Torrance Robert James, Mormina Maru, Sayeed Sadath, Kessel Anthony, Yoon Chang Ho, Cislaghi Beniamino
London School of Hygiene and Tropical Medicine Faculty of Public Health and Policy, London, UK
Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.
J Med Ethics. 2025 Feb 21;51(3):178-181. doi: 10.1136/jme-2023-109146.
This paper examines the institutional mechanisms supporting the ethical oversight of human participant research conducted by the United Nations (UN). The UN has served an instrumental role in shaping international standards on research ethics, which invariably require ethical oversight of all research studies with human participants. The authors' experiences of conducting research collaboratively with UN agencies, in contrast, have led to concern that the UN frequently sponsors, or participates in, studies with human participants that have not received appropriate ethical oversight. It is argued that the institutional mechanisms in place to prevent research with human participants from being undertaken by the UN without ethical oversight do not, at present, extend substantively beyond the provision of guidelines and online training offered by a minority of UN bodies. The WHO and UNICEF are identified as notable exceptions, having implemented various measures to prevent health research with human participants from being undertaken without ethical oversight. Yet, it is highlighted that the WHO and UNICEF are not the only UN bodies that undertake health research with human participants and there are countless actors under the umbrella of the UN system that are regularly involved in non-health research with human participants. Arguments for the pursuit of the highest standard of ethical oversight by UN bodies are presented. Moving forward, the paper asks the question: is it time for the UN to set the standards for the oversight of ethical oversight?
本文探讨了支持对联合国(UN)开展的人类受试者研究进行伦理监督的制度机制。联合国在制定研究伦理国际标准方面发挥了重要作用,这些标准无一例外地要求对所有涉及人类受试者的研究进行伦理监督。然而,作者与联合国机构合作开展研究的经历引发了担忧,即联合国经常赞助或参与未得到适当伦理监督的涉及人类受试者的研究。有人认为,目前为防止联合国在没有伦理监督的情况下开展涉及人类受试者的研究而设立的制度机制,实际上并没有实质性地超越少数联合国机构提供的指导方针和在线培训。世界卫生组织(WHO)和联合国儿童基金会(UNICEF)被视为显著的例外,它们已实施各种措施,以防止在没有伦理监督的情况下开展涉及人类受试者的健康研究。然而,需要强调的是,WHO和UNICEF并非联合国系统内仅有的开展涉及人类受试者健康研究的机构,在联合国系统的框架下,还有无数行为体经常参与涉及人类受试者的非健康研究。文中提出了支持联合国机构追求最高伦理监督标准的论据。展望未来,本文提出一个问题:联合国是否到了为伦理监督制定监督标准的时候了?