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

American Journal of Bioethics 25 (2):47-60 (2023)
  Copy   BIBTEX

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.

Other Versions

No versions found

Links

PhilArchive



    Upload a copy of this work     Papers currently archived: 101,934

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

Group Risks: Thinking Outside the Box.Megan Doerr & Sara Meeder - 2025 - American Journal of Bioethics 25 (2):61-64.
The Ethical Analysis of Risk.Charles Weijer - 2000 - Journal of Law, Medicine and Ethics 28 (4):344-361.
Can informed consent to research be adapted to risk?Danielle Bromwich & Annette Rid - 2015 - Journal of Medical Ethics 41 (7):521-528.

Analytics

Added to PP
2023-11-28

Downloads
35 (#658,033)

6 months
12 (#325,295)

Historical graph of downloads
How can I increase my downloads?

Author Profiles

Arthur L. Caplan
New York University
Patrick Dwyer
Rice University