CLINICAL TRIALS WITHOUT CONSENT?

被引:10
作者
Kim, Scott Y. H. [1 ]
机构
[1] NIH, Dept Bioeth, 10 Ctr Dr,1C118, Bethesda, MD 20892 USA
基金
美国国家卫生研究院;
关键词
INFORMED-CONSENT; RANDOMIZED-TRIALS; MINIMAL RISK; ETHICS; ENROLLMENT;
D O I
10.1353/pbm.2016.0023
中图分类号
N09 [自然科学史]; B [哲学、宗教];
学科分类号
01 ; 0101 ; 010108 ; 060207 ; 060305 ; 0712 ;
摘要
Fifty years after Beecher's landmark article, an old question is being debated anew: is it ethical to conduct clinical research without consent? This paper provides a systematic analysis of this question. First, it describes five clinical trials that have either been conducted (or proposed) without the subjects providing consent. Second, it reviews a number of conditions that are often provided to justify bypassing of consent and finds that only some of them qualify as necessary conditions for bypassing consent. When those conditions are applied to the clinical trials, only one trial without consent (a type of cluster randomized trial) appears clearly justified; bypassing consent in the remaining four trials is more questionable. The present analysis may be useful in the interpretation of the current U.S. regulations that provide for waivers and alterations of informed consent.
引用
收藏
页码:132 / 146
页数:15
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