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Research ethics in practice: the experience of the MSF Ethical Review Board

Research ethics in practice: the experience of the MSF Ethical Review Board. Doris Schopper, MD, DrPH Chairperson Ethical Review Board MSF UK Scientific Day 1 June 2006. The MSF Ethical Review Board (ERB) in a nutshell. Instituted in 2001 according to international standards

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Research ethics in practice: the experience of the MSF Ethical Review Board

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  1. Research ethics in practice: the experience of the MSF Ethical Review Board Doris Schopper, MD, DrPH Chairperson Ethical Review Board MSF UK Scientific Day 1 June 2006

  2. The MSF Ethical Review Board (ERB) in a nutshell • Instituted in 2001 according to international standards • Currently six members  gender balance, 4 continents, various disciplines(bioethics, public health, medicine, anthropology, law) • Independent from MSF • Reviews coordinated by internet + meetings in person ~ every 18 months • Approval of national ERB is “precondition”

  3. Research proposals reviewed 2002-2005 • 32 proposals reviewed • 29 approved (1-3 rounds) • 3 not carried out • Main areas • Malaria (10) • HIV (5 + 3 abandoned) + STI (2) • Trypanosomiasis (3); visceral leishmaniasis (3) • Nutrition (2), tuberculosis (1+ 2 linked to HIV) • Variable research activity • 4 (2002)  14 (2003)  8 (2004)  6 (2005)… 5 in 2006

  4. MSF is asking ethical advice on… • Type of research • 14 / 32 efficacy or clinical equivalence studies • 4 / 32 effectiveness – feasibility studies • 3 / 32 evaluation of test method • Geographical areas • Mainly in Africa (25 / 32) • Asia (4), Latin-America (1), Europe (2) • Some MSF sections ask more than others… • Holland (17), Belgium (13), Spain (1), Switzerland (1)

  5. MSF is asking ethical advice on… • Type of research • 14 / 32 efficacy or clinical equivalence studies • 4 / 32 effectiveness – feasibility studies • 3 / 32 evaluation of test method • Geographical areas • Mainly in Africa (25 / 32) • Asia (4), Latin-America (1), Europe (2) • Some MSF sections ask more than others… • Holland (17), Belgium (13), Spain (1), Switzerland (1)

  6. What should be submitted to the ERB • Clinical research • Production of new generalisable knowledge (testing research hypothesis) within usual monitoring and evaluation • Need for ER based on risk analysis  potential harm and risk of wronging research participants • Routine monitoring and evaluation  ER useful if new public health knowledge generated • Emergency research exempted

  7. A consistent framework for ethical review Since June 2003 ERB uses adapted version of “Emmanuel Framework” • Intends to provide “unified and consistent ethical guidance”, derived from ethical theory and international guidelines • Tailored for developing world context • Employs principles and explicit benchmarks

  8. Recurrent ethical issues in MSF research proposals • Informed consent procedure • Community involvement • Benefits to research participants and community in medium term • Export of tissue samples

  9. How to ensure informed consent • Main shortcomings • Consent form insufficient, too complicated, biased • No pretesting (also of translation) • Overestimation of the benefit for participants and community • No educational process foreseen • What should be done • Explain procedure to obtain informed consent in detail in research protocols • More emphasis on information process than formal consent form • Ensure community involvement

  10. Community Partnerships • Articulated in Emanuel framework as necessary for research in developing world to be ethical • Often neglected in MSF proposals • What to do: • Ideally “functional” community body to follow research from start to end • At minimum, community consultation before – during – after (feedback of research results) • Be careful in defining “community”

  11. Tissue samples • Tissue samples exported from point of origin with uses, storage and destruction unclear • How will MSF weigh interests of research subjects and research partners (also: ensure benefit sharing)? • MSF needs to address 3 distinct situations • Tissue samples taken outside the country: tuberculosis resistance, HIV resistance • A posteriori analysis of samples: lymph node aspirates leishmaniasis • No direct benefit: HIV viral clades

  12. Conclusions • Interaction between ERB and MSF very constructive • “Educational” value of ERB recognized • Ethical framework very useful • Big improvement in research quality since inception of ERB • Is all research in MSF “ethical”? We don’t know…

  13. Issues that need greater attention in future • Should ERB have role in checking what happens after approval? • Developing local (research) capacity • Assessing benefits of research in medium and longer term

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