Alenichev Arsenii
Department of Anthropology, University of Amsterdam, Amsterdam, Netherlands.
Barcelona Institute for Global Health, Barcelona, Spain.
Glob Bioeth. 2020 Feb 21;31(1):13-28. doi: 10.1080/11287462.2020.1726591. eCollection 2020.
Participant non-compliance and withdrawal from randomized clinical trials has increased focus on analysing the results from the "per-protocol" population that complies with a trial's protocols. There is no clear understanding of what shapes protocol compliance in practice. In this paper, I theorize clinical research from the perspective of participants in an Ebola vaccine trial by analysing the practices that contributed to very high compliance rates. In this setting, per-protocol compliance became an essential component in forming a class of "proper" researchers and participants working together in the rapidly expanding market of clinical research. Bioethics supports participants' right to withdraw from research as an ethical safeguard in the process. But participants seeking affiliations with powerful institutions may voluntarily embrace their trial responsibilities over a right to withdraw. To understand this phenomenon, this analysis uses the notion of - the set of rules specifying "proper" and "improper" trial subjects and behaviours - which runs in the shadow of formal bioethics in trials and requires careful transdisciplinary examination.
参与者不遵守规定以及退出随机临床试验的情况，使得人们更加关注对遵循试验方案的“符合方案”人群的结果进行分析。目前对于在实际中影响方案依从性的因素尚无清晰的认识。在本文中，我通过分析促成极高依从率的实践，从埃博拉疫苗试验参与者的角度对临床研究进行理论分析。在这种情况下，符合方案的依从性成为在迅速扩张的临床研究市场中，形成一类共同合作的“合格”研究者和参与者的一个重要组成部分。生物伦理学支持参与者退出研究的权利，将其作为该过程中的一种伦理保障。但寻求与强大机构建立联系的参与者可能会自愿承担试验责任，而放弃退出权。为理解这一现象，本分析采用了“准伦理”这一概念——即规定“合格”与“不合格”试验对象及行为的一系列规则——它在试验中正式生物伦理学的阴影下运行，需要进行细致的跨学科审视。
