The MSF ethics review board
Historically, research was not seen as core to the mission of Médecins Sans Frontières. However, MSF now initiates, sponsors or participates in numerous research projects in multiple field sites. Results from several research projects have had substantial impact on global health policy and provided benefits to populations served by MSF and elsewhere. As a result, research has become increasingly integral to MSF activities, both in the field and in global health advocacy.
MSF has paid particular attention to the ethical issues arising from the research in which they engage, manifested by the creation of an independent ethics review board (ERB) in 2002 that evaluates all research proposals involving MSF.
Why is there a need for ethical review of research?
The World Health Organization defines research with human subjects as any social science, biomedical, behavioural, or epidemiological activity that entails systematic collection or analysis of data with the intent to generate new knowledge, in which human beings:
- are exposed to manipulation, intervention, observation, or other interaction with investigators either directly or through alteration of their environment; or
- become individually identifiable through investigator's collection, preparation, or use of biological material or medical or other records.
Ethical reviews are conducted to protect the dignity, rights, well-being and welfare of research participants and communities. The MSF-ERB thus examines research protocols thoroughly to make sure that what will be done is appropriate, relevant and beneficial for the community and/or the intended participants; that the methods by which the research will be conducted are rigorous; and that the participants’ rights are respected and protected.
MSF-ERB: Beyond ethics review
The MSF-ERB ensures that researchers adhere to universal humanitarian imperatives of alleviating human suffering, preserving human dignity as well as protecting and respecting human rights regardless of race, creed, nationality or political belief – unique ethical challenges, which may not be captured by typical research ethics guidelines. Furthermore, the Board engages with and provides advise to MSF regarding ethical issues.
The MSF-ERB is composed of a diverse group of professionals coming from different continents, with an understanding of humanitarian and NGO realities. The members of the board do not have a working relationship with MSF to avoid conflict of interest and ensure independence. The passion and high level of expertise of the Board pushes the organization and, by its example, the field of research ethics itself to better and higher standards.
The MSF-ERB reviews new protocols and amendments to previously approved protocols; provides advice; and, in some instances, exempts research protocols from review. Monitoring of the implementation of approved research protocols is also done.
In 2015, 105 submissions were processed. The ERB reviewed 80 research protocols (17 amendments, 63 new reviews); provided advice in eight instances and exempted two research protocols. Fifteen on-going studies were granted extension.
The volume of reviews (based on protocols for review or amendment) conducted by the ERB is progressively increasing, from five research protocols in 2002 to 80 protocols in 2015 (Figure 1).
Designs and topics of submitted research protocols
The majority (50%) of the research protocols submitted in 2015 were operational researches, followed by clinical trials and surveys. There were also anthropological and evaluation technology studies. The topics were widespread with a major emphasis on issues pertaining to Ebola and HIV. Other topics included: tuberculosis, malaria, sexual/reproductive health, cholera, chronic conditions, malnutrition, mental health and trauma; there were also topics on health systems research, other infectious diseases and migrants.
A total of 49 new research protocols were approved in 2015. Time from submission to final approval was, on average, 82.8 days (min=0 days, max=416 days). There is a very fast turnover for the Ebola protocols, showing the high reactivity of the board in emergency situations. The average time for approval of Ebola protocols was 34.4 days (min=2 days, max=66 days). (Figure 2)
Amendments were usually approved within an average of 3.6 days (min=0 days, max=35 days); advice was provided within 34.4 days (min 0=days, max 146=days); and exemptions were approved within 10.3 days (min=0 days, max=31 days).
At times, the Board needed to have several exchanges of communications with the Principal Investigators. In all reviews conducted, the highest standards of scholarly and scientific integrity of MSF Research are ensured.
In an unprecedented way, the ERB was solicited to review research protocols in an “emergency” mode during the Ebola epidemic: 27 Ebola-related study protocols were reviewed between March 2014 and August 2015 (Figure 3).
Research protocols covered a variety of different studies, including epidemiological, behavioural and infectivity studies, and clinical trials with investigational products at (very) early development stages. Particularly challenging ethical issues included: conducting research during an epidemic, involving highly vulnerable populations faced with a highly lethal disease; the scale of research activities, which spanned three low-income, poorly-regulated countries; the exclusion of pregnant women in clinical trials; and the storage of blood samples for future use. Over the past year, the MSF ERB thus acquired a unique experience on ethical issues related to Ebola research.
The ERB met in a closed meeting in June 2015 in Geneva to discuss the ethical issues confronted. A paper was subsequently submitted for publication with the objective to draw out key lessons for ethics in future research on Ebola and to foster a broader discussion in the international arena on the “optimal” way for ethics review in an emergency outbreak.