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GF8 – Vilnius, June 2007

GF8 – Vilnius, June 2007. Hugh Whittall Director Nuffield Council on Bioethics Establishing and supporting research ethics infrastructure and networking. Nuffield Council on Bioethics. Independent body that examines ethical questions raised by advances in biology and medicine

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GF8 – Vilnius, June 2007

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  1. GF8 – Vilnius, June 2007 Hugh Whittall Director Nuffield Council on Bioethics Establishing and supporting research ethics infrastructure and networking

  2. Nuffield Council on Bioethics • Independent body that examines ethical questions raised by advances in biology and medicine • Contributes to policy making and stimulates debate

  3. Themes of presentation • Nuffield Reports on research in developing countries • Infrastructures for ethical advice and review • Support and networking

  4. Report (2002); follow-up Discussion Paper (2005)

  5. Key issues • Consent • Standards of care • Ethical review of research • What happens once research is over? • Strengthen capacity in developing countries

  6. Consent • Purpose is to inform and protect • Should fit local context • Simple consent forms • Innovative ways of providing information • Trust of participants is crucial

  7. Standards of care • Potentially beneficial research may be prevented by unrealistic requirements • Guidelines say local standard of care is often acceptable • Discussion with stakeholders in planning stage • Longer term sustainability

  8. After the research is over • Need mechanism for early discussions • Consequences of resource limitations • Unrealistic requirements to provide post-trial interventions • Not always clear when research is complete • Recognise enduring benefits of research

  9. Ethical review • RECs to review both ethical and scientific aspects? • Need to increase efficiency • Local expertise of host REC can be crucial • Developing country RECs face serious difficulties • Particularly lack of expertise

  10. Bioethics: advisory and ethical review bodies • Different models in different countries • Model influenced by: • Impact / timing of scientific development • Cultural / political environment • Existing regulatory framework

  11. UK model • Government advisory bodies • Regulatory authorities • Independent advisory bodies • Research / clinical ethics committees

  12. Governmental advisory bodies • Human Genetics Commission (HGC) • Genetics and Insurance Committee (GAIC) • Gene Therapy Advisory Committee (GTAC) • Animal :Procedures Committee (APC) • National Research Ethics Service (NRES)

  13. Regulatory authorities • Human Fertilisation and Embryology Authority (HFEA) • Human Tissue Authority (HTA) • Medicines and Healthcare Products Regulatory Agency (MHRA)

  14. Independent advisory bodies • British Medical Association Medical Ethics Committee • Medical Royal Colleges Ethics Committees • Nuffield Council on Bioethics

  15. Support and networking • Formal activities • Global Forum • UNESCO Guides and ABC project • MRC CURE • Informal activities • Informal contacts • Sharing of experience • Building an ‘ethics community’

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