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Innovations in research ethics governance in humanitarian settings

机译:人道主义环境中研究伦理治理的创新

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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.
机译:背景无国界医生组织(MSF)是世界领先的人道主义医疗组织之一。无国界医生对研究的日益重视导致在2001年成立了道德审查委员会(ERB)。ERB鼓励在审查提案以及ERB与组织之间的互动方面进行创新。这导致了本文所述的道德治理方面的一些进步。讨论我们首先更新我们从2009年以来描述ERB绩效的工作,然后重点介绍五个创新做法:一个指导道德审查的新框架?是否引入了一项政策,以免对常规收集的数据进行后验分析?是否预先批准了“紧急”协议?对“例行调查”的总体道德认可?评估已批准研究的影响新框架鼓励就道德问题进行对话,而不是强加准法律规则,而是与MSF的特定研究环境紧密结合,并更加突出某些价值观和原则。 ERB实施的某些创新,例如审查豁免或通用协议的批准,可能与许多标准操作程序背道而驰。我们认为,研究伦理审查中的许多标准实践都应接受挑战和修订。无国界医生研究人员与独立的ERB成员之间的持续互动,使得ERB与研究人员之间建立了相互信任,相互尊重的伙伴关系,从而实现了不断的创新。将来,三个领域值得特别关注。首先,应评估新框架的影响。其次,需要对研究的影响进行更精确的定义,这是迈向有意义评估的第一步,包括随着时间的推移影响的变化。最后,应加强无国界医生的ERB与研究国家的道德委员会之间的对话。总结我们希望所描述的研究伦理治理方面的创新可能与其他在脆弱环境下开展研究的组织以及审查此类研究的伦理委员会有关。

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