Preparing a EU Project: The Section on Ethics

Transcription

1 Preparing a EU Project: The Section on Ethics European Commission Research DG Joana Namorado Participating in a EU Funded Project- Preparing and Managing 9 June

2 Overview Why Ethics Rules and legislative basis Ethics Screening/Review Report Practical aspects Ethics as a structuring feature 2

3 How it Works: EU Policy on research Treaties Council of Ministers Results FPs Framework Programmes Legislation EU Parliament Commission Work programmes Calls for proposals Researchers 3

4 Why Ethics Rules and legislative basis?responding to the Media?Insuring the EU funds Ethical Research?FP7 Rules 4

5 Legal Basis for Ethical Reviews in FP7 Seventh Framework Programme (Decision N 1982/2006/EC), Article 6 (1 ): «All the research activities carried out under the Seventh Framework Programme shall be carried out in compliance with fundamental ethical principles.» Rules for Participation, Article 10: «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.» 5

6 Evaluation procedure for single stage and stage 2 of two-stage procedure Eligibility check eligible Proposal submission 1. Individual evaluation not eligible: exclusion If below threshold: CR IER/IER 2. Consensus meeting Consensus Report 1 If above threshold Ethical screening 3. Ranking Panel Commission decision ESR Consensus Report 2 Evaluation Summary Report Priority list Commission: final ranking list and decision Ethical review (if necessary) Report Rejection Reserve list Negotiation 6

7 Ethics check list* Informed Consent? Does the proposal involve children?? Does the proposal involve patients or persons not able to give consent?? Does the proposal involve adult healthy volunteers?? Does the proposal involve Human Genetic Material?? Does the proposal involve Human biological samples?? Does the proposal involve Human data collection? Research on Human embryos/foetus? Does the proposal involve Human Embryos?? Does the proposal involve Human Foetal Tissue/Cells?? Does the proposal involve Human Embryonic Stem Cells? Privacy? Does the proposal involve processing of genetic information or personal data (eg. health, sexual lifestyle, ethnicity, political opinion, religious or philosophical convinction)?? Does the proposal involve tarcking the location or observation of people? Research on Animals? Does the proposal involve research on animals?? Are those animals transgenic small laboratory animals?? Are those animals transgenic farm animals?? Are those animals cloning farm animals?? Are those animals non-human primates? Research Developing countries? Use of local resources (genetic, animal, plant, etc.)?? Benefit to local community (capacity building ie access to healthcare, education, etc. ) Dual Use? Resarch having potential military/terrorist application * Found in the Science and Society w.page 7

8 Ethics Section From the Start???? Why do you need it?? What can you gain?? When do you start?? How do you start? 8

9 When is it needed? (Review at EU level)? Children involved? Developing Countries? hesc? NHP Screening? Healthy volunteers? Human genetic material? Human biological samples? Human data collection INSURANCE!!!!!!!! People : Informed Consent What must be in Consent form? State + explain? Research? Purpose +information? risks /benefits? Treatment/compensation? contact for rights/claims? injury? Voluntary participation? No penalty 9

10 Human Embryonic Stem Cells: Ethics Review at EU level When involving hesc research researchers should specify:? Does not destroy embryos;? Local Legislation, regulations, rules, codes of conduct? Informed consent - Source of the hesc;? Protection data (genetic data and privacy)? Financial inducements? Approval of the Local Ethics Committees/ Positive opinion Regulatory Committee* *prior to the start of the research activities. 10

11 Privacy and Data Protection Relation between tech and privacy? identifiable data? Improper disclosure control Data affected by privacy issues? Health and genetic info.? Criminal justice.? Financial info.? Location.? Data privacy / share data while protecting identifiable information. How to Deal with Data Protection and Privacy?? describe procedures? code or anonymised? security for storage and handling? Fairly and lawfully processed? limited purposes? Adequate, relevant, sufficient? Accurate? Timely storage? Processed? Secure? Not transferred abroad unprotected 11

12 Research on Animals In Summary,? NHP use = MANDATORY EU level Ethics Review? Convincing Application of the 3Rs? Reduction, Replacement, Refinement? To describe and justify:? Species and Numbers? Humane End Points and Pain Suffering? To Check for alternatives (cf. the following websites):? Plus Application of new EU Directive 12

13 Research in Developing Countries DOUBLE Standards? Does the research project provide benefit to the local community (in terms of access to healthcare, education, allocation of property rights, capacity to assess and use modern technologies while respecting the population 's own choices and needs, etc.)?? Does the research project use local resources (genetic resources, animal, and plants)? Result in their benefit or?? Standards Equal or Similar to EU Member States 13

14 Thank You 14