The EU 6 th Framework Programme of Research

1. The EU 6th Framework Programme of Research Fundamental Ethical Principles and Ethical Review Dr David Coles Ethics and Science European Commission

2. FP Article 3: “General Rules” "All the research activities carried out under the Framework Programme 2002-2006 must be carried out in compliance with fundamental ethical principles.” Rules for participation: “A proposal which contravenes fundamental ethical principles….…shall not be selected. Such a proposal may be excluded from the evaluation and selection procedures at any time.”

3. Human cloning for reproductive purposes; Germline gene therapy (research relating to cancer treatment of the gonads can be financed.) Creating human embryos solely for the purpose of researchor of stem cell procurement, including by means of somatic cell nuclear transfer  Until Dec. 2003 No funding of research on human embryonic stem cells with the exception of banked or isolated human embryonic stem cells in culture No-go Areas:- Areas excluded from funding under FP6:

4. As part of the evaluation process an ethical review will be implemented systematically at EU level for proposals dealing with ethically sensitive issues. In specific cases, further ethical review may take place during the implementation of a project Ethical review and monitoring

5. 3 the ethical review …in the evaluation process

6. All proposers have to describe in their proposals the ethical issues raised by their project and how they will handle these. Guide for Proposers Section B.9 “Other issues” Guide for proposers: What needs to be discussed in the proposal? “If there are ethical, safety, socio-economic or other issues associated with the subject of the proposal, show how they have been adequately taken into account - indicate which national and international regulations are applicable and explain how they will be respected. Explore potential ethical aspects of the implementation of project results.”

7. A. Applicants are requested to fill in the following table Guide for proposers: Information required from applicants on the ethical aspects of the proposed research project Does your proposed research raise sensitive ethical questions related to: YES NO Human beings  Human biological samples  Personal data whether identified by name or not   Genetic information Animals 

8. to confirm that the proposed research does not involve: Applicants are requested Research activity aimed at human cloning for reproductive purposes Research activity intended to modify the genetic heritage of human beings which could make such change heritable Research activity 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 Research involving the use of human embryos or embryonic stem cells with the exception of banked or isolated human embryonic stem cells in culture*

9. Proposers have to describe in their proposal the ethical issues raised by their projects in detail….. ….and explain how they will handle these. Scientific evaluators are requested to identify whether there are ethical issues that need further attention Information required from applicants

10. See Guide for Proposers: - Annex3 link to “Crucial Information” http://europa.eu.int/comm/research/science-society/ethics/rules_en.html CRUCIAL INFORMATION FOR PROPOSERS Gives proposers clear explanations of what constitute ethical issues and how these are to be addressed in their proposals and what sort of information they have to provide.

11. The individual assessment form: Scientific Evaluation Asks evaluator to indicate whether further ethical attention is required “Does this proposal have ethical issues that need further attention? Yes  No ” • And to indicates whether ethical issues have been adequately taken into account: “Have the applicants identified the potential ethical and/or safety aspects of the proposed research regarding its objectives, the methodology and the possible implications of the results? Yes  No  If “no”, which ethical and/ or safety issues have not been identified?”

12. Consensus assessment Both the Consensus report (CR) and the Evaluation Summary Report (ESR) will indicate whether further ethical attention is required The documents “Does this proposal have ethical issues that need further attention? If yes, fill in Form EIR Yes  No ” On Form EIR, evaluators are asked to: “List the ethical issues and comment“

13. In this way, the scientific evaluation.. • identifies those projects requiring the special attention of an ethical review due to the importance or sensitivity of the ethical issues raised and/or the inadequacy of the way that ethical issues have been addressed by the applicants in their project

14. After a positive scientific evaluation By a multidisciplinary panel of experts With the possibility of adjusting and improving proposals that impinge on fundamental ethical principles The report of the ethical review will be part of the technical annex The ethical review will be performed

15. The multidisciplinary panel of experts will consist of: Medicine Science Philosophy, theology, ethics Sociology, psychology Law Animalwelfare  from different countries in Europe and the Accession & Candidates countries  Gender balance  primarily those involved in ethical review in their own countries

16. Ensure Article 3 of FP6 s fulfilled Ensure that the proposers properly address ethical issues arising from the research Make sure that research fulfils all ethical and/or legal requirements at national, EC and international level What do they discuss?

17. Ethical review provides for the possibility of excluding a research project that contravene fundamental ethical principles (see FP6 rules for participation) Exclusion of Research Projects “A proposal which contravenes fundamental ethical principles….…shall not be selected. Such a proposal may be excluded from the evaluation and selection procedures at any time.”

18. Comments of ethical review panel = Ethical review report Outcome: e.g.: requirement for more complete information change in the design of the project, or in the methodology. Negotiation of the contract Local ethical review still required The outcome of the ethical review

19. Evaluation procedure including the ethical review Call for Proposals Receipt of full proposal Receipt of outline proposal Evaluation of Outline Proposals Receipt of full proposal Evaluation of full proposals Final ranking lists Ethical Review Inform Programme Committee Commission decisions on rejected proposals Rejection of full proposals Contract Negotiation Negotiation Failed Commission decisions on proposals accepted for funding

20. 5. Follow up Reporting and follow-up to outcome of ethical review

21. The ethical review panel will report on proposals in the period between final ranking of proposals and finalisation of contract negotiations (see earlier flowchart). The Commission’s final approval will be: Contract negotiation and the Ethical Review report “….subject to agreement on requirements and recommendations emerging from any ethical review being included in the technical annex”

22. Requirements and Recommendations The ER panel may present both requirements and recommendations in its report. Must be implemented in order to satisfy the ethical rules of FP6 Requirements Recommendations Recommendations of the panel as to modifications to procedures or provision by proposers of additional information in order to improve the ethical soundness of the project The ER Report will clearly distinguish between requirements and recommendations

23. ETHICAL REVIEW REPORT Programme: Scientific Officer: Proposal Number: Title: Proposal Type: Co-ordinator Name: Ethical Issues Raised Comments and Conclusions on Ethical Issues Requirements Recommendations Reporting Obligations Follow-up (e.g. is there a later phase to the project which may require ethical review?)

24. The report of the ethical review will be handed over to the responsible scientific officer It must be included in the technical annex The ethical review will probably ask for follow-up reports on the sensitive issues Appropriate national approval needs to be seen Is there a new phase which may require further ethical review? Reporting required in the Technical Annex

25. IP foresee specific ethical management within the project if required In this case the ethical reporting is linked to a management component in the project NoE - no specific ethical management - but if it felt necessary, ER panel might for example recommend an ethicist be included on management board Ethical management

26. It is expected that IPs that raise sensitive ethical issues will have an ethics management component or workpackage. These should have expertise which is both appropriate and broad-based. Applicants should provide sufficient information in the proposal for this to be evaluated. Integrated Projects Management

27. Ethical Audit In difficult cases Or in cases where the reporting is not done in a transparent way An ethical audit may be implemented

28. Ethical Audit FP6 Rules of Participation - 16 December 2002 “ The Commission or any representative authorised by it, shall have the right to carry out scientific, technological and financial audits on the participants, in order to ensure that the indirect action is being or has been performed under the conditions claimed and accordance with the terms of the contract”. Implementing provisions for FP6 instruments “ Ethical audits may be launched at any time during the implementation of the project in order to verify that the project is respecting fundamental ethical principles and national regulations”

29. Termination for Irregularity Model Contract II.31 The Commission may terminate the participation of a contractor ”Where the contractor has contravened fundamental ethical principles as identified or referred to in the Regulation”

30. Further information on ethics requirements and rules are given at the science and ethics website at http://europa.eu.int/comm/research/science-society/ethics/ethics_en.html Further Information