The Indefinite "Stay" on Regulatory Reforms for Research With Prisoners.
The Indefinite "Stay" on Regulatory Reforms for Research With Prisoners.
复制标题
囚犯研究监管改革无限期“停留”。
DOI：
10.1080/15265161.2017.1328534
复制
发表时间：
2017
期刊：
影响因子：
--
通讯作者：
Wagner,JenniferK
中科院分区：
文献类型：
--
作者：
Huang,Elaine;Wagner,JenniferK
可以说，判决已经出来了。卫生与公众服务部（HHS）发布了2018年通用规则，据称该规则“允许更大的灵活性，以适应当今动态的研究环境”（HHS 2017）。当研究法规改革“一生一次”（Capron 2017）时，在进一步推进之前，应该达到一个高标准。然而，正如HHS所承认的，“最终规则并未对45 CFR第46部分B、C和D子部分的HHS法规进行修订”（联邦人类受试者保护政策，2017年，7183）。因此，受这些附加子部分管辖的弱势群体中的个人被明确排除在改进监督和促进现代研究所需的早就应该进行的更新之外。由于决定将改革工作仅限于A分节，卫生和公众服务部实际上对囚犯的监管改革实行了无限期的“暂停”。虽然这一结果并不令人惊讶，而且2011年拟议规则制定的预先通知中对研究需求和囚犯利益的考虑给予的关注很少，（ANPRM; 2011年人类受试者研究保护）和2015年拟议规则制定通知（NPRM;联邦人类受试者保护政策，2015年），然而，这是一个令人失望的错过的机会，值得批评。
The verdict is in, so to speak. The Department of Health and Human Services (HHS) has issued the 2018 Common Rule, which purportedly “allows more flexibility in keeping with today’s dynamic research environment”(HHS 2017). When reforms for research regulations come “once in a lifetime”(Capron 2017), a high bar should be met before kicking the can further down the road. Yet, as HHS acknowledged,“The final rule does not make revisions to the HHS regulations at 45 CFR part 46, subparts B, C, and D”(Federal Policy for the Protection of Human Subjects 2017, 7183). Thus, individuals within the vulnerable populations governed by these additional subparts are categorically excluded from long-overdue updates needed to improve oversight and facilitate modern-day research. With its decision to restrict the reform efforts exclusively to subpart A, HHS has effectively imposed an indefinite “stay” on regulatory reforms for prisoners. While this outcome is not surprising and was foreshadowed by the minimal attention given to consideration of research needs and interests of prisoners in the 2011 advance notice of proposed rulemaking (ANPRM; Human Subjects Research Protections 2011) and 2015 notice of proposed rulemaking (NPRM; Federal Policy for the Protection of Human Subjects 2015), it is nevertheless a disappointing missed opportunity that warrants criticism.