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

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Research ethics in practice: the experience of the MSF Ethical Review Board Doris Schopper, MD, DrPH Chairperson Ethical Review Board MSF UK Scientific Day – PowerPoint PPT presentation

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


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 dont 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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