Navigating “regulatory fog”: Challenges to rigorous abortion research after the Dobbs v. Jackson decision

IF 2.3 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Contraception Pub Date : 2025-01-14 DOI:10.1016/j.contraception.2025.110815
Elizabeth A. Mosley , Lucrecia Mena-Meléndez , Heather Gould , Lee Hasselbacher , Melissa Madera , Heidi Moseson , Jane W. Seymour
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Abstract

In 2022, the United States Supreme Court ruling in Dobbs v. Jackson Women’s Health Organization overturned Roe v. Wade and federal protections for abortion. Two years later, 22 states now ban or severely restrict abortion. Sexual and reproductive health scholars aim to document the impacts of these restrictions and bans on individuals, communities, and populations. In this context, human subjects’ protections are more important than ever, as legal risks to abortion providers, seekers, and supporters have increased. However, in this commentary, we discuss how regulatory systems designed to protect human subjects, including Institutional Review Boards and the National Institutes of Health’s Certificates of Confidentiality program, present challenges that create a “regulatory fog,” which stymies abortion scholarship. Research studies have always required a balance of scientific rigor with human subjects’ protections. We argue that, in the current environment, new regulatory constraints make it impossible for some researchers to conduct rigorous abortion research and protect participant confidentiality to the extent that they could before. We offer lessons learned for working in this environment and call for clear guidance and specific protections from federal and institutional leaders to improve research quality and participant safety.
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导航“监管迷雾”:多布斯诉杰克逊案判决后对严格堕胎研究的挑战。
2022年,美国最高法院对多布斯诉杰克逊妇女健康组织案的裁决推翻了罗伊诉韦德案和联邦对堕胎的保护。两年后,现在有22个州禁止或严格限制堕胎。性健康和生殖健康学者的目标是记录这些限制和禁令对个人、社区和人口的影响。在这种情况下,人类受试者的保护比以往任何时候都更加重要,因为堕胎提供者、寻求者和支持者面临的法律风险增加了。然而,在这篇评论中,我们讨论了旨在保护人类受试者的监管系统,包括机构审查委员会和国家卫生研究院的保密证书计划,如何提出挑战,创造了一个“监管迷雾”,阻碍了堕胎研究。研究总是需要在科学的严谨性和人类受试者的保护之间取得平衡。我们认为,在目前的环境下,新的监管约束使得一些研究人员无法进行严格的堕胎研究,也无法像以前那样保护参与者的机密性。我们提供了在这种环境下工作的经验教训,并呼吁联邦和机构领导人提供明确的指导和具体的保护,以提高研究质量和参与者的安全。
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来源期刊
Contraception
Contraception 医学-妇产科学
CiteScore
4.70
自引率
17.20%
发文量
211
审稿时长
69 days
期刊介绍: Contraception has an open access mirror journal Contraception: X, sharing the same aims and scope, editorial team, submission system and rigorous peer review. The journal Contraception wishes to advance reproductive health through the rapid publication of the best and most interesting new scholarship regarding contraception and related fields such as abortion. The journal welcomes manuscripts from investigators working in the laboratory, clinical and social sciences, as well as public health and health professions education.
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Editorial Board Copyright info/Contents Incoming Editor-in-Chief statement Editorial Board Expanding the discourse on patient perceptions of LARC: Beyond trust and relief
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