Clearing complexity from the Common Rule NPRM
Clearing complexity from the Common Rule NPRM
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DOI：
10.1093/jlb/lsw026
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发表时间：
2016-08-01
影响因子：
3.4
通讯作者：
Majumder, Mary A.
中科院分区：
文献类型：
--
作者：
Guerrini, Christi J.;McGuire, Amy L.;Majumder, Mary A.
2015年9月8日，美国卫生与公众服务部提议对被称为“共同规则”的法规进行重大修改，其目的是保护联邦资助研究中的人类受试者。有人批评拟议的改革给研究工作增加了不必要的负担。虽然一些拟议的修改得到了合理的实际、法律的或道德考虑的支持，但我们认为其他修改缺乏令人信服的理由。本文讨论了那些我们认为特别有问题的不合理的变化，重点是在一些条款中对涉及数据的二次研究和涉及生物标本的二次研究的不同处理。这种不同处理的主要理由是，个人对研究使用其生物标本有强烈的自主权，而不涉及其私人信息。我们解释了为什么这一点和其他理由经不起审查，以及拟议的变化将如何为研究的进行引入新的复杂性，同时激励破坏共同规则的有效性和完整性的行为。最后，我们建议从最终通过的法规中删除这些不合理的复杂性。
On September 8, 2015, the U.S. Department of Health and Human Services proposed major changes to the regulations known as the Common Rule, whose purpose is to protect human subjects in federally funded research. The proposed changes have been criticized as unduly burdening the conduct of research. While some of the proposed changes are supported by legitimate practical, legal, or ethical considerations, we believe that others lack compelling justification. This article addresses those unjustified changes that we view as especially problematic, focusing on the proposed disparate treatment of secondary research involving data and secondary research involving biospecimens across a number of provisions. The primary rationale for this disparate treatment is that individuals have a strong autonomy interest in the research use of their biospecimens that does not extend to their private information. We explain why this and other justifications do not hold up to scrutiny and how the proposed changes will introduce new layers of complexity to the conduct of research while incentivizing behaviors that undermine the Common Rule's effectiveness and integrity. We conclude by recommending the removal of these unjustified complexities from the regulations that ultimately are adopted.