed in 2015 in «Small Ruminant Research» journal, is Genetically modified soybean
in a goat diet: Influence on kid performance, by R. Tudisco, S. Calabrò, M.I. Cutrignelli, G. Moniello, M.
Grossi, V. Mastellone, P. Lombardi, M.E. Pero, F. Infascelli (fully available here http://www.ask-
force.org/web/HerbizideTol/Tudisco-GM-Soy-Goat-Kids-performance-2015.pdf).
Twenty days later, Sen. Elena Cattaneo writes a letter to Infascelli, asking for some explanations about
the results he presented during the audition: the letter is publicly available here
http://www.scienzainrete.it/files/lettera_prof_infascelli_2015_07_28.pdf. First of all, Cattaneo
expresses some reservations with regard to the misleading presentation, during the audition, of the
results described in the two articles already mentioned455. Furthermore, Cattaneo raises an issue of
concern about the methodology used by Infascelli and his colleague, especially in the phase of
comparison between GMOs and GMOs free corn456.
The letter written by Cattaneo does not raise any suspects of misconduct; it mostly asks for some
clarifications about research methodology and research results, recalling the importance of
cooperation among scientists and of a high level of communication of scientific studies within
political debates. Nevertheless, Prof. Infascelli does not answer.
Since Infascelli and his colleagues had not responded, Cattaneo, between August and September 2015,
asks Enrico Bucci to analyze three publications by Infascelli's group. Enrico Bucci is well known in Italy:
he is the founder of the biomedical services and information consultancy firm BioDigitalValley in Aosta,
Italy. He usually deals with cases of misconducts in scientific research.
Bucci finds some anomalies related to the images. The papers considered as well as some of the
irregularities observed can be found on PubPeer.com:

Paper 1.
Genetically modified soybean in a goat diet: Influence on kid performance, R. Tudisco, S. Calabrò, M.I.
Cutrignelli, G. Moniello, M. Grossi, V. Mastellone, P. Lombardi, M.E. Pero, F. Infascelli, «Small Ruminant
Research» (2015) --> https://pubpeer.com/publications/9971A31BEC955C2B9684A96E6EE639
The images were re-used from another article, brightened to amplify the results.

Paper 2.
Gamma-Glutamyl Transferase Activity in Kids Born from Goats Fed Genetically Modified Soybean,
Vincenzo Mastellone, Raffaella Tudisco, Giovanni Monastra, Maria Elena Pero, Serena Calabrò, Pietro

455
E. Cattaneo, Letter to Prof. F. Infascelli, 28 July 2015, p. 2.
456
Ibidem, pp. 5-6.
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Lombardi, Micaela Grossi, Monica Isabella Cutrignelli, Luigi Avallone, Federico Infascelli, «Food and
Nutrition Sciences» (2013) -->
https://pubpeer.com/publications/903F7BF22D3C8C46EA499B0C299A23
Re-use of the same image for different contents.

Paper 3.
Fate of transgenic DNA and evaluation of metabolic effects in goats fed genetically modified soybean
and in their offsprings, R. Tudisco, V. Mastellone, M. I. Cutrignelli, P. Lombardi, F. Bovera, N. Mirabella,
G. Piccolo, S. Calabrò, L. Avallone, F. Infascelli, «Animal» (2010) -->
https://pubpeer.com/publications/8B2DD6BE9FBD8918D1EB64D22816E6
Image manipulation: specifically, «the electrophoresis gels have been subject to unwarranted digital
manipulations» (from the retraction notice457 in «Animal»)

In the analysis posted online458 by Bucci, other papers are considered.


Among them, there is a paper published in «Animal Science» in 2006: Genetically modified soya bean
in rabbit feeding: detection of DNA fragments and evaluation of metabolic effects by enzymatic
analysis, R. Tudisco, P. Lombardi, F. Bovera, D. dˇAngelo, M. I. Cutrignelli, V. Mastellone, V. Terzi, L.
Avallone, F. Infascelli, «Animal Science» (2006) -->
https://pubpeer.com/publications/BF5306C0AC57658C9FF1D6C308335E. As shown in Bucci's power
point, many of the images in this paper were manipulated. The figures derived from a thesis by one of
Infascelli's students and they were modified in order to fit with the content of the paper. Several
regions of the pictures were deleted; lanes were cropped and labels were changed (e.g. muscle
instead of heart or heart instead of kidney); finally, some images were re-used and duplicated.
At this point, Cattaneo writes a new letter to the authors of the papers as well as to Prof. Luigi
Zicarelli, at the time Director of the Department of Veterinary Medicine and Animal Science. She
receives no answer and she therefore contacts the journals that published the three papers by
Infascelli, forwarding them the results of Bucci's analysis.
In November 2015 Cattaneo finally writes to the Rector of University of Naples, Gaetano Manfredi,
who names a committee to investigate the case. Tommaso Russo, molecular biologist at the
University of Naples, was responsible for coordinating the investigation.
In the meantime, the journal «Food and Nutrition Science» retracts Infascelli's paper Gamma-
Glutamyl Transferase Activity in Kids Born from Goats Fed Genetically Modified Soybean (2013). In the
Retraction Notice459, we read that the paper has been retracted for fraud and specifically for data
fabrication; that the results of publication were found to be overall invalid and that the author's
conduct was classified non as honest error, but as academic misconduct.
In January 2016, Italian newspapers start to pay attention to the case, reporting that prof. Federico
Infascelli was accused of data falsification:

«There's a scandal involving a professor of Federico II University. Federico Infascelli, professor of


Nutrition and Feeding in the Department of Veterinary Medicine, is accused of falsifying the results
of some researches on the danger of feeds containing GMOs and the products derived from them. A

457
https://www.cambridge.org/core/journals/animal/article/div-classtitlefate-of-transgenic-dna-and-
evaluation-of-metabolic-effects-in-goats-fed-genetically-modified-soybean-and-in-their-offsprings-
retractiondiv/035508C67117039A27DA8A3B3CD37B8F
458
Available here https://www.slideshare.net/EnricoBucci1/infascelli-final/1.
459
Available at http://file.scirp.org/pdf/FNS_2013061411054679.pdf.
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very serious accusation, in the world of scientific research. Which exposes him, if confirmed, to
criminal charges (by third parties) and penalties that might banish him from the possibility to publish
under the name of the University, suspend him from the university offices, or could go further, with
economic or carreer implications»460.

Among the articles published in January 2016 (not many, four in total considering the main Italian
newspapers461), there's also an interview to Prof. Infascelli, where he defends himself and refuses all
the accusations. Infascelli states that his researches dealt with a sensitive argument, the GMOs, and
that he has fallen under investigation for touching relevant and powerful interests, although he had
not committed any kind of misconduct. He also says that he was sure that «truth demistifyers will be
proven wrong».
In March 2016, another paper462 is retracted: it's Fate of transgenic DNA and evaluation of metabolic
effects in goats fed genetically modified soybean and in their offspring, published in «Animal» in 2010.
In December 2016, Infascelli's case is listed among the most memorable retractions of the year by «The
Scientist»:

«5. There aren’t many topics that get researchers as fired up as genetically modified organisms
(GMOs), so traffic surged when we reported that a nutrition journal had retracted a paper by Federico
Infascelli, an animal nutrition researcher at the University of Naples, who showed modified genes
could end up in the bodies of baby goats whose mothers ate GMOs. The initial retraction notice
listed duplication as the reason, but was later updated to include data fabrication»463.

Sanctions and consequences


In February 2016, the committee concludes the investigation and Infascelli and the other ten
researchers of his group of research are judged guilty of image manipulation. The sanctions are the
following:

- for all the group of research: formal reprimand


- for Infascelli and the two corresponding authors: supervision of their researches by the Department
and obligation to obtain the consent of University before publishing

Interestingly, among the newspapers articles published after the investigation was closed (nine in
total), there is one titled Scientific misconduct remains unpunished. The journalist, Anna Meldolesi,
writes that the Committee found Infascelli and papers' co-authors guilty of misconduct, but that they
were not punished: the sanctions decided by Federico II University are in fact judged as inadequate
-too little.

460
B. De Fazio, Ricerche Ogm, un docente della Federico II di Napoli è accusato di aver falsificato i risultati di
alcune ricerche, napoli.repubblica.it, 13 January 2016
(http://napoli.repubblica.it/cronaca/2016/01/12/news/ricerche_ogm_un_docente_della_federico_ii_di_napoli
_e_accusato_di_aver_falsificato_i_risultati_di_alcune_ricerche-131127479/).
461
«Corriere della Sera», «La Stampa», «Repubblica», «Il Sole 24 Ore».
462
See at https://www.cambridge.org/core/services/aop-cambridge-
core/content/view/573558403680E9D29D5B8344412711A8/S1751731110000728a.pdf/div-class-title-fate-of-
transgenic-dna-and-evaluation-of-metabolic-effects-in-goats-fed-genetically-modified-soybean-and-in-their-
offsprings-div.pdf.
463
Retraction Watch, Top 10 Retractions of 2016. A look at this year’s most memorable retractions, «The
Scientist», 21 December 2016.
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The opinion of Rector of University, Prof. Manfredi, is opposite of journalist's viewpoint. According to
the Rector, in fact, the sanctions were particularly strict, as not only Prof. Infascelli was punished,
but also all the co-authors, even those who may have not had a significant role in the manipulation
of the images. The reason for that was basically the impossibility to distinguish who did what within
the group of research464.
Manfredi was also interviewed, on 5th February 2016, in the radio programme Attenti a noi due
(Radio24). During the interview, he clearly explains that sanctions the Committee inflicted on Infascelli
were necessarily limited to University's authority. Apart from this, further disciplinary sanctions should
have been regulated by Italian law, that however does not consider fraud and scientific misconduct as
a crime and does not deal with them.

Protocols and guidelines


It's essential to underline that University of Naples is the first Italian University 465 to have signed the
Guidelines for Research Integrity466, on 31st of July 2015. The Guidelines were drafted after a case of
misconduct occurred in 2013: Prof. Alfredo Fusco, of the Department of Medicine of Federico II
University, was found guilty of manipulating images in cancer researches467. Following the episode, the
University released the Guidelines.
Here below, a resume of the main aspects of the document468.

Definition of misconduct: Falsification; fabrication; plagiarism.

Protocol: in case of suspicious of misconduct by members of the University scientific community, the
Rector appoints an investigation panel consisting of three experts, two of which are external to the
University and one chosen among University's professors. The Commission is required, observing a
confidentiality obligation until the conclusion of the investigation: a) to evaluate within thirty days if
there has been a breach of research integrity; if the Commission's conclusion is that there has not been
any violation, the case is closed without further procedures; b) in case of violation, to describe it in
detail and express themselves on the severity, the extent and, if possible, the degree of intentionality
of the misconduct; c) to send a detailed report to the Chancellor of the University. The Rector shall
inform the person accused or suspected of misconduct of the Commission's report offering the
opportunity, within thirty days, of defence.

Sanctions: After the procedure, the Rector shall inform the Senate about the survey results. The Senate
is required to decide on any sanction. The penalties shall be appropriate with respect to the size, the
severity and the possible recurrence of the violation. They can be: • Private formal warning; • formal

464
L. Capone, Ora anche l'Università punisce le bugie del prof. anti-Ogm, «Il Foglio», 12 February 2016
(http://www.ilfoglio.it/scienza/2016/02/12/news/ora-anche-l-universita-punisce-le-bugie-del-prof-anti-ogm-
92627/).
465
Only three Italian universities have guidelines for research integrity: beyond University of Naples, University
of Catania (https://www.unict.it/sites/default/files/files/LINEE%20GUIDA%20RICERCA.pdf) and University of
Bergamo
(http://www.unibg.it/sites/default/files/normativa/regolamento_integrita_ed_etica_della_ricerca.pdf).
466
https://www.unina.it/documents/11958/7856170/2799_31luglio.pdf/6a0d22c8-00e9-4d3f-bfed-
93780e495b03.
467
A. Abbott, Image search triggers Italian police probe, «Nature», 5 December 2013
(http://www.nature.com/news/image-search-triggers-italian-police-probe-1.14295).
468
The resume is part of the report we drafted about data on misconduct incidence (WP3 - Task III.1).
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warning made public on the bulletin board of the University; • exclusion from access to university
research funding, for a period from one year to three years; • exclusion from participation in the
Graduate School of Ph.D. programs and revocation / suspension in case the person is a member of a
Board, for a period from one year to three years; • exclusion from passive electorates and decadence
/ suspension of the positions held, for a period from one year to three years; • ban from using
University membership in institutional presentations and in the publication of results, for a period from
one year to three years. The decision of the Academic Senate is in any case transmitted to the person
and to the Commission. The Rector implements the decision. The documentation relating to the
sanction is to be stored in the personal file of the person concerned.

Body for investigating and registering cases of misconduct: no permanent body. A temporary
Commission for investigating is named by the Rector in case of need. No register.

3. Highlights and conclusive considerations

The case study appears to be interesting because:


 it was raised up during a Parliamentary audition;
 it happened in the first Italian university to have drafted Guidelines for research integrity
 it led to sanctions against the whole research group and not only against the super-visor (was
the group of research responsible? were other researchers in a position to report the conduct
of their super-visor?)
 it deals with a sensitive theme, such as GMOs.

To conclude, we may observe that, although the misconduct was serious and clear (image
manipulation in several papers), it would have never come up if Sen. Cattaneo and Enrico Bucci had
not started investigations on their own.
Finally, even if University of Naples has Guidelines for research integrity since 2015, it does not have
any kind of training on the issue for students, PhD candidates or researchers.

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4. Chronology

8 July 2015: Audition promoted by the Commission for Agriculture and Food farming industry. Prof.
Federico Infascelli displays to the Senate the results of his studies on GMOs and animal feeds, stating
that his research group had found traces of modified DNA in blood and milk of animals studied (rabbits
and goats).
28 July 2015: Elena Cattaneo writes a letter to prof. Infascelli, asking for some explanations about the
results he presented during the audition. No answer.
August/September 2015: Cattaneo asks Enrico Bucci to analyze three Infascelli's publications. Bucci
finds some anomalies within the images.
September 2015: Cattaneo writes to the authors of the papers and to Director of the Department of
Veterinary Medicine and Animal Science. No answer. Elena Cattaneo contacts the journals that
published the three papers by Infascelli, showing them the results of Bucci's analysis.
November 2015: Sen. Elena Cattaneo writes to the Rector of University of Naples, Gaetano Manfredi,
who names a committee to investigate the case. Tommaso Russo, molecular biologist at the University
of Naples, is responsible for coordinating the investigation.
December 2015: «Food and Nutrition Science» retracts Infascelli's articles Gamma-Glutamyl
Transferase Activity in Kids Born from Goats Fed Genetically Modified Soybean (2013)
14 January 2016: Bucci posts online his analysis.
February 2016: committee concludes investigations, Infascelli and other 10 researchers are judged
guilty of image manipulation. Sanctions: formal recall; ban from publishing autonomously; supervision
of researches by the Department.
March 2016: paper Fate of transgenic DNA and evaluation of metabolic effects in goats fed genetically
modified soybean and in their offsprings (2010) retracted from «Animal».

5. Data sources and methods

A) Articles
13 articles
Newspapers considered: «La Stampa»; «Repubblica»; «Corriere della Sera»; «Il Sole 24 Ore».
Period: January-March 2016.
+ articles on «Nature» and «The Scientist».

B) Video and podcasts


1. Video of the Parliamentary Audition Audizione informale di esperti sull'atto comunitario n. 177 (uso
di alimenti geneticamente modificati) - Min. 24.00
http://www.radioradicale.it/scheda/447585/commissione-agricoltura-e-produzione-agroalimentare-
del-senato
2. Radio programme: Attenti a noi due, 15 February 2016, Radio24
http://www.radio24.ilsole24ore.com/programma/attenti-noi/trasmissione-febbraio-2016-085946-
gSLASK1NXB
Interview to Enrico Bucci - author of Cattivi Scienziati.
Interview to Gaetano Manfredi, Rector of the University of Naples
3. Radio programme: Moebius, 23 January 2016, Radio24
http://www.moebiusonline.eu/trasmissioni/160123trasmissione.shtml
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Interview to Roberto Defez - CNR genetist


Interview to Enrico Bucci
4. Corriere TV, video: Ecco come si svelano le truffe accademiche, 22 February 2016, "Corriere della
Sera". Interview to Enrico Bucci (min. 3.22).

C) Websites
1. Sylvie Coyaud - Oca Sapiens blog http://ocasapiens-dweb.blogautore.repubblica.it/tag/federico-
infascelli/
2. retractionwatch.com
3. pubbeer.com

D) Documents
1. Elena Cattaneo's letter to Prof. Federico Infascelli.
2. Trascription of Federico Infascelli speech at the Senate.
3. Analysis of the set of suspected images, used in four different articles, on PubBeer.
4. Papers
Genetically modified soybean in a goat diet: Influence on kid performance; R. Tudisco, S. Calabrò, M.I.
Cutrignelli, G. Moniello, M. Grossi, V. Mastellone, P. Lombardi, M.E. Pero, F. Infascelli, «Small Ruminant
Research» (2015)
Gamma-Glutamyl Transferase Activity in Kids Born from Goats Fed Genetically Modified Soybean; V.
Mastellone, R. Tudisco, G. Monastra, M. E. Pero, S. Calabrò, P. Lombardi, M. Grossi, M. I. Cutrignelli, L.
Avallone, F. Infascelli, «Food and Nutrition Science» (2013)
Fate of transgenic DNA and evaluation of metabolic effects in goats fed genetically modified soybean
and in their offsprings; R. Tudisco, V. Mastellone, M. I. Cutrignelli, P. Lombardi, F. Bovera, N. Mirabella,
G. Piccolo, S. Calabrò, L. Avallone, F. Infascelli, «Animal» (2010)
https://www.cambridge.org/core/services/aop-cambridge-
core/content/view/573558403680E9D29D5B8344412711A8/S1751731110000728a.pdf/div-class-
title-fate-of-transgenic-dna-and-evaluation-of-metabolic-effects-in-goats-fed-genetically-modified-
soybean-and-in-their-offsprings-div.pdf
Genetically modified soya bean in rabbit feeding: detection of DNA fragments and evaluation of
metabolic effects by enzymatic analysis; R. Tudisco, P. Lombardi, F. Bovera, D. dˇAngelo, M. I.
Cutrignelli, V. Mastellone, V. Terzi, L. Avallone, F. Infascelli, «ASC» (2006)
4. Analysis and explanation of anomalies in images by Enrico Bucci
http://www.slideshare.net/EnricoBucci1/infascelli-final/1

5. Retraction notice of Gamma-Glutamyl Transferase Activity in Kids Born from Goats Fed Genetically
Modified Soybean (2013) in «Food and Nutrition Sciences».

E) Interviews
We contacted Tommaso Russo, but he did not answer.

We contacted Prof. Luigi Zicarelli, but he did not answer.

We interviewed Prof. Mirella Sari Gorla (on the 14th of March), Retired Professor of Genetics,
University of Milan. Former: President of the Italian Society for Agricultural Genetics and President of
the Scientific Committee of the Institute of Biology and Agricultural Biotechnology fo CNR (National
Council for Research).
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Questions:

1. What is the level of competitiveness and pressure that Italian researchers are subjected to -
especially in terms of funding and career of Universities or other research institutes- within the field
of GMOs? What is the level of competitiveness among the research groups?
2. Is the close link with the political sphere (National legislation, European directives) and the public's
attention to GMOs something that affects (positively or negatively) this field of research? If so, how?
3. For what concerns misconduct episodes, do you think there is a good internal regulation in Italy
regarding GMOs research that can prevent fraud (falsification and fabrication of data, manipulation of
images, etc.)? Do you think this research field is more or less exposed to misconduct episodes
compared to others? For what reasons? Finally, do you think there is a sufficient degree of control over
publications by reviewers and editors?

Prof. Mirella Sari Gorla (Retired Professor of Genetics, University of Milan) pointed out that there is
not a competitive funding for research on GMOs in Italy. This because any direct
modification/manipulation of genes is, as we well know, forbidden (she also added that a new type of
technology of genome editing, where you cannot talk of transgenic organisms, will likely change the
situation). In general, politics as well as public opinion, she said, tend to consider GMO as something
extremely negative. For what concerns systems of control and integrity, she did not find any difference
between GMOs field and other scientific fields in terms of lacks or problems and she simply underlined
the increased competitiveness and the frequency of data manipulation.

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Leiden University – Case Study 1


Predatory Publishing and the Imperative of International
Productivity
Authors: Sarah de Rijcke (Centre for Science and Technology Studies, Leiden University), Tereza
Stöckelová (Institute of Sociology, Czech Academy of Sciences)

1. Summary
This report discusses a case of how predatory publishing, gaming of metrics, and exploitation of the
model of gold open access can be partly understood as a logical response to the requirement of
internationalization. Predatory publishing enacts an alternative mode of internationalization for those
researchers and institutions who fail – for better or worse—within the established mode of
international, with its epistemic and economic centers in the global, Anglophone North / West. A
recent misconduct case in the Czech Republic shows how the imperative of internationalization and
productivity inscribed in the country’s research assessment framework impinges on institutional and
individual publication strategies, and produces a market for gaming in the academy. The report
concludes that purification and policing efforts are often based on the ideal of a unified science system,
with internationally shared views ‘from nowhere’ about what constitutes ‘bad’ and ‘proper’ scientific
conduct. This ideal is flawed, because different actors within science systems create and re-enforce
distinctive normative hierarchies between the international, the national, and the local: journals,
databases, evaluators, consultants, publishers, and also researchers.

2. Introduction
The requirement to ‘be international’ cannot be overlooked in current European research policy and
research evaluation. The imports of ‘internationalization’ figure prominently in how value is given to
"international visibility", "international impact", or to the international character of publication
venues. The international is used as a trope in EU funding schemes, in project goals that guide national
assessment exercises, in output measurements, in the formulation of institutional research missions,
and in tenure-track criteria. Particularly in smaller countries (e.g. the Netherlands and the Czech
Republic) the international is often taken as a proxy for quality, proving impact beyond the “academic
pods.” Consequently, the international, the national and the local constitute a clear normative
hierarchy. For example, it is taken for granted that international excellence encompasses national
excellence and (as such) is supposedly more valuable.
In this report we discuss a case that demonstrates how predatory publishing, gaming of
metrics, and exploitation of the model of gold open access (Beall 2012), can be partly understood as a
logical response to the imperative of internationalization. It enacts a different, yet debatable
alternative mode of internationalization for those researchers and institutions who fail—for better or
worse—within the established mode of international, with its epistemic and economic centers in the
global, Anglophone North / West. We zoom in on a recent misconduct case in the Czech Republic to
show how the imperative of internationalization and productivity inscribed in the country’s research
assessment framework impinges on institutional and individual publication strategies, and produces a
market for gaming in the academy.

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3. Gaming the system


In 2015, a major debate on publishing and research evaluation surfaced in the Czech academy. It was
triggered by controversy over a very productive junior researcher at the Faculty of Social Sciences of
Charles University. At first sight he seems a paradigmatic case of a successful scholar with a long list of
international publications, collaborations and co-authorships - exactly what the current research policy
in the Czech Republic holds as a normative ideal. However, on second sight and when some of his
colleagues started to closely scrutinize his production, the case turned out to be something different:
an attempt to game the current research assessment system on various levels - or rather, to take the
imperative of the system to the extreme by some perfectly legitimate and some less legitimate ways.
To understand what happened, the genesis and current state of research assessment in the country
needs to be described first.
Various forms of competitive funding of academic research were introduced with the the
establishment of the Czech Grant Agency in 1992. This was followed by the introduction of a new
methodology for the quantitative assessment of institutional-level research performance in 2001. This
was largely at the initiative of a few natural scientists who came back to the Czech Republic in 1990
after spending several years in the West. Its impact on research funding of academic institutions and
on performance assessment of individuals has since then gradually increased. The central building
blocks of the Evaluation Methodology are so-called RIV-points (RIV standing for “Information Register
of R&D results”i), assigned to pre-defined types of outputs (journal articles, monographs, patents,
prototypes et cetera) and meant to reflect their academic and user value (Office of the Government
of the Czech Republic 2013).ii One of the key claimed rationales of the Evaluation Methodology was to
create objective criteria that would increase the transparency of the research system and depoliticize
its governance. However, during the last 15 years the Methodology developed into a convoluted
metrics-based amalgamation with many unclear algorithms and weights that are far from transparent
not only for ‘ordinary’ researchers but even for research policy managers at the national level (cf.
Miholová and Majer 2016). At present the Evaluation Methodology’s criteria for ‘quality recognition’
soak through the entire system. They have a significant - even if at times indirect - impact on academic
hiring and promotion procedures, individual research grant endowment, and the funding allocation of
public research institutions.
A key trope of the research policy reforms since the 1990s has been internationalization, and
this trope is also inscribed into the current Evaluation Methodology. This is understandable in a small
country where many disciplines tended to operate in closed circles consisting of local scholars.
However, it is more problematic that the international oftentimes stands as a value in itself—
unquestioned and undisputed. E.g. there is currently nearly no peer review evaluation of journal
articles within the national evaluation framework (a peer review evaluation of a limited number of
outputs submitted by research organizations as ‘excellent’ was introduced in 2015) and the journal
impact metrics provided by Web of Science and Scopus are taken for granted as proxies for
international recognition and quality. This is the context in which junior academics start to build their
publication record and careers.
We now return to the controversy. Having gained his PhD in 2007, the academic in question
has claimed to have (co)authored or (co)edited seventeen ‘scientific monographs’ between 2011-2013
and more than eighty journal articles between 2006-2015.iii Apart from the extreme productivity, four
aspects of his CV are noteworthy. Firstly, the author also acts as an editor in chief, editorial board
member, and even publisher of some of the ‘European’ or ‘International’ journals listed on his CV.

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iv
All these journals are English language and target an international audience, have an international
review board and international pool of authors. Secondly, even if in SCOPUS, some of the journals on
his publication list were also listed in Jeffrey Beall’s database of predatory journals.v Thirdly, some of
the co-authors on these articles in predatory journals were colleagues from the faculty - including the
current head of the department.vi And, finally, as the author later confirmed, one of his co-authors was
discovered to be a fictional character supposedly affiliated with prestigious Western European
universities (first the University of Strasbourg and later the University of Cambridge).
While some of the academic’s actions were rather extreme, they stayed in line with the current
imperative of internationalization. The researcher tried to gain ‘Western’ recognition and certification
(listing on the WoS and Scopus databases) for his publishing activities as an author, editor, editorial
board member, and publisher based in the East. Interestingly, he not only strove to gain a position in
the existing international playing field (which is what the research policy framework in fact tries to
encourage) but also, as a skillful academic entrepreneur, to rework and reorder the field at one go by
creating new journals and forging new East–West alliances (even if at times with fictitious co-authors).
He also specifically offered his teaching and publication ‘services’ to researchers from Russia and
Eastern Europe in relation to whom he positioned his activities as international. Apparently, he aimed
at the enactment of a different international than the one of the current global science, in which the
international in fact equals the West.
As a result of a major controversy at the faculty level, during which ‘whistle-blowing’
colleagues from the department filed a complaint to the Ethical Commission of Charles University (the
complaint was deferredvii), and following the publication of a number of articles in national public
media, the author’s contract was terminated in September 2015. In response to the increasing media
and academic community pressure, the Faculty openly distanced itself from unethical publishing
practices connected with the case by issueing ‘publication rules’ which warned against predatory
journals and vanity press publishers. Some other faculties and universities in the country followed suit.
Interestingly, the ‘international’ standards for quality assessment did not seem to count
equally for all involved. A few weeks after the termination of the perpetrator’s contract, the contract
of the main whistle-blower was not renewed either. The faculty chiefly adhered to a ‘bad apple’
approach, a relatively common strategy in misconduct cases in the sense that measures are often taken
mainly at the level of individuals.

4. Qui bono?
Calls for more transparent, trustworthy quality control mechanisms and more open infrastructures for
communicating and publishing research are currently widely heard in European science policy. The
European Commission has introduced several framework programs that focus in particular on
responsible research and innovation, and on ‘open science’. In 2020 all scientific and scholarly output
should be freely available by way of open access. Another important aim for 2020 is a fundamentally
novel approach to data (re)use, based on open data models. But change will not come easily, with
vested interests of established academic elites and large commercial actors with their entrenched
infrastructures for publishing and evaluating research. Paradoxically, part of the answer seems to lie
in the hands of the exactly these commercial parties. At present they appear to be the ultimate
gatekeepers of the ‘international’. The critique of predatory journals inadvertently makes a very strong
case for the value added by corporate, indexed outlets and black-boxed, commercially endorsed
algorithms. Predatory journals seem to play right in the hands of corporate publishers as a
confirmation of the dangers of uncontrolled open access.

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At the same time the predatory publishing industry managed to develop a business model that
taps into both the ‘open science’ and the ‘commercial’ publishing models and normative frameworks.
Evidently, some of the appeal of predatory journals and vanity publishers lies in their offering cheap,
accessible vehicles for the ‘international’—certainly when compared to the costlier ‘gold’ open access
publications, with quality control and more or less US- and Eurocentric gatekeepers. Also, the
predatory publishing business model closely mimics and reproduces the standards and incentive
structures of the ‘global’, dominant publishing industry. This is an industry in which the journal and the
journal article are the most valuable means of communication for international recognition and
visibility, within a ‘market world of justification’ (Boltanski and Thevenot 2006) which is enacted,
among other things, through indicators such as the Journal Impact Factor (Rushforth and De Rijcke
2015, Muller and De Rijcke 2017). Publication practices of predatory publishers are being linked to the
most important and profitable value systems of the dominant publishing industry and the indicator
production market. As such, predatory publishing and its concomitant practices are not outside of the
research system but emerge at the heart of them and are embedded within them. These practices in
effect drive the existing evaluation logic to the extreme. A crucial question then becomes: qui bono (cf.
Star 1995), who actually benefits from this industry?

In the CR and further East, the predatory journals and vanity presses play a role in further
empowering skillful local researchers who used the new industry to boost their publication records,
international visibility and the financial status of their institutions (for instance by gaining RIV points
for books published by international ‘vanity’ presses). The at the first sight useful term ‘predatory
publishing’ or ‘predatory journals’ may be largely misleading, because it obscures much the agency of
individual actors in using these outlets to their advantage. In the case at hand scholars were hardly
‘prey’, as they found clever ways of gaming the assessment system.

The Czech case makes clear how the predatory publishing industry thrives mainly by being
successfully parasitic on existing forms of conduct and material infrastructures for publishing and
evaluating research—without fully incorporating its quality control mechanisms (absence of ‘proper’
peer review, fake editorial boards, et cetera). But this lack of explicit quality control procedures should
not be overemphasized. Some of them apparently have some quality control and rather than belonging
on a blacklist they operate in a grey zone—into which some established quality journals may now be
falling as well with the increased global pressures on production and auditable performance, which
deprives the publication system of available competent reviewers and editors. We think the excessive
parasitism of the ‘predatory’ journals is much more crucial. Many of them deliberately operate on the
edges of dominant publication and citation infrastructures, hosted by big commercial publishers. A lot
of these journals originate from the ‘East’, and these journals permeate the ‘global’ publishing industry
when they are indexed in the WoS and—particularly—Scopus.viii The latter’s reputation is based on
being the ‘largest abstract and citation database of peer reviewed literature’, providing a
‘comprehensive overview of the world’s research output’.ix This is a problematic statement: the
company cannot in practice control this international certification, and is nonetheless taken as proxy
for quality in many evaluation systems.

5. Conclusion
Although the critique of predatory publishing does indeed lead to some sanitization efforts (codes of
conduct, blacklists and whitelists) thus far it has not triggered any serious kind of more radical reform
of the publishing and evaluation infrastructure. This may partly be because it is too soon. It could also

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be due to the fact that purification and policing efforts are often based on the ideal of a unified science
system, with internationally shared views ‘from nowhere’ about what constitutes ‘bad’ and ‘proper’
scientific conduct. Such an ideal is doomed to fail when we see how different actors within science
systems create and re-enforce distinctive normative hierarchies between the international, the
national, and the local: journals, databases, evaluators, consultants, publishers, and also researchers.
Some assessment systems are in fact beginning to recognize the need for contextual evaluation (in
terms of disciplines and fields) and the complex relation between the international, national and local.
But there still is a long way to go before the research policy and wider academic communities
acknowledge that the more, the faster and the more international need not be always the better.

References

Beall, J. ‘Predatory publishers are corrupting open access’, Nature 489 (2012): 179, doi:
10.1038/489179a.

———. “What I learned from predatory publishers.” Biochemia Medica 27, no.2 (2017): 273-9.
https://doi.org/10.11613/BM.2017.029.

Boltanski, Luc, and Thévenot, LaurentOn Justification. The Economies of Worth. Princeton: Princeton
University Press, 2006 [1991].

Good, Barbara, Niki Vermeulen, Brigitte Tiefenthaler, and Erik Arnold. “Counting quality? The Czech
performance-based research funding system.” Research Evaluation 24, no. 2 (2015): 91-105,
https://doi.org/10.1093/reseval/rvu035

Lin, Wen-yuan, and John Law. “Making things differently: on ‘modes of international’.” CRESC
Working Paper No. 129. Centre for Research on Socio-Cultural Change (CRESC), Faculty of Social
Sciences: The Open University, 2013. Available at:
http://hummedia.manchester.ac.uk/institutes/cresc/workingpapers/wp129.pdf.

———.“A correlative STS: Lessons from a Chinese medical practice.” Social Studies of Science 44, no. 6
(2014): 801–824.

Linková, Marcela and Tereza Stöckelová. “Public accountability and the politicization of science: The
peculiar journey of Czech research assessment.” Science & Public Policy 39, no.5 (2012): 618-629.

Macháček, Vít, and Martin Srholec. ‘Predatory journals in Scopus’, Study 2/2017, IDEA – CERGE-EI,
Praha. Available at: https://idea-en.cerge-
ei.cz/files/IDEA_Study_2_2017_Predatory_journals_in_Scopus/mobile/index.html

Miholová, Katerina, and Ondrej Majer. Analýza mechanismu Metodiky hodnocení výsledků [An
analysis of the mechanism of the Evaluation methodology]. Government of the Czech Republic,
Section for Science, Research and Innovation. Unpublished report, 2016.

Office of the Government of the Czech Republic. Methodology of Evaluation of Research


Organizations and Evaluation of Finished Programmes (valid for years 2013 - 2015). Available at:
http://www.vyzkum.cz/storage/att/A7FE6F4477F5064B57B683C62C4A4CFD/Methodology.pdf

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Rushforth, Alexander D., and Sarah de Rijcke. “Accounting for impact. The Journal Impact Factor and
the making of biomedical research in the Netherlands.” Minerva 53: 117-139 (2015).

de Rijcke, Sarah, and Ruth Müller. “Thinking with indicators. Exploring the epistemic impacts of
academic performance indicators in the life sciences.” Research Evaluation (2017), doi:
10.1093/reseval/rvx023.

Silver, Andrew.. “Controversial website that lists ‘predatory’ publishers shuts down Librarian Jeffrey
Beall won’t say why he has unpublished his widely read blog. ” Nature, 18 January, 2017. Available
at: http://www.nature.com/news/controversial-website-that-lists-predatory-publishers-shuts-down-
1.21328

Star, Susan Leigh. “The politics of formal representations: Wizards, gurus, and organizational
complexity." In Susan Leigh Star (ed.) Ecologies of knowledge. Work and politics in science and
technology. Albany: State University of New York Press, 1995.

Stöckelová, Tereza. “Immutable mobiles derailed: STS and the epistemic geopolitics of research
assessment.” Science, Technology & Human Values 37, no.2 (2012): 286-311.

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Leiden University – Case Study 2


Analysis of papers retracted in the Web of Science

Authors: Thed van Leeuwen, Andrea Reyes Elizondo, Sarah de Rijcke (Leiden University)

1. Summary
Work Package III gathers indicators of the extent of misconduct and analyses how institutions respond
to misconduct or deviance in science. Deliverable III.3 focuses on the occurrence of failures in the
science system, in which material is being retracted from the pool of published knowledge. Various
aspects of the retracted literature is analysed, such as geographic and disciplinary spreading of the
phenomenon, as well as the reasons and initiators for retractions from the literature.

2. Introduction
Science seems to be in crisis, as can be concluded from the discussion on the reproducibility of scientific
results, both in the literature as well as in the mass media. Several international conferences have
dedicated attention to the phenomenon (e.g., 4S in Boston, August/September 2017, STI 2017 in Paris,
and the NWBRP in Helsinki, 2017). However, it is not a new phenomenon under debate as already in
the 1980’s scientists wrote about the issue of replication (Broad & Wade, 1982, Collins, 1985). As is
shown by the length of discussions on the topic, the talk about a crisis in replication is more prominent
since the early 2010s, when a number of highly prolific fraud cases surfaced. Since the reproducibility
of experiments is an essential element in the production of scientific knowledge, the inability to
replicate previous studies is potentially harmful for many disciplines whenever theories in those
disciplines are based upon on non-reproducible experiments. The inability to replicate research
findings can be one of the many reasons why some research papers are perceived as possibly flawed,
since non-reproducibility can be a consequence of human error or sloppiness. As sloppiness or human
errors are reasons to retract literature from the public domain, more clear reasons for retraction are
straightforward scientific misconduct, whenever we speak about the so-called FFP, fabrication,
falsification and plagiarism, or about QRP, Questionable Research Practices. FFP is often considered as
more serious as compared to the QRP part of studying science and the actors in the science system.
FFP is considered as more serious as it involves incorrect outcomes from research, misleading the
scientific audience, or stealing intellectual properties from colleagues in the research process, while
QRP does not necessarily lead to incorrect outcomes, it is more about how these are generated.

By publishing their results in the scientific literature researchers claim the ownership of
particular ideas, processes, and results, made public via journals, books, chapters, conference papers,
and talks, to name a few. Prior to publication, the contents of scholarly manuscripts is made accessible
for scrutiny to other researchers from the same discipline. Before a journal with an international
standing accepts a manuscript it is reviewed by one or more reviewers. This peer review process, a
process in which many submitted manuscripts can be rejected for various reasons, for example the
research is not in the scope of the journal, the reported research is flawed, the work is reported in a
bad or insufficient manner, etc.. Finally, manuscripts are either accepted or rejected by a journal. Once
accepted, the manuscripts become included in the journal, and made publicly available. However, this
peer review process in which manuscripts are being judged can be flawed. If results presented in the
scientific literature turn out to be not trustworthy, the publications are (partially) retracted. In principle

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these papers are removed from the common stock of knowledge. There are many reasons for
retracting a paper, scientific misconduct being only one of them. However these cases attract a
considerable amount of attention and undermine the public trust in science.

The scale enlargement through which modern science went over the last 40-50 years, with a
development from smaller communities of scientists to the large-scale big science (Price, 1963) or
techno-science (Ravetz, 1971, Latour, 1999) has been confronted with internal mechanisms for
controlling the quality produced. The ‘Publish-or-Perish’ culture, that affected global science from the
1980’s onwards, created an ever increasing growth of scientific outputs (not to the level predicted by
Price, but still rapidly increasing). This growth of global science and its outputs has also had serious
consequences for the quality control systems in science, as this has put increasing pressure on the peer
review system. So while the Mertonian perspective of academia being a sphere consisting of an
exchange of favors (as no money was involved, and the act of reviewing was considered as mutual
favor), this changed due to the increasing pressure on the peer review system in particular, but on the
scientific system as a whole. Next to this development, we now observe a further marketization or
commodification of academic work (Mirowski, 2011, Radder, 2010). Increasingly, the production of
new knowledge, and the way this is disseminated, is considered as a requirement to pursue an
academic career. With outputs being rewarded, and reviewing not, a certain degree of misbalance
might occur. This increasing pressure on peer review might result in a further decay of the quality
control system.

Over the last couple of years the retraction of publications became a popular subject in science
studies (Grieneisen & Zhang, 2012 and references therein). Authors studied mainly retractions of
papers processed for MEDLINE or subsets of retracted papers published in journals processed for
Clarivate Analytics’ Web of Science (WoS). There is a general perception that the number of retracted
papers is increasing over the years and thus scientific misconduct has become a more relevant topic
(Steen, Casadevall & Fang, 2013 and references therein).

The study’s aim is to provide a comprehensive analysis of all retracted papers published in
journals processed for WoS between 1981 and 2015. A detailed classification is produced of the
motives for the retraction as stated in the retraction notices and of the parties initiating the retraction
form the journal, two subjects paid little attention to in previous work.

3. Methods and data


In the WoS database the suffix “Retracted article” is added to the title of articles that are officially
retracted (Chen et al., 2012). Using this information on publications processed for WoS, we collected
in total 3729 publications. The dataset collected that resulted from this step was used to make a
bibliometric analysis of the retracted papers. When analysing the geographical spreading of retracted
publications, we present the results of the distribution of the countries mentioned in the papers’
address by-line. A full counting scheme at country level is applied.

The journals processed for the WoS are assigned at least to one subject category. The retracted
papers are assigned to the subject category or categories of their journals. These WoS Journal Subject
Categories form the basis for a classification of science on a somewhat higher level of aggregation,
namely that of scientific disciplines. The distribution over the scientific disciplines of the retracted
papers is compared with the distribution of all papers processed for the WoS across those same

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scientific disciplines. Again a full counting scheme is used: a paper published in a journal assigned to
several subject categories, is counted in full to each category, and thus to each discipline.

In the title of the retracted article, the suffix “Retracted article” is followed by the bibliographic
data of the retraction notice (volume, page, year). We manually retrieved the pdf-version of the
retraction notices from the Leiden electronic library or, if not available, we search for the hard copy.
One notice in a journal may contain information on more than one retracted article in that same
journal, solving various problems in one notification, which has the advantage of having to come clear
only once, instead of in multiple notifications. Another entry on the data was formed by the doi’s of
the publications labelled as retractions. The doi, the digital object identifier was a helpful tool in a clear
distinction on the notifications of the retractions.

A previous study of the current one (van Leeuwen & Luwel, 2014) was based upon a much
smaller sample of retracted publications as compared to the current analysis. In that previous analysis,
we also focused on both initiators and reasons for retractions. From the retraction notices the
information on the party responsible for the retraction as well as the reason of retraction (further
called retraction type) is retrieved. A classification scheme was developed for these items. What
became apparent in the current study was that while we classified the reasons and initiators in a simple
straightforward method (that is, one party initiating retraction, for one single reason), we observed
this to be much more complex, in the sense that initiation for retraction occurs frequently based on
two or more parties initiating the retraction, while the reasons for retraction can also be multiple. In
that previous study we allowed for example the authors and editors to be labelled together, while we
now observe that the initiating parties of retractions can be much more varied, and multiple (up to
even four parties initiating or agreeing upon retraction). A similar issue is at stake for the reasons of
retraction. In the previous study, we classified the reasons under one topic alone, while we now
observed a much more varied situation, in which often various issues play a role at the same time. For
example, fabrication, manipulation, and falsification of data are reported sometime similarly as
reasons for a retraction. Similarly, issues around data manipulation, interpretational, and data
unreliability are reported as reasons for a retraction. These combinations are multiple, and varied. So
while we tried to classify the reasons for retraction under one umbrella in the previous analysis, we
now observe these reasons often to coincide with other reasons. Important to notice here is the fact
that the boundaries between FFP and QRP seem to be more fluid than often suggested. For example,
if plagiarism is defined as the usage of text, procedures, outcomes, and ideas created by people who
are not properly acknowledged, how does that relate to discussions on authorship, e.g., the exclusion
of somebody from an author list whose work has substantially contributed to the final outcomes of a
research project?

It is well known that retracted papers are cited often years after the retraction date (see e.g.
Chen et al., 2012). Although interesting, the number of citations gives little information of the
continuing impact of these publications. For a few highly publicised fraud cases we plan to carry out a
sentiment analysis of citations to retracted papers before and after retraction (Li et al., 2013).

4. Results
In Figure 1 we show the development of publications published in the WoS covered journals, which
get retracted later onwards. The trend that is visible indicates a sharp increase in the period between

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1995/2007. From 2007 onwards, we observe a number of peaks, in 2007, in 2010, in 2012, and to a
lesser extent, in 2014. The fact that we observe somewhat of a decreasing number of retractions is not
a positive development, this simply relates to the fact that it takes some time before
erroneous/fraudulent research outputs get recognized. But we will get into this later on in this section.

350

300

250

Number of retractions

200

150

100

50

Figure 1: Number of retracted publications from WoS covered journals, 1981-2015

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Figure 2 shows that the highest number of papers retracted occurs in the first year after
publication, while we simultaneously also notice that a long tail of single occasions get retracted over
a longer period. The accumulation of retractions over time shows that 90% of all publications that get
retracted are retracted within a six year time frame.

1400 100%

90%
1200

80%

1000
70%

60%
800

Number of
Retraction period 50%
retractions
Cumulation of retractions in time
600
40%

30%
400

20%

200
10%

0 0%
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 23 25 26 29
Years

Figure 2: Period of retraction: time before publications get retracted from WoS covered journals,
1981-2015

Another characteristic of the total body of publications that is retracted relates to the actors
involved. Often retractions and research integrity/scientific misconduct is put into the ‘bad apple’
metaphor, or sometimes as the ‘lone wolf’. Here we analyse the involvement of more people per paper
retracted (which does not mean these people are all involved in fraudulent behaviour, more people
involved implies a higher chance of notifying the fact that something is wrong). So the number of
authors involved is important, as a stepping stone towards the analysis of countries involved in
retracted material as well as the various types of scientific activity involved.

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In Figure 3 we present the distribution of the numbers of authors involved in retracted


literature, as well as the cumulative shares of the total. In the line indicating the number of authors
per paper, we find that most publications that are retracted do have three authors attached to them.
Combining the two lines, we observe that 67% of all retracted publications have 1-5 authors, while the
remaining 33 % of all retracted publications have up to 33 authors (95% of all retracted publications
have up to 10 authors). A conclusion could be that the lone wolf as a single author causing retraction
(we avoid for now the reasons for retraction) is only limited as not even 10% of all retracted
publications have one single author attached to them, while in total only 40% of all publications that
are retracted carry up to three author names.

600 1

0,9

500
0,8

0,7
400

0,6
Nr authors to retracted publications
Cumulative %
300 0,5

0,4

200
0,3

0,2
100

0,1

0 0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 24 25 26 33

Figure 3: Distribution of number of authors over publications in WoS covered journals, 1981-2015

Next, we analysed the various types of scientific activity connected to the retracted literature.
We defined three mutually exclusive types of scientific activity, that is papers that carry only one
address (so we then conclude that no scientific cooperation is at stake here), indicated as Single
Institute or SI, publications that stem from international cooperation as can be concluded by the
occurrence of two or more country names in the address by-lines of the papers (indicated as
International Cooperation, or IC), and the remaining part, which carries multiple addresses, but all
from one country (interpreted as national cooperation, indicated as NC). One should note that this

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latter category NC includes intramural research, while the IC category might also include various
address from within one country (which means that IC then also partially covers NC). So mutual
exclusiveness applies within the definition, reality is of course more complex, but for the sake of clarity,
we defined these three types of scientific activity. In this analysis we integrated something from the
previous analysis, underlying Figure 2, while introducing single authored publications in Figure 3.

160

140

120

SI
NC
100
IC
Single authored

80

60

40

20

Figure 4: Distribution of number of authors over retracted publications in WoS covered journals,
1981-2015

Figure 4 shows us that single authored publications are only a small part of all publications
which carry only one address. So if publications that carry only one address are retracted from the
literature, this often involves publications that carry several author names. A next observation is that
most publications that get retracted have a national rather than an international component. This
seems to indicate that publications resulting from international cooperation have a much lower
likelihood of getting retracted.

In general, when conducting similar analyses, we find that publications resulting from international
cooperation outnumber the outputs resulting from both single address of national cooperation. In this
case, we find the opposite, which could be interpreted as indicative of the fact that international
cooperation in relation to scientific misconduct has a prohibitive effect: due to the variety of national
cultures, the possible availability of certain protocols due to regulations by international funding
agencies tighten the situation to such an extent that conducting scientific misconduct might become
more difficult.

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Figure 5 shows the countries which are most often mentioned in the address by-line of the
retracted publications. Papers (co)signed by authors from the USA, PR China, Japan, Germany, and
India are in the top five of most retracted publications per country. Particularly the USA and PR China
outnumber the other countries with retracted publications, as can be expected for the two largest
countries in terms of output. For most other countries the number of retracted publications is much
smaller, on a year-by-year basis.

140

USA
PEOPLES R CHINA
120
JAPAN
GERMANY
INDIA
100 GREAT BRITAIN
SOUTH KOREA
NETHERLANDS
ITALY
80
CANADA

60

40

20

Figure 5: Distribution of number of retracted publications over countries in WoS covered journals,
1981-2015

Table 1 gives the countries which are most often mentioned in the address by-line of the
retracted publications. In the table, we show the comparison between the regular ranking of countries
based on overall output numbers, with the number of retracted papers, and the way that creates a
ranking of countries. Papers (co)signed by authors from especially the PR China, India, the Netherlands,
and Iran are retracted more frequently compared to these countries’ share in the total number of
publications processed for the WoS. Overall for each country the fraction of retracted papers in its
total number of WoS papers is very small, but it varies between countries by a factor of 4. The main
reason for these countries to appear more prominent in this rank order coincides with the structuring
of academic rewards systems. Chinese academics get rewarded for publishing a certain number of
publications in journals with a certain status or reputation (read: those which carry a Journal Impact
Factor) before getting into a next phase in their tenure track, while Stapel indicated the ‘publish-or-
perish’ culture in the Dutch academic system as the main reason for his misbehaviour (Stapel, 2012).

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%
Retracted Country
publications Publications % % Retracted of
01-15 Rank 01-15 Rank country/world of country retracted
USA 838 1 5161565 1 26% 0,0162% 22%
PEOPLES R
CHINA 723 2 1943552 2 10% 0,0372% 19%
JAPAN 255 3 1178425 5 6% 0,0216% 7%
GERMANY 201 4 1320554 4 7% 0,0152% 5%
INDIA 201 5 578237 12 3% 0,0348% 5%
GREAT
BRITAIN 166 6 1442576 3 7% 0,0115% 4%
SOUTH KOREA 150 7 543960 13 3% 0,0276% 4%
NETHERLANDS 97 8 450917 14 2% 0,0215% 3%
ITALY 92 9 772082 9 4% 0,0119% 2%
IRAN 87 10 207817 22 1% 0,0419% 2%
FRANCE 78 11 943925 7 5% 0,0083% 2%
CANADA 73 12 791212 8 4% 0,0092% 2%
AUSTRALIA 67 13 589655 11 3% 0,0114% 2%
SPAIN 61 14 639960 10 3% 0,0095% 2%
TURKEY 50 15 298661 19 2% 0,0167% 1%

Table 1. Country of affiliation of the authors of retracted papers for countries between 2001-2015

Next, we shift our focus to the scientific domains which are affected more by retracted
literature. For this purpose we linked the journals in which the retracted publications appeared to 35
larger disciplines of science, by coupling the journals and the subject fields as these are linked in WoS.
These disciplines were first used in the Dutch Observatory of Science & Technology (NOWT, 2010), and
have as such shown their policy relevance. Note that journals are often classified in several subject
fields in the WoS, and as such contribute to more than one discipline. For now, we focus on the ten
most occurring disciplines when it comes to retractions. The disciplines with most retractions are
Clinical Medicine (32%), Basic Life Sciences (21%), and Biomedical Sciences (15%). Next we find two
large disciplines in the natural sciences realm, Physics & Materials Science and Chemistry & Chemical
Engineering, with 14% and 8% respectively. The next discipline is the set of journals classified as
Multidisciplinary Journals, which contain well known journals such as Nature, Science, and the
Proceedings of the national Academy of Sciences of the US. As this is relatively small domain, it is the
more remarkable it appears among larger disciplines in this analysis.

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retracted % % % field of
pubs 01- Ran Pubs Ran field/worl Retracted retracte
15 k 01-15 k d of field d
530662
CLINICAL MEDICINE 1193 1 2 1 27% 0,0225% 32%
244600
BASIC LIFE SCIENCES 798 2 5 4 12% 0,0326% 21%
221549
BIOMEDICAL SCIENCES 561 3 3 5 11% 0,0253% 15%
PHYSICS AND MATERIALS 400820
SCIENCE 525 4 1 2 20% 0,0131% 14%
CHEMISTRY AND CHEMICAL 299773
ENGINEERING 305 5 3 3 15% 0,0102% 8%
ENVIRONMENTAL SCIENCES 116736
AND TECHNOLOGY 159 6 2 6 6% 0,0136% 4%
MULTIDISCIPLINARY
JOURNALS 142 7 361654 17 2% 0,0393% 4%
109949
BIOLOGICAL SCIENCES 126 8 2 7 6% 0,0115% 3%
PSYCHOLOGY 86 9 432642 15 2% 0,0199% 2%
BASIC MEDICAL SCIENCES 83 10 360890 18 2% 0,0230% 2%
MATHEMATICS 82 11 701868 11 4% 0,0117% 2%
AGRICULTURE AND FOOD
SCIENCE 81 12 710176 10 4% 0,0114% 2%
MECHANICAL ENGINEERING
AND AEROSPACE 75 13 605195 13 3% 0,0124% 2%
ECONOMICS AND BUSINESS 58 14 339777 19 2% 0,0171% 2%
ENERGY SCIENCE AND
TECHNOLOGY 54 15 386264 16 2% 0,0140% 1%
ELECTRICAL ENGINEERING
AND TELECOMMUNICATION 53 16 866373 8 4% 0,0061% 1%

Table 2. Scientific disciplines related to the journals publishing the retracted papers , 2001/2015

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Figure 6 shows the development over time of the ten disciplines with highest intensity of
retractions. As we can see in the overall analysis of retracted publications, or by scientific cooperation,
or country, the main uptake of publications getting retracted seems to be happening since the
Millennium change.

160

CLINICAL MEDICINE
BASIC LIFE SCIENCES
140 BIOMEDICAL SCIENCES
PHYSICS AND MATERIALS SCIENCE
CHEMISTRY AND CHEMICAL ENGINEERING
120 MULTIDISCIPLINARY JOURNALS
ENVIRONMENTAL SCIENCES AND TECHNOLOGY
BIOLOGICAL SCIENCES
100 PSYCHOLOGY
MATHEMATICS

80

60

40

20

Figure 6: Distribution of number of retracted publications over disciplines in science in WoS covered
journals, 1981-2015

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120

100

80

Retracted publications

60

40

20

0
23%
31%
37%
42%
46%
49%
52%
55%
58%
60%
62%
64%
65%
67%
69%
71%
73%
75%
75%
76%
77%
78%
79%
80%
81%
82%
83%
84%
85%
86%
86%
87%
88%
89%
90%
91%
92%
93%
94%
95%
96%
96%
97%
98%
99%
3%

Figure 7: Distribution of retracted publications over journals, 1981-2015

Figure 7 displays a skewed distribution to the left, indicating that most retracted publications
appeared in a limited set of journals. This is further illustrated by Table 3, in which the top 15 journals
cover 549 retractions, which is roughly 16% of all retracted publications in the study.

Share
Retracted % of Cumulative
publications total % of total
ACTA CRYSTALLOGRAPHICA SECTION E-
CRYSTALLOGRAPHIC COMMUNICATIONS 104 3% 3%
PROCEEDINGS OF THE NATIONAL ACADEMY OF
SCIENCES OF THE UNITED STATES OF AMERICA 60 2% 5%
SCIENCE 57 2% 7%
NATURE 50 1% 8%
ANESTHESIA AND ANALGESIA 34 1% 9%
JOURNAL OF BIOLOGICAL CHEMISTRY 34 1% 10%
JOURNAL OF IMMUNOLOGY 33 1% 11%
MOLECULAR BIOLOGY REPORTS 28 1% 12%
BLOOD 27 1% 13%
BIOCHEMICAL AND BIOPHYSICAL RESEARCH
COMMUNICATIONS 23 1% 13%

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CANADIAN JOURNAL OF ANESTHESIA-JOURNAL


CANADIEN D ANESTHESIE 22 1% 14%
CELL 22 1% 15%
TUMOR BIOLOGY 21 1% 15%
EUROPEAN JOURNAL OF MEDICAL RESEARCH 17 1% 16%
MOLECULAR AND CELLULAR BIOLOGY 17 1% 16%

Table 3. The top of the distribution of the retracted papers over journals, 1981-2015

Next to the journals shown in Table 3, we mention a number of journals that are known for
having high Journal Impact Factor (JIF) values, all containing more than 10 retracted publications, such
as PLOS One, Journal of the American Chemical Society (JACS), the New England Journal of Medicine
(NEJM), FASEB Journal, Applied Physics Letters, Physical Review B, and EMBO Journal. Next to the ones
shown in Table 3, the occurrence of journals with high JIF values in the top of the distribution is quite
remarkable, which raises questions about the eagerness to publish quickly, and the quality level of the
peer review process applied in those journals.

Next, we focus on the classification of the parties responsible for the retraction, that is, the
initiators for retraction. Table 4 gives the different parties and the corresponding percentages of
retracted papers. A retracted paper has been assigned to combinations of types. We have kept the
order in which the initiating parties in the retraction process in the notifications have been mentioned.
We printed the most occurring parties involved in retraction in bold print. This means that
combinations of the same parties might occur, for example editor(s)/author(s), or author(s)/editor(s).
With 27%, ‘Author(s)’ are the dominant unique retracting party. Next to that, we also notice
combinations of authors with other retracting parties. Another 8% of all retractions show combinations
of authors with editor(s), and/or publishers. However, within this group it has to be noticed that within
1% of the retractions, one of the authors disagreed (‘Author(s) but not all’), and a few papers were
retracted by one single author. The editors, and in nearly half of the cases together with the publisher,
retracted 35% of the papers. Finally, it is important to remark that in 2% of the retractions, it is unclear
from the notifications who initiated the retraction, while in 25% of all retractions, it is simply unknown
who retracted, as information was not findable on the reason for retraction.

Number of
retractions % of retractions
author(s) 988 27%
author(s) / editor(s) / publisher 157 4%
author(s) / editor(s) 144 4%
author(s) / editor(s) / publisher / society 12 0%
author(s) / editor(s) / institute 9 0%
author(s) / editor(s) / society 6 0%
author(s) / institute 4 0%

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author(s) / Ethical Review Board 2 0%


author(s) / funding agency 1 0%
author(s) / society 1 0%
author(s) but not all 48 1%
author(s) but not all / editor(s) / publisher 7 0%
author(s) but not all / institute 2 0%
editor(s) 671 18%
editor(s) / publisher 559 15%
Editor(s) / author(s) 15 0%
editor(s) / institute 7 0%
editor(s) / publisher / institute 6 0%
editor(s) / publisher / society 4 0%
editor(s) / publisher / COPE 1 0%
Ethical Review Board 1 0%
funding institute 3 0%
institute 22 1%
institute / editor(s) / publisher 6 0%
publisher 5 0%
society 2 0%
unclear from notificiation 82 2%
unknown 950 25%

Table 4. The distribution of the retracted papers over the retracting parties, 1981-2015

For the seven most occurring initiating parties of retraction we plotted the development over
time. This is shown in Figure 8. Again, we immediately notice the sharp increase in all initiating parties
shortly after the Millennium Change, similar as we observed for other entries on our set of retracted
publications. In the previous decade, many retractions are done while the initiating parties are
unknown, as can be understood from the various peaks in the period 2001-2012. From 2001 onwards,
we also notice a shift in initiating parties, with editor(s) and/or publishers taking a more prominent
role in the process. Note that at the end of the period of analysis the numbers decrease, which is not
an indication of the problem disappearing, but that in the most recent years, publications with issues
have not yet been discovered.

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160

140

author(s)
unknown
120 editor(s)
editor(s) / publisher
author(s) / editor(s) / publisher
100 author(s) / editor(s)
unclear from notificiation

80

60

40

20

0
198319861987198919901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015

Figure 8: Distribution of initiating parties of retracted publications, 1981-2015

A next step in our analysis is the focus on the reason for retraction. Again, as we did in the
analysis of initiating parties, we find in Table 5 that in most cases, one single reason for retraction is
given, yet we also find cases in which a combination of reasons is given. It is important to note here
that the distinction between various forms of reasons, in particular the distinction between FFP and
QRP, are sometimes blurred by the occurrence of reasons for retraction that belong to either of these
two large distinctive categories. This occurs in small numbers, but it is still an issue to keep in mind.

Retracted % retracted
publications publications
authorship issues 108 3%
authorship issues / data incorrect 1 0%
authorship issues / duplicate publishing 1 0%
authorship issues / editorial issues 2 0%
authorship issues / errors / interpretational issues 1 0%
authorship issues / ethical issues 1 0%
authorship issues / interpretational issues 3 0%
authorship issues / plagiarism 1 0%
copyright issues 18 0%
data errors 16 0%
data fabrication 122 3%
data fabrication / data falsification 3 0%
data falsification 258 7%

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data falsification / plagiarism 2 0%


data fraud 46 1%
data inaccuracies-inconsistencies-irregularities 110 3%
data integrity 79 2%
data integrity / errors 1 0%
data integrity / ethical issues 1 0%
data integrity / interpretational issues 2 0%
data irreproducible 168 5%
data irreproducible / interpretational issues 2 0%
data unreliability 50 1%
data unreliability / authorship issues 2 0%
data unreliability / ethical issues 1 0%
data validity issues 12 0%
duplicate publishing 386 10%
duplicate publishing / data irregularities 1 0%
duplicate publishing / data issues 2 0%
duplicate publishing / data falsification 2 0%
duplicate publishing / editorial issues 7 0%
duplicate publishing / errors 1 0%
editorial issues 64 2%
editorial issues / authorship issues 2 0%
English & Chinese ? 4 0%
English & German ? 1 0%
Errors 391 10%
errors / duplicate publishing 1 0%
errors / editorial issues 4 0%
errors / interpretational issues 2 0%
errors / plagiarism 1 0%
errors / sloppyness 2 0%
ethical issues 110 3%
ethical issues / data inaccuracies 1 0%
ethical issues / errors 4 0%
ethical issues / study design 1 0%
ghost authorship / incorrect data / data duplication 2 0%
inaccurate methodology 3 0%
incomplete publishing 5 0%
interpretational issues 76 2%
interpretational issues / data falsification 1 0%
interpretational issues / irreproducible data 1 0%
invalid results 8 0%
method inconsistencies 2 0%
methodological flaws 1 0%
misconduct 2 0%

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peer review issues 131 4%


peer review issues / data fabrication 48 1%
peer review issues / editorial issues 1 0%
peer review issues / plagiarism 1 0%
plagiarism 295 8%
plagiarism / authorship issues 1 0%
plagiarism / data fabrication 1 0%
plagiarism / data inaccuracies 1 0%
plagiarism / data falsification 1 0%
plagiarism / duplicate publishing 1 0%
plagiarism / errors 1 0%
plagiarism / referencing issues 8 0%
plagiarism / self plagiarism 11 0%
referencing issues 17 0%
referencing issues / plagiarism 1 0%
research integrity issues 28 1%
self plagiarism 142 4%
self plagiarism / authorship issues 1 0%
self plagiarism / duplicate publishing 4 0%
self plagiarism /data falsification 11 0%
statistical errorrs 6 0%
text inaccuracies 2 0%
unknown 527 14%
unknown (no full text available / no license agreement with
publisher) 98 3%
unknown (no full text available) 154 4%
unknown (not found on journal website) 108 3%
unknown (not/no longer available at publisher) 29 1%

Table 5. The distribution of the retracted papers over the reasons for retraction, 1981-2015

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In Figure 9 we present the distribution of reasons for retraction, in particular the ten most
prominent reasons for retraction.

100

unknown
90
errors
duplicate publishing
80 plagiarism
data falsification
data irreproducible
70
unknown (no full text available)
self plagiarism
60 peer review issues
data fabrication

50

40

30

20

10

Figure 9: Distribution of reasons for retraction of retracted publications, 1981-2015

Except for the two extreme peaks in the category ’Unknown’ in 2007 and 2010, most other
reasons for retraction pop up occasionally, with ‘Plagiarism’ being a main reason for retraction in 2010,
and ‘Peer review issues’ in 2014. The category ‘Duplicate publishing’ is increasingly visible among the
reasons for retraction, which reaches its peak in 2013. Finally, within all the reason, the category
‘Errors’ is given as reason for retraction in about 30 publications per year form 2005 onwards.

A remarkable similarity is visible in various figures. The peak in retracted material in the
geographical break-down, the summing up of Clinical Medicine and Basic Life Sciences, and the peak
in retracted material initiated by editor(s)/publisher points at a large collection of publications from
PR China, in those two domains, which get retracted by the editor(s)/publisher of the journal(s) in
which these Chinese scientists published their work. If we link that to Figure 9, we notice that that
combined peaks in the three analyses mentioned before indicate peer review issues (which was in
most cases lacking the proper references, which in itself suggests plagiarism issues, but also suspicious
behaviour by the referees) as the main reason for retraction of that work.

So we have seen that for most retractions we can identify the reason, although for some 25%
we are empty . However as already remarked in other studies (Fang, Steen & Casadevall, 2012), the
retraction notices can be uninformative opaque, hiding the underlying arguments, and secondary

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sources are often necessary to clarify the real reasons. This is illustrated by the notice published to
retract a number of papers published in Science in the well-known ‘Schön case’ (Reich, 2009):

‘We are writing as co-authors on the following manuscripts published in Science,


which were, in part, the subject of an independent investigation conducted at the
behest of Bell Laboratories, Lucent Technologies. The independent committee
reviewed concerns related to the validity of data associated with the device
measurements described in the papers.

….

As a result of the committee’s findings, we feel obligated to the scientific community


to issue a retraction of the above articles. We note that although these papers may
contain some legitimate ideas and contributions, we think it best to make a complete
retraction.’

(Boa et al, 2002)

In Table 6a, 6b, and 6c, we combine the reasons for retraction (we selected the 18 most
prominent reasons) with the initiators of retraction (here we selected the 8 most prominent
categories). Table 5a gives the absolute numbers observed, while Table 5b presents the relative share
as compared to the column totals, and table 5c presents the relative shares as compared to the row
totals.

When we consider the relatives shares as presented in table 5b (relative shares are based upon
the horizontal perspective, calculated over the rows), we note that Authors are the ones most often
reporting errors, usually on Data falsification and Data irreproducibility. Editors tend to be most
relevant when reporting on Duplicate publishing, Plagiarism, and Data falsification, while editors in
combination with publishers alone report most on Peer review issues (21%) as well as Duplicate
publishing (13%), and Plagiarism (9%). Editors, in combination with the Publisher and the Author(s)
report most on Duplicate publishing (22%), Data fabrication (15%), and Data falsification (9%). Editor(s)
in combination with author(s) report on four issues nearly equally, namely Duplicate publishing (15%),
Errors (14%), Plagiarism (13%, and Authorship issues (13%). When not all authors retract, the most
mentioned reasons are the Irreproducibility of data (17%), Authorship issues (15%), Data falsification
(13%), and Errors (10%). When the initiators are unclear, most common reasons for retraction are
Duplicate publishing (18%), Plagiarism (13%) and Self-plagiarism (12%).

When we take another perspective, namely through the total number of reasons of retraction
(that is, we calculate the relative shares over the columns), in the case of Errors 70% of all retractions
are mentioned by Authors. In the case of Duplicate publishing, it is mainly due to the editors of journals
that initiate retraction: in 70% of the cases, editors play a role in this reason for retraction. In the case
of Plagiarism, again editors in various combinations take the initiative for retraction (in total 74% of
the cases). In the case of Data falsification, we observe some sort of a balance between authors on the
one hand, and editors in various combinations on the other hand retracting from the literature (38%
versus 46% of the retractions). In the case of data irreproducibility, nearly 80% of all cases are initiated
by the authors, in some sort of combination (see Table 3 for the various combinations). In the case of

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self-plagiarism, it is again mostly the editors in some sort of combination that initiate retraction: in
total 76% of the cases, editors are involved. Whenever Peer review issues are at stake, editors are the
dominant factor in retracting, as 96% of all cases editors are responsible for retraction. As it could be
expected, in the case of data fabrication, authors are not very much involved (in 16% of the cases), it
is again the editors in various combinations that play a dominant role here (in over 70% of the cases).
Whenever data inaccuracies, inconsistencies, or irregularities are at stake, authors take their
responsibilities and retract in 62% of the cases. In Ethical issues, it is again the editor in its various
combinations that play an active role in retraction from the literature (66% of the cases). Authorship
issues are also for authors an important reason to initiate for a retraction (43%), while editors in various
combination take a more or less equal part of all retractions due to authorship issues. In the cases of
Data integrity and Interpretational issues, it is mostly authors that take in over 50% of the cases the
initiative to retract. Finally, in the case of editorial issues, it is in 69% of the cases the editors that
initiate retraction.

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author(s)/ unclear author(s)


editor(s)/ editor(s)/ author(s)/ from but not Grand
author(s) unknown editor(s) publisher publisher editor(s) notification all Total
Unknown 49 420 22 20 4 2 2 527
Errors 272 29 15 15 15 20 5 5 391
duplicate publishing 65 20 139 74 35 22 15 2 386
Plagiarism 34 20 142 52 6 18 11 1 295
data falsification 97 12 48 44 14 9 3 6 258
data irreproducible 118 7 12 10 4 3 4 8 169
unknown (no full text available) 154 154
self plagiarism 19 3 50 37 8 13 10 1 142
peer review issues 3 118 5 4 131
data fabrication 20 7 45 19 23 2 1 2 122
data inaccuracies-inconsistencies-
irregularities 68 1 7 17 3 3 3 3 110
ethical issues 21 6 48 16 4 3 7 1 110
authorship issues 46 5 18 5 5 18 4 7 108
unknown (not found on journal
website) 108 108
unknown (no full text available / no
license agreement with publisher)) 98 98
data integrity 41 3 9 6 6 3 2 79
interpretational issues 39 1 14 5 6 6 1 76
editorial issues 14 2 16 19 7 2 4 64
Grand Total 990 955 672 562 158 144 82 48

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Table 6a. The distribution of the initiating parties of retracted papers over the reasons for retraction, 1981-2015

author(s)/ unclear
editor(s)/ editor(s)/ author(s)/ from author(s) but
author(s) unknown editor(s) publisher publisher editor(s) notification not all
Unknown 5% 44% 3% 4% 3% 1% 2% 0%
Errors 27% 3% 2% 3% 9% 14% 6% 10%
duplicate publishing 7% 2% 21% 13% 22% 15% 18% 4%
Plagiarism 3% 2% 21% 9% 4% 13% 13% 2%
data falsification 10% 1% 7% 8% 9% 6% 4% 13%
data irreproducible 12% 1% 2% 2% 3% 2% 5% 17%
unknown (no full text available) 0% 16% 0% 0% 0% 0% 0% 0%
self plagiarism 2% 0% 7% 7% 5% 9% 12% 2%
peer review issues 0% 0% 0% 21% 0% 3% 5% 0%
data fabrication 2% 1% 7% 3% 15% 1% 1% 4%
data inaccuracies-inconsistencies-irregularities 7% 0% 1% 3% 2% 2% 4% 6%
ethical issues 2% 1% 7% 3% 3% 2% 9% 2%
authorship issues 5% 1% 3% 1% 3% 13% 5% 15%
unknown (not found on journal website) 0% 11% 0% 0% 0% 0% 0% 0%
unknown (no full text available / no license
agreement with publisher)) 0% 10% 0% 0% 0% 0% 0% 0%
data integrity 4% 0% 1% 1% 4% 0% 4% 4%
interpretational issues 4% 0% 2% 1% 4% 4% 1% 0%
editorial issues 1% 0% 2% 3% 4% 1% 5% 0%
Sum % 91% 94% 88% 81% 89% 88% 94% 79%

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Table 6b. The relative distribution of the initiating parties of retracted papers over the reasons for retraction, 1981-2015

(percentages based upon the initiating parties perspective)

author(s/ unclear
editor(s)/ editor(s)/ author(s)/ from author(s) but
author(s) unknown editor(s) publisher publisher editor(s) notification not all Sum %
Unknown 9% 80% 4% 4% 1% 0% 0% 0% 98%
Errors 70% 7% 4% 4% 4% 5% 1% 1% 96%
duplicate publishing 17% 5% 36% 19% 9% 6% 4% 1% 96%
Plagiarism 12% 7% 48% 18% 2% 6% 4% 0% 96%
data falsification 38% 5% 19% 17% 5% 3% 1% 2% 90%
data irreproducible 70% 4% 7% 6% 2% 2% 2% 5% 98%
unknown (no full text available) 0% 100% 0% 0% 0% 0% 0% 0% 100%
self plagiarism 13% 2% 35% 26% 6% 9% 7% 1% 99%
peer review issues 0% 0% 2% 90% 0% 4% 3% 0% 99%
data fabrication 16% 6% 37% 16% 19% 2% 1% 2% 98%
data inaccuracies-inconsistencies-
irregularities 62% 1% 6% 15% 3% 3% 3% 3% 95%
ethical issues 19% 5% 44% 15% 4% 3% 6% 1% 96%
authorship issues 43% 5% 17% 5% 5% 17% 4% 6% 100%
unknown (not found on journal
website) 0% 100% 0% 0% 0% 0% 0% 0% 100%
unknown (no full text available / no
license agreement with publisher)) 0% 100% 0% 0% 0% 0% 0% 0% 100%
data integrity 52% 4% 11% 8% 8% 0% 4% 3% 89%

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interpretational issues 51% 1% 18% 7% 8% 8% 1% 0% 95%


editorial issues 22% 3% 25% 30% 11% 3% 6% 0% 100%

Table 6c. The distribution of the retracted papers over the reasons for retraction, 1981-2015

(percentages based upon the reasons for retraction perspective)

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Summarizing we can say that Authors play the most important role in initiating retractions
when it comes to Errors, and various issues related to data and results, namely Data irreproducibility,
Data inaccuracies-inconsistencies-irregularities, Authorship issues, Data integrity, and Interpretational
issues. From the perspective of the typical role of editors or editorial boards, peer review issues and
Editorial issues are their major concern, and thus driving force for retraction whenever this is at stake.
Then we observe for a number of reasons for retraction that relate to FFP and QRP, the most important
role being played by the editors. In the case of Duplicate publishing, Plagiarism and Self-plagiarism,
Data fabrication and Ethical issues, it is the editors in various combinations that initiate retraction. A
remarkable element is data falsification: among the main components of FFP, here we observe a
somewhat more prominent role for authors as compared to the other composing elements of FFP, in
which authors do not play such a prominent role.

5. Conclusions

The study of retracted publications is an interesting topic, however, also complicated. As we have seen
from the study, retracted publications form a relatively small part of the publications visible through a
system such as WoS, yet have a significant impact of the science system and the wider society
surrounding the science system. From the results generated during the study, we can draw a number
of conclusions.

A first point we have to make with respect to the topic of our study on retractions from the scientific
literature, relates to the fact that we have no clear perspective on the scope and volume of the
problem. Often we portray the problem with the Iceberg metaphor, for which it is said that 10% is
visible above the water, and 90% is submerged and hidden from the eye. Thus, following that line of
reasoning, that would mean that roughly some other 30.000 publications in WoS are of a suspicious
nature. If we would reverse the argument, and consider the Wos which contains over 40 million
publications as the 100% of the iceberg, we have a serious issue as not even 4000 publications were
retracted from WoS. Main point here is of course, we do not know what share of the literature is
flawed, and should actually be retracted.

The study has shown that retraction is a complex phenomenon to study with a wide variety of issues
involved. These issues range from honest error to scientific fraud in the most serious forms. In any
case, it is for the people involved in most instances an embarrassing situation: for authors as their work
is nullified (for whatever reason), for editors and publishers as their journals have not functioned
properly in safeguarding science in their field, and for institutions and governments as retractions tend
to affect the global trust in science, in particular in those cases in which scientific integrity is at stake.
The fact that for some 25% of all the retractions in WoS we were unable to find reasons and/or
initiators for retraction was quite indicative of the taboo involved in the act of retraction.

Working with WoS as a database for bibliometric studies which represents only a small portion of the
total volume of serial literature on a global scale (many more journals exist outside WoS, for which we
cannot calculate bibliometric statistics), we can conclude that global science system has increased
substantially over the last nearly four decades. The pressure that came along with this, in a global
research climate that has been influenced by the market such as incentives for researchers to increase

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productivity, has started to erode the academic norms traditionally present in academia and other
research environments. These changes and pressures can potentially lead to situations in which
individuals make honest mistakes, ignore responsible research practices due to time constrains, up to
all the way to complete derailment.

A conclusion related to the previous one revolves around the locations in which retractions happen
most frequently, whereby we mean the scientific domains in which we observe retractions most
frequently. While we mentioned in the previous conclusion the increased pressure to publish, we know
that some scientific domains experience this pressure more as compared to others. The metricization
of global science policy and management, as expressed by the growing influence of in particular the
Journal Impact Factor, has put a high pressure on those domains in science in which journal publishing
was already the dominant publishing model. This situation has only worsened over the last two
decades. What we observe is that in the most prominent fields in which journal publishing is the
standard, the highest number of retractions is found, namely in the natural, life, and biomedical
sciences. This is of course related to the coverage of the database we use, mainly journal oriented.
However, no large scandals involving scientific misconduct leading to retraction popped up outside the
before mentioned fields, for example in the social sciences, law, and the humanities, after the turn of
the century.

Again, in addition to this previous conclusion related to the fields in which most retractions were
observed, we see some resemblance between the occurrence of retractions, and the countries
involved in retracted literature. It is those countries in which particular metrical settings (e.g., Journal
Impact Factor based reward systems) are installed where we observe retractions, in such a way that
the ranking of countries involved in retracted literature deviates from the regular ranking of countries
, based upon production of outputs.

The study indicated that retracted publications tend to be rather concentrated among a small set of
journals, most of them to be found among the top Journal Impact Factor ranked ones in the fields to
which the journals belong. This raises of course the question of the relationship between retractions
from those journals, eagerness to publish, and sometimes dysfunctional peer review processes. These
questions go beyond the range of this study, but could be part of follow-up research.

The study clearly indicates the role played by the editorial boards in the process involving retractions
from the literature. From the retraction notification, we observe many variations in the roles of editors-
in-chief, either in combination with their editorial boards or solely, as well as editorials boards as a
whole. It is important to state that in many cases the editorial function is of major importance in the
process of quality control of scientific dissemination, even after publication has already taken place.

Finally, another important conclusion involving retraction and its reasons relates to the fact that
authors are strongly involved in retractions where errors play a role. This could point towards systemic
time pressure to publish as soon as possible without enough time to evaluate results, however this
should be further investigated in another research.

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i
For details see the website of the Government Office for Science, Research and Innovations
http://www.vyzkum.cz/FrontClanek.aspx?idsekce=1028.
ii
For example, for papers in WoS journals the value would be counted on the basis of the position of the journal
in disciplinary ranking in WoS but it would include other parameters set up in the Evaluation Methodology, for
patents the value would depend on whether it is a EU, USA or Japan patent (100 points), Czech or other
national patent (50 points) or other patent (25 point) (Office of the Government of the Czech Republic 2013).
For a detailed discussion of the evaluation system and its evolution see Linková and Stöckelová 2012,
Stöckelová 2012, Good et al. 2015, Miholová and Majer 2016).
iii
See the archived version of his personal web page
http://web.archive.org/web/20150514044622/http:/www.strielkowski.com/publications (accessed 30 March,
2017).
iv
An example is the International Economics Letters where he serves as an editor in chief, cf.
http://www.ielonline.eu/journal-archive/volume-2-issue-4-2013-/ and http://www.ielonline.eu/editorial-board
(accessed 12 May, 2016), another the SCOPUS indexed journal Economics and Sociology where he is listed as a
board member with the title of “Assoc. Prof.”, cf. http://www.economics-sociology.eu/?eneditorial-board,3
(accessed 12 May, 2016)—a title that incidentally does not match with the information he provides on his own
website according which he became an associated professor only in 2017 (at the Moscow Power Engineering
Institute, Russia) (cf. http://www.strielkowski.com/bio (accessed 12 May, 2016)). The researcher also publishes
a journal European Review of Social Sciences himself through his limited liability company Univerzitní servis.
http://rejstrik.penize.cz/29000335-univerzitni-servis-s-r-o (accessed 13 May, 2016), a journal of which he is
also an editor http://erss2.webnode.cz/editors (accessed 13 May, 2016).

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Promoting Integrity as an Integral Dimension
of Excellence in Research

v
The famous “Beall’s list” of predatory publishers and stand-alone predatory journals was created and
maintained in the period of 2012-2016 by the University of Colorado, Denver librarian Jeffrey Beall at
https://scholarlyoa.com. The list was unexpectedly shut down in January 2017 (Silver 2017). Refusing at first to
comment on the reasons, Beall later stated: “In January 2017, facing intense pressure from my employer, the
University of Colorado Denver, and fearing for my job, I shut down the blog and removed all its content from
the blog platform (Beall 2017).
vi
A summary of the case in English from the whistle-blowers is available at the blog Fakta o Kritice
Problematické Publikační Činnosti na IKSŽ FSV UK, https://zaetickepublikace.wordpress.com/2015/11/17/facts-
about-the-critique-of-questionable-publishing-practices-at-the-institute-of-communication-studies-and-
journalism-faculty-of-social-sciences-at-charles-university-prague (accessed 12 May, 2016).
vii
“Ethical committee communication,” Charles University website, http://www.cuni.cz/UK-5554.html (accessed
12 May, 2016).
viii
See the study by Macháček and Srholec (2017) documenting the sharp rise in recent years of the number of
predatory journals identified according to Beall’s list in Scopus, with authors of the paper primarily based in
middle-income countries Asia and North Africa.
ix
“Homepage,” Scopus, https://www.elsevier.com/solutions/scopus, (accessed 15 May, 2016).

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