Journal Article > LetterFull Text
Trop Med Int Health. 2013 May 30; Volume 18 (Issue 8); DOI:10.1111/tmi.12133
Zachariah R, Reid AJ, Van der Bergh R, Dahmane A, Kosgei RJ, et al.
Trop Med Int Health. 2013 May 30; Volume 18 (Issue 8); DOI:10.1111/tmi.12133
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
Journal Article > ResearchFull Text
BMC Int Health Hum Rights. 2003 April 1; Volume 3 (Issue 1); 2.; DOI:10.1186/1472-698x-3-2
Ioana Chiotan D, Upshur R, Ford NP
BMC Int Health Hum Rights. 2003 April 1; Volume 3 (Issue 1); 2.; DOI:10.1186/1472-698x-3-2
BACKGROUND
Although a grossly disproportionate burden of disease from HIV/AIDS, TB and malaria remains in the Global South, these infectious diseases have finally risen to the top of the international agenda in recent years. Ideal strategies for combating these diseases must balance the advantages and disadvantages of 'vertical' disease control programs and 'horizontal' capacity-building approaches.
DISCUSSION
The Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) represents an important step forward in the struggle against these pathogens. While its goals are laudable, significant barriers persist. Most significant is the pitiful lack of funds committed by world governments, particularly those of the very G8 countries whose discussions gave rise to the Fund. A drastic scaling up of resources is the first clear requirement for the GFATM to live up to the international community's lofty intentions. A directly related issue is that of maintaining a strong commitment to the treatment of the three diseases along with traditional prevention approaches, with the ensuing debates over providing affordable access to medications in the face of the pharmaceutical industry's vigorous protection of patent rights.
SUMMARY
At this early point in the Fund's history, it remains to be seen how these issues will be resolved at the programming level. Nevertheless, it is clear that significant structural changes are required in such domains as global spending priorities, debt relief, trade policy, and corporate responsibility. HIV/AIDS, tuberculosis and malaria are global problems borne of gross socioeconomic inequality, and their solutions require correspondingly geopolitical solutions.
Although a grossly disproportionate burden of disease from HIV/AIDS, TB and malaria remains in the Global South, these infectious diseases have finally risen to the top of the international agenda in recent years. Ideal strategies for combating these diseases must balance the advantages and disadvantages of 'vertical' disease control programs and 'horizontal' capacity-building approaches.
DISCUSSION
The Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) represents an important step forward in the struggle against these pathogens. While its goals are laudable, significant barriers persist. Most significant is the pitiful lack of funds committed by world governments, particularly those of the very G8 countries whose discussions gave rise to the Fund. A drastic scaling up of resources is the first clear requirement for the GFATM to live up to the international community's lofty intentions. A directly related issue is that of maintaining a strong commitment to the treatment of the three diseases along with traditional prevention approaches, with the ensuing debates over providing affordable access to medications in the face of the pharmaceutical industry's vigorous protection of patent rights.
SUMMARY
At this early point in the Fund's history, it remains to be seen how these issues will be resolved at the programming level. Nevertheless, it is clear that significant structural changes are required in such domains as global spending priorities, debt relief, trade policy, and corporate responsibility. HIV/AIDS, tuberculosis and malaria are global problems borne of gross socioeconomic inequality, and their solutions require correspondingly geopolitical solutions.
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.
Journal Article > CommentaryFull Text
Public Health Ethics. 2009 September 22; Volume 3 (Issue 1); DOI:10.1093/phe/php026
Ford NP, Zachariah R, Mills EJ, Upshur R
Public Health Ethics. 2009 September 22; Volume 3 (Issue 1); DOI:10.1093/phe/php026
Journal Article > ResearchFull Text
Environ Health Perspect. 2001 June 1; Volume 109 (Issue 6); 547-549.; DOI:10.1289/ehp.01109547
Small I, van der Meer J, Upshur R
Environ Health Perspect. 2001 June 1; Volume 109 (Issue 6); 547-549.; DOI:10.1289/ehp.01109547
The Aral Sea area in Central Asia has been encountering one of the world's greatest environmental disasters for more than 15 years. During that time, despite many assessments and millions of dollars spent by large, multinational organizations, little has changed. The 5 million people living in this neglected and virtually unknown part of the world are suffering not only from an environmental catastrophe that has no easy solutions but also from a litany of health problems. The region is often dismissed as a chronic problem where nothing positive can be achieved. Within this complicated context, Medecins Sans Frontieres, winner of the Nobel Peace Prize in 1999, is actively trying to assess the impact of the environmental disaster on human health to help the people who live in the Aral Sea area cope with their environment. Medecins Sans Frontieres has combined a direct medical program to improve the health of the population while conducting operational research to gain a better understanding of the relationship between the environmental disaster and human health outcomes. In this paper we explore the health situation of the region and the broader policy context in which it is situated, and present some ideas that could potentially be applied to many other places in the world that are caught up in environmental and human health disasters.
Journal Article > CommentaryFull Text
Confl Health. 2009 July 10; Volume 3 (Issue 1); 7.; DOI:10.1186/1752-1505-3-7
Ford NP, Mills EJ, Zachariah R, Upshur R
Confl Health. 2009 July 10; Volume 3 (Issue 1); 7.; DOI:10.1186/1752-1505-3-7
Humanitarian agencies are increasingly engaged in research in conflict and post-conflict settings. This is justified by the need to improve the quality of assistance provided in these settings and to collect evidence of the highest standard to inform advocacy and policy change. The instability of conflict-affected areas, and the heightened vulnerability of populations caught in conflict, calls for careful consideration of the research methods employed, the levels of evidence sought, and ethical requirements. Special attention needs to be placed on the feasibility and necessity of doing research in conflict-settings, and the harm-benefit ratio for potential research participants.