Barred from better medicine? Reexamining regulatory barriers to the inclusion of prisoners in research.
Barred from better medicine? Reexamining regulatory barriers to the inclusion of prisoners in research.
复制标题
禁止使用更好的医学？重新审查将囚犯纳入研究的监管障碍。
DOI：
10.1093/jlb/lsw064
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发表时间：
2017-04
影响因子：
3.4
通讯作者：
Wagner JK
中科院分区：
文献类型：
--
作者：
Huang E;Cauley J;Wagner JK
2015年，奥巴马总统宣布了精准医学倡议®（PMI）计划，这是一个雄心勃勃的纵向项目，旨在彻底改变医学。这项倡议的一个组成部分是招募超过100万美国人参加志愿者研究队列，即USSM研究计划。这一声明引起了人们的极大兴奋，但却没有讨论如何在大规模监禁和刑事司法和医疗保健中的种族差异的社会现实背景下实施“我们所有人研究计划”可能会加剧健康差异。我们研究如何实现倡议的既定目标，反映美国人口的多样性，包括所有有兴趣参与可能会受到监管和行政障碍，参与者谁成为被监禁在纵向研究。联邦对人类受试者研究保护的政策已经提出了修改，但现行的法规和行政政策--在保护主义范式下制定的，以应对限制人口的可耻研究做法--极大地限制了涉及囚犯的研究。我们的审查提供了合理性的倡议政策，预计招聘和保留的障碍，可能会挫败包容性和加剧健康差距的发展。此外，我们质疑对涉及囚犯的生物医学和行为研究的有效禁令，并倡导恢复囚犯参与研究权利的监管改革。健康和正义的差异交织在一起，如果没有监管改革，以促进囚犯的参与性研究权利，并仔细规划可行和负责任的招募，参与和保留战略，倡议可能会错过发现机会，加剧健康差距，并增加对科学的不信任程度。
In 2015, President Obama announced plans for the Precision Medicine Initiative® (PMI), an ambitious longitudinal project aimed at revolutionizing medicine. Integral to this Initiative is the recruitment of over one million Americans into a volunteer research cohort, the All of UsSM Research Program. The announcement has generated much excitement but absent is a discussion of how the All of Us Research Program—to be implemented within the context of social realities of mass incarcerations and racial disparities in criminal justice and healthcare—might excaberate health disparities. We examine how attainment of Initiative's stated goals of reflecting the diversity of the American population and including all who are interested in participating might be impeded by regulatory and administrative barriers to the involvement of participants who become incarcerated during longitudinal studies. Changes have been proposed to the federal policy for human subjects research protections, but current regulations and administrative policies—developed under a protectionist paradigm in response to scandalous research practices with confined populations—dramatically limit research involving prisoners. Our review provides rationale for the development of Initiative policies that anticipate recruitment and retention obstacles that might frustrate inclusivity and exacerbate health disparities. Furthermore, we question the effective ban on biomedical and behavioral research involving prisoners and advocate for regulatory reforms that restore participatory research rights of prisoners. Disparities in health and justice are intertwined, and without regulatory reforms to facilitate participatory research rights of prisoners and careful planning of viable and responsible recruitment, engagement, and retention strategies, Initiative could miss discovery opportunities, exacerbate health disparities, and increase levels of distrust in science.
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