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
 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
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
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
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!
Kala-azar outbreak investigation in Somalia
Request 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?
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
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?
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
Conclusions (2):
When and how to seek ethical approval
1. Analysing routinely collected data to directly improve
patient / programme management  no ethical review
2. 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
3. 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
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.