Wendler David, Abdoler Emily
Department of Bioethics, NIH Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Kennedy Inst Ethics J. 2010 Dec;20(4):353-70.
There has been long-standing, albeit largely implicit, debate over whether investigator intentions are relevant to the ethical appropriateness of clinical research. Some commentators argue that whether investigators intend to collect generalizable knowledge or to benefit subjects is central to the ethics of clinical research. Others do not even mention investigator intentions when evaluating what makes clinical research ethical. To shed light on this debate, the present paper considers the reasons why investigator intentions might be ethically relevant. This analysis reveals that investigator intentions are related to, but distinct from three ethical requirements: whether subjects understand that they are contributing to a project to help others, whether the included interventions have an appropriate risk/benefit ratio, and whether subjects' interests are adequately protected. Provided these three requirements are satisfied, the ethical appropriateness of clinical research does not depend on what intentions investigators have in conducting it.
关于研究者的意图是否与临床研究的伦理适当性相关，一直存在着长期的争论，尽管这种争论很大程度上是隐含的。一些评论家认为，研究者是打算收集可推广的知识还是使受试者受益，这对临床研究的伦理至关重要。另一些人在评估临床研究的伦理因素时甚至都不提及研究者的意图。为了阐明这场争论，本文探讨了研究者意图可能在伦理上相关的原因。这一分析表明，研究者意图与三项伦理要求相关，但又有所不同：受试者是否明白他们正在为一个帮助他人的项目做出贡献、所采用的干预措施是否具有适当的风险/收益比，以及受试者的利益是否得到充分保护。只要满足这三项要求，临床研究的伦理适当性就不取决于研究者进行该研究时的意图。
