Karlawish Jason H T
Department of Medicine, Division of Geriatric Medicine, Ralston-Penn Center, University of Pennsylvania, Rm. 234, 3615 Chestnut Street, Philadelphia, PA 19104-2676, USA.
J Pain Symptom Manage. 2003 Apr;25(4):S14-24. doi: 10.1016/s0885-3924(03)00098-8.
This paper examines the conditions that describe when it is appropriate to conduct research that enrolls a subject near the end-of-life who cannot provide an informed consent. Specifically, it describes conditions that justify when it is acceptable to expose a person to the risks, burdens or discomforts of an intervention that is not intended to benefit that person but to produce generalizable knowledge that will benefit other people. These conditions are: (1) acceptable research risks, (2) proxy decision making, (3) subject assent and dissent, and (4) subject advance consent.
本文探讨了一些条件，这些条件描述了何时适合开展涉及招募临终受试者且该受试者无法提供知情同意的研究。具体而言，它描述了一些条件，这些条件说明了在何种情况下，让一个人承受并非旨在使其受益而是为了产生能使他人受益的可推广知识的干预措施所带来的风险、负担或不适是可接受的。这些条件包括：（1）可接受的研究风险；（2）代理决策；（3）受试者的同意和不同意；以及（4）受试者的预先同意。
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