Vulnerable Research Participant Policies at U.S. Academic Institutions.

Irene Jonathan, Eliza Akers, Min Shi, David B Resnik
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Abstract

Background: Historically, some of the worst abuses of human research participants have involved populations which are vulnerable to coercion, harm, or exploitation, such as prisoners, children, and people with compromised decision-making abilities. Although there has been considerable philosophical and ethical debate about how to protect vulnerable populations, there have been only a handful of empirical studies on vulnerable population policies. Methods: We conducted a cross-sectional study on vulnerable population policies from the 105 top funded U.S. academic research institutions. We used deductive and inductive methods to develop our framework for coding the policies. We tested for associations between policies and research and development expenditure rank, public vs. private status, geographic region, and Association for Accreditation of Human Research Protection Programs accreditation (AAHRRP). Results: U.S. academic institutions have a variety of policies for research with vulnerable populations. Every institution in our sample had at least 2 policies for research with vulnerable populations (including a general policy) and most had 8 or more. As expected, the most highly prevalent policies pertained to populations covered in subparts B, C, and D of the Common Rule (pregnant women, fetuses, neonates, prisoners, and children) but other groups were well-represented, including people with disabilities; people with impaired decision-making capacity; students/trainees; and people with limited English proficiency including illiteracy. AAHRRP accreditation was positively associated with eight different types of policies. Conclusion: U.S. academic institutions have a variety of policies for research with vulnerable populations. Additional research is needed to better understand the types of safeguards that institutions have adopted to protect vulnerable populations and the factors that influence policy development.

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美国学术机构的弱势研究参与者政策。
背景:从历史上看,一些最严重的虐待人类研究参与者的行为涉及易受胁迫、伤害或剥削的人群,如囚犯、儿童和决策能力受损的人。虽然关于如何保护易受伤害人群的哲学和伦理争论颇多,但关于易受伤害人群政策的实证研究却屈指可数。方法:我们对美国 105 家最受资助的学术研究机构的弱势人群政策进行了横向研究。我们使用演绎法和归纳法制定了政策编码框架。我们检验了政策与研发支出排名、公立与私立地位、地理区域以及人类研究保护计划认证协会(AAHRRP)之间的关联。研究结果美国学术机构针对弱势人群的研究制定了各种政策。在我们的样本中,每所院校都至少有 2 项针对弱势人群的研究政策(包括一项一般政策),大多数院校有 8 项或更多。不出所料,最普遍的政策涉及《共同规则》B、C 和 D 子部分所涵盖的人群(孕妇、胎儿、新生儿、囚犯和儿童),但其他群体也很普遍,包括残障人士、决策能力受损者、学生/受训者以及英语水平有限者(包括文盲)。AAHRRP 认证与八种不同类型的政策呈正相关。结论美国学术机构有各种针对弱势群体的研究政策。为了更好地了解学术机构为保护弱势群体而采取的保障措施类型以及影响政策制定的因素,还需要开展更多的研究。
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来源期刊
CiteScore
3.50
自引率
7.70%
发文量
30
审稿时长
>12 weeks
期刊介绍: The Journal of Empirical Research on Human Research Ethics (JERHRE) is the only journal in the field of human research ethics dedicated exclusively to empirical research. Empirical knowledge translates ethical principles into procedures appropriate to specific cultures, contexts, and research topics. The journal''s distinguished editorial and advisory board brings a range of expertise and international perspective to provide high-quality double-blind peer-reviewed original articles.
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