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. 2025 Feb;25(2):47-60.
doi: 10.1080/15265161.2023.2276161. Epub 2023 Nov 27.

Consideration and Disclosure of Group Risks in Genomics and Other Data-Centric Research: Does the Common Rule Need Revision?

Carolyn Riley Chapman  1 , Gwendolyn P Quinn  1 , Heini M Natri  2 , Courtney Berrios  3   4 , Patrick Dwyer  5 , Kellie Owens  1 , Síofra Heraty  6 , Arthur L Caplan  1
Affiliations

Consideration and Disclosure of Group Risks in Genomics and Other Data-Centric Research: Does the Common Rule Need Revision?

Carolyn Riley Chapman et al. Am J Bioeth. 2025 Feb.

Abstract

Harms and risks to groups and third-parties can be significant in the context of research, particularly in data-centric studies involving genomic, artificial intelligence, and/or machine learning technologies. This article explores whether and how United States federal regulations should be adapted to better align with current ethical thinking and protect group interests. Three aspects of the Common Rule deserve attention and reconsideration with respect to group interests: institutional review board (IRB) assessment of the risks/benefits of research; disclosure requirements in the informed consent process; and criteria for waivers of informed consent. In accordance with respect for persons and communities, investigators and IRBs should systematically consider potential group harm when designing and reviewing protocols, respectively. Research participants should be informed about any potential group harm in the consent process. We call for additional public discussion, empirical research, and normative analysis on these issues to determine the right regulatory and policy path forward.

Keywords: Group harm; big data; genetic research; genomic research; informed consent; institutional review board; research ethics.

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