79C3C34C52B45572883A05D425EB0F82

Horizon 2020: How to Complete your Ethics Self-Assessment

https://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/ethics/h2020_hi_ethics-self-assess_en.pdf

http://leaux.net/URLS/ConvertAPI Text Files/B98FB7942FC8F361E69F77E8AD7AD959.en.txt

Examining the file media/Synopses/B98FB7942FC8F361E69F77E8AD7AD959.html:

This file was generated: 2020-12-01 09:22:04

Indicators in focus are typically shown highlighted in yellow;

Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink;

"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green;

Trigger Words/Phrases are shown highlighted in gray.

Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	Illegal Activity	illegal	1
Political	Refugee Status	asylum	2
Political	criminal	criminal	3
Political	immigrants	immigrant	1
Political	political affiliation	political	1
Political	vulnerable	vulnerable	4
Political	vulnerable	vulnerability	2
Health	Drug Usage	drug	1
Health	Healthy People	healthy volunteers	1
Health	Healthy People	volunteers	4
Health	Mentally Disabled	disability	1
Health	Motherhood/Family	family	1
Health	stem cells	stem cells	7
Social	Access to Social Goods	access	9
Social	Age	age	3
Social	Child	child	2
Social	Child	children	11
Social	Elderly	elderly	1
Social	Ethnicity	ethnic	1
Social	Ethnicity	ethnicity	2
Social	Fetus/Neonate	foetus	1
Social	Fetus/Neonate	foetuses	5
Social	Laboratory Staff	research staff	1
Social	Linguistic Proficiency	language	1
Social	Occupation	occupation	1
Social	Police Officer	officer	4
Social	Presence of Coercion	coerced	1
Social	Racial Minority	minority	1
Social	Racial Minority	race	1
Social	Religion	conviction	1
Social	Religion	religion	1
Social	Religion	religious	1
Social	Soldier	military	5
Social	Trade Union Membership	union	2
Social	Victim of Abuse	abuse	3
Social	Youth/Minors	minor	1
Social	education	education	1
Social	gender	gender	2
Social	parents	parents	1
Social	philosophical differences/differences of opinion	opinion	5
Social	sex worker	sex workers	1
Economic	Economic/Poverty	poor	2
General/Other	Public Emergency	emergency	1
General/Other	Relationship to Authority	authority	1
General/Other	declaration of helsinki	helsinki	4
General/Other	oviedo	oviedo	3

Political / Illegal Activity

Searching for indicator illegal:

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p.000008: Particular attention must be paid to vulnerable categories of individuals such as children, patients, people
p.000008: subject to discrimination, minorities, people unable to give consent, people of dissenting opinion, immigrant or
p.000008: minority communities, sex workers, etc.
p.000008: If your research involves children or other individuals unable to make decisions for themselves, you must
p.000008: maintain an active relationship with their legal guardians and/or carers; you must not only seek their consent,
p.000008: but also allow them to monitor the research.
p.000008: Ensure that data are kept securely and that publication (including publication on the internet) does not lead (either
p.000008: directly or indirectly) to a breach of agreed confidentiality and anonymity.
p.000008:
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p.000009: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000009:
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p.000009:
p.000009: In rare cases, there may be a need to override agreements on confidentiality and anonymity (e.g. if
p.000009: maintaining confidentiality facilitates illegal behaviour such as drug dealing, child abuse, etc. that has come
p.000009: to light in the course of the research). In such circumstances, you must carefully consider disclosure to the
p.000009: appropriate authorities. You must inform the participants or their guardians of your intentions and the
p.000009: reasons for disclosure, unless this makes disclosure impracticable. You should also consider the technical
p.000009: aspects of collecting and storing your research data.
p.000009: Data collection using electronic encoding tools (digital recorders or cameras) should be given special attention (see
p.000009: also section 4). You should also discuss these issues with your organisation’s data protection officer.
p.000009:
p.000009: Medical research —is specifically addressed by the Declaration of Helsinki. Your grant proposal must also comply with:
p.000009: - the principles laid down in the Oviedo Bioethics Convention and
p.000009: - EU Regulation No 536/2014 on clinical trials on medicinal products for human use.
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p.000009: 2.4 What do you need to provide?
p.000009: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000009: self-assessment in Part B of your proposal (i.e. section 5 of the Technical Annex).
...

Political / Refugee Status

Searching for indicator asylum:

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p.000001: several experts from different backgrounds. The Commission/Agency may also make this an ethics requirement during
p.000001: the selection procedure.
p.000001:
p.000001: Other information
p.000001: For a broader overview of how Horizon 2020 grants work, see the Participant Portal Online Manual. For detailed
p.000001: information, see the Horizon 2020 AGA — Annotated Grant Agreement.
p.000001: A comprehensive list of all Horizon 2020 reference documents (including legislation, work programme and templates) can
p.000001: be found on Participant Portal Reference Documents.
p.000001:
p.000001: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: Version Publication
p.000001: Date
p.000001:
p.000001: HISTORY OF CHANGES
p.000001: Change
p.000001:
p.000001: 5.0
p.000001: 5.1
p.000001:
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p.000001:
p.000001: 5.2
p.000001:
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p.000001: 5.3
p.000001: 6.0
p.000001:
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p.000001: 6.1
p.000001: 15.03.2016
p.000001: 01.06.2016
p.000001:
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p.000001: 12.07.2016
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p.000001:
p.000001: 21.02.2018
p.000001: 23.07.2018
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p.000001: 04.02.2019
p.000001: ▪ Document revised by DGT editors
p.000001: ▪ Reparation of hyperlinks
p.000001: ▪ Reference to new Data Protection Regulation
p.000001: ▪ Adapt instructions on providing of documents to new MGA provisions.
p.000001: ▪ Insert link to new guidance note on research on refugees, asylum seekers and migrants
p.000001: ▪ Correction in ethics issues table in section 7.2
p.000001: ▪ H2020 is written as Horizon 2020 throughout the document.
p.000001: ▪ A new reference document is added in section 6 on Non-EU countries.
p.000001: ▪ Adaptation of the section 4 on personal data further to the application of the new GDPR.
p.000001: ▪ Modification of the Important Notice to refer to the ethics by design methodology
p.000001: ▪ Modification of the section 11 to cover ethics by design and add a reference on AI
p.000001: ▪ Replace the reference to the FP7 guidance note on social sciences by the new one (with the link to the
p.000001: document in the Portal)
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p.000001: 1
p.000001:
p.000001: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000001:
p.000001: TABLE OF CONTENTS
p.000001: 1. Human embryos & foetuses 3
p.000001: 2. Human beings
p.000006: 6
p.000006: 3. Human cells or tissues
p.000012: 12
p.000012: 4. Personal data
p.000016: 16
p.000016: 5. Animals
p.000022: 22
p.000022: 6. Non-EU countries
p.000025: 25
...

p.000009: documents already available.
p.000009:
p.000009: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000009: on, if requested by the Commission/Agency.
p.000009:
p.000009:
p.000009: Background documents & further reading
p.000009:
p.000009: Informed consent
p.000009: FP7 guidance: Informed consent
p.000009: Medical research
p.000009: WMA Declaration of Helsinki
p.000009: Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology
p.000009: and Medicine: Convention on Human Rights and Biomedicine (Oviedo, 4 April 1997) (Oviedo Bioethics Convention)
p.000009: EU Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as
p.000009: regards investigational medicinal products for human use as well as the requirements for authorization of the
p.000009: manufacturing or importation of such products (OJ L 91, 9.4.2005, p. 13)
p.000009: EU Regulation No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for
p.000009: human use, repealing Directive 2001/20/EC (OJ L 158, 27.5.2014)
p.000009: Functional Magnetic Resonance Imaging
p.000009: Social science research
p.000009: Social sciences and humanities
p.000009: Research Ethics in Ethnography/Anthropology
p.000009: Guidance note — Research on refugees, asylum seekers & migrants
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000010:
p.000010:
p.000010:
p.000010: Ethics in Social Science and Humanities
p.000010: Research on children
p.000010: FP7 guidance: Ethics for Clinical Trials on Medicinal Products Conducted with Paediatric Population
p.000010:
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p.000011: 11
p.000011:
p.000011: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000011:
p.000011: 3. Human cells or tissues
p.000011: This section refers to research using, producing or collecting human cells or tissues. You may obtain cells or tissues:
p.000011: - from commercial sources
p.000011: - as part of this research project
p.000011: - from another research project, laboratory or institution
p.000011: - from a biobank.
p.000011:
p.000011:
...

Political / criminal

Searching for indicator criminal:

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p.000015:
p.000015: Individuals are not considered ‘identifiable’ if identifying them requires excessive effort.
p.000015: Completely anonymised data does not fall under the data privacy rules (as from the moment it has been
p.000015: completely anonymised).
p.000015: ‘Processing of personal data’ means any operation (or set of operations) performed on personal data, either manually or
p.000015: by automatic means. This includes:
p.000015: - collection (digital audio recording, digital video caption, etc.)
p.000015: - recording
p.000015: - organisation, structuring & storage (cloud, LAN or WAN servers)
p.000015: - adaptation or alteration (merging sets, appification, etc.)
p.000015: - retrieval & consultation
p.000015: - use
p.000015: - disclosure by transmission, dissemination or otherwise making available (share, exchange, transfer)
p.000015: - alignment or combination
p.000015: - restriction, erasure or destruction.
p.000015: Examples: access to/consultation of a database containing personal data; managing of the database; posting/putting a
p.000015: photo of a person on a website; storing IP addresses or MAC addresses; video recording (CCTV); creating a
p.000015: mailing list or a list of participants.
p.000015:
p.000015: Processing normally covers any action that uses data for research purposes (even if interviewees, human
p.000015: volunteers, patients, etc. are not actively included in the research).
p.000015: Personal data may come from any type of research activity (ICT research, genetic sample collection, tissue storage,
p.000015: personal records (financial, criminal, education, etc.), lifestyle and health information, family histories,
p.000015: physical characteristics, gender and ethnic background, location tracking and domicile information, etc.).
p.000015:
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000016:
p.000016: 4.1 Ethics issues checklist
p.000016:
p.000016:
p.000016:
p.000016: Section 4: PROTECTION OF PERSONAL DATA
p.000016:
p.000016:
p.000016: YES/NO
p.000016:
p.000016:
p.000016: Page
p.000016:
p.000016:
p.000016: Information to be provided
p.000016:
p.000016: Documents to be provided/kept on file
p.000016:
p.000016:
p.000016: Does your research involve processing of personal data?
p.000016: 1) Details of the technical and organisational measures to safeguard the rights of the research participants.
p.000016: For instance:
p.000016: For organisations that must appoint a DPO under the GDPR: Involvement of the data protection officer (DPO) and
p.000016: disclosure of the contact details to the research participants.
p.000016: For all other organisations: Details of the data protection policy for the project (i.e. project-specific, not
p.000016: general).
p.000016: 2) Details of the informed consent procedures.
...

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p.000020: 20
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p.000020: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000020:
p.000020:
p.000020:
p.000020: 4.3 What do you need to provide?
p.000020: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000020: self-assessment in Part B of your proposal (i.e. section 5 of the Technical Annex).
p.000020: Your grant proposal must include the information referred to in the ethics issues checklist and any of the
p.000020: documents already available.
p.000020:
p.000020: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000020: on, if requested by the Commission/Agency.
p.000020: Background documents & further reading
p.000020:
p.000020: General
p.000020: Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural
p.000020: persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive
p.000020: 95/46/EC (OJ L 119, 4.5.2016, p. 1)
p.000020: Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural
p.000020: persons with regard to the processing of personal data by competent authorities for the purposes of the
p.000020: prevention, investigation, detection or prosecution of criminal offences or the execution of criminal
p.000020: penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L
p.000020: 119, 4.5.2016, p. 89)
p.000020: Guidelines on Consent under Regulation 2016/679 (wp259rev.01), Article 29 Working Party
p.000020: Guidelines on Transparency under Regulation 2016/679 (wp260rev.01), Article 29 Working Party
p.000020: Guidelines on Automated individual decision-making and Profiling for the purposes of Regulation
p.000020: 2016/679(wp251rev.01), Article 29 Working Party
p.000020: Council of Europe Modernised Convention for the Protection of Individuals with Regard to the Processing of Personal
p.000020: Data, CM/Inf (2018)15-final
p.000020: Handbook on European data protection law (2018 edition), European Union Agency for Fundamental Rights and
p.000020: Council of Europe, European Court of Human Rights, European Data Protection supervisor
p.000020: Data transfers outside the EU - International data transfers using model contracts
p.000020: Electronic communications
p.000020: EU Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the
p.000020: processing of personal data and the protection of privacy in the electronic communications sector (Directive
p.000020: on privacy and electronic communications)
p.000020: EU Directive 2006/24/EC of 15 March 2006 on the retention of data generated or processed in connection with the
...

Political / immigrants

Searching for indicator immigrant:

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p.000008: practices. If such practices are inevitable given the methodology, what action should be taken to mitigate them?
p.000008: For your grant proposal, you should also provide an assessment of risks, stating explicitly what kinds of harm
p.000008: (psychological, social, legal, economic, environmental, etc.) might occur, the likelihood of subjects actually
p.000008: incurring such harm, and the steps that you will take to minimise them.
p.000008: Research entailing more than minimal risk typically involves:
p.000008: - potentially vulnerable groups and people unable to give informed consent
p.000008: - personal or sensitive topics, which might induce psychological stress, anxiety or humiliation
p.000008: - deception
p.000008: - risks to researcher safety or
p.000008: - seeking respondents through the internet/social media (e.g. using identifiable visual images or discussing
p.000008: sensitive issues ).
p.000008: Particular attention must be paid to vulnerable categories of individuals such as children, patients, people
p.000008: subject to discrimination, minorities, people unable to give consent, people of dissenting opinion, immigrant or
p.000008: minority communities, sex workers, etc.
p.000008: If your research involves children or other individuals unable to make decisions for themselves, you must
p.000008: maintain an active relationship with their legal guardians and/or carers; you must not only seek their consent,
p.000008: but also allow them to monitor the research.
p.000008: Ensure that data are kept securely and that publication (including publication on the internet) does not lead (either
p.000008: directly or indirectly) to a breach of agreed confidentiality and anonymity.
p.000008:
p.000008:
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p.000009: 9
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p.000009: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000009:
p.000009:
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p.000009:
p.000009: In rare cases, there may be a need to override agreements on confidentiality and anonymity (e.g. if
p.000009: maintaining confidentiality facilitates illegal behaviour such as drug dealing, child abuse, etc. that has come
p.000009: to light in the course of the research). In such circumstances, you must carefully consider disclosure to the
p.000009: appropriate authorities. You must inform the participants or their guardians of your intentions and the
...

Political / political affiliation

Searching for indicator political:

Political / vulnerable

Searching for indicator vulnerable:

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p.000001: committee approval before publishing research articles. Thus, you should be prepared for ethics procedures even if your
p.000001: research is funded by sources other than Horizon 2020.
p.000001: Your first source should always be at your institution. We would ask you to seek advice from colleagues
p.000001: with expertise in the ethics of research, such as:
p.000001: specialised ethics departments
p.000001: relevant managers in your university/research organisation hospital research ethics committees
p.000001: ethics advisers in your company data protection officers.
p.000001: They will be able to provide you with information appropriate to your specific needs and legal environment.
p.000001: Consider involving/appointing an ethics adviser/advisory board. From the beginning of your project, an ethics adviser
p.000001: can help you deal with ethical issues and put in place the procedures to handle them appropriately. If your research
p.000001: includes several ethical concerns or involves several significant or complex ethical issues (such as
p.000001: participation of children from developing countries, ’non-human primates (NHPs)’, potential misuse or
p.000001: vulnerable populations) we suggest you appoint an ethics adviser or an ethics advisory board comprising
p.000001: several experts from different backgrounds. The Commission/Agency may also make this an ethics requirement during
p.000001: the selection procedure.
p.000001:
p.000001: Other information
p.000001: For a broader overview of how Horizon 2020 grants work, see the Participant Portal Online Manual. For detailed
p.000001: information, see the Horizon 2020 AGA — Annotated Grant Agreement.
p.000001: A comprehensive list of all Horizon 2020 reference documents (including legislation, work programme and templates) can
p.000001: be found on Participant Portal Reference Documents.
p.000001:
p.000001: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: Version Publication
p.000001: Date
p.000001:
p.000001: HISTORY OF CHANGES
p.000001: Change
p.000001:
p.000001: 5.0
p.000001: 5.1
p.000001:
p.000001:
p.000001:
p.000001: 5.2
p.000001:
p.000001:
p.000001: 5.3
p.000001: 6.0
p.000001:
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p.000001: 6.1
p.000001: 15.03.2016
p.000001: 01.06.2016
p.000001:
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p.000001: 12.07.2016
p.000001:
p.000001:
p.000001: 21.02.2018
p.000001: 23.07.2018
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p.000001: 04.02.2019
p.000001: ▪ Document revised by DGT editors
p.000001: ▪ Reparation of hyperlinks
p.000001: ▪ Reference to new Data Protection Regulation
p.000001: ▪ Adapt instructions on providing of documents to new MGA provisions.
...

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p.000004: 4 See also Article 13(2) of the Rules for Participation Regulation (EU) No 1290/2013.
p.000004:
p.000005: 5
p.000005:
p.000005: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000005:
p.000005: 2. Human beings
p.000005: This section refers to any research involving work with humans beings (‘research or study participants’), regardless of
p.000005: its nature or topic.
p.000005: Examples: collection of biological samples, personal data, medical interventions, interviews,
p.000005: observations, tracking or the secondary use of information provided for other purposes, e.g. other research projects,
p.000005: officially collected information, social media sites, etc.
p.000005:
p.000005:
p.000005: 2.1 Ethics issues checklist
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Section 2: HUMANS
p.000005:
p.000005:
p.000005: YES/ NO
p.000005:
p.000005:
p.000005: Page
p.000005:
p.000005: Information to be provided
p.000005:
p.000005: Documents to be provided/kept on file
p.000005:
p.000005:
p.000005: Does your research involve human participants?
p.000005:
p.000005:
p.000005: If YES: - Are they
p.000005: volunteers for social or human sciences research?
p.000005: - Are they persons unable to give informed consent (including children/minors)?
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: - Are they vulnerable individuals or groups?
p.000005:
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p.000005:
p.000005:
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p.000005: - Are they children/minors?
p.000005: 1) Confirm that informed consent has been obtained.
p.000005:
p.000005:
p.000005: 1) Details of the recruitment, inclusion and exclusion criteria and informed consent procedures.
p.000005: 1) Details of the procedures for obtaining approval from the guardian/legal representative and the agreement of the
p.000005: children or other minors.
p.000005: 2) What steps will you take to ensure that participants are not subjected to any form of coercion?
p.000005: 1) Details of the type of vulnerability.
p.000005: 2) Details of the recruitment, inclusion and exclusion criteria and informed consent procedures.
p.000005: These must demonstrate appropriate efforts to ensure fully informed understanding of the implications of participation.
p.000005: 1) Details of the age range.
p.000005: 2) What are your assent
p.000005: 1) Informed Consent Forms + Information Sheets.
p.000005:
p.000005: 1) Copies of ethics approvals (if required).
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
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...

p.000008: - studies with consenting adults would not be effective
p.000008: - participants are subject to only a minimal risk and burden
p.000008: - the results of the research will benefit the individual or group represented by the participant.
p.000008:
p.000008: Social science and humanities research — often involves working with human participants and particular
p.000008: methodological tools (e.g. surveys, questionnaires, interviews, standardised tests, direct observation,
p.000008: ethnography, recordings, experiments with volunteers, and sometimes physical interventions).
p.000008: You must therefore clarify the ethical implications of the chosen methodologies.
p.000008: Example:
p.000008: Describe the sampling methods or recruitment procedures and discuss whether they could result in discriminatory
p.000008: practices. If such practices are inevitable given the methodology, what action should be taken to mitigate them?
p.000008: For your grant proposal, you should also provide an assessment of risks, stating explicitly what kinds of harm
p.000008: (psychological, social, legal, economic, environmental, etc.) might occur, the likelihood of subjects actually
p.000008: incurring such harm, and the steps that you will take to minimise them.
p.000008: Research entailing more than minimal risk typically involves:
p.000008: - potentially vulnerable groups and people unable to give informed consent
p.000008: - personal or sensitive topics, which might induce psychological stress, anxiety or humiliation
p.000008: - deception
p.000008: - risks to researcher safety or
p.000008: - seeking respondents through the internet/social media (e.g. using identifiable visual images or discussing
p.000008: sensitive issues ).
p.000008: Particular attention must be paid to vulnerable categories of individuals such as children, patients, people
p.000008: subject to discrimination, minorities, people unable to give consent, people of dissenting opinion, immigrant or
p.000008: minority communities, sex workers, etc.
p.000008: If your research involves children or other individuals unable to make decisions for themselves, you must
p.000008: maintain an active relationship with their legal guardians and/or carers; you must not only seek their consent,
p.000008: but also allow them to monitor the research.
p.000008: Ensure that data are kept securely and that publication (including publication on the internet) does not lead (either
p.000008: directly or indirectly) to a breach of agreed confidentiality and anonymity.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: In rare cases, there may be a need to override agreements on confidentiality and anonymity (e.g. if
...

Searching for indicator vulnerability:

(return to top)
p.000005:
p.000005:
p.000005:
p.000005: Section 2: HUMANS
p.000005:
p.000005:
p.000005: YES/ NO
p.000005:
p.000005:
p.000005: Page
p.000005:
p.000005: Information to be provided
p.000005:
p.000005: Documents to be provided/kept on file
p.000005:
p.000005:
p.000005: Does your research involve human participants?
p.000005:
p.000005:
p.000005: If YES: - Are they
p.000005: volunteers for social or human sciences research?
p.000005: - Are they persons unable to give informed consent (including children/minors)?
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: - Are they vulnerable individuals or groups?
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: - Are they children/minors?
p.000005: 1) Confirm that informed consent has been obtained.
p.000005:
p.000005:
p.000005: 1) Details of the recruitment, inclusion and exclusion criteria and informed consent procedures.
p.000005: 1) Details of the procedures for obtaining approval from the guardian/legal representative and the agreement of the
p.000005: children or other minors.
p.000005: 2) What steps will you take to ensure that participants are not subjected to any form of coercion?
p.000005: 1) Details of the type of vulnerability.
p.000005: 2) Details of the recruitment, inclusion and exclusion criteria and informed consent procedures.
p.000005: These must demonstrate appropriate efforts to ensure fully informed understanding of the implications of participation.
p.000005: 1) Details of the age range.
p.000005: 2) What are your assent
p.000005: 1) Informed Consent Forms + Information Sheets.
p.000005:
p.000005: 1) Copies of ethics approvals (if required).
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: - Are they patients?
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: - Are they healthy volunteers for medical studies?
p.000006:
p.000006: Does your research involve physical interventions on the study participants?
...

p.000036:
p.000036:
p.000037: 37
p.000037:
p.000037: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000037:
p.000037:
p.000037: - limiting the dissemination of research results
p.000037: - training all staff appropriately.
p.000037: In many cases, overlaps between safety and security measures will exist, but gaps need to be identified and
p.000037: addressed. The most frequent issue relates to research involving pathogens and the need to implement adequate
p.000037: biosecurity measures.
p.000037:
p.000037: Research with a potential impact on human rights — Concerns in this field relate primarily to research on surveillance
p.000037: technologies, new data-gathering and data-merging technologies (e.g. in the context of big data). However, social or
p.000037: genetic research that could lead to discrimination or stigmatisation is also affected.
p.000037: Risk mitigation measures may include:
p.000037: - a human rights impact assessment
p.000037: - involving human rights experts in your research
p.000037: - training personnel and/or technological safeguards
p.000037: - caution when publishing or otherwise disseminating results (e.g. through privacy by design)
p.000037: - adapting the research design (e.g. using dummy data).
p.000037:
p.000037: Research that has other potential misuses — Although anything could ultimately be used for malevolent purposes,
p.000037: research in this category is that which provides terrorists or criminals with information or technologies that would
p.000037: have substantial direct impacts on the security of individuals, groups or states.
p.000037: Examples: infrastructural vulnerability studies, cyber-security-related research
p.000037: In many cases, researchers outside the security domain are not familiar with security safeguards. In such
p.000037: situations, researchers should consult experts familiar with security ethics and/or human rights. If
p.000037: security or human rights abuse concerns exist, you should arrange for:
p.000037: - training on this issue
p.000037: - the appointment of an ethics adviser/ethics advisory board.
p.000037:
p.000037:
p.000037: 10.3 What do you need to provide?
p.000037: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000037: self-assessment in Part B of your proposal (i.e. section 5 of the technical Annex).
p.000037: Your grant proposal must include the information referred to in the ethics issues checklist and any of the
p.000037: documents already available.
p.000037:
p.000037: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000037: on, if requested by the Commission/Agency.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: Background documents & further reading
p.000037:
p.000037: Guidance note — Potential misuse of research results
p.000037: FP7 guidance: A comprehensive strategy on how to minimize research misconduct and the potential misuse of
p.000037: research in EU-funded research
...

Health / Drug Usage

Searching for indicator drug:

Health / Healthy People

Searching for indicator healthy volunteers:

(return to top)
p.000005: 1) Details of the type of vulnerability.
p.000005: 2) Details of the recruitment, inclusion and exclusion criteria and informed consent procedures.
p.000005: These must demonstrate appropriate efforts to ensure fully informed understanding of the implications of participation.
p.000005: 1) Details of the age range.
p.000005: 2) What are your assent
p.000005: 1) Informed Consent Forms + Information Sheets.
p.000005:
p.000005: 1) Copies of ethics approvals (if required).
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: - Are they patients?
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: - Are they healthy volunteers for medical studies?
p.000006:
p.000006: Does your research involve physical interventions on the study participants?
p.000006: procedures and parental consent for children and other minors?
p.000006: 3) What steps will you take to ensure the welfare of the child or other minor?
p.000006: 4) What justification is there for involving minors?
p.000006: 1) What disease/condition
p.000006: /disability do they have?
p.000006: 2) Details of the recruitment, inclusion and exclusion criteria and informed consent procedures.
p.000006: 3) What is your policy on incidental findings?
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) Copies of ethics approvals.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) Copies of ethics approvals.
p.000006:
p.000006: If YES:
p.000006: - Does it involve invasive techniques (e.g. collection of human cells or tissues, surgical or medical interventions,
p.000006: invasive studies on the brain, TMS etc.)?
p.000006: - Does it involve collection of biological samples?
p.000006: 1) Risk assessment for each technique and overall.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) What type of samples will be collected?
...

Searching for indicator volunteers:

(return to top)
p.000001: projects and gives advice on dealing with classic cases. Cases that are not covered must therefore be dealt with
p.000001: outside this guide.
p.000001: The ethics self-assessment will become part of your grant agreement (in Annex 1, as description of the action,
p.000001: ethics requirements, etc.) and may thus give rise to binding obligations that may later on be checked through
p.000001: ethics checks, reviews or audits.
p.000001: This means the time you invest in this self-assessment is not wasted. It will actually improve your research results
p.000001: and:
p.000001: your proposed research will be in line with applicable international, EU and national law
p.000001: your proposal will be processed more easily during the Horizon 2020 proposal selection procedure
p.000001: the results of your research can be published more easily in internationally refereed journals
p.000001: you will contribute to the responsible conduct of research, thereby increasing its social acceptance.
p.000001: Consider that ethics issues arise in many areas of research. Apart from the obvious example, the medical field,
p.000001: research protocols in social sciences, ethnography, psychology, environmental studies, security research, etc. may
p.000001: involve the voluntary participation of research subjects and the collection of data that might be considered as
p.000001: personal. You must protect your volunteers, yourself and your researcher colleagues.
p.000001: Start thinking about ethics while designing your research protocols. Don't wait until the last minute to seek advice or
p.000001: check requirements under national and EU law. Use the ethics by design methodology (see section 11).
p.000001: Ethics also matter for scholarly publication. Major scientific journals in many areas will increasingly require ethics
p.000001: committee approval before publishing research articles. Thus, you should be prepared for ethics procedures even if your
p.000001: research is funded by sources other than Horizon 2020.
p.000001: Your first source should always be at your institution. We would ask you to seek advice from colleagues
p.000001: with expertise in the ethics of research, such as:
p.000001: specialised ethics departments
p.000001: relevant managers in your university/research organisation hospital research ethics committees
p.000001: ethics advisers in your company data protection officers.
p.000001: They will be able to provide you with information appropriate to your specific needs and legal environment.
p.000001: Consider involving/appointing an ethics adviser/advisory board. From the beginning of your project, an ethics adviser
...

p.000004: FP7: Recommendations on the ethical review of hESC FP7 research projects (Opinion 22), European Group on
p.000004: Ethics in Science and New Technologies.
p.000004: FP7 guidance: Research on Human embryos/foetus.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: 4 See also Article 13(2) of the Rules for Participation Regulation (EU) No 1290/2013.
p.000004:
p.000005: 5
p.000005:
p.000005: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000005:
p.000005: 2. Human beings
p.000005: This section refers to any research involving work with humans beings (‘research or study participants’), regardless of
p.000005: its nature or topic.
p.000005: Examples: collection of biological samples, personal data, medical interventions, interviews,
p.000005: observations, tracking or the secondary use of information provided for other purposes, e.g. other research projects,
p.000005: officially collected information, social media sites, etc.
p.000005:
p.000005:
p.000005: 2.1 Ethics issues checklist
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Section 2: HUMANS
p.000005:
p.000005:
p.000005: YES/ NO
p.000005:
p.000005:
p.000005: Page
p.000005:
p.000005: Information to be provided
p.000005:
p.000005: Documents to be provided/kept on file
p.000005:
p.000005:
p.000005: Does your research involve human participants?
p.000005:
p.000005:
p.000005: If YES: - Are they
p.000005: volunteers for social or human sciences research?
p.000005: - Are they persons unable to give informed consent (including children/minors)?
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: - Are they vulnerable individuals or groups?
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: - Are they children/minors?
p.000005: 1) Confirm that informed consent has been obtained.
p.000005:
p.000005:
p.000005: 1) Details of the recruitment, inclusion and exclusion criteria and informed consent procedures.
p.000005: 1) Details of the procedures for obtaining approval from the guardian/legal representative and the agreement of the
p.000005: children or other minors.
p.000005: 2) What steps will you take to ensure that participants are not subjected to any form of coercion?
p.000005: 1) Details of the type of vulnerability.
p.000005: 2) Details of the recruitment, inclusion and exclusion criteria and informed consent procedures.
p.000005: These must demonstrate appropriate efforts to ensure fully informed understanding of the implications of participation.
p.000005: 1) Details of the age range.
p.000005: 2) What are your assent
...

p.000007:
p.000007:
p.000007: You must also ensure that your research methodologies do not result in discriminatory practices
p.000007: or unfair treatment.
p.000007:
p.000007: General principle — maximise benefits and minimise risks/harm.
p.000007: In addition, when conducting surveys, interviews or focus groups where personal information is gathered and
p.000007: stored, you must also pay attention to:
p.000007: - privacy
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000008:
p.000008: - data protection
p.000008: - data management (see also section 4)
p.000008: - the health and safety of participants (see section 7.2).
p.000008:
p.000008:
p.000008:
p.000008: Specific cases
p.000008:
p.000008: Research involving children (or other persons unable to give consent) — should be carried out only if:
p.000008: - studies with consenting adults would not be effective
p.000008: - participants are subject to only a minimal risk and burden
p.000008: - the results of the research will benefit the individual or group represented by the participant.
p.000008:
p.000008: Social science and humanities research — often involves working with human participants and particular
p.000008: methodological tools (e.g. surveys, questionnaires, interviews, standardised tests, direct observation,
p.000008: ethnography, recordings, experiments with volunteers, and sometimes physical interventions).
p.000008: You must therefore clarify the ethical implications of the chosen methodologies.
p.000008: Example:
p.000008: Describe the sampling methods or recruitment procedures and discuss whether they could result in discriminatory
p.000008: practices. If such practices are inevitable given the methodology, what action should be taken to mitigate them?
p.000008: For your grant proposal, you should also provide an assessment of risks, stating explicitly what kinds of harm
p.000008: (psychological, social, legal, economic, environmental, etc.) might occur, the likelihood of subjects actually
p.000008: incurring such harm, and the steps that you will take to minimise them.
p.000008: Research entailing more than minimal risk typically involves:
p.000008: - potentially vulnerable groups and people unable to give informed consent
p.000008: - personal or sensitive topics, which might induce psychological stress, anxiety or humiliation
p.000008: - deception
p.000008: - risks to researcher safety or
p.000008: - seeking respondents through the internet/social media (e.g. using identifiable visual images or discussing
p.000008: sensitive issues ).
p.000008: Particular attention must be paid to vulnerable categories of individuals such as children, patients, people
...

p.000015: Examples: name, address, identification number, pseudonym, occupation, e-mail, CV, location data, Internet Protocol
p.000015: (IP) address, cookie ID, phone number, data provided by smart meters, data held by a hospital or doctor.
p.000015:
p.000015: Individuals are not considered ‘identifiable’ if identifying them requires excessive effort.
p.000015: Completely anonymised data does not fall under the data privacy rules (as from the moment it has been
p.000015: completely anonymised).
p.000015: ‘Processing of personal data’ means any operation (or set of operations) performed on personal data, either manually or
p.000015: by automatic means. This includes:
p.000015: - collection (digital audio recording, digital video caption, etc.)
p.000015: - recording
p.000015: - organisation, structuring & storage (cloud, LAN or WAN servers)
p.000015: - adaptation or alteration (merging sets, appification, etc.)
p.000015: - retrieval & consultation
p.000015: - use
p.000015: - disclosure by transmission, dissemination or otherwise making available (share, exchange, transfer)
p.000015: - alignment or combination
p.000015: - restriction, erasure or destruction.
p.000015: Examples: access to/consultation of a database containing personal data; managing of the database; posting/putting a
p.000015: photo of a person on a website; storing IP addresses or MAC addresses; video recording (CCTV); creating a
p.000015: mailing list or a list of participants.
p.000015:
p.000015: Processing normally covers any action that uses data for research purposes (even if interviewees, human
p.000015: volunteers, patients, etc. are not actively included in the research).
p.000015: Personal data may come from any type of research activity (ICT research, genetic sample collection, tissue storage,
p.000015: personal records (financial, criminal, education, etc.), lifestyle and health information, family histories,
p.000015: physical characteristics, gender and ethnic background, location tracking and domicile information, etc.).
p.000015:
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000016:
p.000016: 4.1 Ethics issues checklist
p.000016:
p.000016:
p.000016:
p.000016: Section 4: PROTECTION OF PERSONAL DATA
p.000016:
p.000016:
p.000016: YES/NO
p.000016:
p.000016:
p.000016: Page
p.000016:
p.000016:
p.000016: Information to be provided
p.000016:
p.000016: Documents to be provided/kept on file
p.000016:
p.000016:
p.000016: Does your research involve processing of personal data?
p.000016: 1) Details of the technical and organisational measures to safeguard the rights of the research participants.
p.000016: For instance:
p.000016: For organisations that must appoint a DPO under the GDPR: Involvement of the data protection officer (DPO) and
p.000016: disclosure of the contact details to the research participants.
...

Health / Mentally Disabled

Searching for indicator disability:

(return to top)
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: - Are they patients?
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: - Are they healthy volunteers for medical studies?
p.000006:
p.000006: Does your research involve physical interventions on the study participants?
p.000006: procedures and parental consent for children and other minors?
p.000006: 3) What steps will you take to ensure the welfare of the child or other minor?
p.000006: 4) What justification is there for involving minors?
p.000006: 1) What disease/condition
p.000006: /disability do they have?
p.000006: 2) Details of the recruitment, inclusion and exclusion criteria and informed consent procedures.
p.000006: 3) What is your policy on incidental findings?
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) Copies of ethics approvals.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) Copies of ethics approvals.
p.000006:
p.000006: If YES:
p.000006: - Does it involve invasive techniques (e.g. collection of human cells or tissues, surgical or medical interventions,
p.000006: invasive studies on the brain, TMS etc.)?
p.000006: - Does it involve collection of biological samples?
p.000006: 1) Risk assessment for each technique and overall.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) What type of samples will be collected?
p.000006: 2) What are your procedures for collecting biological samples?
p.000006: 1) Copies of ethics approvals.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) Copies of ethics approvals.
p.000006: For research involving processing of genetic information, see also section 4.
p.000006:
p.000006:
p.000006: 2.3 How do I deal with the issues?
p.000006: Your research must comply with:
p.000006: - ethical principles
p.000006: - applicable international, EU and national law.
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
...

Health / Motherhood/Family

Searching for indicator family:

(return to top)
p.000015: Completely anonymised data does not fall under the data privacy rules (as from the moment it has been
p.000015: completely anonymised).
p.000015: ‘Processing of personal data’ means any operation (or set of operations) performed on personal data, either manually or
p.000015: by automatic means. This includes:
p.000015: - collection (digital audio recording, digital video caption, etc.)
p.000015: - recording
p.000015: - organisation, structuring & storage (cloud, LAN or WAN servers)
p.000015: - adaptation or alteration (merging sets, appification, etc.)
p.000015: - retrieval & consultation
p.000015: - use
p.000015: - disclosure by transmission, dissemination or otherwise making available (share, exchange, transfer)
p.000015: - alignment or combination
p.000015: - restriction, erasure or destruction.
p.000015: Examples: access to/consultation of a database containing personal data; managing of the database; posting/putting a
p.000015: photo of a person on a website; storing IP addresses or MAC addresses; video recording (CCTV); creating a
p.000015: mailing list or a list of participants.
p.000015:
p.000015: Processing normally covers any action that uses data for research purposes (even if interviewees, human
p.000015: volunteers, patients, etc. are not actively included in the research).
p.000015: Personal data may come from any type of research activity (ICT research, genetic sample collection, tissue storage,
p.000015: personal records (financial, criminal, education, etc.), lifestyle and health information, family histories,
p.000015: physical characteristics, gender and ethnic background, location tracking and domicile information, etc.).
p.000015:
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000016:
p.000016: 4.1 Ethics issues checklist
p.000016:
p.000016:
p.000016:
p.000016: Section 4: PROTECTION OF PERSONAL DATA
p.000016:
p.000016:
p.000016: YES/NO
p.000016:
p.000016:
p.000016: Page
p.000016:
p.000016:
p.000016: Information to be provided
p.000016:
p.000016: Documents to be provided/kept on file
p.000016:
p.000016:
p.000016: Does your research involve processing of personal data?
p.000016: 1) Details of the technical and organisational measures to safeguard the rights of the research participants.
p.000016: For instance:
p.000016: For organisations that must appoint a DPO under the GDPR: Involvement of the data protection officer (DPO) and
p.000016: disclosure of the contact details to the research participants.
p.000016: For all other organisations: Details of the data protection policy for the project (i.e. project-specific, not
p.000016: general).
p.000016: 2) Details of the informed consent procedures.
p.000016: 3) Details of the security measures to prevent unauthorised access to personal data.
...

Health / stem cells

Searching for indicator stem cells:

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p.000001:
p.000001: TABLE OF CONTENTS
p.000001: 1. Human embryos & foetuses 3
p.000001: 2. Human beings
p.000006: 6
p.000006: 3. Human cells or tissues
p.000012: 12
p.000012: 4. Personal data
p.000016: 16
p.000016: 5. Animals
p.000022: 22
p.000022: 6. Non-EU countries
p.000025: 25
p.000025: 7. Environment, health & safety 29
p.000025: 8. Dual use
p.000033: 33
p.000033: 9. Exclusive focus on civil applications 35
p.000033: 10. Potential misuse of research results 37
p.000033: 11. Other ethics issues
p.000040: 40
p.000040:
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p.000040:
p.000040:
p.000040:
p.000002: 2
p.000002:
p.000002: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000002:
p.000002: 1. Human embryos & foetuses
p.000002: This section covers research on human embryos and foetuses (mainly human embryonic stem cells (hESC)).
p.000002:
p.000002: The following fields of research are not eligible for funding under Horizon 2020 and cannot therefore be included in
p.000002: proposals):
p.000002: - research activities directed at human cloning for reproductive purposes
p.000002: - research activity intended to modify the genetic make-up of human beings that could make such
p.000002: changes heritable (apart from research relating to cancer treatment of the gonads, which may be financed)
p.000002: - research activities intended to create human embryos solely for the purposes of research or stem cell
p.000002: procurement, including the technique of somatic cell nuclear transfer1
p.000002: - research that leads to the destruction of human embryos.
p.000002:
p.000002: Research on human stem cells (both adult and embryonic) may be financed — depending on both the content of
p.000002: the scientific proposal and the laws of the Member States involved. No funding will be granted for research activities
p.000002: that are prohibited in all Member States. No activity will be funded in a Member State where such activity is
p.000002: forbidden.2
p.000002:
p.000002:
p.000002: 1.1 Ethics issues checklist
p.000002:
p.000002:
p.000002:
p.000002: Section 1: HUMAN EMBRYOS/ FOETUSES
p.000002:
p.000002:
p.000002: YES/NO
p.000002:
p.000002:
p.000002: Page
p.000002:
p.000002: Information to be provided
p.000002:
p.000002: Documents
p.000002: to be provided/kept on file
p.000002:
p.000002: Does your research involve Human Embryonic Stem Cells (hESCs)?
p.000002:
p.000002: If
p.000002: YES:
p.000002: - Will they be directly derived from embryos within this project?
p.000002: - Are they previously established cells lines?
p.000002: Research not eligible for funding
p.000002:
p.000002:
p.000002:
p.000002: 1) Origin and line of cells.
p.000002: 2) Details of the licensing and control measures by the competent authorities of
p.000002: the Member States involved.
p.000002: Research not eligible for funding
p.000002:
p.000002:
p.000002:
p.000002: 1) Copies of Ethics Approval.
p.000002: 2) Declaration that the human embryonic stem cell lines used in the project are registered in the
p.000002: European hESC registry (www.hescreg.eu) — both for hESCs and
p.000002:
p.000002:
p.000002: 1 See Article 19(3) of the Horizon 2020 Framework Programme Regulation (EU) No 1291/2013.
p.000002: 2 See also Article 19(4) of the Horizon 2020 Framework Programme Regulation (EU) No 1291/2013.
p.000002:
p.000003: 3
p.000003:
p.000003: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: Does
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: your research
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: 1) Origin of embryos.
p.000003: human-induced pluripotent stem cell (hiPSC) lines.
p.000003: 3) Declaration confirming that the 6 specific conditions (see below) for
p.000003: research activities involving human embryonic stem cells are met.
p.000003: 1) Copies of ethics
p.000003:
p.000003: involve the use of human embryos?
p.000003: 2) Details of the recruitment, inclusion and exclusion criteria and informed consent
p.000003: procedures.
p.000003: 3) Confirm that informed consent has been obtained.
p.000003: approval.
p.000003: 2) Informed Consent Forms + Information Sheets.
p.000003:
p.000003: If
p.000003: YES:
p.000003:
p.000003:
p.000003: Does
p.000003: - Will the research lead to their destruction?
p.000003: your research
p.000003: Research not eligible for funding
p.000003:
p.000003:
p.000003: 1) Origin of human
p.000003: Research not eligible for funding
p.000003:
p.000003:
p.000003: 1) Copies of ethics
p.000003:
p.000003: involve the use of human foetal tissues / cells?
p.000003: foetal tissues/cells.
p.000003: 2) Details of the informed consent procedures.
p.000003: 3) Confirm that informed consent has been obtained.
p.000003: approval.
p.000003:
p.000003: 2) Informed Consent Forms + Information Sheets.
p.000003:
p.000003:
p.000003: 1.2 How do I deal with the issues?
p.000003: Your research must comply with:
p.000003: - ethical principles
p.000003: - applicable international, EU and national law (in particular, the Statement of the Commission related to research
p.000003: activities involving human embryonic stem cells3).
p.000003: For research activities involving human embryonic stem cells (hESC), this means you must make sure that:
p.000003: - cells were NOT derived from embryos specially created for research or by somatic cell nuclear transfer
p.000003: - the project uses existing cultured cell lines only
p.000003: - cell lines were derived from supernumerary non-implanted embryos resulting from in vitro fertilisation
p.000003:
p.000003:
p.000003:
p.000003: 3 See Article 19(1) of the Horizon 2020 Framework Programme Regulation (EU) No 1291/2013.
p.000003:
p.000004: 4
p.000004:
p.000004: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000004:
p.000004: - informed consent has been obtained for using donated embryos for the derivation of the cell lines
p.000004: - personal data and privacy of donors of embryos for the derivation of the cells are protected
p.000004: - NO financial inducements were provided for the donation of embryos used for derivation of the cell lines.
p.000004: Moreover, under national law, research on human embryonic stem cells (hESC) is normally subject to strict licensing and
p.000004: control.4
p.000004:
p.000004: You must provide the Commission/Agency with a declaration confirming compliance with these conditions (as part
p.000004: of your proposal).
p.000004: For research on human embryos (hE), you must obtain the donors’ free and fully informed consent.
p.000004:
p.000004: Your research may NOT:
p.000004: - create human embryos solely for the purpose of research or for the purpose of stem cell procurement
p.000004: (including by means of somatic cell nuclear transfer)
p.000004: - destroy human embryos (e.g. to obtain stem cells).
p.000004:
p.000004:
p.000004: 1.3 What do you need to provide?
p.000004: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000004: self-assessment in Part B of your proposal (i.e. section 5 of the Technical Annex).
p.000004: Your proposal must include the information referred to in the ethics issues checklist and any documents that are
p.000004: already available.
p.000004:
p.000004: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000004: on, if requested by the Commission/Agency.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Background documents & further reading
p.000004:
p.000004: Statement of the Commission related to research activities involving human embryonic stem cells.
p.000004: FP7: Recommendations on the ethical review of hESC FP7 research projects (Opinion 22), European Group on
p.000004: Ethics in Science and New Technologies.
p.000004: FP7 guidance: Research on Human embryos/foetus.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: 4 See also Article 13(2) of the Rules for Participation Regulation (EU) No 1290/2013.
p.000004:
p.000005: 5
p.000005:
p.000005: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000005:
p.000005: 2. Human beings
p.000005: This section refers to any research involving work with humans beings (‘research or study participants’), regardless of
p.000005: its nature or topic.
p.000005: Examples: collection of biological samples, personal data, medical interventions, interviews,
p.000005: observations, tracking or the secondary use of information provided for other purposes, e.g. other research projects,
p.000005: officially collected information, social media sites, etc.
p.000005:
p.000005:
p.000005: 2.1 Ethics issues checklist
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Section 2: HUMANS
p.000005:
p.000005:
p.000005: YES/ NO
p.000005:
p.000005:
p.000005: Page
p.000005:
p.000005: Information to be provided
p.000005:
p.000005: Documents to be provided/kept on file
p.000005:
p.000005:
p.000005: Does your research involve human participants?
p.000005:
p.000005:
p.000005: If YES: - Are they
...

Searching for indicator access:

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p.000013: of examples of informed consent documentation) that the donors have given informed consent for the use
p.000013: of their waste cells or tissues (either specifically for the research or generally, for any secondary use).
p.000013: If, for the purposes of your research, you intend to collect more additional material than would normally be collected
p.000013: during the standard clinical procedure (e.g. a larger than normal tissue sample or a sample that includes some
p.000013: additional adjacent material), you must ensure that informed consent has also been given for collecting additional
p.000013: material. You must also explain the need for such material in your grant proposal and show that you have
p.000013: obtained appropriate ethics approvals.
p.000013:
p.000013: Secondary use for future research — If you intend to store the material for future use in other projects, you must:
p.000013: - confirm that you have obtained the donor’s consent for such secondary use
p.000013: - state the legislation under which the material will be stored
p.000013: - state how long it will be stored and what you will do with it at the end of the research.
p.000013:
p.000013: Biobanking — Biobanks raise significant ethical issues concerning informed consent and data privacy.
p.000013: ‘Biobanks’ are repositories for the storage of biological samples (usually human) and play a significant role in
p.000013: biomedical research. These ‘libraries’ provide researchers with access to large numbers of tissue samples, genetic
p.000013: material and associated data.
p.000013: If your project has the aim or effect of setting up a biobank, you must ensure that there is strict compliance with
p.000013: appropriate European and national ethical standards (in particular, regarding data privacy; see section 4).
p.000013: You must confirm that informed consent has been obtained and show that you have obtained all necessary ethics approvals
p.000013: (or that you are exempted under national law).
p.000013: No samples/data may be placed in the biobank before all appropriate consents and ethics approvals have been obtained
p.000013: You will need to make a report on key aspects of the biobank’s activities, including in particular:
p.000013: - information on which donors will be excluded/included (e.g. competent adults, children and minors, adults unable
p.000013: to provide informed consent, individuals in an emergency setting, etc.)
p.000013: - details of the material that will be ‘banked’, including:
p.000013: - personal (coded or fully identifiable) biosamples
p.000013: - personal information associated with a sample (e.g. name/code, gender, age, etc.)
p.000013: - personal data resulting from analysis of a sample (e.g. analysis of genetic material or a genome)
p.000013: - anonymised biosamples
p.000013: - anonymised data resulting from analysis of a sample (from which individuals could be
...

p.000015: reference to an identifier such as a name, an identification number, location data, an online identifier
p.000015: or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or
p.000015: social identity of that natural person (art. 2(a) EU General Data Protection Regulation (GDPR).
p.000015: Examples: name, address, identification number, pseudonym, occupation, e-mail, CV, location data, Internet Protocol
p.000015: (IP) address, cookie ID, phone number, data provided by smart meters, data held by a hospital or doctor.
p.000015:
p.000015: Individuals are not considered ‘identifiable’ if identifying them requires excessive effort.
p.000015: Completely anonymised data does not fall under the data privacy rules (as from the moment it has been
p.000015: completely anonymised).
p.000015: ‘Processing of personal data’ means any operation (or set of operations) performed on personal data, either manually or
p.000015: by automatic means. This includes:
p.000015: - collection (digital audio recording, digital video caption, etc.)
p.000015: - recording
p.000015: - organisation, structuring & storage (cloud, LAN or WAN servers)
p.000015: - adaptation or alteration (merging sets, appification, etc.)
p.000015: - retrieval & consultation
p.000015: - use
p.000015: - disclosure by transmission, dissemination or otherwise making available (share, exchange, transfer)
p.000015: - alignment or combination
p.000015: - restriction, erasure or destruction.
p.000015: Examples: access to/consultation of a database containing personal data; managing of the database; posting/putting a
p.000015: photo of a person on a website; storing IP addresses or MAC addresses; video recording (CCTV); creating a
p.000015: mailing list or a list of participants.
p.000015:
p.000015: Processing normally covers any action that uses data for research purposes (even if interviewees, human
p.000015: volunteers, patients, etc. are not actively included in the research).
p.000015: Personal data may come from any type of research activity (ICT research, genetic sample collection, tissue storage,
p.000015: personal records (financial, criminal, education, etc.), lifestyle and health information, family histories,
p.000015: physical characteristics, gender and ethnic background, location tracking and domicile information, etc.).
p.000015:
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000016:
p.000016: 4.1 Ethics issues checklist
p.000016:
p.000016:
p.000016:
p.000016: Section 4: PROTECTION OF PERSONAL DATA
p.000016:
p.000016:
p.000016: YES/NO
p.000016:
p.000016:
p.000016: Page
p.000016:
p.000016:
p.000016: Information to be provided
p.000016:
p.000016: Documents to be provided/kept on file
p.000016:
p.000016:
p.000016: Does your research involve processing of personal data?
p.000016: 1) Details of the technical and organisational measures to safeguard the rights of the research participants.
p.000016: For instance:
p.000016: For organisations that must appoint a DPO under the GDPR: Involvement of the data protection officer (DPO) and
p.000016: disclosure of the contact details to the research participants.
p.000016: For all other organisations: Details of the data protection policy for the project (i.e. project-specific, not
p.000016: general).
p.000016: 2) Details of the informed consent procedures.
p.000016: 3) Details of the security measures to prevent unauthorised access to personal data.
p.000016: 4) How is all of the processed data relevant and limited to the purposes of the project (‘data minimisation’
p.000016: principle)? Explain.
p.000016: 5) Details of the anonymisation
p.000016: /pseudonymisation techniques.
p.000016: 6) Justification of why research data will not be anonymised/ pseudonymised (if relevant).
p.000016: 7) Details of the data transfers (type of data transferred and country to which it is transferred – for both EU and
p.000016: non-EU countries).
p.000016: 1) Informed Consent Forms + Information Sheets used (if relevant).
p.000016:
p.000016: If
p.000016: YES:
p.000016: - Does it involve the processing of special categories of personal data (e.g. genetic, health, sexual lifestyle,
p.000016: 1) Justification for the processing of special categories of personal data.
p.000016: 2) Why can the research objectives not be reached by processing anonymised/ pseudonymised data (if applicable)?
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000017:
p.000017:
p.000017: ethnicity, political opinion, religious or philosophical conviction.)?
p.000017: - Does it involve processing of genetic, biometric or health data?
p.000017: - Does it involve profiling, systematic monitoring of individuals or processing of large scale of special categories of
p.000017: data, intrusive methods of data processing (such as, tracking, surveillance, audio and video recording, geo- location
...

p.000019: by another legal basis, e.g. legitimate or public interest).
p.000019: - Data processing must NOT be performed in secret and research participants must be made aware that they take
p.000019: part in a research project and be informed of their rights and the potential risks that the data processing may bring.
p.000019: - Data may be processed ONLY if it is really adequate, relevant and limited to what is necessary for your research
p.000019: (‘data minimisation principle’).
p.000019:
p.000019: Collecting personal data (e.g. on religion, sexual orientation, race, ethnicity, etc.) that is not essential to your
p.000019: research may expose you to allegations of ‘hidden objectives’ or ‘mission creep’ (i.e. collecting
p.000019: information with permission for one purpose and using it/making it available — online or otherwise — for
p.000019: another reason, without additional permission).
p.000019: - Data processing operations which are more intrusive and likely to raise higher ethics risks must be subject to
p.000019: higher safeguards.
p.000019: - For complex, sensitive or large-scale data processing or data transfers outside of the EU, you should consult
p.000019: your data protection officer (DPO), if you have one, or a suitably qualified expert.
p.000019: - The level of data security must be appropriate to the risks for the research participants occurring in
p.000019: case of unauthorized access or disclosure, accidental deletion or destruction of the data.
p.000019: - You are responsible for any partners, contractors or service providers that process research data at
p.000019: your request or on your behalf.
p.000019: Generally, one of the best ways how to avoid/limit data protection issues for your project is to use
p.000019: anonymised or pseudonymised data.
p.000019:
p.000019: Pseudonymisation and anonymisation are not the same thing.
p.000019: ‘Anonymised’ means that the data has been rendered anonymous in such a way that the data subject can no
p.000019: longer be identified (and therefore is no longer personal data and thus outside the scope of data protection
p.000019: law).
p.000019: ‘Pseudonymised’ means to divide the data from its direct identifiers so that linkage to a person is
p.000019: only possible with additional information that is held separately. The additional information must be kept
p.000019: separately and securely from processed data to ensure non-attribution.
p.000019: Moreover, if you have a data protection officer (DPO), it is generally recommended to involve them in all stages
p.000019: of your project, whenever it comes to data privacy issues, since this will help your proposal and grant
p.000019: agreement implementation (EU grants are subject to full compliance with data privacy rules).
p.000019:
p.000019: Be aware that even if you solve all privacy-related issues, research data may still raise other ethics issues, such as
...

p.000024: 1) Risk-benefit analysis.
p.000024: 2) What activities are carried out in non-EU countries? Give details.
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024: 1) What type of local resources will be used and how exactly? Give details.
p.000024: 1) Copies of ethics approvals and other authorisations or notifications (if required).
p.000024: 2) Confirmation that the activity could have been legally carried out in an EU country (for instance, an opinion from
p.000024: an appropriate ethics structure in an EU country).
p.000024: 1) For human resources: copies of ethics approvals.
p.000024: For animals, plants, micro-organisms and associated traditional knowledge: documentation demonstrating compliance with
p.000024: the UN
p.000024:
p.000024:
p.000024: 5 See Article 19(4) of the Horizon 2020 Framework Programme Regulation (EU) No 1291/2013.
p.000024:
p.000025: 25
p.000025:
p.000025: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Is it planned to import any material from non-EU countries into the EU?
p.000025:
p.000025: For data imports, see section 4.
p.000025: For imports of human cells or tissues, see section 3.
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 1) What type of materials will you import? Give details.
p.000025: Convention on Biological Diversity (e.g. access permit and benefit sharing agreement).
p.000025: 1) Copies of import licences.
p.000025:
p.000025: If
p.000025: YES:
p.000025: Specify the materials and countries involved:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Is it planned to export any material from the EU to non- EU countries?
p.000025:
p.000025: For data exports, see section 4.
p.000025: 1) Details of the type of materials to be exported.
p.000025: 1) Copies of export licences.
p.000025: If Specify material
p.000025: YE and countries
p.000025: S: involved:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: In case research involves low and/or lower-middle income countries, are any benefit- sharing actions planned?
p.000025:
p.000025:
p.000025:
p.000025: Could the situation in the country put the individuals taking part in the research at risk?
p.000025: 1) Details of the benefit sharing measures.
p.000025: 2) Details of the responsiveness to local research needs.
p.000025: 3) Details of the procedures to facilitate effective capacity building.
p.000025: 1) Details of the safety measures you intend to take, including training for staff and insurance cover.
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000026:
p.000026: 6.2 How do I deal with the issues?
p.000026:
p.000026: Specific cases
p.000026:
p.000026: Research carried out in a non-EU country — For activities carried out outside the EU, it is not enough for that the
p.000026: activity to be accepted and comply with the legal obligations of a non-EU country; the activities must ALSO be allowed
p.000026: in at least one Member State (see art. 19 H2020 Programme Regulation No 1291/2013).
p.000026: Beneficiaries must confirm in the ethics self-assessment section of their proposal that this condition is met.
p.000026:
p.000026: Resources from a non-EU country — Any use of local resources (especially animal and/or human tissue
p.000026: samples, genetic material, live animals, human remains, materials of historical value, endangered fauna or flora
p.000026: samples, fossils) must show respect for cultural traditions and share benefits (i.e. also benefit local
p.000026: participants and their communities, involve local researchers – as equal partners – and respond to local research
p.000026: needs).
p.000026: This is particularly important for low income and lower-middle income countries (see Convention on Biological
p.000026: Diversity and Declaration of Helsinki and follow the Global code of conduct for research in resource-poor
p.000026: settings).
p.000026: For access to genetic resources, you must also comply with the Nagoya Protocol on Access and Benefit Sharing and EU
p.000026: Regulation (EU) No 511/2014 which implements this Protocol.
p.000026:
p.000026: Import/export of material — If genetic resources are transferred across borders, it may be mandatory under the law
p.000026: of the provider country to obtain an authorisation for the transfer. In addition, you must use an agreement
p.000026: which describes the conditions for the export and the terms of utilisation and, if applicable, relevant benefit-sharing
p.000026: measures.
p.000026: For transfers of human cells or tissues, see section 3.
p.000026: For data transfers, see section 4.
p.000026:
p.000026: Sending researchers to a non-EU country — Non-EU countries are not necessarily less safe than EU countries.
p.000026: Nevertheless, a risk assessment must be undertaken when sending researchers abroad and appropriate safety measures
p.000026: must be taken. These may include insurance cover or health and safety measures, such as no lone working, contact
p.000026: points via phone, counselling support, etc. (see also section 7.2).
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: 6.3 What do you need to provide?
p.000026: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000026: self-assessment in Part B of your proposal (i.e. section 5 of the Technical Annex).
p.000026: Your grant proposal must include the information referred to in the ethics issues checklist and any of the
p.000026: documents already available.
p.000026:
p.000026: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000026: on, if requested by the Commission/Agency.
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000027:
p.000027: Background documents & further reading
p.000027:
p.000027: Human resources Declaration of Helsinki Flora & fauna
p.000027: Convention on Biological Diversity
p.000027: Genetic resources
p.000027: Nagoya Protocol on Access and Benefit Sharing
p.000027: EU Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on
p.000027: compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the fair and
p.000027: equitable sharing of benefits arising from their utilization in the Union (ABS Regulation) (OJ L 150,
p.000027: 20.5.2014, p. 59)
p.000027: Commission Implementing Regulation (EU) No 2015/1866 of 13 October 2015 laying down detailed rules for
p.000027: the implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council as regards the
p.000027: register of collections, monitoring user compliance and best practices (OJ L 275, 20.10.2015, p. 4)
p.000027: Developing countries and lower income settings
p.000027: FP 7 guidance: Developing countries
p.000027: Global code of conduct for research in resource-poor settings
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000028:
p.000028: 7. Environment, health & safety
p.000028: This section concerns research that may adversely affect:
p.000028: - the environment or
p.000028: - the health & safety of the researchers involved. This may be due to any of the following:
p.000028: - the experimental design of the research itself
...

Searching for indicator age:

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p.000005:
p.000005:
p.000005: If YES: - Are they
p.000005: volunteers for social or human sciences research?
p.000005: - Are they persons unable to give informed consent (including children/minors)?
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: - Are they vulnerable individuals or groups?
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: - Are they children/minors?
p.000005: 1) Confirm that informed consent has been obtained.
p.000005:
p.000005:
p.000005: 1) Details of the recruitment, inclusion and exclusion criteria and informed consent procedures.
p.000005: 1) Details of the procedures for obtaining approval from the guardian/legal representative and the agreement of the
p.000005: children or other minors.
p.000005: 2) What steps will you take to ensure that participants are not subjected to any form of coercion?
p.000005: 1) Details of the type of vulnerability.
p.000005: 2) Details of the recruitment, inclusion and exclusion criteria and informed consent procedures.
p.000005: These must demonstrate appropriate efforts to ensure fully informed understanding of the implications of participation.
p.000005: 1) Details of the age range.
p.000005: 2) What are your assent
p.000005: 1) Informed Consent Forms + Information Sheets.
p.000005:
p.000005: 1) Copies of ethics approvals (if required).
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: - Are they patients?
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: - Are they healthy volunteers for medical studies?
p.000006:
p.000006: Does your research involve physical interventions on the study participants?
p.000006: procedures and parental consent for children and other minors?
...

p.000007: into giving consent.
p.000007: Participants must normally give their consent in writing (e.g. by signing the informed consent form and
p.000007: information sheets).
p.000007: If consent cannot be given in writing, for example because of illiteracy, non-written consent must be formally
p.000007: documented and independently witnessed.
p.000007: Specific cases
p.000007: Research involving children (or other persons unable to give consent, e.g. certain elderly populations,
p.000007: persons judged as lacking mental capacity) — You must obtain informed consent from the legally authorised
p.000007: representative and ensure that they have sufficient information to enable them to provide this on behalf and in the
p.000007: best interests of the participants. Whenever possible, the assent of the participants should be obtained in
p.000007: addition to the consent of the parents or legal representatives. Participants must be asked for consent
p.000007: if they reach the age of majority in the course
p.000007:
p.000007:
p.000007:
p.000007: You must also ensure that your research methodologies do not result in discriminatory practices
p.000007: or unfair treatment.
p.000007:
p.000007: General principle — maximise benefits and minimise risks/harm.
p.000007: In addition, when conducting surveys, interviews or focus groups where personal information is gathered and
p.000007: stored, you must also pay attention to:
p.000007: - privacy
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000008:
p.000008: - data protection
p.000008: - data management (see also section 4)
p.000008: - the health and safety of participants (see section 7.2).
p.000008:
p.000008:
p.000008:
p.000008: Specific cases
p.000008:
p.000008: Research involving children (or other persons unable to give consent) — should be carried out only if:
p.000008: - studies with consenting adults would not be effective
p.000008: - participants are subject to only a minimal risk and burden
p.000008: - the results of the research will benefit the individual or group represented by the participant.
p.000008:
p.000008: Social science and humanities research — often involves working with human participants and particular
p.000008: methodological tools (e.g. surveys, questionnaires, interviews, standardised tests, direct observation,
...

p.000013: ‘Biobanks’ are repositories for the storage of biological samples (usually human) and play a significant role in
p.000013: biomedical research. These ‘libraries’ provide researchers with access to large numbers of tissue samples, genetic
p.000013: material and associated data.
p.000013: If your project has the aim or effect of setting up a biobank, you must ensure that there is strict compliance with
p.000013: appropriate European and national ethical standards (in particular, regarding data privacy; see section 4).
p.000013: You must confirm that informed consent has been obtained and show that you have obtained all necessary ethics approvals
p.000013: (or that you are exempted under national law).
p.000013: No samples/data may be placed in the biobank before all appropriate consents and ethics approvals have been obtained
p.000013: You will need to make a report on key aspects of the biobank’s activities, including in particular:
p.000013: - information on which donors will be excluded/included (e.g. competent adults, children and minors, adults unable
p.000013: to provide informed consent, individuals in an emergency setting, etc.)
p.000013: - details of the material that will be ‘banked’, including:
p.000013: - personal (coded or fully identifiable) biosamples
p.000013: - personal information associated with a sample (e.g. name/code, gender, age, etc.)
p.000013: - personal data resulting from analysis of a sample (e.g. analysis of genetic material or a genome)
p.000013: - anonymised biosamples
p.000013: - anonymised data resulting from analysis of a sample (from which individuals could be
p.000013: identified) and
p.000013: - epidemiological (population level) data
p.000013: - information on the standard procedures for:
p.000013: - accepting material into the biobank,
p.000013: - processes and standards for sample-quality assurance and ensuring accuracy of data and information
p.000013: - handling requests for release of samples/data from the biobank (including fair and just financial arrangements
p.000013: and benefit-sharing for third countries).
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000014:
p.000014:
p.000014:
p.000014: Genetic testing — For using or storing human cells or tissues for genetic testing, you must obtain the donor's
p.000014: informed consent for the genetic testing, and show that you have obtained approval from the relevant
p.000014: ethics and data protection bodies; and any licence required under national legislation.
p.000014:
p.000014: Transfer to/from non-EU countries — If your research project involves the transfer of cells and tissues from/to
p.000014: non-EU countries, you must comply with the specific provisions on import/export under Directive 2004/23/EC (see also
p.000014: section 6).
...

Searching for indicator child:

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p.000005: 2) What are your assent
p.000005: 1) Informed Consent Forms + Information Sheets.
p.000005:
p.000005: 1) Copies of ethics approvals (if required).
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: - Are they patients?
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: - Are they healthy volunteers for medical studies?
p.000006:
p.000006: Does your research involve physical interventions on the study participants?
p.000006: procedures and parental consent for children and other minors?
p.000006: 3) What steps will you take to ensure the welfare of the child or other minor?
p.000006: 4) What justification is there for involving minors?
p.000006: 1) What disease/condition
p.000006: /disability do they have?
p.000006: 2) Details of the recruitment, inclusion and exclusion criteria and informed consent procedures.
p.000006: 3) What is your policy on incidental findings?
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) Copies of ethics approvals.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) Copies of ethics approvals.
p.000006:
p.000006: If YES:
p.000006: - Does it involve invasive techniques (e.g. collection of human cells or tissues, surgical or medical interventions,
p.000006: invasive studies on the brain, TMS etc.)?
p.000006: - Does it involve collection of biological samples?
p.000006: 1) Risk assessment for each technique and overall.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) What type of samples will be collected?
p.000006: 2) What are your procedures for collecting biological samples?
p.000006: 1) Copies of ethics approvals.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) Copies of ethics approvals.
p.000006: For research involving processing of genetic information, see also section 4.
p.000006:
p.000006:
...

p.000008: subject to discrimination, minorities, people unable to give consent, people of dissenting opinion, immigrant or
p.000008: minority communities, sex workers, etc.
p.000008: If your research involves children or other individuals unable to make decisions for themselves, you must
p.000008: maintain an active relationship with their legal guardians and/or carers; you must not only seek their consent,
p.000008: but also allow them to monitor the research.
p.000008: Ensure that data are kept securely and that publication (including publication on the internet) does not lead (either
p.000008: directly or indirectly) to a breach of agreed confidentiality and anonymity.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: In rare cases, there may be a need to override agreements on confidentiality and anonymity (e.g. if
p.000009: maintaining confidentiality facilitates illegal behaviour such as drug dealing, child abuse, etc. that has come
p.000009: to light in the course of the research). In such circumstances, you must carefully consider disclosure to the
p.000009: appropriate authorities. You must inform the participants or their guardians of your intentions and the
p.000009: reasons for disclosure, unless this makes disclosure impracticable. You should also consider the technical
p.000009: aspects of collecting and storing your research data.
p.000009: Data collection using electronic encoding tools (digital recorders or cameras) should be given special attention (see
p.000009: also section 4). You should also discuss these issues with your organisation’s data protection officer.
p.000009:
p.000009: Medical research —is specifically addressed by the Declaration of Helsinki. Your grant proposal must also comply with:
p.000009: - the principles laid down in the Oviedo Bioethics Convention and
p.000009: - EU Regulation No 536/2014 on clinical trials on medicinal products for human use.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 2.4 What do you need to provide?
p.000009: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000009: self-assessment in Part B of your proposal (i.e. section 5 of the Technical Annex).
p.000009: Your grant proposal must include the information referred to in the ethics issues checklist and any of the
...

Searching for indicator children:

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p.000001: Ethics also matter for scholarly publication. Major scientific journals in many areas will increasingly require ethics
p.000001: committee approval before publishing research articles. Thus, you should be prepared for ethics procedures even if your
p.000001: research is funded by sources other than Horizon 2020.
p.000001: Your first source should always be at your institution. We would ask you to seek advice from colleagues
p.000001: with expertise in the ethics of research, such as:
p.000001: specialised ethics departments
p.000001: relevant managers in your university/research organisation hospital research ethics committees
p.000001: ethics advisers in your company data protection officers.
p.000001: They will be able to provide you with information appropriate to your specific needs and legal environment.
p.000001: Consider involving/appointing an ethics adviser/advisory board. From the beginning of your project, an ethics adviser
p.000001: can help you deal with ethical issues and put in place the procedures to handle them appropriately. If your research
p.000001: includes several ethical concerns or involves several significant or complex ethical issues (such as
p.000001: participation of children from developing countries, ’non-human primates (NHPs)’, potential misuse or
p.000001: vulnerable populations) we suggest you appoint an ethics adviser or an ethics advisory board comprising
p.000001: several experts from different backgrounds. The Commission/Agency may also make this an ethics requirement during
p.000001: the selection procedure.
p.000001:
p.000001: Other information
p.000001: For a broader overview of how Horizon 2020 grants work, see the Participant Portal Online Manual. For detailed
p.000001: information, see the Horizon 2020 AGA — Annotated Grant Agreement.
p.000001: A comprehensive list of all Horizon 2020 reference documents (including legislation, work programme and templates) can
p.000001: be found on Participant Portal Reference Documents.
p.000001:
p.000001: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: Version Publication
p.000001: Date
p.000001:
p.000001: HISTORY OF CHANGES
p.000001: Change
p.000001:
p.000001: 5.0
p.000001: 5.1
p.000001:
p.000001:
p.000001:
p.000001: 5.2
p.000001:
p.000001:
p.000001: 5.3
p.000001: 6.0
p.000001:
p.000001:
p.000001:
p.000001: 6.1
p.000001: 15.03.2016
p.000001: 01.06.2016
p.000001:
p.000001:
p.000001:
p.000001: 12.07.2016
p.000001:
p.000001:
p.000001: 21.02.2018
p.000001: 23.07.2018
p.000001:
p.000001:
p.000001:
p.000001: 04.02.2019
p.000001: ▪ Document revised by DGT editors
p.000001: ▪ Reparation of hyperlinks
...

p.000004: FP7 guidance: Research on Human embryos/foetus.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: 4 See also Article 13(2) of the Rules for Participation Regulation (EU) No 1290/2013.
p.000004:
p.000005: 5
p.000005:
p.000005: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000005:
p.000005: 2. Human beings
p.000005: This section refers to any research involving work with humans beings (‘research or study participants’), regardless of
p.000005: its nature or topic.
p.000005: Examples: collection of biological samples, personal data, medical interventions, interviews,
p.000005: observations, tracking or the secondary use of information provided for other purposes, e.g. other research projects,
p.000005: officially collected information, social media sites, etc.
p.000005:
p.000005:
p.000005: 2.1 Ethics issues checklist
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Section 2: HUMANS
p.000005:
p.000005:
p.000005: YES/ NO
p.000005:
p.000005:
p.000005: Page
p.000005:
p.000005: Information to be provided
p.000005:
p.000005: Documents to be provided/kept on file
p.000005:
p.000005:
p.000005: Does your research involve human participants?
p.000005:
p.000005:
p.000005: If YES: - Are they
p.000005: volunteers for social or human sciences research?
p.000005: - Are they persons unable to give informed consent (including children/minors)?
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: - Are they vulnerable individuals or groups?
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: - Are they children/minors?
p.000005: 1) Confirm that informed consent has been obtained.
p.000005:
p.000005:
p.000005: 1) Details of the recruitment, inclusion and exclusion criteria and informed consent procedures.
p.000005: 1) Details of the procedures for obtaining approval from the guardian/legal representative and the agreement of the
p.000005: children or other minors.
p.000005: 2) What steps will you take to ensure that participants are not subjected to any form of coercion?
p.000005: 1) Details of the type of vulnerability.
p.000005: 2) Details of the recruitment, inclusion and exclusion criteria and informed consent procedures.
p.000005: These must demonstrate appropriate efforts to ensure fully informed understanding of the implications of participation.
p.000005: 1) Details of the age range.
p.000005: 2) What are your assent
p.000005: 1) Informed Consent Forms + Information Sheets.
p.000005:
p.000005: 1) Copies of ethics approvals (if required).
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: - Are they patients?
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: - Are they healthy volunteers for medical studies?
p.000006:
p.000006: Does your research involve physical interventions on the study participants?
p.000006: procedures and parental consent for children and other minors?
p.000006: 3) What steps will you take to ensure the welfare of the child or other minor?
p.000006: 4) What justification is there for involving minors?
p.000006: 1) What disease/condition
p.000006: /disability do they have?
p.000006: 2) Details of the recruitment, inclusion and exclusion criteria and informed consent procedures.
p.000006: 3) What is your policy on incidental findings?
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) Copies of ethics approvals.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) Copies of ethics approvals.
p.000006:
p.000006: If YES:
p.000006: - Does it involve invasive techniques (e.g. collection of human cells or tissues, surgical or medical interventions,
p.000006: invasive studies on the brain, TMS etc.)?
p.000006: - Does it involve collection of biological samples?
p.000006: 1) Risk assessment for each technique and overall.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) What type of samples will be collected?
p.000006: 2) What are your procedures for collecting biological samples?
p.000006: 1) Copies of ethics approvals.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
...

p.000007: that:
p.000007: - are written in a language and in terms they can fully understand
p.000007:
p.000007: - describe the aims, methods and implications of the research, the nature of the participation and any benefits,
p.000007: risks or discomfort that might ensue
p.000007:
p.000007: - explicitly state that participation is voluntary and that anyone has the right to refuse to participate and
p.000007: to withdraw their participation, samples or data at any time — without any consequences
p.000007:
p.000007: - state how biological samples and data will be collected, protected during the project and either destroyed or
p.000007: reused subsequently
p.000007:
p.000007: - state what procedures will be implemented in the event of unexpected or incidental findings (in
p.000007: particular, whether the participants have the right to know, or not to know, about any such findings).
p.000007: You must ensure that potential participants have fully understood the information and do not feel pressured or coerced
p.000007: into giving consent.
p.000007: Participants must normally give their consent in writing (e.g. by signing the informed consent form and
p.000007: information sheets).
p.000007: If consent cannot be given in writing, for example because of illiteracy, non-written consent must be formally
p.000007: documented and independently witnessed.
p.000007: Specific cases
p.000007: Research involving children (or other persons unable to give consent, e.g. certain elderly populations,
p.000007: persons judged as lacking mental capacity) — You must obtain informed consent from the legally authorised
p.000007: representative and ensure that they have sufficient information to enable them to provide this on behalf and in the
p.000007: best interests of the participants. Whenever possible, the assent of the participants should be obtained in
p.000007: addition to the consent of the parents or legal representatives. Participants must be asked for consent
p.000007: if they reach the age of majority in the course
p.000007:
p.000007:
p.000007:
p.000007: You must also ensure that your research methodologies do not result in discriminatory practices
p.000007: or unfair treatment.
p.000007:
p.000007: General principle — maximise benefits and minimise risks/harm.
p.000007: In addition, when conducting surveys, interviews or focus groups where personal information is gathered and
p.000007: stored, you must also pay attention to:
p.000007: - privacy
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000008:
p.000008: - data protection
p.000008: - data management (see also section 4)
p.000008: - the health and safety of participants (see section 7.2).
p.000008:
p.000008:
p.000008:
p.000008: Specific cases
p.000008:
p.000008: Research involving children (or other persons unable to give consent) — should be carried out only if:
p.000008: - studies with consenting adults would not be effective
p.000008: - participants are subject to only a minimal risk and burden
p.000008: - the results of the research will benefit the individual or group represented by the participant.
p.000008:
p.000008: Social science and humanities research — often involves working with human participants and particular
p.000008: methodological tools (e.g. surveys, questionnaires, interviews, standardised tests, direct observation,
p.000008: ethnography, recordings, experiments with volunteers, and sometimes physical interventions).
p.000008: You must therefore clarify the ethical implications of the chosen methodologies.
p.000008: Example:
p.000008: Describe the sampling methods or recruitment procedures and discuss whether they could result in discriminatory
p.000008: practices. If such practices are inevitable given the methodology, what action should be taken to mitigate them?
p.000008: For your grant proposal, you should also provide an assessment of risks, stating explicitly what kinds of harm
p.000008: (psychological, social, legal, economic, environmental, etc.) might occur, the likelihood of subjects actually
p.000008: incurring such harm, and the steps that you will take to minimise them.
p.000008: Research entailing more than minimal risk typically involves:
p.000008: - potentially vulnerable groups and people unable to give informed consent
p.000008: - personal or sensitive topics, which might induce psychological stress, anxiety or humiliation
p.000008: - deception
p.000008: - risks to researcher safety or
p.000008: - seeking respondents through the internet/social media (e.g. using identifiable visual images or discussing
p.000008: sensitive issues ).
p.000008: Particular attention must be paid to vulnerable categories of individuals such as children, patients, people
p.000008: subject to discrimination, minorities, people unable to give consent, people of dissenting opinion, immigrant or
p.000008: minority communities, sex workers, etc.
p.000008: If your research involves children or other individuals unable to make decisions for themselves, you must
p.000008: maintain an active relationship with their legal guardians and/or carers; you must not only seek their consent,
p.000008: but also allow them to monitor the research.
p.000008: Ensure that data are kept securely and that publication (including publication on the internet) does not lead (either
p.000008: directly or indirectly) to a breach of agreed confidentiality and anonymity.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: In rare cases, there may be a need to override agreements on confidentiality and anonymity (e.g. if
p.000009: maintaining confidentiality facilitates illegal behaviour such as drug dealing, child abuse, etc. that has come
p.000009: to light in the course of the research). In such circumstances, you must carefully consider disclosure to the
p.000009: appropriate authorities. You must inform the participants or their guardians of your intentions and the
p.000009: reasons for disclosure, unless this makes disclosure impracticable. You should also consider the technical
p.000009: aspects of collecting and storing your research data.
p.000009: Data collection using electronic encoding tools (digital recorders or cameras) should be given special attention (see
...

p.000009: Medical research
p.000009: WMA Declaration of Helsinki
p.000009: Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology
p.000009: and Medicine: Convention on Human Rights and Biomedicine (Oviedo, 4 April 1997) (Oviedo Bioethics Convention)
p.000009: EU Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as
p.000009: regards investigational medicinal products for human use as well as the requirements for authorization of the
p.000009: manufacturing or importation of such products (OJ L 91, 9.4.2005, p. 13)
p.000009: EU Regulation No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for
p.000009: human use, repealing Directive 2001/20/EC (OJ L 158, 27.5.2014)
p.000009: Functional Magnetic Resonance Imaging
p.000009: Social science research
p.000009: Social sciences and humanities
p.000009: Research Ethics in Ethnography/Anthropology
p.000009: Guidance note — Research on refugees, asylum seekers & migrants
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000010:
p.000010:
p.000010:
p.000010: Ethics in Social Science and Humanities
p.000010: Research on children
p.000010: FP7 guidance: Ethics for Clinical Trials on Medicinal Products Conducted with Paediatric Population
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000011:
p.000011: 3. Human cells or tissues
p.000011: This section refers to research using, producing or collecting human cells or tissues. You may obtain cells or tissues:
p.000011: - from commercial sources
p.000011: - as part of this research project
p.000011: - from another research project, laboratory or institution
p.000011: - from a biobank.
p.000011:
p.000011:
p.000011: 3.1 Ethics issues checklist
p.000011:
p.000011:
p.000011:
p.000011: Section 3: HUMAN CELLS / TISSUES
p.000011:
p.000011: YES/ NO
p.000011:
p.000011: Page
p.000011:
p.000011: Information to be provided
p.000011:
p.000011: Documents to be provided/kept on file
p.000011:
p.000011:
p.000011: Does your research involve human cells or tissues (other than from Human Embryos/Foetuses, see section 1)?
...

p.000013: - confirm that you have obtained the donor’s consent for such secondary use
p.000013: - state the legislation under which the material will be stored
p.000013: - state how long it will be stored and what you will do with it at the end of the research.
p.000013:
p.000013: Biobanking — Biobanks raise significant ethical issues concerning informed consent and data privacy.
p.000013: ‘Biobanks’ are repositories for the storage of biological samples (usually human) and play a significant role in
p.000013: biomedical research. These ‘libraries’ provide researchers with access to large numbers of tissue samples, genetic
p.000013: material and associated data.
p.000013: If your project has the aim or effect of setting up a biobank, you must ensure that there is strict compliance with
p.000013: appropriate European and national ethical standards (in particular, regarding data privacy; see section 4).
p.000013: You must confirm that informed consent has been obtained and show that you have obtained all necessary ethics approvals
p.000013: (or that you are exempted under national law).
p.000013: No samples/data may be placed in the biobank before all appropriate consents and ethics approvals have been obtained
p.000013: You will need to make a report on key aspects of the biobank’s activities, including in particular:
p.000013: - information on which donors will be excluded/included (e.g. competent adults, children and minors, adults unable
p.000013: to provide informed consent, individuals in an emergency setting, etc.)
p.000013: - details of the material that will be ‘banked’, including:
p.000013: - personal (coded or fully identifiable) biosamples
p.000013: - personal information associated with a sample (e.g. name/code, gender, age, etc.)
p.000013: - personal data resulting from analysis of a sample (e.g. analysis of genetic material or a genome)
p.000013: - anonymised biosamples
p.000013: - anonymised data resulting from analysis of a sample (from which individuals could be
p.000013: identified) and
p.000013: - epidemiological (population level) data
p.000013: - information on the standard procedures for:
p.000013: - accepting material into the biobank,
p.000013: - processes and standards for sample-quality assurance and ensuring accuracy of data and information
p.000013: - handling requests for release of samples/data from the biobank (including fair and just financial arrangements
p.000013: and benefit-sharing for third countries).
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000014:
p.000014:
p.000014:
p.000014: Genetic testing — For using or storing human cells or tissues for genetic testing, you must obtain the donor's
p.000014: informed consent for the genetic testing, and show that you have obtained approval from the relevant
...

Searching for indicator elderly:

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p.000007: risks or discomfort that might ensue
p.000007:
p.000007: - explicitly state that participation is voluntary and that anyone has the right to refuse to participate and
p.000007: to withdraw their participation, samples or data at any time — without any consequences
p.000007:
p.000007: - state how biological samples and data will be collected, protected during the project and either destroyed or
p.000007: reused subsequently
p.000007:
p.000007: - state what procedures will be implemented in the event of unexpected or incidental findings (in
p.000007: particular, whether the participants have the right to know, or not to know, about any such findings).
p.000007: You must ensure that potential participants have fully understood the information and do not feel pressured or coerced
p.000007: into giving consent.
p.000007: Participants must normally give their consent in writing (e.g. by signing the informed consent form and
p.000007: information sheets).
p.000007: If consent cannot be given in writing, for example because of illiteracy, non-written consent must be formally
p.000007: documented and independently witnessed.
p.000007: Specific cases
p.000007: Research involving children (or other persons unable to give consent, e.g. certain elderly populations,
p.000007: persons judged as lacking mental capacity) — You must obtain informed consent from the legally authorised
p.000007: representative and ensure that they have sufficient information to enable them to provide this on behalf and in the
p.000007: best interests of the participants. Whenever possible, the assent of the participants should be obtained in
p.000007: addition to the consent of the parents or legal representatives. Participants must be asked for consent
p.000007: if they reach the age of majority in the course
p.000007:
p.000007:
p.000007:
p.000007: You must also ensure that your research methodologies do not result in discriminatory practices
p.000007: or unfair treatment.
p.000007:
p.000007: General principle — maximise benefits and minimise risks/harm.
p.000007: In addition, when conducting surveys, interviews or focus groups where personal information is gathered and
p.000007: stored, you must also pay attention to:
p.000007: - privacy
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000008:
p.000008: - data protection
p.000008: - data management (see also section 4)
p.000008: - the health and safety of participants (see section 7.2).
p.000008:
p.000008:
p.000008:
p.000008: Specific cases
...

Searching for indicator ethnic:

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p.000015: ‘Processing of personal data’ means any operation (or set of operations) performed on personal data, either manually or
p.000015: by automatic means. This includes:
p.000015: - collection (digital audio recording, digital video caption, etc.)
p.000015: - recording
p.000015: - organisation, structuring & storage (cloud, LAN or WAN servers)
p.000015: - adaptation or alteration (merging sets, appification, etc.)
p.000015: - retrieval & consultation
p.000015: - use
p.000015: - disclosure by transmission, dissemination or otherwise making available (share, exchange, transfer)
p.000015: - alignment or combination
p.000015: - restriction, erasure or destruction.
p.000015: Examples: access to/consultation of a database containing personal data; managing of the database; posting/putting a
p.000015: photo of a person on a website; storing IP addresses or MAC addresses; video recording (CCTV); creating a
p.000015: mailing list or a list of participants.
p.000015:
p.000015: Processing normally covers any action that uses data for research purposes (even if interviewees, human
p.000015: volunteers, patients, etc. are not actively included in the research).
p.000015: Personal data may come from any type of research activity (ICT research, genetic sample collection, tissue storage,
p.000015: personal records (financial, criminal, education, etc.), lifestyle and health information, family histories,
p.000015: physical characteristics, gender and ethnic background, location tracking and domicile information, etc.).
p.000015:
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000016:
p.000016: 4.1 Ethics issues checklist
p.000016:
p.000016:
p.000016:
p.000016: Section 4: PROTECTION OF PERSONAL DATA
p.000016:
p.000016:
p.000016: YES/NO
p.000016:
p.000016:
p.000016: Page
p.000016:
p.000016:
p.000016: Information to be provided
p.000016:
p.000016: Documents to be provided/kept on file
p.000016:
p.000016:
p.000016: Does your research involve processing of personal data?
p.000016: 1) Details of the technical and organisational measures to safeguard the rights of the research participants.
p.000016: For instance:
p.000016: For organisations that must appoint a DPO under the GDPR: Involvement of the data protection officer (DPO) and
p.000016: disclosure of the contact details to the research participants.
p.000016: For all other organisations: Details of the data protection policy for the project (i.e. project-specific, not
p.000016: general).
p.000016: 2) Details of the informed consent procedures.
p.000016: 3) Details of the security measures to prevent unauthorised access to personal data.
p.000016: 4) How is all of the processed data relevant and limited to the purposes of the project (‘data minimisation’
p.000016: principle)? Explain.
p.000016: 5) Details of the anonymisation
...

Searching for indicator ethnicity:

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p.000016: disclosure of the contact details to the research participants.
p.000016: For all other organisations: Details of the data protection policy for the project (i.e. project-specific, not
p.000016: general).
p.000016: 2) Details of the informed consent procedures.
p.000016: 3) Details of the security measures to prevent unauthorised access to personal data.
p.000016: 4) How is all of the processed data relevant and limited to the purposes of the project (‘data minimisation’
p.000016: principle)? Explain.
p.000016: 5) Details of the anonymisation
p.000016: /pseudonymisation techniques.
p.000016: 6) Justification of why research data will not be anonymised/ pseudonymised (if relevant).
p.000016: 7) Details of the data transfers (type of data transferred and country to which it is transferred – for both EU and
p.000016: non-EU countries).
p.000016: 1) Informed Consent Forms + Information Sheets used (if relevant).
p.000016:
p.000016: If
p.000016: YES:
p.000016: - Does it involve the processing of special categories of personal data (e.g. genetic, health, sexual lifestyle,
p.000016: 1) Justification for the processing of special categories of personal data.
p.000016: 2) Why can the research objectives not be reached by processing anonymised/ pseudonymised data (if applicable)?
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000017:
p.000017:
p.000017: ethnicity, political opinion, religious or philosophical conviction.)?
p.000017: - Does it involve processing of genetic, biometric or health data?
p.000017: - Does it involve profiling, systematic monitoring of individuals or processing of large scale of special categories of
p.000017: data, intrusive methods of data processing (such as, tracking, surveillance, audio and video recording, geo- location
p.000017: tracking etc.) or any other data processing operation that may result in high risk to the rights and freedoms of the
p.000017: research participants?
p.000017: Does your research involve further processing of previously collected personal data (including use of pre- existing
p.000017: data sets or sources, merging existing data sets)?
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: 1) Details of the methods used for tracking, surveillance or observation of participants.
p.000017: 2) Details of the methods used for profiling.
p.000017: 3) Risk assessment for the data processing activities.
p.000017: 4) How will harm be prevented and the rights of the research participants safeguarded? Explain.
p.000017: 5) Details on the procedures for informing the research participants about profiling, and its possible consequences
p.000017: and the protection measures.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
...

p.000018: relevant legislation, such as on clinical trials).
p.000018: Under these rules, personal data must be processed in accordance with certain principles and conditions
p.000018: that aim to limit the negative impact on the persons concerned and ensure fairness, transparency and
p.000018: accountability of the data processing, data quality and confidentiality.
p.000018: This implies the following main obligations:
p.000018: - Data processing should be subject to appropriate safeguards (see table above).
p.000018: - Data should wherever possible be processed in anonymised or pseudonymised form.
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000019:
p.000019: - Data processing is subject to free and fully informed consent of the persons concerned (unless already covered
p.000019: by another legal basis, e.g. legitimate or public interest).
p.000019: - Data processing must NOT be performed in secret and research participants must be made aware that they take
p.000019: part in a research project and be informed of their rights and the potential risks that the data processing may bring.
p.000019: - Data may be processed ONLY if it is really adequate, relevant and limited to what is necessary for your research
p.000019: (‘data minimisation principle’).
p.000019:
p.000019: Collecting personal data (e.g. on religion, sexual orientation, race, ethnicity, etc.) that is not essential to your
p.000019: research may expose you to allegations of ‘hidden objectives’ or ‘mission creep’ (i.e. collecting
p.000019: information with permission for one purpose and using it/making it available — online or otherwise — for
p.000019: another reason, without additional permission).
p.000019: - Data processing operations which are more intrusive and likely to raise higher ethics risks must be subject to
p.000019: higher safeguards.
p.000019: - For complex, sensitive or large-scale data processing or data transfers outside of the EU, you should consult
p.000019: your data protection officer (DPO), if you have one, or a suitably qualified expert.
p.000019: - The level of data security must be appropriate to the risks for the research participants occurring in
p.000019: case of unauthorized access or disclosure, accidental deletion or destruction of the data.
p.000019: - You are responsible for any partners, contractors or service providers that process research data at
p.000019: your request or on your behalf.
p.000019: Generally, one of the best ways how to avoid/limit data protection issues for your project is to use
p.000019: anonymised or pseudonymised data.
p.000019:
p.000019: Pseudonymisation and anonymisation are not the same thing.
p.000019: ‘Anonymised’ means that the data has been rendered anonymous in such a way that the data subject can no
...

Searching for indicator foetus:

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p.000004:
p.000004: Your research may NOT:
p.000004: - create human embryos solely for the purpose of research or for the purpose of stem cell procurement
p.000004: (including by means of somatic cell nuclear transfer)
p.000004: - destroy human embryos (e.g. to obtain stem cells).
p.000004:
p.000004:
p.000004: 1.3 What do you need to provide?
p.000004: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000004: self-assessment in Part B of your proposal (i.e. section 5 of the Technical Annex).
p.000004: Your proposal must include the information referred to in the ethics issues checklist and any documents that are
p.000004: already available.
p.000004:
p.000004: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000004: on, if requested by the Commission/Agency.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Background documents & further reading
p.000004:
p.000004: Statement of the Commission related to research activities involving human embryonic stem cells.
p.000004: FP7: Recommendations on the ethical review of hESC FP7 research projects (Opinion 22), European Group on
p.000004: Ethics in Science and New Technologies.
p.000004: FP7 guidance: Research on Human embryos/foetus.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: 4 See also Article 13(2) of the Rules for Participation Regulation (EU) No 1290/2013.
p.000004:
p.000005: 5
p.000005:
p.000005: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000005:
p.000005: 2. Human beings
p.000005: This section refers to any research involving work with humans beings (‘research or study participants’), regardless of
p.000005: its nature or topic.
p.000005: Examples: collection of biological samples, personal data, medical interventions, interviews,
p.000005: observations, tracking or the secondary use of information provided for other purposes, e.g. other research projects,
p.000005: officially collected information, social media sites, etc.
p.000005:
p.000005:
p.000005: 2.1 Ethics issues checklist
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Section 2: HUMANS
p.000005:
p.000005:
p.000005: YES/ NO
p.000005:
p.000005:
p.000005: Page
p.000005:
p.000005: Information to be provided
p.000005:
p.000005: Documents to be provided/kept on file
p.000005:
p.000005:
p.000005: Does your research involve human participants?
p.000005:
p.000005:
p.000005: If YES: - Are they
p.000005: volunteers for social or human sciences research?
p.000005: - Are they persons unable to give informed consent (including children/minors)?
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
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p.000001: ▪ Adapt instructions on providing of documents to new MGA provisions.
p.000001: ▪ Insert link to new guidance note on research on refugees, asylum seekers and migrants
p.000001: ▪ Correction in ethics issues table in section 7.2
p.000001: ▪ H2020 is written as Horizon 2020 throughout the document.
p.000001: ▪ A new reference document is added in section 6 on Non-EU countries.
p.000001: ▪ Adaptation of the section 4 on personal data further to the application of the new GDPR.
p.000001: ▪ Modification of the Important Notice to refer to the ethics by design methodology
p.000001: ▪ Modification of the section 11 to cover ethics by design and add a reference on AI
p.000001: ▪ Replace the reference to the FP7 guidance note on social sciences by the new one (with the link to the
p.000001: document in the Portal)
p.000001:
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p.000001:
p.000001: 1
p.000001:
p.000001: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000001:
p.000001: TABLE OF CONTENTS
p.000001: 1. Human embryos & foetuses 3
p.000001: 2. Human beings
p.000006: 6
p.000006: 3. Human cells or tissues
p.000012: 12
p.000012: 4. Personal data
p.000016: 16
p.000016: 5. Animals
p.000022: 22
p.000022: 6. Non-EU countries
p.000025: 25
p.000025: 7. Environment, health & safety 29
p.000025: 8. Dual use
p.000033: 33
p.000033: 9. Exclusive focus on civil applications 35
p.000033: 10. Potential misuse of research results 37
p.000033: 11. Other ethics issues
p.000040: 40
p.000040:
p.000040:
p.000040:
p.000040:
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p.000040:
p.000040:
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p.000040:
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p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000002: 2
p.000002:
p.000002: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000002:
p.000002: 1. Human embryos & foetuses
p.000002: This section covers research on human embryos and foetuses (mainly human embryonic stem cells (hESC)).
p.000002:
p.000002: The following fields of research are not eligible for funding under Horizon 2020 and cannot therefore be included in
p.000002: proposals):
p.000002: - research activities directed at human cloning for reproductive purposes
p.000002: - research activity intended to modify the genetic make-up of human beings that could make such
p.000002: changes heritable (apart from research relating to cancer treatment of the gonads, which may be financed)
p.000002: - research activities intended to create human embryos solely for the purposes of research or stem cell
p.000002: procurement, including the technique of somatic cell nuclear transfer1
p.000002: - research that leads to the destruction of human embryos.
p.000002:
p.000002: Research on human stem cells (both adult and embryonic) may be financed — depending on both the content of
p.000002: the scientific proposal and the laws of the Member States involved. No funding will be granted for research activities
p.000002: that are prohibited in all Member States. No activity will be funded in a Member State where such activity is
p.000002: forbidden.2
p.000002:
p.000002:
p.000002: 1.1 Ethics issues checklist
p.000002:
p.000002:
p.000002:
p.000002: Section 1: HUMAN EMBRYOS/ FOETUSES
p.000002:
p.000002:
p.000002: YES/NO
p.000002:
p.000002:
p.000002: Page
p.000002:
p.000002: Information to be provided
p.000002:
p.000002: Documents
p.000002: to be provided/kept on file
p.000002:
p.000002: Does your research involve Human Embryonic Stem Cells (hESCs)?
p.000002:
p.000002: If
p.000002: YES:
p.000002: - Will they be directly derived from embryos within this project?
p.000002: - Are they previously established cells lines?
p.000002: Research not eligible for funding
p.000002:
p.000002:
p.000002:
p.000002: 1) Origin and line of cells.
p.000002: 2) Details of the licensing and control measures by the competent authorities of
p.000002: the Member States involved.
p.000002: Research not eligible for funding
p.000002:
p.000002:
p.000002:
p.000002: 1) Copies of Ethics Approval.
p.000002: 2) Declaration that the human embryonic stem cell lines used in the project are registered in the
p.000002: European hESC registry (www.hescreg.eu) — both for hESCs and
p.000002:
p.000002:
p.000002: 1 See Article 19(3) of the Horizon 2020 Framework Programme Regulation (EU) No 1291/2013.
p.000002: 2 See also Article 19(4) of the Horizon 2020 Framework Programme Regulation (EU) No 1291/2013.
p.000002:
p.000003: 3
p.000003:
p.000003: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: Does
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
...

p.000010: FP7 guidance: Ethics for Clinical Trials on Medicinal Products Conducted with Paediatric Population
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
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p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000011:
p.000011: 3. Human cells or tissues
p.000011: This section refers to research using, producing or collecting human cells or tissues. You may obtain cells or tissues:
p.000011: - from commercial sources
p.000011: - as part of this research project
p.000011: - from another research project, laboratory or institution
p.000011: - from a biobank.
p.000011:
p.000011:
p.000011: 3.1 Ethics issues checklist
p.000011:
p.000011:
p.000011:
p.000011: Section 3: HUMAN CELLS / TISSUES
p.000011:
p.000011: YES/ NO
p.000011:
p.000011: Page
p.000011:
p.000011: Information to be provided
p.000011:
p.000011: Documents to be provided/kept on file
p.000011:
p.000011:
p.000011: Does your research involve human cells or tissues (other than from Human Embryos/Foetuses, see section 1)?
p.000011: 1) Details of the cells or tissue types.
p.000011: 1) Copies of relevant ethics approvals.
p.000011: 2) Copies of accreditation
p.000011: /designation/authorisati on/ licensing for using, processing or collecting the human cells or tissues (if required).
p.000011:
p.000011:
p.000011:
p.000011: If
p.000011: YES:
p.000011:
p.000011: - Are they available commercially?
p.000011: - Are they obtained within this project?
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: - Are they obtained from another project, laboratory or institution?
p.000011:
p.000011: 1) Details of the provider (company or other).
p.000011: 1) Details of the source of the material, the amount to be collected and the procedure for collection.
p.000011: 2) Details of the duration of storage and what you will do with the material at the end of the research.
p.000011: 3) Confirm that informed consent has been obtained.
p.000011: 1) Country where the material is stored.
p.000011: 2) Details of the legislation under which material is stored.
p.000011: 3) How long will the material be stored and what will you do with it at the end of the research project?
p.000011:
p.000011: 1) Copies of import licences (if relevant).
p.000011:
p.000011: 1) Informed Consent Forms + Information Sheets.
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: 1) Copies of import licences (if relevant).
p.000011: 2) Statement of laboratory/institution that informed consent has been obtained.
p.000011:
p.000011:
p.000012: 12
p.000012:
...

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p.000029: risks.
p.000029: However, research in both familiar and unfamiliar settings can involve added safety concerns. Even in
p.000029: familiar settings, surprising, non-routine things can happen which pose safety risks.
p.000029: Moreover, in certain types of research, the risk of harm to the researcher is caused by the topic of study
p.000029: or by the actions of the researchers themselves. Lack of caution or failure to obey standard procedures may
p.000029: lead to physical or psychological harm.
p.000029:
p.000029: Improved safety practices may impose additional cost burdens, which can be included in your estimated budget.
p.000029:
p.000029:
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p.000030: 30
p.000030:
p.000030: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000030:
p.000030: 7.2.1 Ethics issues checklist
p.000030:
p.000030:
p.000030:
p.000030: Section 7: ENVIRONMENT & HEALTH AND SAFETY
p.000030:
p.000030:
p.000030: YES/NO
p.000030:
p.000030:
p.000030: Page
p.000030:
p.000030: Information to be provided
p.000030:
p.000030: Documents to be provided/kept on file
p.000030:
p.000030:
p.000030: Does your research involve the use of elements that may cause harm to humans, including research staff?
p.000030: For research involving human participants, see section 2.
p.000030: 1) Details of the health and safety procedures.
p.000030: 1) Safety classification of laboratory.
p.000030:
p.000030:
p.000030: 7.2.2 How do I deal with the issues?
p.000030: Your research must comply with:
p.000030: - ethical principles
p.000030: - applicable international, EU and national law (in particular, the legislation on public-health control (e.g.
p.000030: regulating conduct in animal epidemics, food imports, consumer protection, etc.) and safety at work (e.g.
p.000030: Directive 2006/25/EC)).
p.000030: This means you must warn and advise researchers. In some cases you must even remove them from dangerous
p.000030: situations.
p.000030: Moreover, you should establish and follow a set of safety checks and procedures (or a more in-depth risk assessment)
p.000030: for each project they conduct.
p.000030: You must also obtain:
p.000030: - the necessary health and safety authorisations (if applicable).
p.000030:
p.000030:
p.000030: Specific cases
p.000030:
p.000030: Toxic chemicals and/or explosives — Staff should have adequate training in storing, handling and disposing of such
p.000030: substances. If new substances and/or formulations (e.g. nanomaterials) are developed, you must provide adequate risk
p.000030: assessments.
p.000030: Radioactive material — Clear legislation exists in all EU countries on the storage, handling and disposal
p.000030: of radioactive materials.
p.000030: The release of radioactive material into the environment is allowed only if you can show that use of alternatives (e.g.
p.000030: non-radioactive stable isotopes, simulants etc.) is not possible.
p.000030:
...

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p.000006: For research involving processing of genetic information, see also section 4.
p.000006:
p.000006:
p.000006: 2.3 How do I deal with the issues?
p.000006: Your research must comply with:
p.000006: - ethical principles
p.000006: - applicable international, EU and national law.
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000007:
p.000007: This implies that you must ensure respect for people and for human dignity and fair distribution of the benefits and
p.000007: burden of research, and that you must protect the values, rights and interests of the research participants.
p.000007: Moreover, you must obtain:
p.000007: - the necessary ethics approvals (if required)
p.000007: - free and fully informed consent of the research participants.
p.000007:
p.000007:
p.000007: Informed consent
p.000007: Participation must be entirely voluntary and you must obtain and clearly document participants’ informed
p.000007: consent in advance.
p.000007: No consent is required if national law provides for an exception (e.g. in the public interest).
p.000007: Participants must be given an informed consent form and detailed information sheets
p.000007: that:
p.000007: - are written in a language and in terms they can fully understand
p.000007:
p.000007: - describe the aims, methods and implications of the research, the nature of the participation and any benefits,
p.000007: risks or discomfort that might ensue
p.000007:
p.000007: - explicitly state that participation is voluntary and that anyone has the right to refuse to participate and
p.000007: to withdraw their participation, samples or data at any time — without any consequences
p.000007:
p.000007: - state how biological samples and data will be collected, protected during the project and either destroyed or
p.000007: reused subsequently
p.000007:
p.000007: - state what procedures will be implemented in the event of unexpected or incidental findings (in
p.000007: particular, whether the participants have the right to know, or not to know, about any such findings).
p.000007: You must ensure that potential participants have fully understood the information and do not feel pressured or coerced
p.000007: into giving consent.
p.000007: Participants must normally give their consent in writing (e.g. by signing the informed consent form and
p.000007: information sheets).
p.000007: If consent cannot be given in writing, for example because of illiteracy, non-written consent must be formally
p.000007: documented and independently witnessed.
p.000007: Specific cases
...

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p.000014:
p.000014: EU Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of
p.000014: quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution
p.000014: of human tissues and cells (OJ L 102, 7.4.2004, p.48).
p.000014:
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p.000014:
p.000015: 15
p.000015:
p.000015: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000015:
p.000015: 4. Personal data
p.000015: This section concerns research which involves processing of personal data, regardless of the method used (e.g.
p.000015: interviews, questionnaires, direct online retrieval etc.).
p.000015:
p.000015: ‘Personal data’ means information relating to an identified or identifiable natural person.
p.000015: An identifiable natural person is one who can be identified, directly or indirectly, in particular by
p.000015: reference to an identifier such as a name, an identification number, location data, an online identifier
p.000015: or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or
p.000015: social identity of that natural person (art. 2(a) EU General Data Protection Regulation (GDPR).
p.000015: Examples: name, address, identification number, pseudonym, occupation, e-mail, CV, location data, Internet Protocol
p.000015: (IP) address, cookie ID, phone number, data provided by smart meters, data held by a hospital or doctor.
p.000015:
p.000015: Individuals are not considered ‘identifiable’ if identifying them requires excessive effort.
p.000015: Completely anonymised data does not fall under the data privacy rules (as from the moment it has been
p.000015: completely anonymised).
p.000015: ‘Processing of personal data’ means any operation (or set of operations) performed on personal data, either manually or
p.000015: by automatic means. This includes:
p.000015: - collection (digital audio recording, digital video caption, etc.)
p.000015: - recording
p.000015: - organisation, structuring & storage (cloud, LAN or WAN servers)
p.000015: - adaptation or alteration (merging sets, appification, etc.)
p.000015: - retrieval & consultation
p.000015: - use
p.000015: - disclosure by transmission, dissemination or otherwise making available (share, exchange, transfer)
p.000015: - alignment or combination
p.000015: - restriction, erasure or destruction.
p.000015: Examples: access to/consultation of a database containing personal data; managing of the database; posting/putting a
p.000015: photo of a person on a website; storing IP addresses or MAC addresses; video recording (CCTV); creating a
p.000015: mailing list or a list of participants.
p.000015:
p.000015: Processing normally covers any action that uses data for research purposes (even if interviewees, human
p.000015: volunteers, patients, etc. are not actively included in the research).
p.000015: Personal data may come from any type of research activity (ICT research, genetic sample collection, tissue storage,
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p.000008: but also allow them to monitor the research.
p.000008: Ensure that data are kept securely and that publication (including publication on the internet) does not lead (either
p.000008: directly or indirectly) to a breach of agreed confidentiality and anonymity.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
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p.000009: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: In rare cases, there may be a need to override agreements on confidentiality and anonymity (e.g. if
p.000009: maintaining confidentiality facilitates illegal behaviour such as drug dealing, child abuse, etc. that has come
p.000009: to light in the course of the research). In such circumstances, you must carefully consider disclosure to the
p.000009: appropriate authorities. You must inform the participants or their guardians of your intentions and the
p.000009: reasons for disclosure, unless this makes disclosure impracticable. You should also consider the technical
p.000009: aspects of collecting and storing your research data.
p.000009: Data collection using electronic encoding tools (digital recorders or cameras) should be given special attention (see
p.000009: also section 4). You should also discuss these issues with your organisation’s data protection officer.
p.000009:
p.000009: Medical research —is specifically addressed by the Declaration of Helsinki. Your grant proposal must also comply with:
p.000009: - the principles laid down in the Oviedo Bioethics Convention and
p.000009: - EU Regulation No 536/2014 on clinical trials on medicinal products for human use.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 2.4 What do you need to provide?
p.000009: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000009: self-assessment in Part B of your proposal (i.e. section 5 of the Technical Annex).
p.000009: Your grant proposal must include the information referred to in the ethics issues checklist and any of the
p.000009: documents already available.
p.000009:
p.000009: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000009: on, if requested by the Commission/Agency.
p.000009:
p.000009:
p.000009: Background documents & further reading
p.000009:
p.000009: Informed consent
p.000009: FP7 guidance: Informed consent
p.000009: Medical research
p.000009: WMA Declaration of Helsinki
p.000009: Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology
...

p.000015: volunteers, patients, etc. are not actively included in the research).
p.000015: Personal data may come from any type of research activity (ICT research, genetic sample collection, tissue storage,
p.000015: personal records (financial, criminal, education, etc.), lifestyle and health information, family histories,
p.000015: physical characteristics, gender and ethnic background, location tracking and domicile information, etc.).
p.000015:
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000016:
p.000016: 4.1 Ethics issues checklist
p.000016:
p.000016:
p.000016:
p.000016: Section 4: PROTECTION OF PERSONAL DATA
p.000016:
p.000016:
p.000016: YES/NO
p.000016:
p.000016:
p.000016: Page
p.000016:
p.000016:
p.000016: Information to be provided
p.000016:
p.000016: Documents to be provided/kept on file
p.000016:
p.000016:
p.000016: Does your research involve processing of personal data?
p.000016: 1) Details of the technical and organisational measures to safeguard the rights of the research participants.
p.000016: For instance:
p.000016: For organisations that must appoint a DPO under the GDPR: Involvement of the data protection officer (DPO) and
p.000016: disclosure of the contact details to the research participants.
p.000016: For all other organisations: Details of the data protection policy for the project (i.e. project-specific, not
p.000016: general).
p.000016: 2) Details of the informed consent procedures.
p.000016: 3) Details of the security measures to prevent unauthorised access to personal data.
p.000016: 4) How is all of the processed data relevant and limited to the purposes of the project (‘data minimisation’
p.000016: principle)? Explain.
p.000016: 5) Details of the anonymisation
p.000016: /pseudonymisation techniques.
p.000016: 6) Justification of why research data will not be anonymised/ pseudonymised (if relevant).
p.000016: 7) Details of the data transfers (type of data transferred and country to which it is transferred – for both EU and
p.000016: non-EU countries).
p.000016: 1) Informed Consent Forms + Information Sheets used (if relevant).
p.000016:
p.000016: If
p.000016: YES:
p.000016: - Does it involve the processing of special categories of personal data (e.g. genetic, health, sexual lifestyle,
p.000016: 1) Justification for the processing of special categories of personal data.
p.000016: 2) Why can the research objectives not be reached by processing anonymised/ pseudonymised data (if applicable)?
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000017:
p.000017:
...

p.000019:
p.000019: - Data processing is subject to free and fully informed consent of the persons concerned (unless already covered
p.000019: by another legal basis, e.g. legitimate or public interest).
p.000019: - Data processing must NOT be performed in secret and research participants must be made aware that they take
p.000019: part in a research project and be informed of their rights and the potential risks that the data processing may bring.
p.000019: - Data may be processed ONLY if it is really adequate, relevant and limited to what is necessary for your research
p.000019: (‘data minimisation principle’).
p.000019:
p.000019: Collecting personal data (e.g. on religion, sexual orientation, race, ethnicity, etc.) that is not essential to your
p.000019: research may expose you to allegations of ‘hidden objectives’ or ‘mission creep’ (i.e. collecting
p.000019: information with permission for one purpose and using it/making it available — online or otherwise — for
p.000019: another reason, without additional permission).
p.000019: - Data processing operations which are more intrusive and likely to raise higher ethics risks must be subject to
p.000019: higher safeguards.
p.000019: - For complex, sensitive or large-scale data processing or data transfers outside of the EU, you should consult
p.000019: your data protection officer (DPO), if you have one, or a suitably qualified expert.
p.000019: - The level of data security must be appropriate to the risks for the research participants occurring in
p.000019: case of unauthorized access or disclosure, accidental deletion or destruction of the data.
p.000019: - You are responsible for any partners, contractors or service providers that process research data at
p.000019: your request or on your behalf.
p.000019: Generally, one of the best ways how to avoid/limit data protection issues for your project is to use
p.000019: anonymised or pseudonymised data.
p.000019:
p.000019: Pseudonymisation and anonymisation are not the same thing.
p.000019: ‘Anonymised’ means that the data has been rendered anonymous in such a way that the data subject can no
p.000019: longer be identified (and therefore is no longer personal data and thus outside the scope of data protection
p.000019: law).
p.000019: ‘Pseudonymised’ means to divide the data from its direct identifiers so that linkage to a person is
p.000019: only possible with additional information that is held separately. The additional information must be kept
p.000019: separately and securely from processed data to ensure non-attribution.
p.000019: Moreover, if you have a data protection officer (DPO), it is generally recommended to involve them in all stages
p.000019: of your project, whenever it comes to data privacy issues, since this will help your proposal and grant
p.000019: agreement implementation (EU grants are subject to full compliance with data privacy rules).
p.000019:
p.000019: Be aware that even if you solve all privacy-related issues, research data may still raise other ethics issues, such as
p.000019: the potential misuse of the research methodology/ findings or ethics harms to specific groups.
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000020: 20
p.000020:
p.000020: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000020:
p.000020:
p.000020:
p.000020: 4.3 What do you need to provide?
p.000020: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000020: self-assessment in Part B of your proposal (i.e. section 5 of the Technical Annex).
p.000020: Your grant proposal must include the information referred to in the ethics issues checklist and any of the
p.000020: documents already available.
p.000020:
p.000020: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000020: on, if requested by the Commission/Agency.
p.000020: Background documents & further reading
p.000020:
p.000020: General
...

Searching for indicator coerced:

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p.000007:
p.000007:
p.000007: Informed consent
p.000007: Participation must be entirely voluntary and you must obtain and clearly document participants’ informed
p.000007: consent in advance.
p.000007: No consent is required if national law provides for an exception (e.g. in the public interest).
p.000007: Participants must be given an informed consent form and detailed information sheets
p.000007: that:
p.000007: - are written in a language and in terms they can fully understand
p.000007:
p.000007: - describe the aims, methods and implications of the research, the nature of the participation and any benefits,
p.000007: risks or discomfort that might ensue
p.000007:
p.000007: - explicitly state that participation is voluntary and that anyone has the right to refuse to participate and
p.000007: to withdraw their participation, samples or data at any time — without any consequences
p.000007:
p.000007: - state how biological samples and data will be collected, protected during the project and either destroyed or
p.000007: reused subsequently
p.000007:
p.000007: - state what procedures will be implemented in the event of unexpected or incidental findings (in
p.000007: particular, whether the participants have the right to know, or not to know, about any such findings).
p.000007: You must ensure that potential participants have fully understood the information and do not feel pressured or coerced
p.000007: into giving consent.
p.000007: Participants must normally give their consent in writing (e.g. by signing the informed consent form and
p.000007: information sheets).
p.000007: If consent cannot be given in writing, for example because of illiteracy, non-written consent must be formally
p.000007: documented and independently witnessed.
p.000007: Specific cases
p.000007: Research involving children (or other persons unable to give consent, e.g. certain elderly populations,
p.000007: persons judged as lacking mental capacity) — You must obtain informed consent from the legally authorised
p.000007: representative and ensure that they have sufficient information to enable them to provide this on behalf and in the
p.000007: best interests of the participants. Whenever possible, the assent of the participants should be obtained in
p.000007: addition to the consent of the parents or legal representatives. Participants must be asked for consent
p.000007: if they reach the age of majority in the course
p.000007:
p.000007:
p.000007:
...

Searching for indicator minority:

Searching for indicator race:

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p.000018: relevant legislation, such as on clinical trials).
p.000018: Under these rules, personal data must be processed in accordance with certain principles and conditions
p.000018: that aim to limit the negative impact on the persons concerned and ensure fairness, transparency and
p.000018: accountability of the data processing, data quality and confidentiality.
p.000018: This implies the following main obligations:
p.000018: - Data processing should be subject to appropriate safeguards (see table above).
p.000018: - Data should wherever possible be processed in anonymised or pseudonymised form.
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000019:
p.000019: - Data processing is subject to free and fully informed consent of the persons concerned (unless already covered
p.000019: by another legal basis, e.g. legitimate or public interest).
p.000019: - Data processing must NOT be performed in secret and research participants must be made aware that they take
p.000019: part in a research project and be informed of their rights and the potential risks that the data processing may bring.
p.000019: - Data may be processed ONLY if it is really adequate, relevant and limited to what is necessary for your research
p.000019: (‘data minimisation principle’).
p.000019:
p.000019: Collecting personal data (e.g. on religion, sexual orientation, race, ethnicity, etc.) that is not essential to your
p.000019: research may expose you to allegations of ‘hidden objectives’ or ‘mission creep’ (i.e. collecting
p.000019: information with permission for one purpose and using it/making it available — online or otherwise — for
p.000019: another reason, without additional permission).
p.000019: - Data processing operations which are more intrusive and likely to raise higher ethics risks must be subject to
p.000019: higher safeguards.
p.000019: - For complex, sensitive or large-scale data processing or data transfers outside of the EU, you should consult
p.000019: your data protection officer (DPO), if you have one, or a suitably qualified expert.
p.000019: - The level of data security must be appropriate to the risks for the research participants occurring in
p.000019: case of unauthorized access or disclosure, accidental deletion or destruction of the data.
p.000019: - You are responsible for any partners, contractors or service providers that process research data at
p.000019: your request or on your behalf.
p.000019: Generally, one of the best ways how to avoid/limit data protection issues for your project is to use
p.000019: anonymised or pseudonymised data.
p.000019:
p.000019: Pseudonymisation and anonymisation are not the same thing.
p.000019: ‘Anonymised’ means that the data has been rendered anonymous in such a way that the data subject can no
...

Searching for indicator conviction:

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p.000016: general).
p.000016: 2) Details of the informed consent procedures.
p.000016: 3) Details of the security measures to prevent unauthorised access to personal data.
p.000016: 4) How is all of the processed data relevant and limited to the purposes of the project (‘data minimisation’
p.000016: principle)? Explain.
p.000016: 5) Details of the anonymisation
p.000016: /pseudonymisation techniques.
p.000016: 6) Justification of why research data will not be anonymised/ pseudonymised (if relevant).
p.000016: 7) Details of the data transfers (type of data transferred and country to which it is transferred – for both EU and
p.000016: non-EU countries).
p.000016: 1) Informed Consent Forms + Information Sheets used (if relevant).
p.000016:
p.000016: If
p.000016: YES:
p.000016: - Does it involve the processing of special categories of personal data (e.g. genetic, health, sexual lifestyle,
p.000016: 1) Justification for the processing of special categories of personal data.
p.000016: 2) Why can the research objectives not be reached by processing anonymised/ pseudonymised data (if applicable)?
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000017:
p.000017:
p.000017: ethnicity, political opinion, religious or philosophical conviction.)?
p.000017: - Does it involve processing of genetic, biometric or health data?
p.000017: - Does it involve profiling, systematic monitoring of individuals or processing of large scale of special categories of
p.000017: data, intrusive methods of data processing (such as, tracking, surveillance, audio and video recording, geo- location
p.000017: tracking etc.) or any other data processing operation that may result in high risk to the rights and freedoms of the
p.000017: research participants?
p.000017: Does your research involve further processing of previously collected personal data (including use of pre- existing
p.000017: data sets or sources, merging existing data sets)?
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: 1) Details of the methods used for tracking, surveillance or observation of participants.
p.000017: 2) Details of the methods used for profiling.
p.000017: 3) Risk assessment for the data processing activities.
p.000017: 4) How will harm be prevented and the rights of the research participants safeguarded? Explain.
p.000017: 5) Details on the procedures for informing the research participants about profiling, and its possible consequences
p.000017: and the protection measures.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: 1) Details of the database used or of the source of the data.
p.000017: 2) Details of the data processing operations.
p.000017: 3) How will the rights of the research participants be safeguarded? Explain.
...

Searching for indicator religion:

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p.000018: - ethical principles
p.000018: - applicable international, EU and national law (in particular, the GDPR, national data protection laws and other
p.000018: relevant legislation, such as on clinical trials).
p.000018: Under these rules, personal data must be processed in accordance with certain principles and conditions
p.000018: that aim to limit the negative impact on the persons concerned and ensure fairness, transparency and
p.000018: accountability of the data processing, data quality and confidentiality.
p.000018: This implies the following main obligations:
p.000018: - Data processing should be subject to appropriate safeguards (see table above).
p.000018: - Data should wherever possible be processed in anonymised or pseudonymised form.
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000019:
p.000019: - Data processing is subject to free and fully informed consent of the persons concerned (unless already covered
p.000019: by another legal basis, e.g. legitimate or public interest).
p.000019: - Data processing must NOT be performed in secret and research participants must be made aware that they take
p.000019: part in a research project and be informed of their rights and the potential risks that the data processing may bring.
p.000019: - Data may be processed ONLY if it is really adequate, relevant and limited to what is necessary for your research
p.000019: (‘data minimisation principle’).
p.000019:
p.000019: Collecting personal data (e.g. on religion, sexual orientation, race, ethnicity, etc.) that is not essential to your
p.000019: research may expose you to allegations of ‘hidden objectives’ or ‘mission creep’ (i.e. collecting
p.000019: information with permission for one purpose and using it/making it available — online or otherwise — for
p.000019: another reason, without additional permission).
p.000019: - Data processing operations which are more intrusive and likely to raise higher ethics risks must be subject to
p.000019: higher safeguards.
p.000019: - For complex, sensitive or large-scale data processing or data transfers outside of the EU, you should consult
p.000019: your data protection officer (DPO), if you have one, or a suitably qualified expert.
p.000019: - The level of data security must be appropriate to the risks for the research participants occurring in
p.000019: case of unauthorized access or disclosure, accidental deletion or destruction of the data.
p.000019: - You are responsible for any partners, contractors or service providers that process research data at
p.000019: your request or on your behalf.
p.000019: Generally, one of the best ways how to avoid/limit data protection issues for your project is to use
p.000019: anonymised or pseudonymised data.
p.000019:
p.000019: Pseudonymisation and anonymisation are not the same thing.
...

Searching for indicator religious:

Searching for indicator military:

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p.000031: into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106,
p.000031: 17.4.2001, p. 1)
p.000031: EU Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a
p.000031: framework for community action in the field of marine environmental policy (Marine Strategy Framework
p.000031: Directive) (OJ L 164, 25.6.2008, p. 19)
p.000031: GMOs
p.000031: EU Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on trans-boundary
p.000031: movements of genetically modified organisms (OJ L 287, 5.11.2003, p. 1)
p.000031: EU Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically
p.000031: modified micro-organisms (OJ L 125, 21.5.2009, p. 75)
p.000031: Public health & consumer protection
p.000031: Consumer safety
p.000031: Health & safety at work
p.000031: EU Directive 2006/25/EC of the European Parliament and of the Council of 5 April 2006 on the minimum health and safety
p.000031: requirements regarding the exposure of the workers to risks arising from physical agents (OJ L 114, 27.4.2006, p.38)
p.000031: A Code of Practice for the Safety of Social Researchers
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000032:
p.000032: 8. Dual use
p.000032: This section concerns research involving goods, software and technologies covered by the EU Export Control Regulation
p.000032: No 482/2009. These dual-use items are normally used for civilian purposes but may have military applications, or may
p.000032: contribute to the proliferation of weapons of mass destruction.
p.000032:
p.000032:
p.000032: 8.1 Ethics issues checklist
p.000032:
p.000032:
p.000032:
p.000032: Section 8: DUAL USE
p.000032:
p.000032:
p.000032: YES/NO
p.000032:
p.000032:
p.000032: Page
p.000032:
p.000032: Information to be provided
p.000032:
p.000032: Documents to be provided/kept on file
p.000032:
p.000032:
p.000032: Does this research involve dual-use items in the sense of Regulation 428/2009, or other items for which an
p.000032: authorisation is required?
p.000032: 1) What goods and information used and produced in your research will need export licences?
p.000032: 2) How exactly will you ensure compliance?
p.000032: 3) How exactly will you avoid negative implications?
p.000032: 1) Copies of export licences.
p.000032:
p.000032:
p.000032: 8.2 How to deal with the issues?
p.000032: Your research must comply with:
p.000032: - ethical principles
p.000032: - applicable international, EU and national law (in particular, the EU Export Control Regulation No
p.000032: 428/2009).
p.000032:
p.000032: In certain exceptional cases, publication of research findings (e.g. a scientific article in a journal
p.000032: published both outside or inside the EU) may be classed as an intangible technology transfer (ITT) and may
p.000032: require an authorisation (which is not always granted).
p.000032:
p.000032:
p.000032: Specific cases
p.000032:
p.000032: Cross-border transfers — For cross-border transfers of dual-use materials, technologies and information, you must
p.000032: observe the EU Export Control Regulation No 428/2009. If you have any doubts, you should consult the relevant national
...

p.000033: required authorisation(s)/license(s).
p.000033: Your grant proposal must include the information referred to in the ethics issues checklist and any of the
p.000033: documents already available.
p.000033:
p.000033: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000033: on, if requested by the Commission/Agency.
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: Background documents & further reading
p.000033:
p.000033: Guidance note — Research involving dual use items
p.000033: EU Regulation No 428/2009 setting up a Community regime for the control of exports, transfer, brokering and transit of
p.000033: dual-use items
p.000033: EU Charter of Fundamental Rights Biological and Toxin Weapons Convention UN Security Council Resolution 1540
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000034: 34
p.000034:
p.000034: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000034:
p.000034: 9. Exclusive focus on civil applications
p.000034: This section explains the exact meaning of the 'exclusive focus on civil applications'.
p.000034:
p.000034: Only research that has an exclusive focus on civil applications is eligible for funding.6
p.000034: However, this does not rule out the participation of military partners or the development of generic
p.000034: technologies, products or knowledge that may meet the needs of both civil and military end-users
p.000034: (known as 'dual-use' goods or technologies), provided that the research itself has a clear focus on civil
p.000034: applications.
p.000034:
p.000034:
p.000034: 9.1 Ethics issues checklist
p.000034:
p.000034:
p.000034:
p.000034: Section 9: EXCLUSIVE FOCUS ON CIVIL APPLICATIONS
p.000034:
p.000034:
p.000034: YES/NO
p.000034:
p.000034:
p.000034: Page
p.000034:
p.000034: Information to be provided
p.000034:
p.000034: Documents to be provided/kept on file
p.000034:
p.000034:
p.000034: Could your research raise concerns regarding the exclusive focus on civil applications?
p.000034: 1) Explain the exclusive civilian focus of your research.
p.000034: 2) Justify inclusion of military partners or military technologies (i.e. explain how they relate to civilian
p.000034: applications, e.g. in the context of law enforcement activities).
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034: 9.2 How to deal with the issues?
p.000034: Your research must comply with:
p.000034: - ethical principles
p.000034: - applicable international, EU and national law (in particular Horizon 2020 Regulation No 1291/2013) which
p.000034: limits funding of research to activities having an exclusive focus on civil applications).
p.000034:
p.000034: Research activities aimed at the development or improvement of dual-use technologies or goods can be financed
p.000034: through Horizon 2020, provided that the research is fully motivated by, and limited to civil applications.
p.000034:
p.000034:
p.000034: 9.3 What do you need to provide?
p.000034: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000034: self-assessment in Part B of your proposal (i.e. section 5 of the technical Annex).
p.000034:
p.000034:
p.000034: 6 See Article 19(2) of the Horizon 2020 Framework Programme Regulation (EU) No 1291/2013.
p.000034:
p.000035: 35
p.000035:
p.000035: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000035:
p.000035: Your grant proposal must include the information referred to in the ethics issues checklist and any of the
p.000035: documents already available.
p.000035:
p.000035: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
...

Searching for indicator union:

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p.000020: General
p.000020: Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural
p.000020: persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive
p.000020: 95/46/EC (OJ L 119, 4.5.2016, p. 1)
p.000020: Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural
p.000020: persons with regard to the processing of personal data by competent authorities for the purposes of the
p.000020: prevention, investigation, detection or prosecution of criminal offences or the execution of criminal
p.000020: penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L
p.000020: 119, 4.5.2016, p. 89)
p.000020: Guidelines on Consent under Regulation 2016/679 (wp259rev.01), Article 29 Working Party
p.000020: Guidelines on Transparency under Regulation 2016/679 (wp260rev.01), Article 29 Working Party
p.000020: Guidelines on Automated individual decision-making and Profiling for the purposes of Regulation
p.000020: 2016/679(wp251rev.01), Article 29 Working Party
p.000020: Council of Europe Modernised Convention for the Protection of Individuals with Regard to the Processing of Personal
p.000020: Data, CM/Inf (2018)15-final
p.000020: Handbook on European data protection law (2018 edition), European Union Agency for Fundamental Rights and
p.000020: Council of Europe, European Court of Human Rights, European Data Protection supervisor
p.000020: Data transfers outside the EU - International data transfers using model contracts
p.000020: Electronic communications
p.000020: EU Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the
p.000020: processing of personal data and the protection of privacy in the electronic communications sector (Directive
p.000020: on privacy and electronic communications)
p.000020: EU Directive 2006/24/EC of 15 March 2006 on the retention of data generated or processed in connection with the
p.000020: provision of publicly available electronic communications services or of public communications networks
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000021: 21
p.000021:
p.000021: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000021:
p.000021: 5. Animals
p.000021: This section refers to research involving animals.
p.000021:
p.000021:
p.000021: 5.1 Ethics issues checklist
p.000021:
p.000021:
p.000021:
p.000021: Section 5: ANIMALS
p.000021:
p.000021: YES/NO
p.000021:
p.000021: Page
p.000021:
p.000021: Information to be provided
p.000021:
p.000021: Documents to be provided/kept on file
p.000021:
p.000021:
p.000021: Does your research involve animals?
p.000021: 1) Details of the species and rationale for their use, numbers of animals to be used, nature of the experiments,
...

p.000026:
p.000026:
p.000026: 6.3 What do you need to provide?
p.000026: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000026: self-assessment in Part B of your proposal (i.e. section 5 of the Technical Annex).
p.000026: Your grant proposal must include the information referred to in the ethics issues checklist and any of the
p.000026: documents already available.
p.000026:
p.000026: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000026: on, if requested by the Commission/Agency.
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000027:
p.000027: Background documents & further reading
p.000027:
p.000027: Human resources Declaration of Helsinki Flora & fauna
p.000027: Convention on Biological Diversity
p.000027: Genetic resources
p.000027: Nagoya Protocol on Access and Benefit Sharing
p.000027: EU Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on
p.000027: compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the fair and
p.000027: equitable sharing of benefits arising from their utilization in the Union (ABS Regulation) (OJ L 150,
p.000027: 20.5.2014, p. 59)
p.000027: Commission Implementing Regulation (EU) No 2015/1866 of 13 October 2015 laying down detailed rules for
p.000027: the implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council as regards the
p.000027: register of collections, monitoring user compliance and best practices (OJ L 275, 20.10.2015, p. 4)
p.000027: Developing countries and lower income settings
p.000027: FP 7 guidance: Developing countries
p.000027: Global code of conduct for research in resource-poor settings
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000028:
p.000028: 7. Environment, health & safety
p.000028: This section concerns research that may adversely affect:
p.000028: - the environment or
p.000028: - the health & safety of the researchers involved. This may be due to any of the following:
p.000028: - the experimental design of the research itself
p.000028: - undesirable side-effects of the technologies used.
p.000028:
p.000028:
p.000028: 7.1 Environment
p.000028: 7.1.1 Ethics issues checklist
...

Searching for indicator abuse:

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p.000008: subject to discrimination, minorities, people unable to give consent, people of dissenting opinion, immigrant or
p.000008: minority communities, sex workers, etc.
p.000008: If your research involves children or other individuals unable to make decisions for themselves, you must
p.000008: maintain an active relationship with their legal guardians and/or carers; you must not only seek their consent,
p.000008: but also allow them to monitor the research.
p.000008: Ensure that data are kept securely and that publication (including publication on the internet) does not lead (either
p.000008: directly or indirectly) to a breach of agreed confidentiality and anonymity.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: In rare cases, there may be a need to override agreements on confidentiality and anonymity (e.g. if
p.000009: maintaining confidentiality facilitates illegal behaviour such as drug dealing, child abuse, etc. that has come
p.000009: to light in the course of the research). In such circumstances, you must carefully consider disclosure to the
p.000009: appropriate authorities. You must inform the participants or their guardians of your intentions and the
p.000009: reasons for disclosure, unless this makes disclosure impracticable. You should also consider the technical
p.000009: aspects of collecting and storing your research data.
p.000009: Data collection using electronic encoding tools (digital recorders or cameras) should be given special attention (see
p.000009: also section 4). You should also discuss these issues with your organisation’s data protection officer.
p.000009:
p.000009: Medical research —is specifically addressed by the Declaration of Helsinki. Your grant proposal must also comply with:
p.000009: - the principles laid down in the Oviedo Bioethics Convention and
p.000009: - EU Regulation No 536/2014 on clinical trials on medicinal products for human use.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 2.4 What do you need to provide?
p.000009: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000009: self-assessment in Part B of your proposal (i.e. section 5 of the Technical Annex).
p.000009: Your grant proposal must include the information referred to in the ethics issues checklist and any of the
p.000009: documents already available.
p.000009:
...

p.000030: - the necessary health and safety authorisations (if applicable).
p.000030:
p.000030:
p.000030: Specific cases
p.000030:
p.000030: Toxic chemicals and/or explosives — Staff should have adequate training in storing, handling and disposing of such
p.000030: substances. If new substances and/or formulations (e.g. nanomaterials) are developed, you must provide adequate risk
p.000030: assessments.
p.000030: Radioactive material — Clear legislation exists in all EU countries on the storage, handling and disposal
p.000030: of radioactive materials.
p.000030: The release of radioactive material into the environment is allowed only if you can show that use of alternatives (e.g.
p.000030: non-radioactive stable isotopes, simulants etc.) is not possible.
p.000030:
p.000030: Research ‘in the field’ — Establish and abide by recognised procedures to help keep researchers and subjects
p.000030: safe. These should include:
p.000030: - keeping careful notes of all research engagements
p.000030: - ensuring projects are adequately staffed
p.000030: - using mobile phones to keep in touch with the research base
p.000030: - conducting full risk assessments of fieldwork sites
p.000030:
p.000030:
p.000030:
p.000030:
p.000031: 31
p.000031:
p.000031: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000031:
p.000031:
p.000031: - formally notifying authorities of research being conducted in an area
p.000031: - carrying authorised identification
p.000031: - researcher preparation & training covering techniques for handling conflict, threats, abuse or
p.000031: compromising situations
p.000031: - debriefing after field research with an assessment of fieldwork safety and
p.000031: - reporting any health & safety incidents.
p.000031:
p.000031:
p.000031:
p.000031: 7.2.3 What do you need to provide?
p.000031: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000031: self-assessment in Part B of your proposal (i.e. section 5 of the Technical Annex).
p.000031: Your grant proposal must include the information referred to in the ethics issues checklist and any of the
p.000031: documents already available.
p.000031:
p.000031: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000031: on, if requested by the Commission/Agency.
p.000031:
p.000031:
p.000031: Background documents & further reading
p.000031:
p.000031: General environment
p.000031: EU Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206,
p.000031: 22.7.1992, p.7)
p.000031: EU Directive 79/409/EEC of 2 April 1979 on the conservation of wild birds (OJ L 103, 25.4.1979, p.1)
p.000031: EU Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating
p.000031: trade therein (OJ L 103, 25.4.1979, p.1)
p.000031: Cartagena Protocol on Biosafety
p.000031: EU Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release
p.000031: into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106,
...

p.000037: addressed. The most frequent issue relates to research involving pathogens and the need to implement adequate
p.000037: biosecurity measures.
p.000037:
p.000037: Research with a potential impact on human rights — Concerns in this field relate primarily to research on surveillance
p.000037: technologies, new data-gathering and data-merging technologies (e.g. in the context of big data). However, social or
p.000037: genetic research that could lead to discrimination or stigmatisation is also affected.
p.000037: Risk mitigation measures may include:
p.000037: - a human rights impact assessment
p.000037: - involving human rights experts in your research
p.000037: - training personnel and/or technological safeguards
p.000037: - caution when publishing or otherwise disseminating results (e.g. through privacy by design)
p.000037: - adapting the research design (e.g. using dummy data).
p.000037:
p.000037: Research that has other potential misuses — Although anything could ultimately be used for malevolent purposes,
p.000037: research in this category is that which provides terrorists or criminals with information or technologies that would
p.000037: have substantial direct impacts on the security of individuals, groups or states.
p.000037: Examples: infrastructural vulnerability studies, cyber-security-related research
p.000037: In many cases, researchers outside the security domain are not familiar with security safeguards. In such
p.000037: situations, researchers should consult experts familiar with security ethics and/or human rights. If
p.000037: security or human rights abuse concerns exist, you should arrange for:
p.000037: - training on this issue
p.000037: - the appointment of an ethics adviser/ethics advisory board.
p.000037:
p.000037:
p.000037: 10.3 What do you need to provide?
p.000037: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000037: self-assessment in Part B of your proposal (i.e. section 5 of the technical Annex).
p.000037: Your grant proposal must include the information referred to in the ethics issues checklist and any of the
p.000037: documents already available.
p.000037:
p.000037: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000037: on, if requested by the Commission/Agency.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: Background documents & further reading
p.000037:
p.000037: Guidance note — Potential misuse of research results
p.000037: FP7 guidance: A comprehensive strategy on how to minimize research misconduct and the potential misuse of
p.000037: research in EU-funded research
p.000037: Council Common Position 2003/805/CFSP on the universalisation and reinforcement of multilateral
p.000037: agreements in the field of non-proliferation of weapons of mass destruction and means of delivery
p.000037:
p.000037:
p.000037:
p.000038: 38
p.000038:
p.000038: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000038:
...

Searching for indicator minor:

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p.000005: 1) Informed Consent Forms + Information Sheets.
p.000005:
p.000005: 1) Copies of ethics approvals (if required).
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: - Are they patients?
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: - Are they healthy volunteers for medical studies?
p.000006:
p.000006: Does your research involve physical interventions on the study participants?
p.000006: procedures and parental consent for children and other minors?
p.000006: 3) What steps will you take to ensure the welfare of the child or other minor?
p.000006: 4) What justification is there for involving minors?
p.000006: 1) What disease/condition
p.000006: /disability do they have?
p.000006: 2) Details of the recruitment, inclusion and exclusion criteria and informed consent procedures.
p.000006: 3) What is your policy on incidental findings?
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) Copies of ethics approvals.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) Copies of ethics approvals.
p.000006:
p.000006: If YES:
p.000006: - Does it involve invasive techniques (e.g. collection of human cells or tissues, surgical or medical interventions,
p.000006: invasive studies on the brain, TMS etc.)?
p.000006: - Does it involve collection of biological samples?
p.000006: 1) Risk assessment for each technique and overall.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) What type of samples will be collected?
p.000006: 2) What are your procedures for collecting biological samples?
p.000006: 1) Copies of ethics approvals.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) Copies of ethics approvals.
p.000006: For research involving processing of genetic information, see also section 4.
p.000006:
p.000006:
p.000006: 2.3 How do I deal with the issues?
p.000006: Your research must comply with:
...

Searching for indicator education:

Searching for indicator gender:

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p.000013: ‘Biobanks’ are repositories for the storage of biological samples (usually human) and play a significant role in
p.000013: biomedical research. These ‘libraries’ provide researchers with access to large numbers of tissue samples, genetic
p.000013: material and associated data.
p.000013: If your project has the aim or effect of setting up a biobank, you must ensure that there is strict compliance with
p.000013: appropriate European and national ethical standards (in particular, regarding data privacy; see section 4).
p.000013: You must confirm that informed consent has been obtained and show that you have obtained all necessary ethics approvals
p.000013: (or that you are exempted under national law).
p.000013: No samples/data may be placed in the biobank before all appropriate consents and ethics approvals have been obtained
p.000013: You will need to make a report on key aspects of the biobank’s activities, including in particular:
p.000013: - information on which donors will be excluded/included (e.g. competent adults, children and minors, adults unable
p.000013: to provide informed consent, individuals in an emergency setting, etc.)
p.000013: - details of the material that will be ‘banked’, including:
p.000013: - personal (coded or fully identifiable) biosamples
p.000013: - personal information associated with a sample (e.g. name/code, gender, age, etc.)
p.000013: - personal data resulting from analysis of a sample (e.g. analysis of genetic material or a genome)
p.000013: - anonymised biosamples
p.000013: - anonymised data resulting from analysis of a sample (from which individuals could be
p.000013: identified) and
p.000013: - epidemiological (population level) data
p.000013: - information on the standard procedures for:
p.000013: - accepting material into the biobank,
p.000013: - processes and standards for sample-quality assurance and ensuring accuracy of data and information
p.000013: - handling requests for release of samples/data from the biobank (including fair and just financial arrangements
p.000013: and benefit-sharing for third countries).
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000014:
p.000014:
p.000014:
p.000014: Genetic testing — For using or storing human cells or tissues for genetic testing, you must obtain the donor's
p.000014: informed consent for the genetic testing, and show that you have obtained approval from the relevant
p.000014: ethics and data protection bodies; and any licence required under national legislation.
p.000014:
p.000014: Transfer to/from non-EU countries — If your research project involves the transfer of cells and tissues from/to
p.000014: non-EU countries, you must comply with the specific provisions on import/export under Directive 2004/23/EC (see also
p.000014: section 6).
...

p.000015: completely anonymised).
p.000015: ‘Processing of personal data’ means any operation (or set of operations) performed on personal data, either manually or
p.000015: by automatic means. This includes:
p.000015: - collection (digital audio recording, digital video caption, etc.)
p.000015: - recording
p.000015: - organisation, structuring & storage (cloud, LAN or WAN servers)
p.000015: - adaptation or alteration (merging sets, appification, etc.)
p.000015: - retrieval & consultation
p.000015: - use
p.000015: - disclosure by transmission, dissemination or otherwise making available (share, exchange, transfer)
p.000015: - alignment or combination
p.000015: - restriction, erasure or destruction.
p.000015: Examples: access to/consultation of a database containing personal data; managing of the database; posting/putting a
p.000015: photo of a person on a website; storing IP addresses or MAC addresses; video recording (CCTV); creating a
p.000015: mailing list or a list of participants.
p.000015:
p.000015: Processing normally covers any action that uses data for research purposes (even if interviewees, human
p.000015: volunteers, patients, etc. are not actively included in the research).
p.000015: Personal data may come from any type of research activity (ICT research, genetic sample collection, tissue storage,
p.000015: personal records (financial, criminal, education, etc.), lifestyle and health information, family histories,
p.000015: physical characteristics, gender and ethnic background, location tracking and domicile information, etc.).
p.000015:
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000016:
p.000016: 4.1 Ethics issues checklist
p.000016:
p.000016:
p.000016:
p.000016: Section 4: PROTECTION OF PERSONAL DATA
p.000016:
p.000016:
p.000016: YES/NO
p.000016:
p.000016:
p.000016: Page
p.000016:
p.000016:
p.000016: Information to be provided
p.000016:
p.000016: Documents to be provided/kept on file
p.000016:
p.000016:
p.000016: Does your research involve processing of personal data?
p.000016: 1) Details of the technical and organisational measures to safeguard the rights of the research participants.
p.000016: For instance:
p.000016: For organisations that must appoint a DPO under the GDPR: Involvement of the data protection officer (DPO) and
p.000016: disclosure of the contact details to the research participants.
p.000016: For all other organisations: Details of the data protection policy for the project (i.e. project-specific, not
p.000016: general).
p.000016: 2) Details of the informed consent procedures.
p.000016: 3) Details of the security measures to prevent unauthorised access to personal data.
p.000016: 4) How is all of the processed data relevant and limited to the purposes of the project (‘data minimisation’
...

Searching for indicator parents:

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p.000007: particular, whether the participants have the right to know, or not to know, about any such findings).
p.000007: You must ensure that potential participants have fully understood the information and do not feel pressured or coerced
p.000007: into giving consent.
p.000007: Participants must normally give their consent in writing (e.g. by signing the informed consent form and
p.000007: information sheets).
p.000007: If consent cannot be given in writing, for example because of illiteracy, non-written consent must be formally
p.000007: documented and independently witnessed.
p.000007: Specific cases
p.000007: Research involving children (or other persons unable to give consent, e.g. certain elderly populations,
p.000007: persons judged as lacking mental capacity) — You must obtain informed consent from the legally authorised
p.000007: representative and ensure that they have sufficient information to enable them to provide this on behalf and in the
p.000007: best interests of the participants. Whenever possible, the assent of the participants should be obtained in
p.000007: addition to the consent of the parents or legal representatives. Participants must be asked for consent
p.000007: if they reach the age of majority in the course
p.000007:
p.000007:
p.000007:
p.000007: You must also ensure that your research methodologies do not result in discriminatory practices
p.000007: or unfair treatment.
p.000007:
p.000007: General principle — maximise benefits and minimise risks/harm.
p.000007: In addition, when conducting surveys, interviews or focus groups where personal information is gathered and
p.000007: stored, you must also pay attention to:
p.000007: - privacy
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000008:
p.000008: - data protection
p.000008: - data management (see also section 4)
p.000008: - the health and safety of participants (see section 7.2).
p.000008:
p.000008:
p.000008:
p.000008: Specific cases
p.000008:
p.000008: Research involving children (or other persons unable to give consent) — should be carried out only if:
p.000008: - studies with consenting adults would not be effective
p.000008: - participants are subject to only a minimal risk and burden
p.000008: - the results of the research will benefit the individual or group represented by the participant.
p.000008:
...

Searching for indicator opinion:

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p.000004: control.4
p.000004:
p.000004: You must provide the Commission/Agency with a declaration confirming compliance with these conditions (as part
p.000004: of your proposal).
p.000004: For research on human embryos (hE), you must obtain the donors’ free and fully informed consent.
p.000004:
p.000004: Your research may NOT:
p.000004: - create human embryos solely for the purpose of research or for the purpose of stem cell procurement
p.000004: (including by means of somatic cell nuclear transfer)
p.000004: - destroy human embryos (e.g. to obtain stem cells).
p.000004:
p.000004:
p.000004: 1.3 What do you need to provide?
p.000004: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000004: self-assessment in Part B of your proposal (i.e. section 5 of the Technical Annex).
p.000004: Your proposal must include the information referred to in the ethics issues checklist and any documents that are
p.000004: already available.
p.000004:
p.000004: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000004: on, if requested by the Commission/Agency.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Background documents & further reading
p.000004:
p.000004: Statement of the Commission related to research activities involving human embryonic stem cells.
p.000004: FP7: Recommendations on the ethical review of hESC FP7 research projects (Opinion 22), European Group on
p.000004: Ethics in Science and New Technologies.
p.000004: FP7 guidance: Research on Human embryos/foetus.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: 4 See also Article 13(2) of the Rules for Participation Regulation (EU) No 1290/2013.
p.000004:
p.000005: 5
p.000005:
p.000005: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000005:
p.000005: 2. Human beings
p.000005: This section refers to any research involving work with humans beings (‘research or study participants’), regardless of
p.000005: its nature or topic.
p.000005: Examples: collection of biological samples, personal data, medical interventions, interviews,
p.000005: observations, tracking or the secondary use of information provided for other purposes, e.g. other research projects,
p.000005: officially collected information, social media sites, etc.
p.000005:
p.000005:
p.000005: 2.1 Ethics issues checklist
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Section 2: HUMANS
p.000005:
p.000005:
p.000005: YES/ NO
p.000005:
p.000005:
p.000005: Page
p.000005:
p.000005: Information to be provided
p.000005:
p.000005: Documents to be provided/kept on file
p.000005:
p.000005:
p.000005: Does your research involve human participants?
p.000005:
p.000005:
p.000005: If YES: - Are they
p.000005: volunteers for social or human sciences research?
...

p.000008: Example:
p.000008: Describe the sampling methods or recruitment procedures and discuss whether they could result in discriminatory
p.000008: practices. If such practices are inevitable given the methodology, what action should be taken to mitigate them?
p.000008: For your grant proposal, you should also provide an assessment of risks, stating explicitly what kinds of harm
p.000008: (psychological, social, legal, economic, environmental, etc.) might occur, the likelihood of subjects actually
p.000008: incurring such harm, and the steps that you will take to minimise them.
p.000008: Research entailing more than minimal risk typically involves:
p.000008: - potentially vulnerable groups and people unable to give informed consent
p.000008: - personal or sensitive topics, which might induce psychological stress, anxiety or humiliation
p.000008: - deception
p.000008: - risks to researcher safety or
p.000008: - seeking respondents through the internet/social media (e.g. using identifiable visual images or discussing
p.000008: sensitive issues ).
p.000008: Particular attention must be paid to vulnerable categories of individuals such as children, patients, people
p.000008: subject to discrimination, minorities, people unable to give consent, people of dissenting opinion, immigrant or
p.000008: minority communities, sex workers, etc.
p.000008: If your research involves children or other individuals unable to make decisions for themselves, you must
p.000008: maintain an active relationship with their legal guardians and/or carers; you must not only seek their consent,
p.000008: but also allow them to monitor the research.
p.000008: Ensure that data are kept securely and that publication (including publication on the internet) does not lead (either
p.000008: directly or indirectly) to a breach of agreed confidentiality and anonymity.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: In rare cases, there may be a need to override agreements on confidentiality and anonymity (e.g. if
p.000009: maintaining confidentiality facilitates illegal behaviour such as drug dealing, child abuse, etc. that has come
p.000009: to light in the course of the research). In such circumstances, you must carefully consider disclosure to the
p.000009: appropriate authorities. You must inform the participants or their guardians of your intentions and the
...

p.000016: For all other organisations: Details of the data protection policy for the project (i.e. project-specific, not
p.000016: general).
p.000016: 2) Details of the informed consent procedures.
p.000016: 3) Details of the security measures to prevent unauthorised access to personal data.
p.000016: 4) How is all of the processed data relevant and limited to the purposes of the project (‘data minimisation’
p.000016: principle)? Explain.
p.000016: 5) Details of the anonymisation
p.000016: /pseudonymisation techniques.
p.000016: 6) Justification of why research data will not be anonymised/ pseudonymised (if relevant).
p.000016: 7) Details of the data transfers (type of data transferred and country to which it is transferred – for both EU and
p.000016: non-EU countries).
p.000016: 1) Informed Consent Forms + Information Sheets used (if relevant).
p.000016:
p.000016: If
p.000016: YES:
p.000016: - Does it involve the processing of special categories of personal data (e.g. genetic, health, sexual lifestyle,
p.000016: 1) Justification for the processing of special categories of personal data.
p.000016: 2) Why can the research objectives not be reached by processing anonymised/ pseudonymised data (if applicable)?
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000017:
p.000017:
p.000017: ethnicity, political opinion, religious or philosophical conviction.)?
p.000017: - Does it involve processing of genetic, biometric or health data?
p.000017: - Does it involve profiling, systematic monitoring of individuals or processing of large scale of special categories of
p.000017: data, intrusive methods of data processing (such as, tracking, surveillance, audio and video recording, geo- location
p.000017: tracking etc.) or any other data processing operation that may result in high risk to the rights and freedoms of the
p.000017: research participants?
p.000017: Does your research involve further processing of previously collected personal data (including use of pre- existing
p.000017: data sets or sources, merging existing data sets)?
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: 1) Details of the methods used for tracking, surveillance or observation of participants.
p.000017: 2) Details of the methods used for profiling.
p.000017: 3) Risk assessment for the data processing activities.
p.000017: 4) How will harm be prevented and the rights of the research participants safeguarded? Explain.
p.000017: 5) Details on the procedures for informing the research participants about profiling, and its possible consequences
p.000017: and the protection measures.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: 1) Details of the database used or of the source of the data.
p.000017: 2) Details of the data processing operations.
p.000017: 3) How will the rights of the research participants be safeguarded? Explain.
p.000017: 4) How is all of the processed data relevant and limited to the purposes of the project (‘data minimisation’
p.000017: principle)? Explain.
p.000017: 5) Justification of why the research data will not be
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: 1) Declaration confirming compliance with the laws of the country where the data was collected.
p.000017: 1) Opinion of the data controller on the need for a data protection impact assessment (art.35 GDPR) (if relevant).
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: 1) Declaration confirming lawful basis for the data processing.
p.000017: 2) Permission by the owner/manager of the data sets (e.g. social media databases) (if applicable).
p.000017: 3) Informed Consent Forms + Information Sheets
p.000017: + other consent documents (opt in processes, etc.). (if
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000018:
p.000018:
p.000018: anonymised/ pseudonymised (if relevant).
p.000018: applicable).
p.000018:
p.000018:
p.000018:
p.000018: Does your research involve publicly available data?
p.000018:
p.000018:
p.000018:
p.000018: Is it planned to export personal data from the EU to non-EU countries?
p.000018: Specify the type of personal data and countries involved
p.000018: 1) Confirm that the data used in the project is publicly available and can be freely used for the project.
p.000018:
p.000018:
p.000018: Details of the types of personal data to be exported.
p.000018: How will the rights of the research participants be safeguarded? Explain.
p.000018: 1) Permission by the owner/manager of the data sets (e.g. social media databases) (if applicable).
p.000018: 1) Declaration of confirming compliance with Chapter V of the GDPR.
p.000018:
p.000018:
p.000018:
p.000018:
...

p.000024: - exploitation of research participants
p.000024: - exploitation of local resources
p.000024: - risks to researchers & staff
p.000024: - research that is prohibited in the EU.
p.000024:
p.000024: Horizon 2020 funding cannot be granted for activities carried out outside the EU if they are prohibited in all Member
p.000024: States.5
p.000024:
p.000024:
p.000024: 6.1 Ethics issues checklist
p.000024:
p.000024:
p.000024:
p.000024: Section 6: THIRD COUNTRIES
p.000024:
p.000024: YES/ NO
p.000024:
p.000024: Page
p.000024:
p.000024: Information to be provided
p.000024:
p.000024: Documents to be provided/kept on file
p.000024:
p.000024:
p.000024: In case non-EU countries are involved, do the research related activities undertaken in these countries raise potential
p.000024: ethics issues?
p.000024: Specify the countries involved:
p.000024:
p.000024:
p.000024: Is it planned to use local resources (e.g. animal and/or human tissue samples, genetic material, live animals, human
p.000024: remains, materials of historical value, endangered fauna or flora samples, etc.)?
p.000024: 1) Risk-benefit analysis.
p.000024: 2) What activities are carried out in non-EU countries? Give details.
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024: 1) What type of local resources will be used and how exactly? Give details.
p.000024: 1) Copies of ethics approvals and other authorisations or notifications (if required).
p.000024: 2) Confirmation that the activity could have been legally carried out in an EU country (for instance, an opinion from
p.000024: an appropriate ethics structure in an EU country).
p.000024: 1) For human resources: copies of ethics approvals.
p.000024: For animals, plants, micro-organisms and associated traditional knowledge: documentation demonstrating compliance with
p.000024: the UN
p.000024:
p.000024:
p.000024: 5 See Article 19(4) of the Horizon 2020 Framework Programme Regulation (EU) No 1291/2013.
p.000024:
p.000025: 25
p.000025:
p.000025: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Is it planned to import any material from non-EU countries into the EU?
p.000025:
p.000025: For data imports, see section 4.
p.000025: For imports of human cells or tissues, see section 3.
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 1) What type of materials will you import? Give details.
p.000025: Convention on Biological Diversity (e.g. access permit and benefit sharing agreement).
p.000025: 1) Copies of import licences.
p.000025:
p.000025: If
p.000025: YES:
p.000025: Specify the materials and countries involved:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Is it planned to export any material from the EU to non- EU countries?
p.000025:
p.000025: For data exports, see section 4.
p.000025: 1) Details of the type of materials to be exported.
p.000025: 1) Copies of export licences.
p.000025: If Specify material
p.000025: YE and countries
p.000025: S: involved:
p.000025:
p.000025:
p.000025:
p.000025:
...

Searching for indicator sex workers:

(return to top)
p.000008: For your grant proposal, you should also provide an assessment of risks, stating explicitly what kinds of harm
p.000008: (psychological, social, legal, economic, environmental, etc.) might occur, the likelihood of subjects actually
p.000008: incurring such harm, and the steps that you will take to minimise them.
p.000008: Research entailing more than minimal risk typically involves:
p.000008: - potentially vulnerable groups and people unable to give informed consent
p.000008: - personal or sensitive topics, which might induce psychological stress, anxiety or humiliation
p.000008: - deception
p.000008: - risks to researcher safety or
p.000008: - seeking respondents through the internet/social media (e.g. using identifiable visual images or discussing
p.000008: sensitive issues ).
p.000008: Particular attention must be paid to vulnerable categories of individuals such as children, patients, people
p.000008: subject to discrimination, minorities, people unable to give consent, people of dissenting opinion, immigrant or
p.000008: minority communities, sex workers, etc.
p.000008: If your research involves children or other individuals unable to make decisions for themselves, you must
p.000008: maintain an active relationship with their legal guardians and/or carers; you must not only seek their consent,
p.000008: but also allow them to monitor the research.
p.000008: Ensure that data are kept securely and that publication (including publication on the internet) does not lead (either
p.000008: directly or indirectly) to a breach of agreed confidentiality and anonymity.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: In rare cases, there may be a need to override agreements on confidentiality and anonymity (e.g. if
p.000009: maintaining confidentiality facilitates illegal behaviour such as drug dealing, child abuse, etc. that has come
p.000009: to light in the course of the research). In such circumstances, you must carefully consider disclosure to the
p.000009: appropriate authorities. You must inform the participants or their guardians of your intentions and the
p.000009: reasons for disclosure, unless this makes disclosure impracticable. You should also consider the technical
p.000009: aspects of collecting and storing your research data.
...

Economic / Economic/Poverty

Searching for indicator poor:

(return to top)
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000026:
p.000026: 6.2 How do I deal with the issues?
p.000026:
p.000026: Specific cases
p.000026:
p.000026: Research carried out in a non-EU country — For activities carried out outside the EU, it is not enough for that the
p.000026: activity to be accepted and comply with the legal obligations of a non-EU country; the activities must ALSO be allowed
p.000026: in at least one Member State (see art. 19 H2020 Programme Regulation No 1291/2013).
p.000026: Beneficiaries must confirm in the ethics self-assessment section of their proposal that this condition is met.
p.000026:
p.000026: Resources from a non-EU country — Any use of local resources (especially animal and/or human tissue
p.000026: samples, genetic material, live animals, human remains, materials of historical value, endangered fauna or flora
p.000026: samples, fossils) must show respect for cultural traditions and share benefits (i.e. also benefit local
p.000026: participants and their communities, involve local researchers – as equal partners – and respond to local research
p.000026: needs).
p.000026: This is particularly important for low income and lower-middle income countries (see Convention on Biological
p.000026: Diversity and Declaration of Helsinki and follow the Global code of conduct for research in resource-poor
p.000026: settings).
p.000026: For access to genetic resources, you must also comply with the Nagoya Protocol on Access and Benefit Sharing and EU
p.000026: Regulation (EU) No 511/2014 which implements this Protocol.
p.000026:
p.000026: Import/export of material — If genetic resources are transferred across borders, it may be mandatory under the law
p.000026: of the provider country to obtain an authorisation for the transfer. In addition, you must use an agreement
p.000026: which describes the conditions for the export and the terms of utilisation and, if applicable, relevant benefit-sharing
p.000026: measures.
p.000026: For transfers of human cells or tissues, see section 3.
p.000026: For data transfers, see section 4.
p.000026:
p.000026: Sending researchers to a non-EU country — Non-EU countries are not necessarily less safe than EU countries.
p.000026: Nevertheless, a risk assessment must be undertaken when sending researchers abroad and appropriate safety measures
p.000026: must be taken. These may include insurance cover or health and safety measures, such as no lone working, contact
p.000026: points via phone, counselling support, etc. (see also section 7.2).
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: 6.3 What do you need to provide?
p.000026: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000026: self-assessment in Part B of your proposal (i.e. section 5 of the Technical Annex).
...

p.000026: on, if requested by the Commission/Agency.
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000027:
p.000027: Background documents & further reading
p.000027:
p.000027: Human resources Declaration of Helsinki Flora & fauna
p.000027: Convention on Biological Diversity
p.000027: Genetic resources
p.000027: Nagoya Protocol on Access and Benefit Sharing
p.000027: EU Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on
p.000027: compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the fair and
p.000027: equitable sharing of benefits arising from their utilization in the Union (ABS Regulation) (OJ L 150,
p.000027: 20.5.2014, p. 59)
p.000027: Commission Implementing Regulation (EU) No 2015/1866 of 13 October 2015 laying down detailed rules for
p.000027: the implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council as regards the
p.000027: register of collections, monitoring user compliance and best practices (OJ L 275, 20.10.2015, p. 4)
p.000027: Developing countries and lower income settings
p.000027: FP 7 guidance: Developing countries
p.000027: Global code of conduct for research in resource-poor settings
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000028:
p.000028: 7. Environment, health & safety
p.000028: This section concerns research that may adversely affect:
p.000028: - the environment or
p.000028: - the health & safety of the researchers involved. This may be due to any of the following:
p.000028: - the experimental design of the research itself
p.000028: - undesirable side-effects of the technologies used.
p.000028:
p.000028:
p.000028: 7.1 Environment
p.000028: 7.1.1 Ethics issues checklist
p.000028:
p.000028:
p.000028:
p.000028: Section 7: ENVIRONMENT & HEALTH AND SAFETY
p.000028:
p.000028:
p.000028: YES/NO
p.000028:
p.000028:
p.000028: Page
p.000028:
p.000028: Information to be provided
p.000028:
p.000028: Documents to be provided/kept on file
p.000028:
p.000028:
p.000028: Does your research involve the use of elements that may cause harm to the environment, to animals or plants?
p.000028:
p.000028: For research involving animal experiments, see section 5.
p.000028: Does your research deal with endangered fauna and/or flora
p.000028: /protected areas?
p.000028: 1) Risk-benefit analysis.
...

General/Other / Public Emergency

Searching for indicator emergency:

(return to top)
p.000013: - state the legislation under which the material will be stored
p.000013: - state how long it will be stored and what you will do with it at the end of the research.
p.000013:
p.000013: Biobanking — Biobanks raise significant ethical issues concerning informed consent and data privacy.
p.000013: ‘Biobanks’ are repositories for the storage of biological samples (usually human) and play a significant role in
p.000013: biomedical research. These ‘libraries’ provide researchers with access to large numbers of tissue samples, genetic
p.000013: material and associated data.
p.000013: If your project has the aim or effect of setting up a biobank, you must ensure that there is strict compliance with
p.000013: appropriate European and national ethical standards (in particular, regarding data privacy; see section 4).
p.000013: You must confirm that informed consent has been obtained and show that you have obtained all necessary ethics approvals
p.000013: (or that you are exempted under national law).
p.000013: No samples/data may be placed in the biobank before all appropriate consents and ethics approvals have been obtained
p.000013: You will need to make a report on key aspects of the biobank’s activities, including in particular:
p.000013: - information on which donors will be excluded/included (e.g. competent adults, children and minors, adults unable
p.000013: to provide informed consent, individuals in an emergency setting, etc.)
p.000013: - details of the material that will be ‘banked’, including:
p.000013: - personal (coded or fully identifiable) biosamples
p.000013: - personal information associated with a sample (e.g. name/code, gender, age, etc.)
p.000013: - personal data resulting from analysis of a sample (e.g. analysis of genetic material or a genome)
p.000013: - anonymised biosamples
p.000013: - anonymised data resulting from analysis of a sample (from which individuals could be
p.000013: identified) and
p.000013: - epidemiological (population level) data
p.000013: - information on the standard procedures for:
p.000013: - accepting material into the biobank,
p.000013: - processes and standards for sample-quality assurance and ensuring accuracy of data and information
p.000013: - handling requests for release of samples/data from the biobank (including fair and just financial arrangements
p.000013: and benefit-sharing for third countries).
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000014:
p.000014:
p.000014:
p.000014: Genetic testing — For using or storing human cells or tissues for genetic testing, you must obtain the donor's
p.000014: informed consent for the genetic testing, and show that you have obtained approval from the relevant
p.000014: ethics and data protection bodies; and any licence required under national legislation.
p.000014:
...

General/Other / Relationship to Authority

Searching for indicator authority:

(return to top)
p.000032: contribute to the proliferation of weapons of mass destruction.
p.000032:
p.000032:
p.000032: 8.1 Ethics issues checklist
p.000032:
p.000032:
p.000032:
p.000032: Section 8: DUAL USE
p.000032:
p.000032:
p.000032: YES/NO
p.000032:
p.000032:
p.000032: Page
p.000032:
p.000032: Information to be provided
p.000032:
p.000032: Documents to be provided/kept on file
p.000032:
p.000032:
p.000032: Does this research involve dual-use items in the sense of Regulation 428/2009, or other items for which an
p.000032: authorisation is required?
p.000032: 1) What goods and information used and produced in your research will need export licences?
p.000032: 2) How exactly will you ensure compliance?
p.000032: 3) How exactly will you avoid negative implications?
p.000032: 1) Copies of export licences.
p.000032:
p.000032:
p.000032: 8.2 How to deal with the issues?
p.000032: Your research must comply with:
p.000032: - ethical principles
p.000032: - applicable international, EU and national law (in particular, the EU Export Control Regulation No
p.000032: 428/2009).
p.000032:
p.000032: In certain exceptional cases, publication of research findings (e.g. a scientific article in a journal
p.000032: published both outside or inside the EU) may be classed as an intangible technology transfer (ITT) and may
p.000032: require an authorisation (which is not always granted).
p.000032:
p.000032:
p.000032: Specific cases
p.000032:
p.000032: Cross-border transfers — For cross-border transfers of dual-use materials, technologies and information, you must
p.000032: observe the EU Export Control Regulation No 428/2009. If you have any doubts, you should consult the relevant national
p.000032: export control authority to clarify whether transfer licences are needed.
p.000032: Research that may affect ethics standards — If international non-proliferation laws or international humanitarian laws
p.000032: may have a bearing on your research (e.g. in the case of pathogen-related research, development of autonomous robotics,
p.000032: drones and certain laser technologies), you must comply with the relevant international law (in particular,
p.000032: the Biological and Toxin Weapons Convention).
p.000032: You may also want to appoint an independent ethics adviser/ethics board, with relevant ethics and
p.000032: security expertise, to carry out a risk-benefit analysis of the intended research and to suggest appropriate
p.000032: safeguards to cover security risks (during and beyond the lifetime of the project) and training for researchers.
p.000032:
p.000032:
p.000032:
p.000032:
p.000033: 33
p.000033:
p.000033: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000033:
p.000033:
p.000033:
p.000033: 8.3 What do you need to provide?
p.000033: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000033: self-assessment in Part B of your proposal (i.e. section 5 of the technical Annex) and fill in the critical risk table
...

General/Other / declaration of helsinki

Searching for indicator helsinki:

(return to top)
p.000008: Ensure that data are kept securely and that publication (including publication on the internet) does not lead (either
p.000008: directly or indirectly) to a breach of agreed confidentiality and anonymity.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: In rare cases, there may be a need to override agreements on confidentiality and anonymity (e.g. if
p.000009: maintaining confidentiality facilitates illegal behaviour such as drug dealing, child abuse, etc. that has come
p.000009: to light in the course of the research). In such circumstances, you must carefully consider disclosure to the
p.000009: appropriate authorities. You must inform the participants or their guardians of your intentions and the
p.000009: reasons for disclosure, unless this makes disclosure impracticable. You should also consider the technical
p.000009: aspects of collecting and storing your research data.
p.000009: Data collection using electronic encoding tools (digital recorders or cameras) should be given special attention (see
p.000009: also section 4). You should also discuss these issues with your organisation’s data protection officer.
p.000009:
p.000009: Medical research —is specifically addressed by the Declaration of Helsinki. Your grant proposal must also comply with:
p.000009: - the principles laid down in the Oviedo Bioethics Convention and
p.000009: - EU Regulation No 536/2014 on clinical trials on medicinal products for human use.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 2.4 What do you need to provide?
p.000009: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000009: self-assessment in Part B of your proposal (i.e. section 5 of the Technical Annex).
p.000009: Your grant proposal must include the information referred to in the ethics issues checklist and any of the
p.000009: documents already available.
p.000009:
p.000009: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000009: on, if requested by the Commission/Agency.
p.000009:
p.000009:
p.000009: Background documents & further reading
p.000009:
p.000009: Informed consent
p.000009: FP7 guidance: Informed consent
p.000009: Medical research
p.000009: WMA Declaration of Helsinki
p.000009: Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology
p.000009: and Medicine: Convention on Human Rights and Biomedicine (Oviedo, 4 April 1997) (Oviedo Bioethics Convention)
p.000009: EU Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as
p.000009: regards investigational medicinal products for human use as well as the requirements for authorization of the
p.000009: manufacturing or importation of such products (OJ L 91, 9.4.2005, p. 13)
p.000009: EU Regulation No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for
p.000009: human use, repealing Directive 2001/20/EC (OJ L 158, 27.5.2014)
p.000009: Functional Magnetic Resonance Imaging
p.000009: Social science research
p.000009: Social sciences and humanities
p.000009: Research Ethics in Ethnography/Anthropology
p.000009: Guidance note — Research on refugees, asylum seekers & migrants
p.000009:
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p.000010:
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p.000010: Ethics in Social Science and Humanities
p.000010: Research on children
p.000010: FP7 guidance: Ethics for Clinical Trials on Medicinal Products Conducted with Paediatric Population
...

p.000025: 1) Details of the safety measures you intend to take, including training for staff and insurance cover.
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p.000026:
p.000026: 6.2 How do I deal with the issues?
p.000026:
p.000026: Specific cases
p.000026:
p.000026: Research carried out in a non-EU country — For activities carried out outside the EU, it is not enough for that the
p.000026: activity to be accepted and comply with the legal obligations of a non-EU country; the activities must ALSO be allowed
p.000026: in at least one Member State (see art. 19 H2020 Programme Regulation No 1291/2013).
p.000026: Beneficiaries must confirm in the ethics self-assessment section of their proposal that this condition is met.
p.000026:
p.000026: Resources from a non-EU country — Any use of local resources (especially animal and/or human tissue
p.000026: samples, genetic material, live animals, human remains, materials of historical value, endangered fauna or flora
p.000026: samples, fossils) must show respect for cultural traditions and share benefits (i.e. also benefit local
p.000026: participants and their communities, involve local researchers – as equal partners – and respond to local research
p.000026: needs).
p.000026: This is particularly important for low income and lower-middle income countries (see Convention on Biological
p.000026: Diversity and Declaration of Helsinki and follow the Global code of conduct for research in resource-poor
p.000026: settings).
p.000026: For access to genetic resources, you must also comply with the Nagoya Protocol on Access and Benefit Sharing and EU
p.000026: Regulation (EU) No 511/2014 which implements this Protocol.
p.000026:
p.000026: Import/export of material — If genetic resources are transferred across borders, it may be mandatory under the law
p.000026: of the provider country to obtain an authorisation for the transfer. In addition, you must use an agreement
p.000026: which describes the conditions for the export and the terms of utilisation and, if applicable, relevant benefit-sharing
p.000026: measures.
p.000026: For transfers of human cells or tissues, see section 3.
p.000026: For data transfers, see section 4.
p.000026:
p.000026: Sending researchers to a non-EU country — Non-EU countries are not necessarily less safe than EU countries.
p.000026: Nevertheless, a risk assessment must be undertaken when sending researchers abroad and appropriate safety measures
p.000026: must be taken. These may include insurance cover or health and safety measures, such as no lone working, contact
p.000026: points via phone, counselling support, etc. (see also section 7.2).
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: 6.3 What do you need to provide?
p.000026: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000026: self-assessment in Part B of your proposal (i.e. section 5 of the Technical Annex).
p.000026: Your grant proposal must include the information referred to in the ethics issues checklist and any of the
p.000026: documents already available.
p.000026:
p.000026: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000026: on, if requested by the Commission/Agency.
p.000026:
p.000026:
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p.000027: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000027:
p.000027: Background documents & further reading
p.000027:
p.000027: Human resources Declaration of Helsinki Flora & fauna
p.000027: Convention on Biological Diversity
p.000027: Genetic resources
p.000027: Nagoya Protocol on Access and Benefit Sharing
p.000027: EU Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on
p.000027: compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the fair and
p.000027: equitable sharing of benefits arising from their utilization in the Union (ABS Regulation) (OJ L 150,
p.000027: 20.5.2014, p. 59)
p.000027: Commission Implementing Regulation (EU) No 2015/1866 of 13 October 2015 laying down detailed rules for
p.000027: the implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council as regards the
p.000027: register of collections, monitoring user compliance and best practices (OJ L 275, 20.10.2015, p. 4)
p.000027: Developing countries and lower income settings
p.000027: FP 7 guidance: Developing countries
p.000027: Global code of conduct for research in resource-poor settings
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General/Other / oviedo

Searching for indicator oviedo:

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p.000009: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: In rare cases, there may be a need to override agreements on confidentiality and anonymity (e.g. if
p.000009: maintaining confidentiality facilitates illegal behaviour such as drug dealing, child abuse, etc. that has come
p.000009: to light in the course of the research). In such circumstances, you must carefully consider disclosure to the
p.000009: appropriate authorities. You must inform the participants or their guardians of your intentions and the
p.000009: reasons for disclosure, unless this makes disclosure impracticable. You should also consider the technical
p.000009: aspects of collecting and storing your research data.
p.000009: Data collection using electronic encoding tools (digital recorders or cameras) should be given special attention (see
p.000009: also section 4). You should also discuss these issues with your organisation’s data protection officer.
p.000009:
p.000009: Medical research —is specifically addressed by the Declaration of Helsinki. Your grant proposal must also comply with:
p.000009: - the principles laid down in the Oviedo Bioethics Convention and
p.000009: - EU Regulation No 536/2014 on clinical trials on medicinal products for human use.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 2.4 What do you need to provide?
p.000009: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000009: self-assessment in Part B of your proposal (i.e. section 5 of the Technical Annex).
p.000009: Your grant proposal must include the information referred to in the ethics issues checklist and any of the
p.000009: documents already available.
p.000009:
p.000009: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000009: on, if requested by the Commission/Agency.
p.000009:
p.000009:
p.000009: Background documents & further reading
p.000009:
p.000009: Informed consent
p.000009: FP7 guidance: Informed consent
p.000009: Medical research
p.000009: WMA Declaration of Helsinki
p.000009: Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology
p.000009: and Medicine: Convention on Human Rights and Biomedicine (Oviedo, 4 April 1997) (Oviedo Bioethics Convention)
p.000009: EU Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as
p.000009: regards investigational medicinal products for human use as well as the requirements for authorization of the
p.000009: manufacturing or importation of such products (OJ L 91, 9.4.2005, p. 13)
p.000009: EU Regulation No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for
p.000009: human use, repealing Directive 2001/20/EC (OJ L 158, 27.5.2014)
p.000009: Functional Magnetic Resonance Imaging
p.000009: Social science research
p.000009: Social sciences and humanities
p.000009: Research Ethics in Ethnography/Anthropology
p.000009: Guidance note — Research on refugees, asylum seekers & migrants
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000010:
p.000010:
p.000010:
p.000010: Ethics in Social Science and Humanities
p.000010: Research on children
p.000010: FP7 guidance: Ethics for Clinical Trials on Medicinal Products Conducted with Paediatric Population
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Orphaned Trigger Words

p.000001: Start thinking about ethics while designing your research protocols. Don't wait until the last minute to seek advice or
p.000001: check requirements under national and EU law. Use the ethics by design methodology (see section 11).
p.000001: Ethics also matter for scholarly publication. Major scientific journals in many areas will increasingly require ethics
p.000001: committee approval before publishing research articles. Thus, you should be prepared for ethics procedures even if your
p.000001: research is funded by sources other than Horizon 2020.
p.000001: Your first source should always be at your institution. We would ask you to seek advice from colleagues
p.000001: with expertise in the ethics of research, such as:
p.000001: specialised ethics departments
p.000001: relevant managers in your university/research organisation hospital research ethics committees
p.000001: ethics advisers in your company data protection officers.
p.000001: They will be able to provide you with information appropriate to your specific needs and legal environment.
p.000001: Consider involving/appointing an ethics adviser/advisory board. From the beginning of your project, an ethics adviser
p.000001: can help you deal with ethical issues and put in place the procedures to handle them appropriately. If your research
p.000001: includes several ethical concerns or involves several significant or complex ethical issues (such as
p.000001: participation of children from developing countries, ’non-human primates (NHPs)’, potential misuse or
p.000001: vulnerable populations) we suggest you appoint an ethics adviser or an ethics advisory board comprising
p.000001: several experts from different backgrounds. The Commission/Agency may also make this an ethics requirement during
p.000001: the selection procedure.
p.000001:
p.000001: Other information
p.000001: For a broader overview of how Horizon 2020 grants work, see the Participant Portal Online Manual. For detailed
p.000001: information, see the Horizon 2020 AGA — Annotated Grant Agreement.
p.000001: A comprehensive list of all Horizon 2020 reference documents (including legislation, work programme and templates) can
p.000001: be found on Participant Portal Reference Documents.
p.000001:
p.000001: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: Version Publication
p.000001: Date
p.000001:
p.000001: HISTORY OF CHANGES
p.000001: Change
p.000001:
p.000001: 5.0
p.000001: 5.1
p.000001:
p.000001:
p.000001:
p.000001: 5.2
p.000001:
p.000001:
p.000001: 5.3
p.000001: 6.0
p.000001:
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p.000001:
p.000001: 6.1
p.000001: 15.03.2016
p.000001: 01.06.2016
p.000001:
p.000001:
p.000001:
p.000001: 12.07.2016
p.000001:
p.000001:
p.000001: 21.02.2018
p.000001: 23.07.2018
p.000001:
p.000001:
p.000001:
p.000001: 04.02.2019
p.000001: ▪ Document revised by DGT editors
p.000001: ▪ Reparation of hyperlinks
p.000001: ▪ Reference to new Data Protection Regulation
p.000001: ▪ Adapt instructions on providing of documents to new MGA provisions.
p.000001: ▪ Insert link to new guidance note on research on refugees, asylum seekers and migrants
p.000001: ▪ Correction in ethics issues table in section 7.2
p.000001: ▪ H2020 is written as Horizon 2020 throughout the document.
p.000001: ▪ A new reference document is added in section 6 on Non-EU countries.
p.000001: ▪ Adaptation of the section 4 on personal data further to the application of the new GDPR.
p.000001: ▪ Modification of the Important Notice to refer to the ethics by design methodology
p.000001: ▪ Modification of the section 11 to cover ethics by design and add a reference on AI
p.000001: ▪ Replace the reference to the FP7 guidance note on social sciences by the new one (with the link to the
p.000001: document in the Portal)
p.000001:
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p.000001: 1
p.000001:
p.000001: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000001:
p.000001: TABLE OF CONTENTS
p.000001: 1. Human embryos & foetuses 3
p.000001: 2. Human beings
p.000006: 6
p.000006: 3. Human cells or tissues
p.000012: 12
p.000012: 4. Personal data
p.000016: 16
p.000016: 5. Animals
p.000022: 22
p.000022: 6. Non-EU countries
p.000025: 25
p.000025: 7. Environment, health & safety 29
p.000025: 8. Dual use
p.000033: 33
p.000033: 9. Exclusive focus on civil applications 35
p.000033: 10. Potential misuse of research results 37
p.000033: 11. Other ethics issues
p.000040: 40
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p.000002: 2
p.000002:
p.000002: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000002:
p.000002: 1. Human embryos & foetuses
p.000002: This section covers research on human embryos and foetuses (mainly human embryonic stemXcells (hESC)).
p.000002:
p.000002: The following fields of research are not eligible for funding under Horizon 2020 and cannot therefore be included in
p.000002: proposals):
p.000002: - research activities directed at human cloning for reproductive purposes
p.000002: - research activity intended to modify the genetic make-up of human beings that could make such
p.000002: changes heritable (apart from research relating to cancer treatment of the gonads, which may be financed)
p.000002: - research activities intended to create human embryos solely for the purposes of research or stem cell
p.000002: procurement, including the technique of somatic cell nuclear transfer1
p.000002: - research that leads to the destruction of human embryos.
p.000002:
p.000002: Research on human stem cells (both adult and embryonic) may be financed — depending on both the content of
p.000002: the scientific proposal and the laws of the Member States involved. No funding will be granted for research activities
p.000002: that are prohibited in all Member States. No activity will be funded in a Member State where such activity is
p.000002: forbidden.2
p.000002:
p.000002:
p.000002: 1.1 Ethics issues checklist
p.000002:
p.000002:
p.000002:
p.000002: Section 1: HUMAN EMBRYOS/ FOETUSES
p.000002:
p.000002:
p.000002: YES/NO
p.000002:
p.000002:
p.000002: Page
p.000002:
p.000002: Information to be provided
p.000002:
p.000002: Documents
p.000002: to be provided/kept on file
p.000002:
p.000002: Does your research involve Human Embryonic StemXCells (hESCs)?
p.000002:
p.000002: If
p.000002: YES:
p.000002: - Will they be directly derived from embryos within this project?
p.000002: - Are they previously established cells lines?
p.000002: Research not eligible for funding
p.000002:
p.000002:
p.000002:
p.000002: 1) Origin and line of cells.
p.000002: 2) Details of the licensing and control measures by the competent authorities of
p.000002: the Member States involved.
p.000002: Research not eligible for funding
p.000002:
p.000002:
p.000002:
p.000002: 1) Copies of Ethics Approval.
p.000002: 2) Declaration that the human embryonic stem cell lines used in the project are registered in the
p.000002: European hESC registry (www.hescreg.eu) — both for hESCs and
p.000002:
p.000002:
p.000002: 1 See Article 19(3) of the Horizon 2020 Framework Programme Regulation (EU) No 1291/2013.
p.000002: 2 See also Article 19(4) of the Horizon 2020 Framework Programme Regulation (EU) No 1291/2013.
p.000002:
p.000003: 3
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p.000003: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000003:
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p.000003: Does
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p.000003:
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p.000003: your research
p.000003:
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p.000003:
p.000003:
p.000003: 1) Origin of embryos.
p.000003: human-induced pluripotent stem cell (hiPSC) lines.
p.000003: 3) Declaration confirming that the 6 specific conditions (see below) for
p.000003: research activities involving human embryonic stemXcells are met.
p.000003: 1) Copies of ethics
p.000003:
p.000003: involve the use of human embryos?
p.000003: 2) Details of the recruitment, inclusion and exclusion criteria and informed consent
p.000003: procedures.
p.000003: 3) Confirm that informed consent has been obtained.
p.000003: approval.
p.000003: 2) Informed Consent Forms + Information Sheets.
p.000003:
p.000003: If
p.000003: YES:
p.000003:
p.000003:
p.000003: Does
p.000003: - Will the research lead to their destruction?
p.000003: your research
p.000003: Research not eligible for funding
p.000003:
p.000003:
p.000003: 1) Origin of human
p.000003: Research not eligible for funding
p.000003:
p.000003:
p.000003: 1) Copies of ethics
p.000003:
p.000003: involve the use of human foetal tissues / cells?
p.000003: foetal tissues/cells.
p.000003: 2) Details of the informed consent procedures.
p.000003: 3) Confirm that informed consent has been obtained.
p.000003: approval.
p.000003:
p.000003: 2) Informed Consent Forms + Information Sheets.
p.000003:
p.000003:
p.000003: 1.2 How do I deal with the issues?
p.000003: Your research must comply with:
p.000003: - ethical principles
p.000003: - applicable international, EU and national law (in particular, the Statement of the Commission related to research
p.000003: activities involving human embryonic stem cells3).
p.000003: For research activities involving human embryonic stemXcells (hESC), this means you must make sure that:
p.000003: - cells were NOT derived from embryos specially created for research or by somatic cell nuclear transfer
p.000003: - the project uses existing cultured cell lines only
p.000003: - cell lines were derived from supernumerary non-implanted embryos resulting from in vitro fertilisation
p.000003:
p.000003:
p.000003:
p.000003: 3 See Article 19(1) of the Horizon 2020 Framework Programme Regulation (EU) No 1291/2013.
p.000003:
p.000004: 4
p.000004:
p.000004: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000004:
p.000004: - informed consent has been obtained for using donated embryos for the derivation of the cell lines
p.000004: - personal data and privacy of donors of embryos for the derivation of the cells are protected
p.000004: - NO financial inducements were provided for the donation of embryos used for derivation of the cell lines.
p.000004: Moreover, under national law, research on human embryonic stemXcells (hESC) is normally subject to strict licensing and
p.000004: control.4
p.000004:
p.000004: You must provide the Commission/Agency with a declaration confirming compliance with these conditions (as part
p.000004: of your proposal).
p.000004: For research on human embryos (hE), you must obtain the donors’ free and fully informed consent.
p.000004:
p.000004: Your research may NOT:
p.000004: - create human embryos solely for the purpose of research or for the purpose of stem cell procurement
p.000004: (including by means of somatic cell nuclear transfer)
p.000004: - destroy human embryos (e.g. to obtain stemXcells).
p.000004:
p.000004:
p.000004: 1.3 What do you need to provide?
p.000004: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000004: self-assessment in Part B of your proposal (i.e. section 5 of the Technical Annex).
p.000004: Your proposal must include the information referred to in the ethics issues checklist and any documents that are
p.000004: already available.
p.000004:
p.000004: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000004: on, if requested by the Commission/Agency.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Background documents & further reading
p.000004:
p.000004: Statement of the Commission related to research activities involving human embryonic stemXcells.
p.000004: FP7: Recommendations on the ethical review of hESC FP7 research projects (Opinion 22), European Group on
p.000004: Ethics in Science and New Technologies.
p.000004: FP7 guidance: Research on Human embryos/foetus.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: 4 See also Article 13(2) of the Rules for Participation Regulation (EU) No 1290/2013.
p.000004:
p.000005: 5
p.000005:
p.000005: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000005:
p.000005: 2. Human beings
p.000005: This section refers to any research involving work with humans beings (‘research or study participants’), regardless of
p.000005: its nature or topic.
p.000005: Examples: collection of biological samples, personal data, medical interventions, interviews,
p.000005: observations, tracking or the secondary use of information provided for other purposes, e.g. other research projects,
p.000005: officially collected information, social media sites, etc.
p.000005:
p.000005:
p.000005: 2.1 Ethics issues checklist
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Section 2: HUMANS
p.000005:
p.000005:
p.000005: YES/ NO
p.000005:
p.000005:
p.000005: Page
p.000005:
p.000005: Information to be provided
p.000005:
p.000005: Documents to be provided/kept on file
p.000005:
p.000005:
p.000005: Does your research involve human participants?
p.000005:
p.000005:
p.000005: If YES: - Are they
p.000005: volunteers for social or human sciences research?
p.000005: - Are they persons unable to give informed consent (including children/minors)?
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: - Are they vulnerable individuals or groups?
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: - Are they children/minors?
p.000005: 1) Confirm that informed consent has been obtained.
p.000005:
p.000005:
p.000005: 1) Details of the recruitment, inclusion and exclusion criteria and informed consent procedures.
p.000005: 1) Details of the procedures for obtaining approval from the guardian/legal representative and the agreement of the
p.000005: children or other minors.
p.000005: 2) What steps will you take to ensure that participants are not subjected to any form of coercion?
p.000005: 1) Details of the type of vulnerability.
p.000005: 2) Details of the recruitment, inclusion and exclusion criteria and informed consent procedures.
p.000005: These must demonstrate appropriate efforts to ensure fully informed understanding of the implications of participation.
p.000005: 1) Details of the age range.
p.000005: 2) What are your assent
p.000005: 1) Informed Consent Forms + Information Sheets.
p.000005:
p.000005: 1) Copies of ethics approvals (if required).
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: 1) Copies of ethics approvals.
p.000005:
p.000005:
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p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: - Are they patients?
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: - Are they healthyXvolunteers for medical studies?
p.000006:
p.000006: Does your research involve physical interventions on the study participants?
p.000006: procedures and parental consent for children and other minors?
p.000006: 3) What steps will you take to ensure the welfare of the child or other minor?
p.000006: 4) What justification is there for involving minors?
p.000006: 1) What disease/condition
p.000006: /disability do they have?
p.000006: 2) Details of the recruitment, inclusion and exclusion criteria and informed consent procedures.
p.000006: 3) What is your policy on incidental findings?
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) Copies of ethics approvals.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) Copies of ethics approvals.
p.000006:
p.000006: If YES:
p.000006: - Does it involve invasive techniques (e.g. collection of human cells or tissues, surgical or medical interventions,
p.000006: invasive studies on the brain, TMS etc.)?
p.000006: - Does it involve collection of biological samples?
p.000006: 1) Risk assessment for each technique and overall.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) What type of samples will be collected?
p.000006: 2) What are your procedures for collecting biological samples?
p.000006: 1) Copies of ethics approvals.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1) Copies of ethics approvals.
p.000006: For research involving processing of genetic information, see also section 4.
p.000006:
p.000006:
p.000006: 2.3 How do I deal with the issues?
p.000006: Your research must comply with:
p.000006: - ethical principles
p.000006: - applicable international, EU and national law.
p.000006:
p.000006:
p.000006:
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p.000007:
p.000007: This implies that you must ensure respect for people and for human dignity and fair distribution of the benefits and
p.000007: burden of research, and that you must protect the values, rights and interests of the research participants.
p.000007: Moreover, you must obtain:
p.000007: - the necessary ethics approvals (if required)
p.000007: - free and fully informed consent of the research participants.
p.000007:
p.000007:
p.000007: Informed consent
p.000007: Participation must be entirely voluntary and you must obtain and clearly document participants’ informed
p.000007: consent in advance.
p.000007: No consent is required if national law provides for an exception (e.g. in the public interest).
p.000007: Participants must be given an informed consent form and detailed information sheets
p.000007: that:
p.000007: - are written in a language and in terms they can fully understand
p.000007:
p.000007: - describe the aims, methods and implications of the research, the nature of the participation and any benefits,
p.000007: risks or discomfort that might ensue
p.000007:
p.000007: - explicitly state that participation is voluntary and that anyone has the right to refuse to participate and
p.000007: to withdraw their participation, samples or data at any time — without any consequences
p.000007:
p.000007: - state how biological samples and data will be collected, protected during the project and either destroyed or
p.000007: reused subsequently
p.000007:
p.000007: - state what procedures will be implemented in the event of unexpected or incidental findings (in
p.000007: particular, whether the participants have the right to know, or not to know, about any such findings).
p.000007: You must ensure that potential participants have fully understood the information and do not feel pressured or coerced
p.000007: into giving consent.
p.000007: Participants must normally give their consent in writing (e.g. by signing the informed consent form and
p.000007: information sheets).
p.000007: If consent cannot be given in writing, for example because of illiteracy, non-written consent must be formally
p.000007: documented and independently witnessed.
p.000007: Specific cases
p.000007: Research involving children (or other persons unable to give consent, e.g. certain elderly populations,
p.000007: persons judged as lacking mental capacity) — You must obtain informed consent from the legally authorised
p.000007: representative and ensure that they have sufficient information to enable them to provide this on behalf and in the
p.000007: best interests of the participants. Whenever possible, the assent of the participants should be obtained in
p.000007: addition to the consent of the parents or legal representatives. Participants must be asked for consent
p.000007: if they reach the age of majority in the course
p.000007:
p.000007:
p.000007:
p.000007: You must also ensure that your research methodologies do not result in discriminatory practices
p.000007: or unfair treatment.
p.000007:
p.000007: General principle — maximise benefits and minimise risks/harm.
p.000007: In addition, when conducting surveys, interviews or focus groups where personal information is gathered and
p.000007: stored, you must also pay attention to:
p.000007: - privacy
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000008:
p.000008: - data protection
p.000008: - data management (see also section 4)
p.000008: - the health and safety of participants (see section 7.2).
p.000008:
p.000008:
p.000008:
p.000008: Specific cases
p.000008:
p.000008: Research involving children (or other persons unable to give consent) — should be carried out only if:
p.000008: - studies with consenting adults would not be effective
p.000008: - participants are subject to only a minimal risk and burden
p.000008: - the results of the research will benefit the individual or group represented by the participant.
p.000008:
p.000008: Social science and humanities research — often involves working with human participants and particular
p.000008: methodological tools (e.g. surveys, questionnaires, interviews, standardised tests, direct observation,
p.000008: ethnography, recordings, experiments with volunteers, and sometimes physical interventions).
p.000008: You must therefore clarify the ethical implications of the chosen methodologies.
p.000008: Example:
p.000008: Describe the sampling methods or recruitment procedures and discuss whether they could result in discriminatory
p.000008: practices. If such practices are inevitable given the methodology, what action should be taken to mitigate them?
p.000008: For your grant proposal, you should also provide an assessment of risks, stating explicitly what kinds of harm
p.000008: (psychological, social, legal, economic, environmental, etc.) might occur, the likelihood of subjects actually
p.000008: incurring such harm, and the steps that you will take to minimise them.
p.000008: Research entailing more than minimal risk typically involves:
p.000008: - potentially vulnerable groups and people unable to give informed consent
p.000008: - personal or sensitive topics, which might induce psychological stress, anxiety or humiliation
p.000008: - deception
p.000008: - risks to researcher safety or
p.000008: - seeking respondents through the internet/social media (e.g. using identifiable visual images or discussing
p.000008: sensitive issues ).
p.000008: Particular attention must be paid to vulnerable categories of individuals such as children, patients, people
p.000008: subject to discrimination, minorities, people unable to give consent, people of dissenting opinion, immigrant or
p.000008: minority communities, sexXworkers, etc.
p.000008: If your research involves children or other individuals unable to make decisions for themselves, you must
p.000008: maintain an active relationship with their legal guardians and/or carers; you must not only seek their consent,
p.000008: but also allow them to monitor the research.
p.000008: Ensure that data are kept securely and that publication (including publication on the internet) does not lead (either
p.000008: directly or indirectly) to a breach of agreed confidentiality and anonymity.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
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p.000009:
p.000009:
p.000009:
p.000009:
p.000009: In rare cases, there may be a need to override agreements on confidentiality and anonymity (e.g. if
p.000009: maintaining confidentiality facilitates illegal behaviour such as drug dealing, child abuse, etc. that has come
p.000009: to light in the course of the research). In such circumstances, you must carefully consider disclosure to the
p.000009: appropriate authorities. You must inform the participants or their guardians of your intentions and the
p.000009: reasons for disclosure, unless this makes disclosure impracticable. You should also consider the technical
p.000009: aspects of collecting and storing your research data.
p.000009: Data collection using electronic encoding tools (digital recorders or cameras) should be given special attention (see
p.000009: also section 4). You should also discuss these issues with your organisation’s data protection officer.
p.000009:
p.000009: Medical research —is specifically addressed by the Declaration of Helsinki. Your grant proposal must also comply with:
p.000009: - the principles laid down in the Oviedo Bioethics Convention and
p.000009: - EU Regulation No 536/2014 on clinical trials on medicinal products for human use.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 2.4 What do you need to provide?
p.000009: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000009: self-assessment in Part B of your proposal (i.e. section 5 of the Technical Annex).
p.000009: Your grant proposal must include the information referred to in the ethics issues checklist and any of the
p.000009: documents already available.
p.000009:
p.000009: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000009: on, if requested by the Commission/Agency.
p.000009:
p.000009:
p.000009: Background documents & further reading
p.000009:
p.000009: Informed consent
p.000009: FP7 guidance: Informed consent
p.000009: Medical research
p.000009: WMA Declaration of Helsinki
p.000009: Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology
p.000009: and Medicine: Convention on Human Rights and Biomedicine (Oviedo, 4 April 1997) (Oviedo Bioethics Convention)
p.000009: EU Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as
p.000009: regards investigational medicinal products for human use as well as the requirements for authorization of the
p.000009: manufacturing or importation of such products (OJ L 91, 9.4.2005, p. 13)
p.000009: EU Regulation No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for
p.000009: human use, repealing Directive 2001/20/EC (OJ L 158, 27.5.2014)
p.000009: Functional Magnetic Resonance Imaging
p.000009: Social science research
p.000009: Social sciences and humanities
p.000009: Research Ethics in Ethnography/Anthropology
p.000009: Guidance note — Research on refugees, asylum seekers & migrants
p.000009:
p.000009:
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p.000010:
p.000010:
p.000010:
p.000010: Ethics in Social Science and Humanities
p.000010: Research on children
p.000010: FP7 guidance: Ethics for Clinical Trials on Medicinal Products Conducted with Paediatric Population
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
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p.000010:
p.000010:
p.000010:
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p.000010:
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p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
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p.000010:
p.000010:
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p.000010:
p.000010:
p.000010:
p.000010:
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p.000010:
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p.000010:
p.000010:
p.000010:
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p.000011:
p.000011: 3. Human cells or tissues
p.000011: This section refers to research using, producing or collecting human cells or tissues. You may obtain cells or tissues:
p.000011: - from commercial sources
p.000011: - as part of this research project
p.000011: - from another research project, laboratory or institution
p.000011: - from a biobank.
p.000011:
p.000011:
p.000011: 3.1 Ethics issues checklist
p.000011:
p.000011:
p.000011:
p.000011: Section 3: HUMAN CELLS / TISSUES
p.000011:
p.000011: YES/ NO
p.000011:
p.000011: Page
p.000011:
p.000011: Information to be provided
p.000011:
p.000011: Documents to be provided/kept on file
p.000011:
p.000011:
p.000011: Does your research involve human cells or tissues (other than from Human Embryos/Foetuses, see section 1)? ...

p.000013: ‘Biobanks’ are repositories for the storage of biological samples (usually human) and play a significant role in
p.000013: biomedical research. These ‘libraries’ provide researchers with access to large numbers of tissue samples, genetic
p.000013: material and associated data.
p.000013: If your project has the aim or effect of setting up a biobank, you must ensure that there is strict compliance with
p.000013: appropriate European and national ethical standards (in particular, regarding data privacy; see section 4).
p.000013: You must confirm that informed consent has been obtained and show that you have obtained all necessary ethics approvals
p.000013: (or that you are exempted under national law).
p.000013: No samples/data may be placed in the biobank before all appropriate consents and ethics approvals have been obtained
p.000013: You will need to make a report on key aspects of the biobank’s activities, including in particular:
p.000013: - information on which donors will be excluded/included (e.g. competent adults, children and minors, adults unable
p.000013: to provide informed consent, individuals in an emergency setting, etc.)
p.000013: - details of the material that will be ‘banked’, including:
p.000013: - personal (coded or fully identifiable) biosamples
p.000013: - personal information associated with a sample (e.g. name/code, gender, age, etc.)
p.000013: - personal data resulting from analysis of a sample (e.g. analysis of genetic material or a genome)
p.000013: - anonymised biosamples ...

p.000015: social identity of that natural person (art. 2(a) EU General Data Protection Regulation (GDPR).
p.000015: Examples: name, address, identification number, pseudonym, occupation, e-mail, CV, location data, Internet Protocol
p.000015: (IP) address, cookie ID, phone number, data provided by smart meters, data held by a hospital or doctor.
p.000015:
p.000015: Individuals are not considered ‘identifiable’ if identifying them requires excessive effort.
p.000015: Completely anonymised data does not fall under the data privacy rules (as from the moment it has been
p.000015: completely anonymised).
p.000015: ‘Processing of personal data’ means any operation (or set of operations) performed on personal data, either manually or
p.000015: by automatic means. This includes:
p.000015: - collection (digital audio recording, digital video caption, etc.)
p.000015: - recording
p.000015: - organisation, structuring & storage (cloud, LAN or WAN servers)
p.000015: - adaptation or alteration (merging sets, appification, etc.)
p.000015: - retrieval & consultation
p.000015: - use
p.000015: - disclosure by transmission, dissemination or otherwise making available (share, exchange, transfer)
p.000015: - alignment or combination
p.000015: - restriction, erasure or destruction.
p.000015: Examples: access to/consultation of a database containing personal data; managing of the database; posting/putting a
p.000015: photo of a person on a website; storing IP addresses or MAC addresses; video recording (CCTV); creating a
p.000015: mailing list or a list of participants.
p.000015:
p.000015: Processing normally covers any action that uses data for research purposes (even if interviewees, human
p.000015: volunteers, patients, etc. are not actively included in the research).
p.000015: Personal data may come from any type of research activity (ICT research, genetic sample collection, tissue storage,
p.000015: personal records (financial, criminal, education, etc.), lifestyle and health information, family histories,
p.000015: physical characteristics, gender and ethnic background, location tracking and domicile information, etc.).
p.000015:
p.000015:
p.000015:
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p.000016:
p.000016: 4.1 Ethics issues checklist
p.000016:
p.000016:
p.000016:
p.000016: Section 4: PROTECTION OF PERSONAL DATA
p.000016:
p.000016:
p.000016: YES/NO
p.000016:
p.000016:
p.000016: Page
p.000016:
p.000016:
p.000016: Information to be provided
p.000016:
p.000016: Documents to be provided/kept on file
p.000016:
p.000016:
p.000016: Does your research involve processing of personal data?
p.000016: 1) Details of the technical and organisational measures to safeguard the rights of the research participants.
p.000016: For instance:
p.000016: For organisations that must appoint a DPO under the GDPR: Involvement of the data protection officer (DPO) and
p.000016: disclosure of the contact details to the research participants.
p.000016: For all other organisations: Details of the data protection policy for the project (i.e. project-specific, not
p.000016: general).
p.000016: 2) Details of the informed consent procedures.
p.000016: 3) Details of the security measures to prevent unauthorised access to personal data.
p.000016: 4) How is all of the processed data relevant and limited to the purposes of the project (‘data minimisation’
p.000016: principle)? Explain.
p.000016: 5) Details of the anonymisation
p.000016: /pseudonymisation techniques.
p.000016: 6) Justification of why research data will not be anonymised/ pseudonymised (if relevant).
p.000016: 7) Details of the data transfers (type of data transferred and country to which it is transferred – for both EU and
p.000016: non-EU countries).
p.000016: 1) Informed Consent Forms + Information Sheets used (if relevant).
p.000016:
p.000016: If
p.000016: YES:
p.000016: - Does it involve the processing of special categories of personal data (e.g. genetic, health, sexual lifestyle,
p.000016: 1) Justification for the processing of special categories of personal data.
p.000016: 2) Why can the research objectives not be reached by processing anonymised/ pseudonymised data (if applicable)?
p.000016:
p.000016:
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p.000017:
p.000017:
p.000017: ethnicity, political opinion, religious or philosophical conviction.)?
p.000017: - Does it involve processing of genetic, biometric or health data?
p.000017: - Does it involve profiling, systematic monitoring of individuals or processing of large scale of special categories of
p.000017: data, intrusive methods of data processing (such as, tracking, surveillance, audio and video recording, geo- location
p.000017: tracking etc.) or any other data processing operation that may result in high risk to the rights and freedoms of the
p.000017: research participants?
p.000017: Does your research involve further processing of previously collected personal data (including use of pre- existing
p.000017: data sets or sources, merging existing data sets)?
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: 1) Details of the methods used for tracking, surveillance or observation of participants.
p.000017: 2) Details of the methods used for profiling.
p.000017: 3) Risk assessment for the data processing activities.
p.000017: 4) How will harm be prevented and the rights of the research participants safeguarded? Explain.
p.000017: 5) Details on the procedures for informing the research participants about profiling, and its possible consequences
p.000017: and the protection measures.
p.000017:
p.000017:
p.000017:
p.000017:
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p.000017:
p.000017:
p.000017:
p.000017: 1) Details of the database used or of the source of the data.
p.000017: 2) Details of the data processing operations.
p.000017: 3) How will the rights of the research participants be safeguarded? Explain.
p.000017: 4) How is all of the processed data relevant and limited to the purposes of the project (‘data minimisation’
p.000017: principle)? Explain.
p.000017: 5) Justification of why the research data will not be
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: 1) Declaration confirming compliance with the laws of the country where the data was collected.
p.000017: 1) Opinion of the data controller on the need for a data protection impact assessment (art.35 GDPR) (if relevant).
p.000017:
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p.000017:
p.000017:
p.000017: 1) Declaration confirming lawful basis for the data processing.
p.000017: 2) Permission by the owner/manager of the data sets (e.g. social media databases) (if applicable).
p.000017: 3) Informed Consent Forms + Information Sheets
p.000017: + other consent documents (opt in processes, etc.). (if
p.000017:
p.000017:
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p.000018:
p.000018:
p.000018: anonymised/ pseudonymised (if relevant).
p.000018: applicable).
p.000018:
p.000018:
p.000018:
p.000018: Does your research involve publicly available data?
p.000018:
p.000018:
p.000018:
p.000018: Is it planned to export personal data from the EU to non-EU countries?
p.000018: Specify the type of personal data and countries involved
p.000018: 1) Confirm that the data used in the project is publicly available and can be freely used for the project.
p.000018:
p.000018:
p.000018: Details of the types of personal data to be exported.
p.000018: How will the rights of the research participants be safeguarded? Explain.
p.000018: 1) Permission by the owner/manager of the data sets (e.g. social media databases) (if applicable).
p.000018: 1) Declaration of confirming compliance with Chapter V of the GDPR.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: Is it planned to import personal data from non-EU countries into the EU?
p.000018: Specify the type of personal data and countries involved
p.000018: 1) Details of the types of personal data to be imported.
p.000018: 1) Declaration confirming compliance with the laws of the country in which the data was collected.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: 4.2 How do I deal with the issues?
p.000018: Your research must comply with:
p.000018: - ethical principles
p.000018: - applicable international, EU and national law (in particular, the GDPR, national data protection laws and other
p.000018: relevant legislation, such as on clinical trials).
p.000018: Under these rules, personal data must be processed in accordance with certain principles and conditions
p.000018: that aim to limit the negative impact on the persons concerned and ensure fairness, transparency and
p.000018: accountability of the data processing, data quality and confidentiality.
p.000018: This implies the following main obligations:
p.000018: - Data processing should be subject to appropriate safeguards (see table above).
p.000018: - Data should wherever possible be processed in anonymised or pseudonymised form.
p.000018:
p.000018:
p.000018:
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p.000019:
p.000019: - Data processing is subject to free and fully informed consent of the persons concerned (unless already covered
p.000019: by another legal basis, e.g. legitimate or public interest).
p.000019: - Data processing must NOT be performed in secret and research participants must be made aware that they take
p.000019: part in a research project and be informed of their rights and the potential risks that the data processing may bring.
p.000019: - Data may be processed ONLY if it is really adequate, relevant and limited to what is necessary for your research
p.000019: (‘data minimisation principle’).
p.000019:
p.000019: Collecting personal data (e.g. on religion, sexual orientation, race, ethnicity, etc.) that is not essential to your
p.000019: research may expose you to allegations of ‘hidden objectives’ or ‘mission creep’ (i.e. collecting
p.000019: information with permission for one purpose and using it/making it available — online or otherwise — for
p.000019: another reason, without additional permission).
p.000019: - Data processing operations which are more intrusive and likely to raise higher ethics risks must be subject to
p.000019: higher safeguards.
p.000019: - For complex, sensitive or large-scale data processing or data transfers outside of the EU, you should consult
p.000019: your data protection officer (DPO), if you have one, or a suitably qualified expert.
p.000019: - The level of data security must be appropriate to the risks for the research participants occurring in
p.000019: case of unauthorized access or disclosure, accidental deletion or destruction of the data.
p.000019: - You are responsible for any partners, contractors or service providers that process research data at
p.000019: your request or on your behalf.
p.000019: Generally, one of the best ways how to avoid/limit data protection issues for your project is to use
p.000019: anonymised or pseudonymised data.
p.000019:
p.000019: Pseudonymisation and anonymisation are not the same thing.
p.000019: ‘Anonymised’ means that the data has been rendered anonymous in such a way that the data subject can no
p.000019: longer be identified (and therefore is no longer personal data and thus outside the scope of data protection
p.000019: law).
p.000019: ‘Pseudonymised’ means to divide the data from its direct identifiers so that linkage to a person is
p.000019: only possible with additional information that is held separately. The additional information must be kept
p.000019: separately and securely from processed data to ensure non-attribution.
p.000019: Moreover, if you have a data protection officer (DPO), it is generally recommended to involve them in all stages
p.000019: of your project, whenever it comes to data privacy issues, since this will help your proposal and grant
p.000019: agreement implementation (EU grants are subject to full compliance with data privacy rules).
p.000019:
p.000019: Be aware that even if you solve all privacy-related issues, research data may still raise other ethics issues, such as
p.000019: the potential misuse of the research methodology/ findings or ethics harms to specific groups.
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
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p.000020:
p.000020:
p.000020:
p.000020: 4.3 What do you need to provide?
p.000020: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000020: self-assessment in Part B of your proposal (i.e. section 5 of the Technical Annex).
p.000020: Your grant proposal must include the information referred to in the ethics issues checklist and any of the
p.000020: documents already available.
p.000020:
p.000020: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000020: on, if requested by the Commission/Agency.
p.000020: Background documents & further reading
p.000020:
p.000020: General
p.000020: Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural
p.000020: persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive
p.000020: 95/46/EC (OJ L 119, 4.5.2016, p. 1)
p.000020: Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural
p.000020: persons with regard to the processing of personal data by competent authorities for the purposes of the
p.000020: prevention, investigation, detection or prosecution of criminal offences or the execution of criminal
p.000020: penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L
p.000020: 119, 4.5.2016, p. 89)
p.000020: Guidelines on Consent under Regulation 2016/679 (wp259rev.01), Article 29 Working Party
p.000020: Guidelines on Transparency under Regulation 2016/679 (wp260rev.01), Article 29 Working Party
p.000020: Guidelines on Automated individual decision-making and Profiling for the purposes of Regulation
p.000020: 2016/679(wp251rev.01), Article 29 Working Party
p.000020: Council of Europe Modernised Convention for the Protection of Individuals with Regard to the Processing of Personal
p.000020: Data, CM/Inf (2018)15-final
p.000020: Handbook on European data protection law (2018 edition), European Union Agency for Fundamental Rights and
p.000020: Council of Europe, European Court of Human Rights, European Data Protection supervisor
p.000020: Data transfers outside the EU - International data transfers using model contracts
p.000020: Electronic communications
p.000020: EU Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the
p.000020: processing of personal data and the protection of privacy in the electronic communications sector (Directive
p.000020: on privacy and electronic communications)
p.000020: EU Directive 2006/24/EC of 15 March 2006 on the retention of data generated or processed in connection with the
p.000020: provision of publicly available electronic communications services or of public communications networks
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
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p.000021:
p.000021: 5. Animals
p.000021: This section refers to research involving animals.
p.000021:
p.000021:
p.000021: 5.1 Ethics issues checklist
p.000021:
p.000021:
p.000021:
p.000021: Section 5: ANIMALS
p.000021:
p.000021: YES/NO
p.000021:
p.000021: Page
p.000021:
p.000021: Information to be provided
p.000021:
p.000021: Documents to be provided/kept on file
p.000021:
p.000021:
p.000021: Does your research involve animals? ...

p.000024: 2) What activities are carried out in non-EU countries? Give details.
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024: 1) What type of local resources will be used and how exactly? Give details.
p.000024: 1) Copies of ethics approvals and other authorisations or notifications (if required).
p.000024: 2) Confirmation that the activity could have been legally carried out in an EU country (for instance, an opinion from
p.000024: an appropriate ethics structure in an EU country).
p.000024: 1) For human resources: copies of ethics approvals.
p.000024: For animals, plants, micro-organisms and associated traditional knowledge: documentation demonstrating compliance with
p.000024: the UN
p.000024:
p.000024:
p.000024: 5 See Article 19(4) of the Horizon 2020 Framework Programme Regulation (EU) No 1291/2013.
p.000024:
p.000025: 25
p.000025:
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p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Is it planned to import any material from non-EU countries into the EU?
p.000025:
p.000025: For data imports, see section 4.
p.000025: For imports of human cells or tissues, see section 3.
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 1) What type of materials will you import? Give details.
p.000025: Convention on Biological Diversity (e.g. access permit and benefit sharing agreement).
p.000025: 1) Copies of import licences.
p.000025:
p.000025: If
p.000025: YES:
p.000025: Specify the materials and countries involved:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Is it planned to export any material from the EU to non- EU countries?
p.000025:
p.000025: For data exports, see section 4.
p.000025: 1) Details of the type of materials to be exported.
p.000025: 1) Copies of export licences.
p.000025: If Specify material
p.000025: YE and countries
p.000025: S: involved:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: In case research involves low and/or lower-middle income countries, are any benefit- sharing actions planned?
p.000025:
p.000025:
p.000025:
p.000025: Could the situation in the country put the individuals taking part in the research at risk?
p.000025: 1) Details of the benefit sharing measures.
p.000025: 2) Details of the responsiveness to local research needs.
p.000025: 3) Details of the procedures to facilitate effective capacity building.
p.000025: 1) Details of the safety measures you intend to take, including training for staff and insurance cover.
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
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p.000026: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000026:
p.000026: 6.2 How do I deal with the issues?
p.000026:
p.000026: Specific cases
p.000026:
p.000026: Research carried out in a non-EU country — For activities carried out outside the EU, it is not enough for that the
p.000026: activity to be accepted and comply with the legal obligations of a non-EU country; the activities must ALSO be allowed
p.000026: in at least one Member State (see art. 19 H2020 Programme Regulation No 1291/2013).
p.000026: Beneficiaries must confirm in the ethics self-assessment section of their proposal that this condition is met.
p.000026:
p.000026: Resources from a non-EU country — Any use of local resources (especially animal and/or human tissue
p.000026: samples, genetic material, live animals, human remains, materials of historical value, endangered fauna or flora
p.000026: samples, fossils) must show respect for cultural traditions and share benefits (i.e. also benefit local
p.000026: participants and their communities, involve local researchers – as equal partners – and respond to local research
p.000026: needs).
p.000026: This is particularly important for low income and lower-middle income countries (see Convention on Biological
p.000026: Diversity and Declaration of Helsinki and follow the Global code of conduct for research in resource-poor
p.000026: settings).
p.000026: For access to genetic resources, you must also comply with the Nagoya Protocol on Access and Benefit Sharing and EU
p.000026: Regulation (EU) No 511/2014 which implements this Protocol.
p.000026:
p.000026: Import/export of material — If genetic resources are transferred across borders, it may be mandatory under the law
p.000026: of the provider country to obtain an authorisation for the transfer. In addition, you must use an agreement
p.000026: which describes the conditions for the export and the terms of utilisation and, if applicable, relevant benefit-sharing
p.000026: measures.
p.000026: For transfers of human cells or tissues, see section 3.
p.000026: For data transfers, see section 4.
p.000026:
p.000026: Sending researchers to a non-EU country — Non-EU countries are not necessarily less safe than EU countries.
p.000026: Nevertheless, a risk assessment must be undertaken when sending researchers abroad and appropriate safety measures
p.000026: must be taken. These may include insurance cover or health and safety measures, such as no lone working, contact
p.000026: points via phone, counselling support, etc. (see also section 7.2).
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: 6.3 What do you need to provide?
p.000026: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000026: self-assessment in Part B of your proposal (i.e. section 5 of the Technical Annex).
p.000026: Your grant proposal must include the information referred to in the ethics issues checklist and any of the
p.000026: documents already available.
p.000026:
p.000026: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000026: on, if requested by the Commission/Agency.
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000027: 27
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p.000027: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000027:
p.000027: Background documents & further reading
p.000027:
p.000027: Human resources Declaration of Helsinki Flora & fauna
p.000027: Convention on Biological Diversity
p.000027: Genetic resources
p.000027: Nagoya Protocol on Access and Benefit Sharing
p.000027: EU Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on
p.000027: compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the fair and
p.000027: equitable sharing of benefits arising from their utilization in the Union (ABS Regulation) (OJ L 150,
p.000027: 20.5.2014, p. 59)
p.000027: Commission Implementing Regulation (EU) No 2015/1866 of 13 October 2015 laying down detailed rules for
p.000027: the implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council as regards the
p.000027: register of collections, monitoring user compliance and best practices (OJ L 275, 20.10.2015, p. 4)
p.000027: Developing countries and lower income settings
p.000027: FP 7 guidance: Developing countries
p.000027: Global code of conduct for research in resource-poor settings
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
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p.000028: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000028:
p.000028: 7. Environment, health & safety
p.000028: This section concerns research that may adversely affect:
p.000028: - the environment or ...

p.000030: For research involving human participants, see section 2.
p.000030: 1) Details of the health and safety procedures.
p.000030: 1) Safety classification of laboratory.
p.000030:
p.000030:
p.000030: 7.2.2 How do I deal with the issues?
p.000030: Your research must comply with:
p.000030: - ethical principles
p.000030: - applicable international, EU and national law (in particular, the legislation on public-health control (e.g.
p.000030: regulating conduct in animal epidemics, food imports, consumer protection, etc.) and safety at work (e.g.
p.000030: Directive 2006/25/EC)).
p.000030: This means you must warn and advise researchers. In some cases you must even remove them from dangerous
p.000030: situations.
p.000030: Moreover, you should establish and follow a set of safety checks and procedures (or a more in-depth risk assessment)
p.000030: for each project they conduct.
p.000030: You must also obtain:
p.000030: - the necessary health and safety authorisations (if applicable).
p.000030:
p.000030:
p.000030: Specific cases
p.000030:
p.000030: Toxic chemicals and/or explosives — Staff should have adequate training in storing, handling and disposing of such
p.000030: substances. If new substances and/or formulations (e.g. nanomaterials) are developed, you must provide adequate risk
p.000030: assessments.
p.000030: Radioactive material — Clear legislation exists in all EU countries on the storage, handling and disposal
p.000030: of radioactive materials.
p.000030: The release of radioactive material into the environment is allowed only if you can show that use of alternatives (e.g.
p.000030: non-radioactive stable isotopes, simulants etc.) is not possible.
p.000030:
p.000030: Research ‘in the field’ — Establish and abide by recognised procedures to help keep researchers and subjects
p.000030: safe. These should include:
p.000030: - keeping careful notes of all research engagements
p.000030: - ensuring projects are adequately staffed
p.000030: - using mobile phones to keep in touch with the research base
p.000030: - conducting full risk assessments of fieldwork sites
p.000030:
p.000030:
p.000030:
p.000030:
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p.000031: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000031:
p.000031:
p.000031: - formally notifying authorities of research being conducted in an area
p.000031: - carrying authorised identification
p.000031: - researcher preparation & training covering techniques for handling conflict, threats, abuse or
p.000031: compromising situations
p.000031: - debriefing after field research with an assessment of fieldwork safety and
p.000031: - reporting any health & safety incidents.
p.000031:
p.000031:
p.000031:
p.000031: 7.2.3 What do you need to provide?
p.000031: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000031: self-assessment in Part B of your proposal (i.e. section 5 of the Technical Annex).
p.000031: Your grant proposal must include the information referred to in the ethics issues checklist and any of the
p.000031: documents already available.
p.000031:
p.000031: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000031: on, if requested by the Commission/Agency.
p.000031:
p.000031:
p.000031: Background documents & further reading
p.000031:
p.000031: General environment
p.000031: EU Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206,
p.000031: 22.7.1992, p.7)
p.000031: EU Directive 79/409/EEC of 2 April 1979 on the conservation of wild birds (OJ L 103, 25.4.1979, p.1)
p.000031: EU Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating
p.000031: trade therein (OJ L 103, 25.4.1979, p.1)
p.000031: Cartagena Protocol on Biosafety
p.000031: EU Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release
p.000031: into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106,
p.000031: 17.4.2001, p. 1)
p.000031: EU Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a
p.000031: framework for community action in the field of marine environmental policy (Marine Strategy Framework
p.000031: Directive) (OJ L 164, 25.6.2008, p. 19)
p.000031: GMOs
p.000031: EU Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on trans-boundary
p.000031: movements of genetically modified organisms (OJ L 287, 5.11.2003, p. 1)
p.000031: EU Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically
p.000031: modified micro-organisms (OJ L 125, 21.5.2009, p. 75)
p.000031: Public health & consumer protection
p.000031: Consumer safety
p.000031: Health & safety at work
p.000031: EU Directive 2006/25/EC of the European Parliament and of the Council of 5 April 2006 on the minimum health and safety
p.000031: requirements regarding the exposure of the workers to risks arising from physical agents (OJ L 114, 27.4.2006, p.38)
p.000031: A Code of Practice for the Safety of Social Researchers
p.000031:
p.000031:
p.000031:
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p.000032:
p.000032: 8. Dual use
p.000032: This section concerns research involving goods, software and technologies covered by the EU Export Control Regulation
p.000032: No 482/2009. These dual-use items are normally used for civilian purposes but may have military applications, or may
p.000032: contribute to the proliferation of weapons of mass destruction.
p.000032:
p.000032:
p.000032: 8.1 Ethics issues checklist
p.000032:
p.000032:
p.000032:
p.000032: Section 8: DUAL USE
p.000032:
p.000032:
p.000032: YES/NO
p.000032:
p.000032:
p.000032: Page
p.000032:
p.000032: Information to be provided
p.000032:
p.000032: Documents to be provided/kept on file
p.000032:
p.000032:
p.000032: Does this research involve dual-use items in the sense of Regulation 428/2009, or other items for which an
p.000032: authorisation is required?
p.000032: 1) What goods and information used and produced in your research will need export licences?
p.000032: 2) How exactly will you ensure compliance?
p.000032: 3) How exactly will you avoid negative implications?
p.000032: 1) Copies of export licences.
p.000032:
p.000032:
p.000032: 8.2 How to deal with the issues?
p.000032: Your research must comply with:
p.000032: - ethical principles
p.000032: - applicable international, EU and national law (in particular, the EU Export Control Regulation No
p.000032: 428/2009).
p.000032:
p.000032: In certain exceptional cases, publication of research findings (e.g. a scientific article in a journal
p.000032: published both outside or inside the EU) may be classed as an intangible technology transfer (ITT) and may
p.000032: require an authorisation (which is not always granted).
p.000032:
p.000032:
p.000032: Specific cases
p.000032:
p.000032: Cross-border transfers — For cross-border transfers of dual-use materials, technologies and information, you must
p.000032: observe the EU Export Control Regulation No 428/2009. If you have any doubts, you should consult the relevant national
p.000032: export control authority to clarify whether transfer licences are needed.
p.000032: Research that may affect ethics standards — If international non-proliferation laws or international humanitarian laws
p.000032: may have a bearing on your research (e.g. in the case of pathogen-related research, development of autonomous robotics,
p.000032: drones and certain laser technologies), you must comply with the relevant international law (in particular,
p.000032: the Biological and Toxin Weapons Convention).
p.000032: You may also want to appoint an independent ethics adviser/ethics board, with relevant ethics and
p.000032: security expertise, to carry out a risk-benefit analysis of the intended research and to suggest appropriate
p.000032: safeguards to cover security risks (during and beyond the lifetime of the project) and training for researchers.
p.000032:
p.000032:
p.000032:
p.000032:
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p.000033:
p.000033:
p.000033:
p.000033: 8.3 What do you need to provide?
p.000033: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000033: self-assessment in Part B of your proposal (i.e. section 5 of the technical Annex) and fill in the critical risk table
p.000033: Part B in section 3, in which you describe what action you would take if the national authorities do not grant the
p.000033: required authorisation(s)/license(s).
p.000033: Your grant proposal must include the information referred to in the ethics issues checklist and any of the
p.000033: documents already available.
p.000033:
p.000033: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000033: on, if requested by the Commission/Agency.
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: Background documents & further reading
p.000033:
p.000033: Guidance note — Research involving dual use items
p.000033: EU Regulation No 428/2009 setting up a Community regime for the control of exports, transfer, brokering and transit of
p.000033: dual-use items
p.000033: EU Charter of Fundamental Rights Biological and Toxin Weapons Convention UN Security Council Resolution 1540
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
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p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000034: 34
p.000034:
p.000034: EU Grants: Horizon 2020 Guidance — How to complete your ethics self-assessment: V6.1 – 04.02.2019
p.000034:
p.000034: 9. Exclusive focus on civil applications
p.000034: This section explains the exact meaning of the 'exclusive focus on civil applications'.
p.000034:
p.000034: Only research that has an exclusive focus on civil applications is eligible for funding.6
p.000034: However, this does not rule out the participation of military partners or the development of generic
p.000034: technologies, products or knowledge that may meet the needs of both civil and military end-users
p.000034: (known as 'dual-use' goods or technologies), provided that the research itself has a clear focus on civil
p.000034: applications.
p.000034:
p.000034:
p.000034: 9.1 Ethics issues checklist
p.000034:
p.000034:
p.000034:
p.000034: Section 9: EXCLUSIVE FOCUS ON CIVIL APPLICATIONS
p.000034:
p.000034:
p.000034: YES/NO
p.000034:
p.000034:
p.000034: Page
p.000034:
p.000034: Information to be provided
p.000034:
p.000034: Documents to be provided/kept on file
p.000034:
p.000034:
p.000034: Could your research raise concerns regarding the exclusive focus on civil applications?
p.000034: 1) Explain the exclusive civilian focus of your research.
p.000034: 2) Justify inclusion of military partners or military technologies (i.e. explain how they relate to civilian
p.000034: applications, e.g. in the context of law enforcement activities).
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034: 9.2 How to deal with the issues?
p.000034: Your research must comply with:
p.000034: - ethical principles
p.000034: - applicable international, EU and national law (in particular Horizon 2020 Regulation No 1291/2013) which
p.000034: limits funding of research to activities having an exclusive focus on civil applications).
p.000034:
p.000034: Research activities aimed at the development or improvement of dual-use technologies or goods can be financed
p.000034: through Horizon 2020, provided that the research is fully motivated by, and limited to civil applications.
p.000034:
p.000034: ...

p.000037: research in this category is that which provides terrorists or criminals with information or technologies that would
p.000037: have substantial direct impacts on the security of individuals, groups or states.
p.000037: Examples: infrastructural vulnerability studies, cyber-security-related research
p.000037: In many cases, researchers outside the security domain are not familiar with security safeguards. In such
p.000037: situations, researchers should consult experts familiar with security ethics and/or human rights. If
p.000037: security or human rights abuse concerns exist, you should arrange for:
p.000037: - training on this issue
p.000037: - the appointment of an ethics adviser/ethics advisory board.
p.000037:
p.000037:
p.000037: 10.3 What do you need to provide?
p.000037: If your proposal raises one of the issues listed in the ethics issue checklist above, you must complete the ethics
p.000037: self-assessment in Part B of your proposal (i.e. section 5 of the technical Annex).
p.000037: Your grant proposal must include the information referred to in the ethics issues checklist and any of the
p.000037: documents already available.
p.000037:
p.000037: Documents that are not submitted together with the proposal should be kept on file and may have to be provided later
p.000037: on, if requested by the Commission/Agency.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: Background documents & further reading
p.000037:
p.000037: Guidance note — Potential misuse of research results ...
.000040: The ethics adviser or ethics advisory board should maintain an ...
...

Appendix

Indicator List

Indicator	Vulnerability
abuse	Victim of Abuse
access	Access to Social Goods
age	Age
asylum	Refugee Status
authority	Relationship to Authority
child	Child
children	Child
coerced	Presence of Coercion
conviction	Religion
criminal	criminal
disability	Mentally Disabled
drug	Drug Usage
education	education
elderly	Elderly
emergency	Public Emergency
ethnic	Ethnicity
ethnicity	Ethnicity
family	Motherhood/Family
foetus	Fetus/Neonate
foetuses	Fetus/Neonate
gender	gender
healthy volunteers	Healthy People
helsinki	declaration of helsinki
illegal	Illegal Activity
immigrant	immigrants
language	Linguistic Proficiency
military	Soldier
minor	Youth/Minors
minority	Racial Minority
occupation	Occupation
officer	Police Officer
opinion	philosophical differences/differences of opinion
oviedo	oviedo
parents	parents
political	political affiliation
poor	Economic/Poverty
race	Racial Minority
religion	Religion
religious	Religion
research staff	Laboratory Staff
sex workers	sex worker
stem cells	stem cells
union	Trade Union Membership
volunteers	Healthy People
vulnerability	vulnerable
vulnerable	vulnerable

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers
child	['children']
children	['child']
conviction	['religion', 'religious']
ethnic	['ethnicity']
ethnicity	['ethnic']
foetus	['foetuses']
foetuses	['foetus']
healthy volunteers	['volunteers']
minority	['race']
race	['minority']
religion	['conviction', 'religious']
religious	['conviction', 'religion']
volunteers	['healthyXvolunteers']
vulnerability	['vulnerable']
vulnerable	['vulnerability']

Trigger Words

capacity

coercion

consent

cultural

developing

ethics

harm

protect

protection

risk

sensitive

welfare

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	Illegal Activity	illegal	1
Political	Refugee Status	asylum	2
Political	criminal	criminal	3
Political	immigrants	immigrant	1
Political	political affiliation	political	1
Political	vulnerable	vulnerable	4
Political	vulnerable	vulnerability	2
Health	Drug Usage	drug	1
Health	Healthy People	healthy volunteers	1
Health	Healthy People	volunteers	4
Health	Mentally Disabled	disability	1
Health	Motherhood/Family	family	1
Health	stem cells	stem cells	7
Social	Access to Social Goods	access	9
Social	Age	age	3
Social	Child	child	2
Social	Child	children	11
Social	Elderly	elderly	1
Social	Ethnicity	ethnic	1
Social	Ethnicity	ethnicity	2
Social	Fetus/Neonate	foetus	1
Social	Fetus/Neonate	foetuses	5
Social	Laboratory Staff	research staff	1
Social	Linguistic Proficiency	language	1
Social	Occupation	occupation	1
Social	Police Officer	officer	4
Social	Presence of Coercion	coerced	1
Social	Racial Minority	minority	1
Social	Racial Minority	race	1
Social	Religion	conviction	1
Social	Religion	religion	1
Social	Religion	religious	1
Social	Soldier	military	5
Social	Trade Union Membership	union	2
Social	Victim of Abuse	abuse	3
Social	Youth/Minors	minor	1
Social	education	education	1
Social	gender	gender	2
Social	parents	parents	1
Social	philosophical differences/differences of opinion	opinion	5
Social	sex worker	sex workers	1
Economic	Economic/Poverty	poor	2
General/Other	Public Emergency	emergency	1
General/Other	Relationship to Authority	authority	1
General/Other	declaration of helsinki	helsinki	4
General/Other	oviedo	oviedo	3

Horizon 2020: How to Complete your Ethics Self-Assessment

Applicable Type / Vulnerability / Indicator Overlay for this Input

Political / Illegal Activity

Political / Refugee Status

Political / criminal

Political / immigrants

Political / political affiliation

Political / vulnerable

Health / Drug Usage

Health / Healthy People

Health / Mentally Disabled

Health / Motherhood/Family

Health / stem cells

Social / Access to Social Goods

Social / Age

Social / Child

Social / Elderly

Social / Ethnicity

Social / Fetus/Neonate

Social / Laboratory Staff

Social / Linguistic Proficiency

Social / Occupation

Social / Police Officer

Social / Presence of Coercion

Social / Racial Minority

Social / Religion

Social / Soldier

Social / Trade Union Membership

Social / Victim of Abuse

Social / Youth/Minors

Social / education

Social / gender

Social / parents

Social / philosophical differences/differences of opinion

Social / sex worker

Economic / Economic/Poverty

General/Other / Public Emergency

General/Other / Relationship to Authority

General/Other / declaration of helsinki

General/Other / oviedo

Orphaned Trigger Words

Appendix

Indicator List

Indicator Peers (Indicators in Same Vulnerability)

Trigger Words

Applicable Type / Vulnerability / Indicator Overlay for this Input