Jansen Lynn A
Oregon Health & Science University, Portland, Oregon, USA.
J Med Philos. 2018 May 9;43(3):342-360. doi: 10.1093/jmp/jhy006.
There is broad agreement among research ethicists that investigators have a duty to obtain the informed consent of all subjects who participate in their research trials. On a common view, the duty to obtain this informed consent follows from the need to respect persons and their autonomous decisions. However, the nature of informed consent and the demands it places on investigators are open to dispute and recently have been challenged. Respect for persons, it has been claimed, does not require investigators to guarantee that the subjects enrolled in their trials comprehend the risk/benefit information disclosed to them or even that they appreciate the difference between research and therapy. According to this critique, the significance of defects in informed consent, like therapeutic misconception or unrealistic optimism, has been greatly exaggerated. This article reevaluates informed consent in clinical research in light of this critique. It not only rebuts the main points the critics raise, but also shows that other points they raise can be accepted by a doctrine of informed consent that resembles the common view in maintaining that autonomous authorization is central to informed consent.
研究伦理学家们普遍认为，研究者有责任获得所有参与其研究试验的受试者的知情同意。一种常见的观点认为，获得这种知情同意的责任源于尊重个人及其自主决定的需要。然而，知情同意的性质及其对研究者的要求存在争议，并且最近受到了挑战。有人声称，尊重个人并不要求研究者保证参与其试验的受试者理解向他们披露的风险/益处信息，甚至不要求他们理解研究与治疗之间的区别。根据这种批评，知情同意中的缺陷，如治疗性误解或不切实际的乐观态度，其重要性被大大夸大了。本文根据这种批评重新评估了临床研究中的知情同意。它不仅反驳了批评者提出的主要观点，还表明他们提出的其他观点可以被一种类似于常见观点的知情同意学说所接受，这种学说认为自主授权是知情同意的核心。
