commentaries 731
A framework for the ethics review of education research
Jonneke I Eikelboom,1 Olle Th J ten Cate,1 Debbie Jaarsma,2 Janet A N Raat,3 Lambert Schuwirth4 & Johannes J M
van Delden1
Health professions education is
a rapidly growing domain of
research.1 Along with this rapid
growth comes an increased concern
for quality. One element of quality
refers to the ethical conduct of
researchers towards research
participants. Recently, editors of
major medical education journals
formulated criteria for research
ethics, including the condition that
experimental research must be
approved by an ethics committee if
one is available.2,3 In some coun-
tries, including the Netherlands,
health professions education
research is not habitually reviewed,
usually because it is not recognised
policy for ethics review boards
(ERBs) to include such research in
their considerations. However, in
other countries, ERBs for biomed-
ical research do accept education
research projects for review.
Legislation governing ERBs usually
reflects the Nuremberg Code and
the Declaration of Helsinki, which
were designed to ensure the
protection of patients in medical
research and were not specifically
intended for application in
education research. Education
research bodies, such as the
American Educational Research
Association (AERA) Janet and the
Australian Association for Research
1 when participants have signed a
Utrecht, the Netherlands
2
Amsterdam, the Netherlands
3 Given the importance of this issue, we
Groningen, the Netherlands
4
Adelaide, South Australia, Australia
Correspondence: Jonneke Eikelboom,
University Medical Centre Utrecht, Julius
Centre for Medical Ethics, Universiteitsweg
100, 3584 CG Utrecht, the Netherlands.
Tel: 00 31 887 551348; Fax: 00 31 8875 5485;
E-mail: j.i.dankerlui-eikelboom-2@
umcutrecht.nl
doi: 10.1111/j.1365-2923.2012.04293.x
ª Blackwell Publishing Ltd 2012. MEDICAL EDUCATION 2012; 46: 728–737
in Education (AARE), have
developed codes of research
conduct, but in the medical
domain much more stringent and
legal procedures apply.4
One element of quality refers to the ethical
conduct of researchers towards research
participants
Invited by the Netherlands
Association for Medical Education
(Nederlandse Vereniging voor
Medische Onderwijs [NVMO]), we
developed a specific framework for
the ethics review of education re-
search. Pugsley and Dornan5 voiced
a need for evaluation by specialists
in education research as a powerful
motivator to improve health profes-
sions education and enthuse
researchers. We support their view
that the specific conditions of edu-
cation research and the specificity of
the expertise needed to review such
studies warrant the creation of a
dedicated ERB for the ethics review
of health professions education
research.
The aim of this commentary is to
discuss a new framework for the
ethics review of health professions
education research that specifically
takes into account the characteristics
of research in this domain and that
can be applied by a national ERB.
believe this will be of interest to an
international audience.
The specific conditions of education
research warrant the creation of a dedi-
cated ERB for the ethics review of health
professions education research
Ethically justified research must
comply with several terms. There is
no universally accepted framework,
but several elements have been
suggested.6,7 From these and other
sources, we have identified four
principles.8
1 The justification of research is
to advance knowledge and
understanding. This requires
valid research designs and a
reasonable prospect that the
research will generate valuable
knowledge; this is the first
principle.6
2 Respect for participants is the
second principle. Participation
in research should be voluntary
and informed consent should
be sought. Voluntary participa-
tion implies that neither
coercion nor manipulation of
choice by others has taken
place. Gaining informed
consent obliges researchers to
provide participants with
sufficient and appropriate
information in an understand-
able form6 and to exert
reasonable effort to ensure
participants understand this
information.7 Protection of
privacy and confidentiality
reflects respect for the
autonomy of participants6 as
ethical conduct does not end
consent form.7
3 Beneficence, the third principle,
implies a need to maximise
benefit for participants (if
possible) and for society and to
minimise any risk for physical
or mental harm to participants,
including any disadvantages for
participants. All research can
potentially involve harm,
731
commentaries
however minimal, and this
should be proportionate to the
benefit of advancing
knowledge.7
4 The fourth principle, of justice,
refers to the equitable treat-
ment of research participants
and to distributive justice,
which requires an equitable
distribution of burdens and
benefits over populations and
the special protection of
vulnerable persons.9
Ethics review boards must protect
potential research participants in
these respects. The legitimacy and
authority of their evaluations are
derived from a process of expert
and reasoned deliberation.10
Distributive justice requires an equitable
distribution of burdens and benefits over
populations and the special protection of
vulnerable persons
Health professions education re-
search and medical research have
similarities and differences. In both,
human beings may be involved and
interventions may be applied. How-
ever, students are, in some respects,
not equivalent to patients and there
may be a difference in how harm and
autonomy are weighed.11 Students
are usually less dependent on
teachers than patients are on doc-
tors. Harm and disadvantage may
differ as the risks involved in educa-
tion research are arguably often less
severe than those associated with
medical research. The vulnerability
of participants is likely to differ too.
Disease can threaten patients in
their very existence, whereas
education seldom has such
existential impact on students. With
this in mind, the four principles can
be nuanced for education research.
Valuable knowledge is important in all
research. Education research ap-
plies designs and methods12 that
732
differ from those used in medical
research and the ethics review of
health professions education
research therefore requires specific
expertise.
Disease can threaten patients in their very
existence, whereas education seldom has
such existential impact on students
Respect for persons refers to
participants in education research,
who are usually students or
teachers. Their autonomy is less
threatened and they are better
equipped to make decisions about
participation than patients in
medical research. Health profes-
sions education research usually
involves topics and questions that
are familiar to and comprehensible
by all participants. Participants
can weigh arguments and
considerations. This obviously
requires adequate provision of
information.
Pertaining to the beneficience principle,
the risks associated with education
research are usually low and
physical harm is exceptional. Harm
can pertain to negatively affected
study results and study progress, or
to enforcing an experimental
condition that would not have been
a primary choice.
Health professions education research
usually involves topics that are familiar
to all participants
The vulnerability of participants in
education research is lower than in
medical research. Justice is a
particular issue of interest in
education research as many
studies pertain to groups of
participants who are more aware of
one another’s experimental treat-
ment than are patients. Particularly
with assessments, employed in many
ª Blackwell Publishing Ltd 2012. MEDICAL EDUCATION 2012; 46: 728–737
education studies, the equal and
just treatment of students within
cohorts is a critical issue.
Based on this evaluation of the
characteristics of education re-
search, we propose a procedure for
the ethics review of medical educa-
tion research, containing four lev-
els of consideration.
Level A applies to research outside
the relevant domain, in which the
research is either not eligible for
review or may be referred to a
regular biomedical ERB.
Level B applies to proposed
research that uses existing data.
We believe that this type of
research does not require debated
ethics review, provided that data
are stored and handled properly
and used anonymously and there
are no issues concerning
autonomy, privacy or risk.13,14
Fully protocolised approval in
response to solicited procedural
statements from the researcher
should suffice.
Level C involves research that raises
autonomy issues only and does not
imply harm or risk. Ensuring the
provision of proper informed con-
sent is the focus of review. We
believe that a limited expert review
can suffice and in many cases can
be handled by only one or two
members of a review board, who
can decide whether a full review is
indicated. If not, approval can be
given without delay.
Level D review applies to all other
research that requires full review
by a properly composed review
board.
Particularly with assessments, the equal
and just treatment of students within
cohorts is a critical issue

We developed a web-based proce-
dure that automatically generates
responses for research considered
at Levels A and B. The researcher’s
responses to a web-based, self-
administered questionnaire deter-
mine the appropriate level of re-
view. The questionnaire includes a
statement that questions are an-
swered truthfully. The review board
that administers this protocol
should include experts in educa-
tion, law and ethics, and a student
among its members.
The NVMO ERB operates
nationally and is not linked with a
specific university. We think this
ensures objectivity, independence
and equality in evaluations.
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Western medicine (European med-
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Correspondence: Dr Manisha Nair, Room 302,
Department of Public Health, University of
Oxford, Rosemary Rue Building, Old Road
Campus, Headington, Oxford OX3 7LF,
UK. Tel: 00 44 7405 744536;
Fax: 00 44 1865 289260;
E-mail: dr.manisha.das@gmail.com
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parallel, Western medical education
is also making inroads into medical
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ising the medical curriculum risks
the likelihood of causing a ‘new
wave of imperialism’.2
Bleakley et al.2 have illustrated how
medical schools in non-Western
countries struggle with the
commentaries 733
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ingrained cultural assumptions of
some curricular innovations, such
as the objective structured clinical
examination, problem-based learn-
ing and the teaching of clinical
skills.
Globalising the medical curriculum
risks the likelihood of a ‘new wave of
imperialism’
Education systems for health pro-
fessionals in many LMICs are
undergoing reforms to keep pace
with the population health needs,
disease burden and health system
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