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
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 > ResearchFull Text
N Engl J Med. 2016 January 7; Volume 374 (Issue 1); 33-42.; DOI:10.1056/NEJMoa1511812
van Griensven J, Edwards T, de Lamballerie X, Semple MG, Gallian P, et al.
N Engl J Med. 2016 January 7; Volume 374 (Issue 1); 33-42.; DOI:10.1056/NEJMoa1511812
BACKGROUND
In the wake of the recent outbreak of Ebola virus disease (EVD) in several African countries, the World Health Organization prioritized the evaluation of treatment with convalescent plasma derived from patients who have recovered from the disease. We evaluated the safety and efficacy of convalescent plasma for the treatment of EVD in Guinea.
METHODS
In this nonrandomized, comparative study, 99 patients of various ages (including pregnant women) with confirmed EVD received two consecutive transfusions of 200 to 250 ml of ABO-compatible convalescent plasma, with each unit of plasma obtained from a separate convalescent donor. The transfusions were initiated on the day of diagnosis or up to 2 days later. The level of neutralizing antibodies against Ebola virus in the plasma was unknown at the time of administration. The control group was 418 patients who had been treated at the same center during the previous 5 months. The primary outcome was the risk of death during the period from 3 to 16 days after diagnosis with adjustments for age and the baseline cycle-threshold value on polymerase-chain-reaction assay; patients who had died before day 3 were excluded. The clinically important difference was defined as an absolute reduction in mortality of 20 percentage points in the convalescent-plasma group as compared with the control group.
RESULTS
A total of 84 patients who were treated with plasma were included in the primary analysis. At baseline, the convalescent-plasma group had slightly higher cycle-threshold values and a shorter duration of symptoms than did the control group, along with a higher frequency of eye redness and difficulty in swallowing. From day 3 to day 16 after diagnosis, the risk of death was 31% in the convalescent-plasma group and 38% in the control group (risk difference, -7 percentage points; 95% confidence interval [CI], -18 to 4). The difference was reduced after adjustment for age and cycle-threshold value (adjusted risk difference, -3 percentage points; 95% CI, -13 to 8). No serious adverse reactions associated with the use of convalescent plasma were observed.
CONCLUSIONS
The transfusion of up to 500 ml of convalescent plasma with unknown levels of neutralizing antibodies in 84 patients with confirmed EVD was not associated with a significant improvement in survival. (Funded by the European Union's Horizon 2020 Research and Innovation Program and others; ClinicalTrials.gov number, NCT02342171.).
In the wake of the recent outbreak of Ebola virus disease (EVD) in several African countries, the World Health Organization prioritized the evaluation of treatment with convalescent plasma derived from patients who have recovered from the disease. We evaluated the safety and efficacy of convalescent plasma for the treatment of EVD in Guinea.
METHODS
In this nonrandomized, comparative study, 99 patients of various ages (including pregnant women) with confirmed EVD received two consecutive transfusions of 200 to 250 ml of ABO-compatible convalescent plasma, with each unit of plasma obtained from a separate convalescent donor. The transfusions were initiated on the day of diagnosis or up to 2 days later. The level of neutralizing antibodies against Ebola virus in the plasma was unknown at the time of administration. The control group was 418 patients who had been treated at the same center during the previous 5 months. The primary outcome was the risk of death during the period from 3 to 16 days after diagnosis with adjustments for age and the baseline cycle-threshold value on polymerase-chain-reaction assay; patients who had died before day 3 were excluded. The clinically important difference was defined as an absolute reduction in mortality of 20 percentage points in the convalescent-plasma group as compared with the control group.
RESULTS
A total of 84 patients who were treated with plasma were included in the primary analysis. At baseline, the convalescent-plasma group had slightly higher cycle-threshold values and a shorter duration of symptoms than did the control group, along with a higher frequency of eye redness and difficulty in swallowing. From day 3 to day 16 after diagnosis, the risk of death was 31% in the convalescent-plasma group and 38% in the control group (risk difference, -7 percentage points; 95% confidence interval [CI], -18 to 4). The difference was reduced after adjustment for age and cycle-threshold value (adjusted risk difference, -3 percentage points; 95% CI, -13 to 8). No serious adverse reactions associated with the use of convalescent plasma were observed.
CONCLUSIONS
The transfusion of up to 500 ml of convalescent plasma with unknown levels of neutralizing antibodies in 84 patients with confirmed EVD was not associated with a significant improvement in survival. (Funded by the European Union's Horizon 2020 Research and Innovation Program and others; ClinicalTrials.gov number, NCT02342171.).
Journal Article > ResearchFull Text
BMJ Open. 2019 May 1; Volume 9 (Issue 5); e029141.; DOI:10.1136/bmjopen-2019-029141
Sunyoto T, Potet J, den Boer ML, Ritmeijer KKD, Postigo JAR, et al.
BMJ Open. 2019 May 1; Volume 9 (Issue 5); e029141.; DOI:10.1136/bmjopen-2019-029141
OBJECTIVES:
To understand stakeholders' perceptions of the access barriers to quality-assured diagnostics and medicines for leishmaniasis in the high-burden region of eastern Africa, and to identify key bottlenecks to improve the supply of commodities for neglected tropical diseases.
DESIGN:
Desk reviews and qualitative in-depth interview study with purposive sampling.
METHODS:
A landscape analysis through literature and desk review was performed. Next, 29 representatives from international organisations, non-governmental agencies, national control programmes from six countries (Ethiopia, Kenya, Somalia, South Sudan, Sudan and Uganda) and manufacturers were interviewed between May and July 2018. Participants were selected purposively and expanded through a snowballing technique.Data analysis was aided by NVivo, applying the framework method as a part of the thematic content analysis approach.
RESULTS:
The barriers along the visceral leishmaniasis (VL) supply chain were identified as emerging themes, grouped across supply chain activities and health systems component(s). Stakeholders expressed the perception of progress, but bottlenecks persist. VL medicines, in general, lack multisource production capacity and with small market volume, expansion of suppliers is difficult. Procurement is plagued by forecasting difficulties, complex regulatory policies and procedures, and distribution challenges. Weak communication and coordination across different levels resulted in shortages and loss of trust among different actors. Cross-cutting issues spanned from limited political and resource commitment due to low awareness and limited in-country capacity. However, study respondents were optimistic to pursue several remedies, most importantly to build bridges between supply and demand sides through continued dialogue and collaborations. Diagnostics supply has mostly been overlooked; thus, improved investment in this area is needed.
CONCLUSIONS:
Addressing supply barriers in eastern Africa requires consistent, specific efforts at the global and national levels, progressing from current partnerships and agreements. Priority actions include pooled procurement, improved forecast, and increased commitment and resources. Sustainability remains an elusive goal, yet to be integrated into discussions moving forward.
To understand stakeholders' perceptions of the access barriers to quality-assured diagnostics and medicines for leishmaniasis in the high-burden region of eastern Africa, and to identify key bottlenecks to improve the supply of commodities for neglected tropical diseases.
DESIGN:
Desk reviews and qualitative in-depth interview study with purposive sampling.
METHODS:
A landscape analysis through literature and desk review was performed. Next, 29 representatives from international organisations, non-governmental agencies, national control programmes from six countries (Ethiopia, Kenya, Somalia, South Sudan, Sudan and Uganda) and manufacturers were interviewed between May and July 2018. Participants were selected purposively and expanded through a snowballing technique.Data analysis was aided by NVivo, applying the framework method as a part of the thematic content analysis approach.
RESULTS:
The barriers along the visceral leishmaniasis (VL) supply chain were identified as emerging themes, grouped across supply chain activities and health systems component(s). Stakeholders expressed the perception of progress, but bottlenecks persist. VL medicines, in general, lack multisource production capacity and with small market volume, expansion of suppliers is difficult. Procurement is plagued by forecasting difficulties, complex regulatory policies and procedures, and distribution challenges. Weak communication and coordination across different levels resulted in shortages and loss of trust among different actors. Cross-cutting issues spanned from limited political and resource commitment due to low awareness and limited in-country capacity. However, study respondents were optimistic to pursue several remedies, most importantly to build bridges between supply and demand sides through continued dialogue and collaborations. Diagnostics supply has mostly been overlooked; thus, improved investment in this area is needed.
CONCLUSIONS:
Addressing supply barriers in eastern Africa requires consistent, specific efforts at the global and national levels, progressing from current partnerships and agreements. Priority actions include pooled procurement, improved forecast, and increased commitment and resources. Sustainability remains an elusive goal, yet to be integrated into discussions moving forward.
Journal Article > CommentaryFull Text
Lancet. 2009 June 20; Volume 373 (Issue 9681); DOI:10.1016/S0140-6736(09)61151-X
Ravinetto R, Lodesani C, D'Alessandro U, De Filippi L, Pontiroli A
Lancet. 2009 June 20; Volume 373 (Issue 9681); DOI:10.1016/S0140-6736(09)61151-X
Journal Article > ResearchFull Text
Clin Infect Dis. 2017 September 13; Volume 66 (Issue 3); DOI:10.1093/cid/cix807
Diro EGJ, Ritmeijer KKD, Boelaert M, Alves F, Mohammed R, et al.
Clin Infect Dis. 2017 September 13; Volume 66 (Issue 3); DOI:10.1093/cid/cix807
We have conducted a single-arm trial evaluating monthly pentamidine secondary prophylaxis (PSP) to prevent visceral leishmaniasis (VL) relapse in Ethiopian HIV-patients. Outcomes at 12 months of PSP have been previously reported, supporting PSP effectiveness and safety. However, remaining relapse-free after PSP discontinuation is vital. We now report outcomes and associated factors for a period of upto 2.5 years after initiating PSP, including one year follow-up after PSP discontinuation.
Journal Article > ReviewFull Text
PLoS Negl Trop Dis. 2016 November 3; Volume 10 (Issue 11); DOI:10.1371/journal.pntd.0004654
Ravinetto R, Alirol E, Mahendradhata Y, Rijal S, Lutumba P, et al.
PLoS Negl Trop Dis. 2016 November 3; Volume 10 (Issue 11); DOI:10.1371/journal.pntd.0004654
Journal Article > CommentaryFull Text
J Pharm Policy Pract. 2016 November 10; Volume 9 (Issue 1); 36.; DOI:10.1186/s40545-016-0088-0
Ravinetto R, Vandenbergh D, Macé C, Pouget C, Renchon B, et al.
J Pharm Policy Pract. 2016 November 10; Volume 9 (Issue 1); 36.; DOI:10.1186/s40545-016-0088-0
The globalization of pharmaceutical production has not been accompanied by a strengthening and harmonization of the regulatory systems worldwide. Thus, the global market is characterized today by a situation of multiple standards, and patients in low- and middle-income countries are exposed to the risk of receiving poor-quality medicines. Among those who first raised the alarm on this problem, there were pioneering humanitarian groups, who were in a privileged position to witness the gap in quality of medicines between high-income countries and low- and middle-income countries.
Despite an increasing awareness of the problem and the launch of some positive initiatives, the divide in pharmaceutical quality between the North and the South remains important, and insufficiently addressed. More advocacy is needed for universal access to quality-assured medicines. It should target all those who are strongly "involved" with medicines: regulators, international organizations, journalists, purchasers, prescribers, program managers, policy makers, public health actors and the patients. Advocacy should be based on evidence from research and monitoring programs, and technical concepts should be translated in lay language through communication tools that address all the stakeholders. The fight to ensure universal access to quality medicines needs the participation of all, and can only be successful if grounded in common understanding.
Despite an increasing awareness of the problem and the launch of some positive initiatives, the divide in pharmaceutical quality between the North and the South remains important, and insufficiently addressed. More advocacy is needed for universal access to quality-assured medicines. It should target all those who are strongly "involved" with medicines: regulators, international organizations, journalists, purchasers, prescribers, program managers, policy makers, public health actors and the patients. Advocacy should be based on evidence from research and monitoring programs, and technical concepts should be translated in lay language through communication tools that address all the stakeholders. The fight to ensure universal access to quality medicines needs the participation of all, and can only be successful if grounded in common understanding.