Evidence map›Paper›PMID 38010648›Full record

ArticleThe American journal of bioethics : AJOB2025

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

Carolyn Riley Chapman, Gwendolyn P Quinn, Heini M Natri, Courtney Berrios, Patrick Dwyer, Kellie Owens, Síofra Heraty, Arthur L Caplan

Abstract read
In one paragraph

Article in The American journal of bioethics : AJOB, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Participant Perspectives on Data Sharing in Clinical Craniofacial Research: Qualitative Interviews With Participants With Craniofacial Microsomia and Their Caregivers.The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association · 2026
    Article
  3. Review
  4. Navigating data sharing in research.American journal of human genetics · 2026
    Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Why Revise When We Should Reconcile?The American journal of bioethics : AJOB · 2025
    Article
  12. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Carolyn Riley ChapmanNYU Grossman School of Medicine.ORCID 0000-0002-8793-6412
Gwendolyn P QuinnNYU Grossman School of Medicine.ORCID 0000-0002-4208-9889
Heini M NatriThe Translational Genomics Research Institute.ORCID 0000-0003-4698-6103
Courtney BerriosChildren's Mercy Kansas City.ORCID 0000-0001-5170-070X
Patrick DwyerUniversity of California, Davis.ORCID 0000-0003-1779-5252
Kellie OwensNYU Grossman School of Medicine.ORCID 0000-0002-2602-5762
Síofra HeratyBirkbeck, University of London.ORCID 0000-0001-8023-367X
Arthur L CaplanNYU Grossman School of Medicine.ORCID 0000-0002-4061-8011

Funding

Conceptualizing Actionability in Clinical Genomic ScreeningR00HG010905 · NHGRI · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI OWENS, KELLIE NICOLE · 2022 to 2024
$727k
NHGRI NIH HHS R00 HG010905
6 · The paper itself

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.

Indexed as

DisclosureGenomicsInformed ConsentResearch SubjectsArtificial IntelligenceEthics Committees, ResearchEthics, ResearchHumansRisk AssessmentUnited Statesbig datagenetic researchgenomic researchGroup harminformed consentinstitutional review boardresearch ethics

Identifiers

PMID38010648
PMCPMC11167719

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.