School of Health Sciences, City, University of London, UK.
Department of Intensive Care Medicine, Nottingham University NHS Trust, Nottingham, UK.
Anaesthesia. 2020 Sep;75(9):1229-1235. doi: 10.1111/anae.15039. Epub 2020 Apr 24.
In the last decade, research in transplant medicine has focused on developing interventions in the management of the deceased organ donor to improve the quality and quantity of transplantable organs. Despite the promise of interventional donor research, there remain debates about the ethics of this research, specifically regarding gaining research consent. Here, we examine the concerns and ambiguities around consent for interventional donor research, which incorporate questions about who should consent for interventional donor research and what people are being asked to consent for. We highlight the US and UK policy responses to these concerns and argue that, whereas guidance in this area has done much to clarify these ambiguities, there is little consideration of the nature, practicalities and context around consent in this area, particularly regarding organ donors and their families. We review wider studies of consent in critical care research and social science studies of consent in medical research, to gain a broader view of consent in this area as a relational and contextual process. We contend a lack of consideration has been given to: what it might mean to consent to interventional donor research; how families, patients and health professionals might experience providing and seeking this consent; who is best placed to have these discussions; and the socio-institutional contexts affecting these processes. Further, empirical research is required to establish an ethical and sensitive model for consent in interventional donor research, ensuring the principles enshrined in research ethics are met and public trust in organ donation is maintained.
在过去的十年中，移植医学领域的研究重点是开发干预措施来管理已故器官捐献者，以提高可移植器官的质量和数量。尽管有介入性供体研究的承诺，但人们仍对这项研究的伦理道德存在争议，特别是在获取研究同意方面。在这里，我们研究了介入性供体研究同意的关注问题和模糊性，其中包括谁应该同意介入性供体研究以及人们被要求同意什么。我们强调了美国和英国对这些问题的政策回应，并认为，尽管这方面的指导在很大程度上澄清了这些模糊性，但几乎没有考虑到这一领域同意的性质、实际情况和背景，特别是关于器官捐献者及其家属。我们回顾了重症监护研究中的更广泛的同意研究以及医学研究中社会科学对同意的研究，以更全面地了解这一领域作为一个关系和背景过程的同意。我们认为，人们没有考虑到：同意介入性供体研究意味着什么；家属、患者和医疗保健专业人员提供和寻求这种同意的经历如何；谁最适合进行这些讨论；以及影响这些过程的社会制度背景。此外，需要进行实证研究，为介入性供体研究中的同意建立一个合乎伦理和敏感的模式，确保研究伦理中所确立的原则得到遵守，并维护公众对器官捐赠的信任。
