Consideration and Disclosure of Group Risks in Genomics and Other Data-Centric Research: Does the Common Rule Need Revision?
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...
| Publicado en: | American Journal of Bioethics Vol. 25; no. 2; pp. 47 - 61 |
|---|---|
| Autores principales: | , , , , , , , |
| Formato: | Journal Article |
| Publicado: |
Taylor & Francis Ltd
Feb2025
|
| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=182607506&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 182607506 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 15265161 FKZ jtl: American Journal of Bioethics issn: 15265161 maglogo: N pubinfo: dt: Feb2025 vid: 25 iid: 2 pid: 377 pub: Taylor & Francis Ltd place: Philadelphia, Pennsylvania artinfo: ui: 182607506 10.1080/15265161.2023.2276161 182607506 ppf: 47 ppct: 14 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Consideration and Disclosure of Group Risks in Genomics and Other Data-Centric Research: Does the Common Rule Need Revision? aug: au: Chapman, Carolyn Riley Quinn, Gwendolyn P. Natri, Heini M. Berrios, Courtney Dwyer, Patrick Owens, Kellie Heraty, Síofra Caplan, Arthur L. affil: NYU Grossman School of Medicine sug: subj: Genetic Research Ethical Issues Genomics Government Regulations United States Data Analytics United States Research Subject Recruitment Ethical Issues Consent Ethical Issues Communities ab: 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. pubtype: Academic Journal doctype: Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
|---|