Innovations in research ethics governance in humanitarian settings

Abstract

BackgroundMédecins 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.DiscussionWe 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 studiesThe 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.SummaryWe 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.

Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands

“…The variations in exemptions from 'full' ethics review we have identified suggest opportunities to extend documentation of international and intranational differences and proposals for streamlining of ethics review processes. Although innovation in the area of ethics review may pose considerable challenge, some innovations in this area have recently been implemented and described [34][35][36]; for example, in a review of its research ethics processes, Médecins Sans Frontières developed four innovative practices, namely (1) introduction of a policy exempting a posteriori analysis of routinely collected data; (2) the preapproval of 'emergency' protocols; (3) general ethics approval of 'routine' surveys; and (4) evaluating the impact of approved studies [36]. Nevertheless, the aforementioned criticisms of current practices in ethics reviewsthat they impede research, fail to protect participants, are burdensome and inconsistent across sitescoupled with the calls to investigate and implement 'alternative' models of review, make clear that further innovation and evaluation is still much needed [36,37].…”

The ethical contours of research in crisis settings: five practical considerations for academic institutional review boards and researchers

“…Lastly, literacy levels may be particularly low in areas of chronic conflict, making written consent inappropriate. It follows that verbal consent or other forms of agreement, such as thumbprinting without names (Tindana, Kass, and Akweongo, 2006; Schopper et al, 2015), must be considered by IRBs, as long as the criteria for waiving documentation of consent have been met.…”

“…As research in humanitarian settings has increased in recent years, the requirement of academic IRBs for a parallel review by national or local IRBs remains fundamentally and critically important (Ford et al, 2009; Schopper et al, 2015). As a principle of conducting ethical research, although not mandated by US federal regulations, national IRBs, wherever possible, should review and approve proposed research.…”

Multiple ethical review in North–South collaborative research: the experience of the Ebola-Tx trial in Guinea

“…Committee-specific questionnaires or templates were to be filled in for the majority of ECs (4/6). There were major differences across these templates, which ranged from simple checklists, to an on-line submission form including both checklists and narrative texts, to the template of the MSF ethics review board (ERB), based on a series of open-ended questions (11). As for the submission methods, one EC used a web-based submission platform, requiring log-in credentials; three required the submission package on paper as well as an electronic copy; and the two remaining ECs received all documents electronically only.…”