1. Ethics in projects involving nanomaterials 2009-2011 Ms. Timea Balogh Ethics Sector DG Research and Innovation European Commission

2. Compliance of applicants with ethical rules: a legal obligation (1) Seventh Framework Programme (Decision N° 1982/2006/EC) Article 6: 'All the research activities carried out under the Seventh Framework Programme shall be in compliance with fundamental ethical principles’ Fields of research excluded from funding: - research activity aiming at human cloning for reproductive purposes - research activity intended to modify the genetic heritage of human beings which could make such changes heritable - research activities intended to create human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer 2

3. Compliance of applicants with ethical rules: a legal obligation (2) Rules for submission of proposals, and the related evaluation, selection and award procedures 'Ethical and security considerations: Any proposal which contravenes fundamental ethical principles, or which fails to comply with the relevant security procedures may be excluded at any time from the process of evaluation, selection and award' (Introduction) 'The Commission may reject proposals on ethical grounds following an ethical review' (Part 4.3) 'Any proposal that contravenes fundamental ethical principles shall not be selected' (Article 15.2 of the EC Rules for Participation, and article 14.2 of the equivalent Euratom Rules for Participation)

4. Ethics Review Procedures 1. Applicants should complete the “Ethical Issues Table” included in the Guide for Applicants 2. Ethics review procedures The evaluation is followed by an ethics review of proposals that are in line for funding and raise ethical issues. Phase 1: Ethics screening Objectives: (a) identifying proposals that fall under EU and Euratom law and require an approval and/or a positive opinion at the national level and (b) identifying proposals that in addition to national approvals, require an Ethics Review by the Commission due to the nature of ethical issues raised primarily intervention on humans, use of non-human primates in research, research on human embryos and human embryonic stem cells —> Ethics Review undertaken by the Ethics Sector of DG Research and Innovation 4

5. Phase 2: Ethics review After the ethics screening process, the Commission may decide to submit proposals that fall under category (b) and proposals under category (a) that raise challenging ethical issues, to an ethics review panel. Three mandatory categories, plus particular attention to research involving children, undertaken in developing countries, and security-related research Ethics Review Report (ERR) - includes a list of ethical issues - is an account on how ethical issues are addressed by the applicants - includes the requirements and recommendations made by the panel - may indicate the need to organise an ethics audit at a later stage - is sent to the applicants without disclosing the identity of the experts 5

6. Ethics follow-up and audit - introduced in 2010 - experts can ask for an Ethics follow-up/audit - conducted by experts specialised in ethical issues - on the date of the first reporting period at the earliest - the objective is to assist the beneficiaries to deal with the ethical issues raised and - if necessary - take preventative and/or corrective measures 6

7. 7 Most common ethical issues in projects involving nanomaterial YEAR ETHICAL ISSUES (number of proposals) 2009 13 proposals 1. adults (11) 4. human tissue (7) 2. data protection (11) 5. human intervention (5) 3. privacy (9) 6. animals/genetically modified animals (9) 2010 5 proposals 1. animals/transgenic animals (3) 4. data protection (1) 2. developing countries (3) 5. human samples (1) 3. safety and hazard (4) 6. patients (1) 2011 14 proposals 1. data protection(10)privacy (8) 4. research on humans (6) 2. human biological samples (9) 5. patients (7) 3. safety and hazard (5) 6. animals/transgenic animals (8) TOTAL 32 proposals 1. data protection 4. safety and hazard 2. animals/transgenic animals 5. research on humans 3. human intervention and biological samples 6. privacy

8. 8 General and domain-specific requirements in ERRs 1. (most frequent requirements) Requirements become contractual obligations General - Copies of ethical/legal approvals by the competent local/national ethics/legal Committees (where the research takes place) and submission to the EC prior to the commencement of the research - Appointment of independent Ethics Advisor/Ethics Board, description of their work, submission of reports prepared by them - Rigorous application of ethical standards and guidelines compatible with, and equivalent to those of FP7, regardless of the country of the research - Reference to/enlisting the relevant European/national legislation and ethical guidelines to be observed - Plan/information/protocol on the management of incidental findings

9. 9 Domain-specific requirements in ERRs 2. (most frequent requirements) Data protection and privacy: - Detailed information on procedures and measures to be taken for data collection, storage, protection, retention and destruction, right to access etc. - Information on data security and the proper handling of data, clarification on the nature of the data to be collected (de-identified or anonymous) - Copies of authorisations from relevant data protection authorities - Compliance with local and EC regulations with regard to confidentiality and data protection - Detailed information on measures to ensure privacy/confidentiality Animals: - Compliance with the EU guidelines/directives and the 3R principle – reduction, refinement, replacement - Copies of relevant authorisations for animal experimentation - Clarification on the number of animals used, on the choice of species, on the nature of the experiments, the procedures and their anticipated impact and the minimalization of adverse effects. Justification if living animals are used. - Details on ensuring welfare of animals during their lives

10. 10 Domain-specific requirements in ERRS 3. (most frequent requirement) Human intervention and use of human biological samples: - Information on the source of the samples, the way the samples are collected and anonymised, the duration of storage - Clarification what will happen to the samples afterwards and their possible usage for other purposes - Possible commercial applications - Insurance cover for the research - Information on voluntary nature of participation, right to withdraw from the study and withdraw samples and data at any time Safety and hazard related to nanotechnology: - Clarification on measures ensuring that no health risks are associated with the handling of the nanodevices by researchers and the way to minimize potential risks - Thorough risk assessment of the novel technologies for human therapies, assessment of potential health, safety and environmental risks associated with nanotechnology101010

11. 11 Domain-specific requirements in ERRs 4. (most frequent requirements) Research on humans – informed consent (research on patients, healthy volunteers, adults, vulnerable people): - Detailed information on procedures for recruitment of participants, on inclusion/exclusion criteria, on direct/indirect incentives, on informed consent procedures, the risk/benefit analysis, the nature of material to be collected - Submission of copies of all information sheets and informed consent forms written in the language and terms understandable to the participants - Justification on the participation of children in the research - parents’ consent and children's assent - Information on the voluntary nature of participation, right of withdrawal - Possible commercial exploitation - Ensuring adequate insurance cover for the participant to cover any potential adverse effects

12. 12 From insufficiency to sufficiency Overall assessment of proposals (as of 2010) 1. The proposal adequately identifies and addresses the relevant ethical issues. Specific requirements, if any, are provided in the 'Requirements‘ 2. The proposal addresses the ethical issues only in general terms but there are aspects which require substantial clarification. These are highlighted in the 'Requirements' section 3. The proposal fails to identify and to address the relevant ethical issues. A supplementary Ethics Review is recommended (resubmission) To be considered… 1. The description of ethical aspects of the research regarding the objectives 2. The description of ethical aspects of the research regarding the methodology 3. The description of ethical aspects of the research regarding the possible implication of the results 4. The indication how the proposal meet the national legal and ethical requirements of the country of the research 5. The indication of timeframe for approval by relevant authority at national level

13. 13 Some messages from experts - Besides the dissemination of results among the scientific audience, dissemination of results to the general public - The purpose is to increase the knowledge and awareness about the potential of nanotechnologies… - To improve the quality of the research the applicants should take into account the Recommendation of 07/02/2008 on a Code of Conduct for a Responsible Nanosciences and Nanotechnologies Research - Not sufficient preparation might entail delay in negotiations

14. More information Website on Ethics review: http://cordis.europa.eu/fp7/ethics_en.html http://ec.europa.eu/research/science-society/index.cfm?fuseaction=public.topic&id=1289 Ethics Review Help Desk: - all FP7 funded projects can request specific assistance on ethical issues from the Ethics Review Help Desk: http://www.cordis.europa.eu/fp7/get-support_en.html

15. More information Horizon 2020 http://ec.europa.eu/research/horizon2020/index _en.cfm Science in Society Portal (EUROPA) http://ec.europa.eu/research/science- society/home_en.cfm European Research Area http://ec.europa.eu/research/era/index_en.htm

16. Thank you for your attention!