MSF Ethics Review Board > Templates & procedures
MSF Ethics Review Board
2017 February 1
This Exemption Criteria Document No 2 (February 2017) is for surveys based on the standardized intersectional protocols approved by the MSF ERB.
At the MSF Ethics Review Board (ERB) meeting in 2012, the handling of ethics clearance for routine surveys was discussed. The ERB decided that surveys for vaccination, nutrition and mortality that make use of the ERB-approved standardized survey protocols do not require ERB review if the Medical Directors take responsibility for addressing the ethics issues, as described in this document.
At the MSF Ethics Review Board (ERB) meeting in 2012, the handling of ethics clearance for routine surveys was discussed. The ERB decided that surveys for vaccination, nutrition and mortality that make use of the ERB-approved standardized survey protocols do not require ERB review if the Medical Directors take responsibility for addressing the ethics issues, as described in this document.
MSF Ethics Review Board > Publications
BMC Medical Ethics. 2015 February 26; Volume 16; 10.; DOI:10.1186/s12910-015-0002-3
Schopper D, Dawson A, Upshur R, Ahmad ASI, Jesani A, et al.
BMC Medical Ethics. 2015 February 26; Volume 16; 10.; DOI:10.1186/s12910-015-0002-3
BACKGROUND
Médecins Sans Frontières (MSF) is one of the world’s leading humanitarian medical organizations. The increased emphasis in MSF on research led to the creation of an ethics review board (ERB) in 2001. The ERB has
encouraged innovation in the review of proposals and the interaction between the ERB and the organization. This has led to some of the advances in ethics governance described in this paper.
DISCUSSION
We first update our previous work from 2009 describing ERB performance and then highlight five innovative practices:
• A new framework to guide ethics review
• The introduction of a policy exempting a posteriori analysis of routinely collected data
• The preapproval of “emergency” protocols
• General ethical approval of “routine surveys”
• Evaluating the impact of approved studies
The new framework encourages a conversation about ethical issues, rather than imposing quasi-legalistic rules, is more engaged with the specific MSF research context and gives greater prominence to certain values and
principles. Some of the innovations implemented by the ERB, such as review exemption or approval of generic protocols, may run counter to many standard operating procedures. We argue that much standard practice in research ethics review ought to be open to challenge and revision. Continued interaction between MSF researchers and independent ERB members has allowed for progressive innovations based on a trustful and respectful partnership between the ERB and the researchers. In the future, three areas merit particular attention. First, the impact of the new framework should be assessed. Second, the impact of research needs to be defined more precisely as a first step towards being meaningfully assessed, including changes of impact over time. Finally, the dialogue between the MSF ERB and the ethics committees in the study countries should be enhanced.
SUMMARY
We hope that the innovations in research ethics governance described may be relevant for other organisations carrying out research in fragile contexts and for ethics committees reviewing such research.
Médecins Sans Frontières (MSF) is one of the world’s leading humanitarian medical organizations. The increased emphasis in MSF on research led to the creation of an ethics review board (ERB) in 2001. The ERB has
encouraged innovation in the review of proposals and the interaction between the ERB and the organization. This has led to some of the advances in ethics governance described in this paper.
DISCUSSION
We first update our previous work from 2009 describing ERB performance and then highlight five innovative practices:
• A new framework to guide ethics review
• The introduction of a policy exempting a posteriori analysis of routinely collected data
• The preapproval of “emergency” protocols
• General ethical approval of “routine surveys”
• Evaluating the impact of approved studies
The new framework encourages a conversation about ethical issues, rather than imposing quasi-legalistic rules, is more engaged with the specific MSF research context and gives greater prominence to certain values and
principles. Some of the innovations implemented by the ERB, such as review exemption or approval of generic protocols, may run counter to many standard operating procedures. We argue that much standard practice in research ethics review ought to be open to challenge and revision. Continued interaction between MSF researchers and independent ERB members has allowed for progressive innovations based on a trustful and respectful partnership between the ERB and the researchers. In the future, three areas merit particular attention. First, the impact of the new framework should be assessed. Second, the impact of research needs to be defined more precisely as a first step towards being meaningfully assessed, including changes of impact over time. Finally, the dialogue between the MSF ERB and the ethics committees in the study countries should be enhanced.
SUMMARY
We hope that the innovations in research ethics governance described may be relevant for other organisations carrying out research in fragile contexts and for ethics committees reviewing such research.
MSF Ethics Review Board > Publications
PLOS Med. 2009 July 28; Volume 6 (Issue 7); e1000115.; DOI:10.1371/journal.pmed.1000115
Schopper D, Upshur R, Matthys F, Singh JA, Bandewar SS, et al.
PLOS Med. 2009 July 28; Volume 6 (Issue 7); e1000115.; DOI:10.1371/journal.pmed.1000115
MSF Ethics Review Board > Other guidance
MSF Ethics Review Board
2013 November 1
MSF Ethics Review Board > Templates & procedures
MSF Ethics Review Board
2016 November 7
MSF Ethics Review Board > Publications
Public Health Ethics. 2016 November 1; Volume 10 (Issue 1); 49-61.; DOI:10.1093/phe/phw039
Schopper D, Ravinetto R, Schwartz L, Kamaara E, Sheel S, et al.
Public Health Ethics. 2016 November 1; Volume 10 (Issue 1); 49-61.; DOI:10.1093/phe/phw039
The Médecins Sans Frontières (MSF) ethics review board (ERB) has been solicited in an unprecedented way to provide advice and review research protocols in an 'emergency' mode during the recent Ebola epidemic. Twenty-seven Ebola-related study protocols were reviewed between March 2014 and August 2015, ranging from epidemiological research, to behavioural research, infectivity studies and clinical trials with investigational products at (very) early development stages. This article examines the MSF ERB's experience addressing issues related to both the process of review and substantive ethical issues in this context. These topics include lack of policies regarding blood sample collection and use, and engaging communities regarding their storage and future use; exclusion of pregnant women from clinical and vaccine trials; and the difficulty of implementing timely and high-quality qualitative/anthropological research to consider potential upfront harms. Having noticed different standards across ethics committees (ECs), we propose that when multiple ethics reviews of clinical and vaccine trials are carried out during a public health emergency they should be accompanied by transparent communication between the ECs involved. The MSF ERB experience should trigger a broader discussion on the 'optimal' ethics review in an emergency outbreak and what enduring structural changes are needed to improve the ethics review process.
MSF Ethics Review Board > Templates & procedures
MSF Ethics Review Board
2023 September 6
MSF Ethics Review Board > Internal Procedures
MSF Ethics Review Board
2017 February 1
MSF Ethics Review Board > Templates & procedures
MSF Ethics Review Board
2016 November 4
MSF Ethics Review Board > Templates & procedures
Gerstl S, Grandesso F, Siddiqui R, Greig J, du Cros PAK, et al.
2022 October 25