Professional Documents
Culture Documents
Ethics Supporting Documents Uslu
Ethics Supporting Documents Uslu
Ethics Supporting Documents Uslu
Fatma Uslu
Responsibilities
• Informing all faculties and researchers about project calls and funding opportunities
• Supporting or directing the process through formal submission, developing budgets
and overseeing completion of forms and documents
• Reviewing grant and contract proposals for accuracy, completeness and compliance
with agency regulations and institutional policies
• Providing ongoing trainings, seminars, workshops for academic and administrative
staff on the development and preparation of grants and related matters.
Table of Content
• Ethics Issues Checklist
• Ethics Self-Assesment
If we have entered any ethics issues in the ethical issue table in the
administrative proposal forms, we need to
-the potential impact of the research (e.g. dual use issues, environmental
damage, stigmatisation of particular social groups, political or financial
retaliation, benefit-sharing, malevolent use , etc.).
Ethics self-assesment
If your proposal raises one of the issues listed in the ethics issue checklist above,
you must proceed to the ethics self-assessment in Part B of your proposal.
Your proposal must include the information indicated in the ethics issues checklist
and any of the documents that are already available. ( For documents that are not
yet available, provide an approximate timeline for their submission.)
Describes how the proposal meets the national legal and ethical
requirements of the country or countries where the tasks raising
ethical issues are to be carried out.
Ethics Self Assesment Form Sample
This document summarizes potential ethics issues that a proposal could raise, as well as guidance on the information to be provided in the
proposal (Part B section 6) in order to complete the ethics self-assessment. The last column of the table focuses on the documents to be provided
– when relevant, should the proposal be selected for funding.
- Are they previously established cells lines? Origin and line of cells. Copies of relevant Ethics Approvals.
Details on licensing and
control measures by the
competent authorities of
the Member States
involved.
Does your research involve the use of human embryos? Origin of embryos. Copies of relevant Ethics Approvals.
If YES: Details on recruitment, Informed Consent Forms.
inclusion and exclusion
Information Sheets.
criteria and informed
consent procedures.
Does your research involve the use of human foetal tissues / cells? Origin of human foetal Copies of relevant Ethics Approvals.
tissues/cells. Informed Consent Forms.
If YES:
Details on informed
Information Sheets.
consent procedures.
Section 2: HUMANS YES/ NO Page
Information to be provided Documents to be provided
Does your research involve human participants? Please provide information in
one of the subcategories below:
- Are they volunteers for social or human sciences research? Details on recruitment, Copies of relevant Ethics Approvals.
If inclusion and exclusion
YES: Informed Consent Forms.
criteria and informed consent
procedures. Information Sheets.
- Are they persons unable to give informed consent? Information above plus: Documents as above.
Details on the procedures to
obtain approval from
guardian/ legal
representative.
Details on the procedures
used to ensure that there is no
coercion on participants.
- Are they vulnerable individuals or groups? Details on the type of Documents as above.
vulnerability.
Details on recruitment,
inclusion and exclusion
criteria and informed consent
procedures. This must
demonstrate appropriate
efforts to ensure fully
informed understanding of
the implications of
participation.
- Are they children/minors? Information above plus: Documents as above.
Details on the age range.
Details on children/minors
assent procedures and
parental consent. This must
demonstrate appropriate
efforts to ensure fully
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informed understanding of
the implications of
participation.
Describe the procedures to
ensure welfare of the
child/minor.
- Are they patients? Details on the nature of Documents as above.
disease/condition/disability.
Details on recruitment,
inclusion and exclusion
criteria and informed consent
procedures
Details on policy for incidental
findings.
- Are they healthy volunteers for medical studies? Information as above Copies of relevant Ethics Approvals.
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Section 3: HUMAN CELLS / TISSUES YES/ NO Page Information to be provided Documents to be provided
Does your research involve human cells or tissues? (Other than from Details of the cells and tissue
“Human Embryos/Foetuses” i.e. Section 1) types involved.
- Are they available commercially? Details on cell types and Any relevant import licences
If YES: provider (company or
other).
- Are they obtained within this project? Details on cell types. Copies of relevant Ethics Approvals or
regulatory licences.
Copies of examples of Informed
Consent documents.
- Are they obtained within another project? Details on cell types. Authorisation by primary owner of
cells/tissues (including references to
Provider of the cell types.
relevant licences or ethics approval
Country in which the and evidence of consent for secondary
material is located. use).
Copy of any Material Transfer
Agreement.
- Are they deposited in a biobank? Details on cell types. Details of the biobank, the legislation
under which it is licenced, criteria for
Name of the biobank.
access and its data protection policy
Country in which the including any Material Transfer
biobank is located Agreement.
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Section 4: PROTECTION OF PERSONAL DATA2 YES/NO Page Information to be Documents to be provided
provided
Does your research involve personal data collection and/or
processing?
2. Any data that you are using should be taken into account, regardless of
the method by which they are/were collected: for example, through
interviews, questionnaires, direct online retrieval etc.
3. Processing should be understood to not only include data usage, but also
merging, transformation, transfer and, more generally, as all actions using
data for research purposes.
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- Does it involve the collection and/or processing of sensitive Details of the data safety Copies of relevant Ethics Approvals for
If YES: personal data (e.g. health, sexual lifestyle, ethnicity, political procedures (compliance the collection and/or processing of
opinion, religious or philosophical conviction)? with privacy by design personal data.
and protection of
privacy/confidentiality). If relevant, Informed Consent Forms
It should be noted that this involvement applies, whatever the or other consent documents (opt in
research topic or Programme. The above list is only indicative. If Details of procedures for processes, etc.).
the type of data that you will be handling in your research is not data collection, storage,
included the list, it does not mean you should not take into protection, retention, If relevant, Information Sheets or
consideration the subject of data processing. transfer if any, other terms and conditions, factsheets,
destruction or re-use. etc.
Does your research involve further processing of previously Details of the database Explicit confirmation of open public
collected personal data (secondary use)? used or to the source of access to the data (e.g. print screen
data. from Website) or authorisation by
If YES: primary owner(s) of data.
Confirmation of open
It should be noted that this question is threefold. If you answer YES to any of public access to the data If relevant/applicable, copies of
the 3 questions below, you fall within its scope: or of authorisation for Informed Consent Forms or other
secondary use. More consent documents (opt in processes,
1. Are you planning not to collect any data directly but rather to use pre- specifically, detail how etc.).
existing other data sets or sources and/or does your research involve further this consent was obtained
processing of previously collected data? specifically in case of Copies of relevant permissions and
public archives usage description of procedures.
2. Does your research involve merging existing data sets?
(automatic opt in, etc.).
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If data transfer to USA/Canada:
3. Are you planning to share data with non-EU member states?
Permissions from the confirmation of compliance with safe
owner/manager of the harbour.
data sets.
If data transfer to non-EU country,
A mitigation procedure to affidavit of compliance with EU
avoid private legislation.
appropriation of the data.
A mitigation procedure to
avoid the unforeseen
disclosure of personal
information (i.e.: mosaic
effect).
Explicit confirmation of
compliance with national
and EU legislation.
Conformity to Safe
Harbour, if applicable.
Does your research involve animals? Details on implementation Copies of all appropriate
of the Three Rs authorisations for the supply of
(Replacement, Reduction animals and the project experiments.
and Refinement). Copies of training certificates/
Justification of animal use personal licences of the staff
and why alternatives involved in animal experiments.
cannot be used.
Confirmation of compliance with
Details on species and relevant EU and national legislation.
rationale for their use,
numbers of animals to be
used, nature of the
experiments, procedures
and techniques to be used
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in a chronological order.
Details on procedures to
ensure animal welfare
during their lifetime and
during the experiment and
how its impact will be
minimised.
Details on severity
assessment and
justification.
- Are they vertebrates or live cephalopods? Information as above. Documents as above.
If YES:
(See Art. 1.3 of Directive
2010/63/EU).
- Are they non-human primates (NHP)? Information above plus: Documents as above.
Confirmation of Personal history file of NHP
compliance with Art. 8, 10, (See Art. 31.2 of Directive
28, 31, 32 (Directive
2010/63/EU).
2010/63/EU).
Discussion of specific
ethics issues related to
their use.
- Are they genetically modified?4 Confirmation of Copies of all appropriate
compliance with relevant authorisations for the supply of
EU and national legislation animals and the project experiments,
and details as for non- copies of GMO authorisation and
genetically modified evidence of compliance with GMO
animals above. Regulations, and supporting
documents as for other experimental
animals.
Copies of training certificates/
personal licences of the staff
involved in animal experiments
- Are they cloned farm animals? Information as above Copies of all appropriate
authorisations for the supply of
animals and the project experiments
as for other experimental animals.
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Copies of training certificates/
personal licences of the staff
involved in animal experiments.
Copies of specific authorisation for
cloning, if appropriate.
- Are they an endangered species? Information above plus: Copies of all appropriate
Discussion of specific authorisations for the supply of
ethics issues related to animals and the project experiments
as for other experimental animals,
their use.
including CITES.
Confirmation of compliance with Art.
7 - Directive 2010/63/EU.
Please indicate the species involved (Maximum number of characters allowed: 1000)
Does your research involve third countries? Details on activities carried Copies of relevant Ethics Approvals
Countries:(Maximum number of characters allowed: 1000) out in non-EU countries. from EU country host and non-EU
country (double Ethics Review).
Do you plan to use local resources (e.g. animal and/or human tissue Details on type of local If human resources are involved,
samples, genetic material, live animals, human remains, materials of resources to be used and copies of relevant Ethics Approvals, as
historical value, endangered fauna or flora samples, etc.)? modalities for their use. above.
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“Protection of Personal Data” i.e. Section 4.
Do you plan to export any material, including personal data, from the EU Details on type of materials Authorisation for export from EU.
to third/non-EU countries? or data to be exported. Material Transfer Agreement (MTA).
If your research involves exporting data, please also complete the section
“Protection of Personal Data” i.e. Section 4.
If YES: - Specify material and countries involved (maximum number of
characters allowed: 1000)
If your research involves low and/or lower-middle income countries, are Details on benefit sharing As above (use of local resources) and
any benefit-sharing actions planned? measures. narrative document describing benefit
sharing, responsiveness to local
Details on responsiveness research needs and capacity building.
to local research needs.
Details on procedures to
facilitate effective capacity
building.
Could the situation in the country put the individuals taking part in the Details on safety measures Insurance cover
research at risk? that will be implemented,
including personnel
training.
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Section 7: ENVIRONMENTAL PROTECTION AND SAFETY YES/ NO Page Information to be Documents to be provided
provided
Does your research involve the use of elements that may cause harm to Details on safety Safety classification of laboratory.
the environment, animals or plants? measures to be GMO authorisation, if applicable.
If YES: implemented.
Confirmation of compliance with
national/local
guidelines/legislation.
Does your research deal with endangered fauna and/or flora Specific approvals, if applicable.
/protected areas?
If YES: Confirmation of compliance with
national/local
guidelines/legislation.
Does your research involve the use of elements that may cause harm to Details on health and University/Research organisation
humans, including research staff? safety procedures. safety procedures.
If YES:
Safety classification of laboratory.
Does your research involve the use of elements that may cause harm to Details on health and University/Research organisation
humans, including research staff? safety procedures. safety procedures.
If YES Does your research involve harmful biological agents?5 Safety classification of laboratory.
Confirmation of compliance with
Does your research involve harmful chemical and explosive national/local guidelines/legislation
agents?6
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Section 8: DUAL USE 8 YES/NO Page Information to be provided Documents to be provided
If YES Does your research have an exclusive civilian application focus? Explanations on the Confirmation that the inclusion of
exclusive civilian focus of the military partners and technologies
research relates to civilian applications e.g.
in the context of law enforcement
activities.
Will your research use or produce goods or information that Details on what goods and Copies of relevant approvals from
will require export licenses in accordance with legislation on information used and national export control authorities,
dual use items? produced in your research if applicable.
will need export licences
Does your research affect current standards in military ethics – Details on how the research A detailed description on what risk
e.g., global ban on weapons of mass destruction, issues of might affect current mitigation strategies will be
proportionality, discrimination of combatants and standards in military ethics. implemented to avoid negative
accountability in drone and autonomous robotics implications on military ethics
developments, incendiary or laser weapons? standards outlined in international
humanitarian law.
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Section 9: MISUSE YES/NO Page Information to be provided Documents to be provided
If YES Does your research involve information on/or the use of Details on the legal Copies of relevant Approvals, if
biological-, chemical-, nuclear/radiological-security sensitive requirements of the applicable.
materials and explosives, and means of their delivery? possession of such items
and proposed risk Copies of personnel security
mitigation strategies. clearances, if applicable
Does your research involve the development of technologies or Details on measures to Copies of relevant Ethics Approvals,
the creation of information that could have severe negative prevent malevolent abuse. if applicable.
impacts on human rights standards (e.g. privacy, stigmatization,
discrimination), if misapplied? Details on risk mitigation
strategies.
Does your research have the potential for terrorist or criminal Details on measures to Copies of relevant Ethics Approvals,
abuse e.g. infrastructural vulnerability studies, cybersecurity prevent malevolent abuse. if applicable.
related research?
Details on risk mitigation Copies of personnel security
strategies. clearances, if applicable.
SECTION 10: OTHER ETHICS ISSUES YES/ NO Page Information to be provided Documents to be provided
Are there any other ethics issues that should be taken into consideration? Any relevant information. Any relevant document.
Please specify: (Maximum number of characters allowed: 1000)
References to legislation and guidelines
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1. Regulation of the European Parliament and of the Council laying down the rules for the participation and dissemination in 'Horizon 2020 –
the Framework Programme for Research and Innovation (2014-2020).
Regulation of the European Parliament and of the Council establishing Horizon 2020 - The Framework Programme for Research and Innovation
(2014-2020).
2. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the
processing of personal data and on the free movement of such data.
3. Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific
purposes.
4. Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified
microorganisms.
Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on trans boundary movements of genetically
modified organisms – see specifically its articles 4 to 11 and its annexes III to V.
5. Directive 2009/41/EC and Regulation (EC) No 1946/2003.
6. Regulation (EC) No 1907/2006.
7. Directive 96/29/Euratom, Directive 97/43/Euratom, Directive 2006/117/EU, Directive 2003/122/Euratom.
8. Regulation of the European Parliament and of the Council establishing Horizon 2020 - The Framework Programme for Research and
Innovation (2014-2020).
Council Regulation (EC) No 428/2009 of 5 May 2009 setting up a Community regime for the control of exports, transfer, brokering and transit of
dual-use items.
Biological and Toxin Weapons Convention 1972.
Chemical Weapons Convention 1992.
Non-Proliferation Treaty 1968.
Directive 2008/56/EC; Council Directive 92/43/EEC; Council Directive 79/409/EEC.
Council Regulation (EC) No 338/97.
Council Decision 93/626/EEC.
Council Decision 2002/628/EC.
Directive 2009/41/EC and Regulation (EC) No 1946/2003.
Regulation (EC) No 1907/2006.
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Section 5: Ethics and Security
5.1 Ethics
This section will address the ethical issues regarding the following adequately:
Ethical aspects of WoMUNE’s research methods have been considered and will be
addressed by implementing the following measures:
2. The questions in the questionnaire which are based on pre-existing surveys have
been adapted to reflect the academic context of UK universities and research institutions
(See Questionnaire).
3. Some interview questions have been provided in the participant information sheet
to inform participation.
4. Potential participants will be given sufficient time to think about taking part in the
research.
The following Code of Ethics will be strictly adhered to throughout the research process:
Informed consents of participants will be obtained before involving them in the study.
The process of recruiting participants will not involve coercion in any way.
The protection of privacy of the research participants, including third parties, will be
ensured.
Participation in surveys and in-depth interviews will be voluntary.
Adequate level of confidentiality of the research data will be ensured.
Anonymity of individuals and organisations participating in the research will be ensured.
Affiliations in any forms, sources of funding, as well as any possible conflicts of interests
will be declared.
The research will be communicated with honesty and transparency at all levels.
Misleading and biased representation of data and findings will be avoided.
Falsification, fabrication and misinterpretation of data will be avoided at all times.
Works of other researchers and authors used in research will be referenced.
Hence, ethical consideration is not a task completed upon the approval of the ethics
application. It is a process that has to be revisited all throughout the study. This is particularly
important in relation to network data where participants may be identified based on their ego-
networks, particularly in WP5. This will be monitored carefully and will be noted in reporting
findings and publications without misrepresentation or misinterpretation of the network data
collected.
WoMUNE is designed to primarily collect survey and interview data. The Project Coordinator
and WP leaders will comply with the legal and ethical requirements existing in the relevant
research sites. Collaborators from each of the research sites will provide guidance to ensure
compliance to local ethical guidelines and obtain approval before engaging any full-time
academics and researchers. The project will obtain informed consent from participants to
participate in each of the relevant work packages for use of the information collected.
Consent will also provide a clear statement relating to data archiving and sharing or any
other future uses of data. The consent form will provide sufficient information for clarity and
explicit description of data management in terms of how research data will be stored,
preserved and used in the long-term; and how confidentiality will be maintained, e.g. by
anonymising data; how data will be shared where anonymisation is not desirable, e.g.
network data. Participant’s consent to use data unaltered will be explicitly sought and data
protection will be exercised with additional access controls on the data, if necessary.
Responsibility: LJMU will have overall responsibility for data management over the course of
the research project and will monitor compliance with the project plan. The coordinator will
ensure that the research data is managed in complete compliance with European
Commission’s Research Data Management Policy and guidelines.
Access and Sharing: Data will be available via the project website. Standard identifiers and
formats will be agreed and used to facilitate data management.
Ethics and Privacy: Whether or not required as a condition of Research Ethics approval, all
data will be de-identified before long-term storage and sharing with the research community.
The information sheet and consent form for this programme will clearly state that the data will
be imported or exported from/to the host site from/to the different research sites.
Storage and Backup: To ensure on-going and long-term security of the data generated by
this project, a complete (master) copy of each digital file (i.e., research data files,
documentation, and other related files) will be generated and stored independently on
primary and backup sources at LJMU’s archival storage.
Archiving and Preservation: On completion of WoMUNE, the PI will identify which project
materials are of probable long-term interest for archiving and preservation. Materials will be
anonymised or de-identified as appropriate, converted to searchable pdf document format,
and stored locally. Data will be retained for 10 years. LJMU will archive the full dataset and
its documentation for the long term, supporting the data through changing technologies, new
media, and data formats. The opportunity to participate in open data access will be
considered.
EMAIL INVITATION TO COMPLETE SURVEY
Dear Colleague,
I am writing to ask you to take part in a survey which seeks to understand the
network relations and networking behaviours that create and influence the academic
climate at your institution that either facilitates or inhibits the advancement of female
academics. Network relations include mentoring schemes, informal meetings and
social gatherings.
The research covers all full-time academics and researchers in all disciplines. It is not
only targeting female colleagues in anyway. The academic climate is sustained by
both genders. All of the responses will be treated in the strictest confidence and will
be used for academic purposes only. All data collected as part of this survey will be
stored in anonymised form.
If at any point you find any of the questions upsetting for any reason, you may
choose to discontinue from completing the survey.
Completing the survey should take no more than 15 minutes. If you have any queries,
please feel free to contact me at j.g.enriquezgibson@ljmu.ac.uk.
We realise the great pressures on your time and would like to thank you in advance
for taking the trouble to read this e-mail and, we hope, to complete the survey.
Yours sincerely
Judith Enriquez-Gibson
CONSENT FORM
I confirm that I have read and understand the information provided for the
above study. I have had the opportunity to consider the information, ask
questions and have had these answered satisfactorily.
I understand that any personal information collected during the study will be
anonymised and remain confidential.
Name of Person taking consent (if different from researcher) Date Signature
Note: When completed 1 copy for participant and 1 copy for researcher.