Ethics in H2020 Proposals

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

3. Ethics Legal Basis Horizon 2020 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

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.

5. Gettingyourproposal • ethicsready • for H2020

6. 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): http://ec.europa.eu/research/participants/docs/h2020-funding-guide/cross-cutting-issues/ethics_en.htm

7. Ethics Self-Assessment Guidance • Key document for applicants •  • ! • Regularly updated • Version 5.2 • 12 July 2016 • http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/ethics/h2020_hi_ethics-self-assess_en.pdf

8. Main Ethics Issues • The main areas that are addressed during the Ethics Appraisal procedure and in the Ethics Self-Assessment guidance documentinclude: • 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 (Ethicsintegrity)

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. 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? 2. Humans • Part B: Riskassessment (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 theOviedo 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? • 1+2+3+4 • 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 • http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/ethics/h2020_hi_ethics-self-assess_en.pdf

14. 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)? 4. Personal data • 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 • http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/ethics/h2020_hi_ethics-self-assess_en.pdf

16. Main Ethics Issues • The main areas that are addressed during the Ethics Appraisal procedure and in the Ethics Self-Assessment guidance documentinclude: • 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 (Ethicsintegrity)

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) foetalforms of mammals as from the last third of their normal development; • (b) live cephalopods • Some EU Member States have stricterrules!

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. Involvement of Animals • Details on species (e.g. mice) • Number of animals • Rationale for their use and why alternatives cannotbeused • Nature of the experiments, procedures and techniques to beused • Institution(s) performingexperiments • Live non-humanvertebrates • Details on implementation of the ThreeR’s • Measures to ensure animal welfareduringtheirlifetime and during the experiment • Method of killingwith minimum pain • Details on severity classification of procedures and justification • Commitment to deliverfollowing documents: • Authorisations for supply of animals • Authorisation animal experiments • Copies of training certificates/ personnel licences of involved staff • Personalhistory file of cats, dogs 5. Animals • Non-human primates • ExplanationwhyNHPs are the onlysuitableresearchsubjects to achieve the scientific objectives • Details on the purpose of the animal testing • Details on provenance of the animals • Commitment to deliverfollowing documents: • Personalhistory file of NHP • Geneticallymodified / Clonedfarmanimals • Details on phenotype and anyinherentsufferingexpected • Details on scientific justification for producingsuchanimals • Measures to minimise suffering in the breeding, maintenance of the colony and use of the GM animals • Commitment to deliverfollowing documents: • Copies of GMO authorisations (for genetically-modified) • Copies of authorisations for cloning (for clonedfarmanimals) • Endangeredspecies • Details on whythereis no alternative to the use of thisspecies • Details on the purpose of the research • Commitment to deliverfollowing documents: • Copies of authorisations for supply of endangered animal species

20. 6. Non-EU countries • Associated country = non-EU Member State • Researchcanraisespecificethical issues (particularly in developing countries), in particular: • Exploitation of research participants • Exploitation of local resources • Risk for researchers and staff • Researchthatisprohibited in the EU (i.e. fundingcannotbegranted)

21. Non-EU Country • Risk-benefitanalysis • Import / Export • Details on type of materials to beimported • Specifymaterials and countries involved • Commitment to deliverfollowing documents: • Copies of import/export licences 6. Non-EU countries • Research activities in non-EU Country • Details on activities carries out in non-EU countries and specify countries involved • Commitment to deliverfollowing documents: • Copies of EthicsApprovals and otherauthorisations (if required) • Confirmation thatactivitycould have been legallycarried out in (at least) one EU MS • Lowincome • Details on on benefit sharing measures • Details on responsiveness to local research needs • Details on procedures to facilitate effective capacity building. • Potentialrisk for individuals • Details on safetymeasuresapplicantsintend to apply, including personnel training and insurancecoverage • Riskassessmentwhensendingresearchersabroad and appropriatesafetymeasures must betaken, e.g. insurancecover or health and safetymeasures (e.g. no loneworking, 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 deliverfollowing documents: • For humans: ethicalapprovals • For animals, plants and micro-organisms: documentation demonstratingcompliancewith UN Convention on BiologicalDiversity

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.

23. 7. Environment & Health and Safety

24. Main Ethics Issues • The main areas that are addressed during the Ethics Appraisal procedure and in the Ethics Self-Assessment guidance documentinclude: • 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 (Ethicsintegrity)

25. 8. Dual Use • Goods, software and technologies covered by the EU export control Regulation no428/2009 (amended byCommission 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: • Whatgoods and information used and produced in yourresearchwillneed 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

27. 9. Exclusive focus on civil applications • Concerns regarding the exclusive focus on civil applications? • Part B: • Explain the exclusive civilian focus of yourresearch • 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)

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

29. Have a look at the sanctions in place:http://eeas.europa.eu/cfsp/sanctions/docs/measures_en.pdf(the list has been updated on 20.4.2016)

30. 10. Misuse • 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. 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. Ethicsappraisal in H2020 • All mainlistedproposalsare carefullyverified by ethics experts to see if there are anyethics issues raised in the proposal. • The implementation of ethics issues ismonitoredduring the entireproject life cycle

33. Ethics appraisal

34. Researcher Misconduct • 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. Ethics Guidance Horizon 2020 Ethics Documents • Participant Portal H2020 Ethics section- H2020 Online Manual: http://ec.europa.eu/research/participants/docs/h2020-funding-guide/cross-cutting-issues/ethics_en.htm • Ethics issues Self-Assessment Guidance: http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/ethics/h2020_hi_ethics-self-assess_en.pdf • Link to the Ethics Issues Table template: http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/ethics/h2020_hi_ethics-self-assess_en.pdf • new Guidance note — Research on refugees, asylum seekers & migrants

36. Thank you for your attention