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Using routinely collected data a posteriori for research purposes: How can MSF deal with the ethical issues?

Using routinely collected data a posteriori for research purposes: How can MSF deal with the ethical issues?. Doris Schopper, MD, DrPH Chairperson Ethics Review Board MSF UK Scientific Day 7 June 2007. Research proposals reviewed 2002-5/2007. 67 proposals reviewed

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Using routinely collected data a posteriori for research purposes: How can MSF deal with the ethical issues?

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  1. Using routinely collected data a posteriori for research purposes:How can MSF deal with the ethical issues? Doris Schopper, MD, DrPH Chairperson Ethics Review Board MSF UK Scientific Day 7 June 2007

  2. Research proposals reviewed 2002-5/2007 • 67 proposals reviewed • usually approved in 1-3 rounds • 5 studies cancelled; 1 re-designed • more expedited reviews recently • Variable research activity • 4 (2002)  14 (2003)  8 (2004)  6 (2005)  17 (2006)  18 (May 2007) • Recently requests for ethical advice/review of research papers before publication • 2 in 2006, 5 since Jan 2007

  3. Main ethical issues • Insufficient informed consent procedure • Lack of explicit community involvement • Difficulty to get assurance that benefits will be made available to research participants and community in the medium term • Need to prevent potential abuse of tissue samples provided by research participants • Collaboration with for-profit entities

  4. Why worry about ethical issues when analyzing routinely collected data? • If data used for programme monitoring, main issue is correct storage and use of data to protect patients and guarantee confidentiality (medical ethics) • If data used to test research hypothesis: same ethical requirements as research • If formal publication envisaged: ethics approval often requested

  5. HIV in prisons in Thailand: ethics review necessary? Diverging views between journal and MSF ERB • Descriptive use of routine data (FUCHIA) • Qualitative information collected purposefully • 3 case vignettes Queries by journal editor and advice by journal ethics committee • Is this research? (divergent views) • Potential exploitation of and harm to (research) participants MSF ERB position • It is not research, but purely descriptive • Routine data collection ethically okay • Potential harm for individuals described in case vignettes: written informed consent had been obtained!

  6. Kala-azar outbreak investigation in SomaliaRequest for ethical advice before submitting • No testing of research hypothesis • Routine monitoring and evaluation activity Question: are persons involved protected from exploitation and harm and is information gathered treated respectfully? Ethical issues to address explicitly: • Were patients informed why blood was taken and that it would be exported for analysis? • What is the fate of blood samples in foreign research laboratory?

  7. Interesting findings from evaluation of sleeping sickness programme in the Republic of Congo 2 papers submitted to WHO Bulletin Queries: • safeguards that data are secure, and that links to original records can not be reformed at later date • ownership of data and plans to communicate results to MoH  • data are a necessary component of treatment programme and will improve patient care and scientific knowledge WHO Bulletin published after submitting papers to 2 WHO ethics committees: • public health interests outweigh any potential harm to research participants • after permission by MoH of RoC to use the data for this purpose Editorial in same WHO Bulletin puts onus on MSF to do better

  8. Conclusions (1): relevant ethical issues • Protection of patient confidentiality (initial collection and storage of information received from the patient) • Individual informed consent necessary or possible to waive • Collaboration and partnership with local/national researchers • Do public health benefits largely outweigh potential harms to the individual (autonomy of patients) and to the community (discrimination, stigmatization)? • Will study community receive benefits of the research?

  9. Avoid premeditated research disguised as retrospective analysis of routine data to circumvent ethical review! The example of the FUCHIA data base • 200 days booked with Epicentre to do pooled analysis of HIV cohort data in several MSF projects • Research questions not yet defined, will emerge during analysis What to do? • This goes way beyond improving patient management • As soon as research questions or hypothesis to verify are formulated, MSF should seek ethical review

  10. Conclusions (2): When and how to seek ethical approval • Analysing routinely collected data to directly improve patient / programme management  no ethical review • Generalisable research hypothesis to be tested by a posteriori analysis of routinely collected data  ethical review ideally at stage of data analysis or draft research paper • Grey area “knowledge of general interest” (between testing generalisable research hypothesis and routine monitoring): • Be prepared to answer ethics questions • Journals may request ethics review

  11. For the future…? Short “decision framework” to: • raise awareness about ethics issues for authors of papers based on an analysis of routinely collected data; • give direction as to when it is appropriate to submit a proposal to the ethics review board • present a simplified version of the full ERB framework.

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