Schopper Doris, Ravinetto Raffaella, Schwartz Lisa, Kamaara Eunice, Sheel Sunita, Segelid Michael J, Ahmad Aasim, Dawson Angus, Singh Jerome, Jesani Amar, Upshur Ross
Medical Faculty, University of Geneva, Center for Education and Research in Humanitarian Action (CERAH).
Department of Clinical Sciences, Institute of Tropical Medicine, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven.
Public Health Ethics. 2017 Apr;10(1):49-61. doi: 10.1093/phe/phw039. Epub 2016 Nov 1.
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.
在最近的埃博拉疫情期间,无国界医生组织(MSF)的伦理审查委员会(ERB)以前所未有的方式被要求以“紧急”模式提供建议并审查研究方案。2014年3月至2015年8月期间,对27项与埃博拉相关的研究方案进行了审查,范围从流行病学研究、行为研究、感染性研究到处于(非常)早期开发阶段的使用研究产品的临床试验。本文考察了无国界医生组织伦理审查委员会在这种情况下处理与审查过程及实质性伦理问题相关事宜的经验。这些议题包括缺乏关于血样采集和使用的政策,以及让社区参与血样储存及未来使用的讨论;将孕妇排除在临床试验和疫苗试验之外;以及开展及时且高质量的定性/人类学研究以考虑潜在前期危害的困难。注意到各伦理委员会(EC)之间存在不同标准后,我们建议,在突发公共卫生事件期间对临床试验和疫苗试验进行多次伦理审查时,相关伦理委员会之间应进行透明的沟通。无国界医生组织伦理审查委员会的经验应引发关于紧急疫情期间“最佳”伦理审查以及需要进行哪些持久的结构性变革以改进伦理审查过程的更广泛讨论。