1. Research Executive Agency
Ethics in H2020 Proposals
Audrey ARFI
Research Executive Agency
Unit REA-MSCA-ITN

3. Horizon 2020 Model Grant Agreement
Ethics Legal Basis
Horizon Model Grant Agreement
Article 34 – Ethics
34.1 – Obligation to comply with ethical principles
34.2 – Activities raising ethical issues
The documents must be kept on file and be submitted upon request by the coordinator to the Agency (see Article 52). If they are not in English, they must be submitted together with an English summary, which shows that the action tasks in question are covered and includes the conclusions of the committee or authority concerned (if available).
34.3 – Activities involving human embryos or hESC
Article 39 – Processing of Personal Data
Article Obligation to comply with ethical principles
The beneficiaries must carry out the action in compliance with:
(a) ethical principles (including the highest standards of research integrity — as set out, for instance, in the European Code of Conduct for Research Integrity — and including, in particular, avoiding fabrication, falsification, plagiarism or other research misconduct), and
(b) applicable international, EU and national law.
Funding will not be granted for activities carried out outside the EU if they are prohibited in all Member States. The beneficiaries must ensure that the activities under the action have an exclusive focus on civil applications.
Article Activities raising ethical issues
Activities raising ethical issues must comply with the ethics requirements set out in Annex 1. Before the beginning of an activity raising an ethical issue, the coordinator must submit (see Article 52) to the Commission copy of:
(a) any ethics committee opinion required under national law, and
(b) any notification or authorisation for activities raising ethical issues required under national law.
If these documents are not in English, the coordinator must also submit an English summary of the submitted opinions, notifications and authorisations (containing, if available, the conclusions of the committee or authority concerned). If these documents are specifically requested for the action, the request must contain an explicit reference to the action title. The coordinator must submit a declaration by each beneficiary concerned that all submitted documents specifically cover the action tasks.
Article Activities involving human embryos or hESC
Activities involving research on human embryos or human embryonic stem cells may be carried out only if:
they are set out in Annex 1 or
the coordinator has obtained explicit approval (in writing) from the Agency (see Article 52).
Article 39 - Processing of Personal Data
The beneficiaries must process personal data under the Agreement in compliance with applicable EU and national law on data protection (including authorisations or notification requirements).

4. Importance of Research Ethics in H2020
Research ethics is crucial for all scientific domains (NOT only in Life Sciences). For example:
Data protection & Privacy
Dual use issues
Environmental risks and safety issues
Research integrity aspects
In Horizon 2020, all proposals considered for funding will be submitted to an Ethics Review procedure.
Only proposals that comply with ethical principles and legislation may receive funding.

5. Getting your proposal ethics ready for H2020

6. How to complete your Ethics Self-Assessment
Ethics relevant for ALL applicants
How to complete your Ethics Self-Assessment
Guide with information and advice on how to address ethics in research / Horizon 2020
For ALL applicants (NOT only medical research)
Fill-in the Ethics issues table in Part A in SEP
All ethics issues should be addressed in your proposal part B (specific section)!
Guidance available on the Participant Portal H2020 Online Manual (Ethics section):

7. Ethics Self-Assessment Guidance
Key document for applicants  !
Regularly updated
Version 5.2
12 July 2016
The Ethics Self-Assessment Guidance for the applicants is also a key document for the work of the ethics expert. This document contains important details on the different ethics issues, including tables that mention the information and documents applicants must provide. This document supports the experts in looking for the necessary information in the proposals and drafting in their reports the requirements addressing missing items.
The document is available in the participant portal

8. Main Ethics Issues
The main areas that are addressed during the Ethics Appraisal procedure and in the Ethics Self-Assessment guidance document include:
Human embryos and foetuses
Human beings
Human cells/tissues
Personal data
Animals
Non-EU Countries
Environment & Health and Safety
Dual use
Exclusive focus on civil applications
Potential misuse of research results
Other issues (Ethics integrity)

9. 1. Human Embryos & Foetuses
The following fields of research are not eligible for funding under Horizon 2020 and cannot therefore be included in proposals:
research activities directed at human cloning for reproductive purposes
research activity intended to modify the genetic make-up of human beings that could make such changes heritable (apart from research relating to cancer treatment of the gonads, which may be financed)
research activities intended to create human embryos solely for the purposes of research or stem cell procurement, including the technique of somatic cell nuclear transfer
research that leads to the destruction of human embryos.
Research on human stem cells (both adult and embryonic) may be financed — depending on both the content of the scientific proposal and the laws of the Member States involved. No funding will be granted for research activities that are prohibited in all Member States. No activity will be funded in a Member State where such activity is forbidden.

10. Physical interventions on the study participants
2. Humans
Humans participants
Are they volunteers for social or human sciences research?
Are they persons unable to give informed consent (including children/minors)?
Are they vulnerable individuals or groups?
Are they children/minors?
Are they patients?
Are they healthy volunteers for medical studies?
Physical interventions on the study participants
Does it involve invasive techniques (e.g. collection of human cells or tissues, surgical or medical interventions, invasive studies on the brain, TMS etc.)?
Does it involve collection of biological samples?
Part B: Risk assessment (invasive technique), details on the type of samples and procedures for samples collection
Copies of ethics approvals (English summary) (upon request)
Part B: Details on recruitment/informed consent procedures (specificities for vulnerable people/children/patients)
Informed Consent Template + Information Sheet (upon request)
Copies of ethics approvals (English summary) (upon request)

11. Medical studies — Medical research is specifically addressed by the Declaration of Helsinki.
The action must also comply with:
the principles in the Oviedo Bioethics Convention and
- EU Regulation No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.

12. 3. Human cells/tissues
Human cells or tissues (other than from Human Embryos/Foetuses, see section 1)?
1. Are they obtained from commercial sources?
2. Do they originate from another laboratory/institution/biobank
3. Were they produced or collected by you from previous research activities?
4. Are they produced or collected by you as part of this project?
Part B: Details of the cells/ tissue types.
Copies of relevant Ethics Approvals (English summary) (upon request)
Copies of accreditation/designation/authorisation/ licensing for using, processing or collecting the human cells or tissues (if required, upon request)

13. Specific cases:
Cells or tissues from clinical practice (secondary use)
Secondary use for future research
Biobanking
Genetic testing
Transfer to/from third countries –> data protection

14. 4. Personal data Personal data collection and/or processing?
Does it involve the collection or processing of sensitive personal data?
Does it involve processing of genetic information?
Does it involve tracking or observation of participants?
Further processing of previously collected personal data (‘secondary use’) (including use of pre-existing data sets or sources, merging existing data sets, sharing data with non-EU member states)?
Data Management plan (Personal data):Details on the database used or of the source of the data; Details on procedures for data processing; Details on data safety procedures (part B)
Confirmation that data is openly and publicly accessible or that consent for secondary use has been obtained (Part B)
Confirmation permissions by the owner/manager of the data sets (Part B)
Evidence of open public access (e.g. print screen from website).
Informed Consent Forms + Information Sheets + other consent documents
Copies of permissions (if required, upon request)
Part B: Data management plan (personal data): Details on procedures for data collection, storage, protection, retention, transfer, destruction or re-use; Details on data safety procedures; Details on data transfers to third countries (if applicable)
Copies of notifications/authorisations for the collection and/or processing of the personal data (if required, upon request)
Informed Consent Forms + Information Sheets + Other consent documents (if relevant, upon request)
Copy of authorisation for data transfer to third country (if required, upon request)

15. Specific cases:
Secondary use
Recording of information
Sensitive data
Tracking or observing of participants
Data transfer within EU/EEA countries
Data transfer to third countries
Electronic data

16. Main Ethics Issues
The main areas that are addressed during the Ethics Appraisal procedure and in the Ethics Self-Assessment guidance document include:
Human embryos and foetuses
Human beings
Human cells/tissues
Personal data
Animals
Non-EU Countries
Environment & Health and Safety
Dual use
Exclusive focus on civil applications
Potential misuse of research results
Other issues (Ethics integrity)

17. 5. Animals Directive 2010/63/EU
Scope of Directive 2010/63/EU: (a) live non-human vertebrate animals, including: (i) independently feeding larval forms; and (ii) foetal forms of mammals as from the last third of their normal development; (b) live cephalopods Some EU Member States have stricter rules!

18. 5. Animals
3 Rs
Replacement: replace animals by an alternative method or testing strategy (without use of live animals)
Reduction: reduce number of animals used
Refinement: improve breeding, accomodation and care of animals and methods to minimise pain, suffering, distress and lasting harm

19. 5. Animals Involvement of Animals Details on species (e.g. mice)
Number of animals
Rationale for their use and why alternatives cannot be used
Nature of the experiments, procedures and techniques to be used
Institution(s) performing experiments
Live non-human vertebrates
Details on implementation of the Three R’s
Measures to ensure animal welfare during their lifetime and during the experiment
Method of killing with minimum pain
Details on severity classification of procedures and justification
Commitment to deliver following documents:
Authorisations for supply of animals
Authorisation animal experiments
Copies of training certificates/ personnel licences of involved staff
Personal history file of cats, dogs
Non-human primates
Explanation why NHPs are the only suitable research subjects to achieve the scientific objectives
Details on the purpose of the animal testing
Details on provenance of the animals
Commitment to deliver following documents:
Personal history file of NHP
Genetically modified / Cloned farm animals
Details on phenotype and any inherent suffering expected
Details on scientific justification for producing such animals
Measures to minimise suffering in the breeding, maintenance of the colony and use of the GM animals
Commitment to deliver following documents:
Copies of GMO authorisations (for genetically-modified)
Copies of authorisations for cloning (for cloned farm animals)
Endangered species
Details on why there is no alternative to the use of this species
Details on the purpose of the research
Commitment to deliver following documents:
Copies of authorisations for supply of endangered animal species

20. 6. Non-EU countries Associated country = non-EU Member State
Research can raise specific ethical issues (particularly in developing countries), in particular:
Exploitation of research participants
Exploitation of local resources
Risk for researchers and staff
Research that is prohibited in the EU (i.e. funding cannot be granted)

21. Research activities in non-EU Country Potential risk for individuals
6. Non-EU countries
Non-EU Country
Risk-benefit analysis
Import / Export
Details on type of materials to be imported
Specify materials and countries involved
Commitment to deliver following documents:
Copies of import/export licences
Research activities in non-EU Country
Details on activities carries out in non-EU countries and specify countries involved
Commitment to deliver following documents:
Copies of Ethics Approvals and other authorisations (if required)
Confirmation that activity could have been legally carried out in (at least) one EU MS
Low income
Details on on benefit sharing measures
Details on responsiveness to local research needs
Details on procedures to facilitate effective capacity building.
Potential risk for individuals
Details on safety measures applicants intend to apply, including personnel training and insurance coverage
Risk assessment when sending researchers abroad and appropriate safety measures must be taken, e.g. insurance cover or health and safety measures (e.g. no lone working, counselling support, contact point via phone …)
Use of local resources
Details on type of local resources to be used and modalities for their use.
Commitment to deliver following documents:
For humans: ethical approvals
For animals, plants and micro-organisms: documentation demonstrating compliance with UN Convention on Biological Diversity

22. 7. Environment & Health and Safety
This section concerns research that may have a negative impact on:
the environment or
the health and safety of the researchers involved.
This may be due to any of the following:
the experimental design of the research itself
undesirable side-effects of the technologies used.
The health and safety of all human participants in research, either as subjects, as investigators or as unconcerned third parties, must be a priority in all research studies.

23. 7. Environment & Health and Safety
Harmful biological agents (pathogenic organisms) or GMOs of Risk Class 2 or higher
Harmful chemical and explosive agents
Harmful radioactive agents
Harmful materials or equipment (e.g. high-powered laser systems)?
Part B:
Risk-assessment and risk-mitigation plan
Commitment to provide following documents (as applicable):
GMO and other authorisations
Authorisations for possession of toxic substances and for the handling and transfer of explosives.
Authorisations of use of radioactive material.
Authorisation of release of radioactive material into the environment.
Copies of authorisations

24. Main Ethics Issues
The main areas that are addressed during the Ethics Appraisal procedure and in the Ethics Self-Assessment guidance document include:
Human embryos and foetuses
Human beings
Human cells/tissues
Personal data
Animals
Non-EU Countries
Environment & Health and Safety
Dual use
Exclusive focus on civil applications
Potential misuse of research results
Other issues (Ethics integrity)

25. 8. Dual Use
Goods, software and technologies covered by the EU export control Regulation no 428/2009 (amended by Commission Delegated Regulation 1382/2014)
These dual-use items are normally used for civilian purposes, but may have military applications, or may contribute to the proliferation of weapons of mass destruction.
Article 34.1 of the GA "The beneficiaries must ensure that the activities under the action have an exclusive focus on civil applications."
This does not rule out the participation of military partners.

26. 8. Dual Use
Dual-use items in the sense of Regulation 428/2009, or other items for which an authorisation is required?
Part B:
What goods and information used and produced in your research will need export licenses?
How exactly will you ensure compliance?
How exactly will you avoid negative implications?
Commitment to deliver following documents:
Copy of export licenses (Upon request)
Specific clause in GA
Your research must comply with:
 ethical principles
 applicable international, EU and national law (in particular, the precautionary principle and the legislation on nature conservation and pollution control).
Moreover, you must obtain:
 the necessary environmental authorisations (if applicable).
The precautionary principle requires that — where scientific evidence suggests that serious risks are plausible — you must prove that a new technology will not harm the environment.
The legislation on nature conservation and pollution control includes:
the Habitats Directive 92/43/EEC
the Wild Birds Directive 79/409/EEC -> new Directive 2009/147/EC
Regulation (EC) No 338/97 on protection of wild fauna –> amended by Regulation (EC) 1320/2014
the GMO Directive 2009/41/EC - OK
Cartagena Protocol on Biosafety.

27. Concerns regarding the exclusive focus on civil applications?
Part B:
Explain the exclusive civilian focus of your research
Justify inclusion of military partners or military technologies (i.e., explain how they relate to civilian applications, e.g., in the context of law reinforcement activities)
Your research must comply with:
 ethical principles
 applicable international, EU and national law (in particular, the precautionary principle and the legislation on nature conservation and pollution control).
Moreover, you must obtain:
 the necessary environmental authorisations (if applicable).
The precautionary principle requires that — where scientific evidence suggests that serious risks are plausible — you must prove that a new technology will not harm the environment.
The legislation on nature conservation and pollution control includes:
the Habitats Directive 92/43/EEC
the Wild Birds Directive 79/409/EEC -> new Directive 2009/147/EC
Regulation (EC) No 338/97 on protection of wild fauna –> amended by Regulation (EC) 1320/2014
the GMO Directive 2009/41/EC - OK
Cartagena Protocol on Biosafety.

28. Specific cases:
Cross-border transfers
Research that may affect ethics standards
Appoint an independent ethics adviser
EU Sanctions: we do not request the clearance certificates unless there is a concern of dual use issues (see your Description of Work).

29. Have a look at the sanctions in place: http://eeas. europa
Have a look at the sanctions in place: (the list has been updated on )

30. Potential for misuse of research results?
Research involving or generating materials, methods, technologies or knowledge that could be misused for unethical purposes.
Although such research is usually carried out with benign intentions, it has the potential to harm humans, animals or the environment.
Potential for misuse of research results?
Part B:
Risk-assessment
Details of the applicable legal requirements
Details of the measures you plan to take to prevents misuse
Commitment to deliver following documents:
Copy of authorisations (if required)
Copy of security clearance (if applicable)
Copies of ethics approvals (if applicable) (Upon request)

31. Ethics advisors / advisory boards
11. Other issues
Ethics advisors / advisory boards
A suitably experienced ethics advisor can help deal with ethical issues and putting into place the procedures to handle them appropriately.
The ethics advisor must be:
external to the project and to the department
totally independent and
free from any conflict of interest.

32. Ethics appraisal in H2020
All mainlisted proposals are carefully verified by ethics experts to see if there are any ethics issues raised in the proposal. The implementation of ethics issues is monitored during the entire project life cycle

33. Ethics appraisal

34. Researcher Misconduct Now part of Article 34.1 of the GA
Research Integrity
The European Code of Conduct for Research Integrity of ALLEA (All European Academies) and ESF (European Science Foundation) of March 2011.
Situation that may create confusion with respect to fabrication, falsification, plagiarism or other research misconduct:
Missing the appropriate citation and references
Using the same text in different proposals or ongoing projects - if it is the case provide the appropriate explanation/citation
Missing the indication about the provenience of the text used in the proposal
Now part of Article 34.1 of the GA

35. Horizon 2020 Ethics Documents
Ethics Guidance
Horizon 2020 Ethics Documents
Participant Portal H2020 Ethics section- H2020 Online Manual:
Ethics issues Self-Assessment Guidance:
Link to the Ethics Issues Table template:
new Guidance note — Research on refugees, asylum seekers & migrants
Useful Links

36. Thank you for your attention
End of Presentation.