The European Research Council

1. The European Research Council The EthicsReview Ethicsreviewproceduresin Horizon 2020 Filipa Ferraz de OliveiraERC/European CommissionERCEA, Unit B1 NCP meeting – 19-20 November 2013

2. Whatis new in Ethics H2020 • Legal base • Art.16 in H2020 Framework Programme • Art.12 and 13 Rules for Participation • List of ethics issues • ERC Rules for Submission in H2020 • Ethicsprocedure • EthicsAppraisal • Ethics in submission system • Integral part of the proposal (part A) • New templates • EIT ethics issues table

3. Legalbase - Article 16 Ethical principles 1. All activities shall comply with ethical principles (Charter of Fundamental Rights of the European Union and the European Convention on Human Rights and its Supplementary Protocols). Particular attention to : - the principle of proportionality; - the right to privacy; - the right to the protection of personal data; - the right to the physical and mental integrity of a person; - the right to non-discrimination; - the need to ensure high levels of human health protection.

4. Legal base - Article 16 Ethical principles 2. Activities shall have an exclusive focus on civil applications. 3. The fields that shall not be financed: (a) human cloning for reproductive purposes; (b) modify the genetic heritage of human beings; (c) create human embryos solely for the purpose of research or of stem cell procurement. 4. Research on human stem cells (adult and embryonic) may be financed. No funding shall be granted for activities prohibited in all the Member States. No activity shall be funded in a Member State where such activity is forbidden. 5. The fields of research set out in 3. may be reviewed.

5. Legal base - Article 12 Proposals: 1. shall include a draft plan for the exploitation and dissemination of the results. 2. shall include, for research on human embryonic stem cells, details of licensing and control measures as well as details of the ethical approvals that will be provided. 3. A proposal which contravenes ethical principles (…) may be excluded from the evaluation, selection and award procedures at any time.

6. Legal base - Article 13 Ethics review The Commission shall systematically carry out ethics reviews for proposals raising ethical issues. This review shall verify the respect of ethical principles and legislation and, in the case of research carried out outside the Union, that the same research would have been allowed in a Member State.

7. List of ethicsissues 1 • Data protection • Which data? • - genetic data • sensitive data (health, political or religious opinions, sexual orientation, etc.) • Which procedure? • - procedure for collection – how, by whom, information on rights, info and consent forms, anonymisation • procedure for protection of data – how it is protected, encrypted, where, for how long? • Documents to provide • - data protection officer/authority authorisations • - information and consent forms • - security measures • Humans • Which humans are involved? • - vulnerable persons • - persons unable to give consent • Children • Are some interventions on the body foreseen? • - invasive techniques (biopsy, EEG, fMRI) • - Patients? Healthy volunteers? • Which are the procedures for recruitment and consent? • Documents to provide • - ethics authorisations • - information and consent forms

8. List of ethics issues 2 • Cells and Tissues • What type? • - hESCs • - foetal cells/tissues • - use or creation of cells/cells lines • What for? • - justification of use • - origin: direct collection/ biobanks /secondary use • Documents to provide • - ethics authorisations • - information and consent forms • - justification of right for secondary use • Animals • Which animals are involved? • - vertebrates • - GMOs • - Primates • - wild / protected animals • For what use? • - Justification for choice of species • - 3Rs, precise evaluation of number • - Description of procedure, husbandry, • anaesthesia, euthanasia • - applicable legislation • Documents to provide • - ethics authorisations / project license • - personal and laboratory licenses

9. List of ethics issues 3 • Non EU countries • Which countries? • - associated countries, low income, others? • - to do what with? Whom with? • Export/import of ressources? • - which sources (including data)? • -export/import from/to EU • Benefit sharing measures for low income countries • Documents to provide • - National and local ethics authorisations • - Authorisations for import/export • - Contact with local researchers/local authorities • BUT, if politically sensitive research there can be exceptions • Misuse and Security • Which threats? • - health for team and/or society • - misuse risks/ terrorist abuse • - dual use • - threats on human rights • What for? • Justification • Documents to provide • - ethics authorisations • - mitigation measures • - balance of rights

10. List of ethics issues 4 • Environment Protection • Is the project taking place in sensitive areas? • Is the project using/collecting protected elements? • - oceans – Directive on Oceans? • - natural areas – Directive Habitat? • - areas with endangered/protected species – Directive on birds, CITES convention? • What for? • - justification • - measures to minimize impact • - benefit of the research to the environment • Documents to provide • - ethics authorisations • - specific zone authorisations NEW!

11. Ethicsprocedure EthicsAppraisal EthicsReview: Ethicspre-screening Ethics screening Before Granting EthicsChecks Ethics Audits Ethics assessment After Granting After Granting Ethics monitoring R&I ERCEA

12. Ethics in submissionsystem • Ethics Issues Table EIT • Part A • Ethics Self-assessment • Part B

13. New templates • EIT • Covering all ethics issues mentioned • YES/NO questions and open questions • Detailed instruction

14. Ethics Pre- Screening Proposals concerned by ethics review are frozen until Clearance is emitted. Ethics Clearance Lists with evaluated proposals (main + reserve lists) Ethics Screening EIT+ Ethics Self-Assessment Ethics Assessment ERCEA Ethics Assessment R&I Ethics Clearance Note Signature of Grant Agreements • hESCs are • submitted to : • Programme • Committee • EC decision Aftergranting: monitoring