J Leg Med. 2021 Jan-Jun;41(1-2):1-28. doi: 10.1080/01947648.2021.1917464.
We examine the evolution of policies permitting exceptions to or waivers of informed consent for research in the United States. This review reveals that (1) exceptions to the duty to secure informed consent were originally quite narrow; (2) there were two alternative approaches to allowing research on human subjects without their prospective consent: (i) exceptions in which individual capacity to consent is to be assessed and consent tailored to each person's abilities and (ii) waivers of the general requirement for a population of potential subjects, where securing prospective consent would "destroy or invalidate" critically important research; (3) waivers only appeared in the final rulemakings for research regulations issued by the National Institute of Education in 1974 and the Department of Health and Human Services in 1981, limiting the opportunity for the public to weigh in on the scope and use of waivers; and (4) rules adopted since 1981 have almost uniformly added extra requirements to justify waivers. Examples drawn from recent research show expansion of the use of waivers far beyond the bounds originally envisioned. Greater transparency about the use of waivers is needed for the public to weigh in on the standards for foregoing informed consent in human research.
我们考察了美国允许研究中豁免或放弃知情同意的政策的演变。这一审查揭示了：(1) 豁免获取知情同意的义务最初相当狭窄；(2) 有两种替代方法可以在没有潜在研究对象预期同意的情况下进行人体研究：(i) 对个体同意能力进行评估，并根据每个人的能力量身定制同意书的例外情况；(ii) 对潜在研究对象群体的一般要求进行豁免，因为获得预期同意将“破坏或无效”至关重要的研究；(3) 豁免仅出现在 1974 年国家教育研究所和 1981 年卫生与公众服务部发布的研究法规的最终规则制定中，限制了公众对豁免范围和使用的意见；(4) 自 1981 年以来通过的规则几乎一致地增加了额外的要求来证明豁免的合理性。最近的研究例子表明，豁免的使用远远超出了最初设想的范围。为了让公众对人类研究中放弃知情同意的标准进行权衡，需要更加透明地使用豁免。
