Ethical considerations for sharing aggregate results from pragmatic clinical trials.
A growing literature has explored the ethical obligations and current practices related to sharing aggregate results with research participants. However, no prior work has examined these issues in the context of pragmatic clinical trials. Several characteristics of pragmatic clinical trials may comp...
| Publicado en: | Clinical Trials Vol. 22; no. 2; pp. 248 - 255 |
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| Autores principales: | , , , , , , , , , |
| Formato: | tables/charts Journal Article |
| Publicado: |
Sage Publications, Ltd.
Apr2025
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| 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=184442798&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 184442798 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 17407745 AB6 jtl: Clinical Trials issn: 17407745 maglogo: N pubinfo: dt: Apr2025 vid: 22 iid: 2 pid: 33180 pub: Sage Publications, Ltd. place: <Blank> artinfo: ui: 184442798 181127649 184442798 184442798 10.1177/17407745241290782 184442798 ppf: 248 ppct: 7 formats: tig: atl: Ethical considerations for sharing aggregate results from pragmatic clinical trials. aug: au: Morain, Stephanie R Brickler, Abigail Ali, Joseph O'Rourke, Patricia Pearl Spector-Bagdady, Kayte Wilfond, Benjamin Rahimzadeh, Vasiliki Propes, Caleigh Mehl, Kayla Wendler, David affil: Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA sug: subj: Clinical Trials Ethical Issues Decision Making, Ethical Communication Research Subjects Research Personnel Trust Respect Privacy and Confidentiality Access to Information Health Facilities Institutional Review ab: A growing literature has explored the ethical obligations and current practices related to sharing aggregate results with research participants. However, no prior work has examined these issues in the context of pragmatic clinical trials. Several characteristics of pragmatic clinical trials may complicate both the ethics and the logistics of sharing aggregate results. Among these characteristics include that pragmatic clinical trials may affect the rights, welfare, and interests of not only patient-subjects but also clinicians, meaning that results may be owed to a broader range of groups than typically considered in other research contexts. In addition, some pragmatic clinical trials are conducted under a waiver of informed consent, meaning sharing results may alert participants that they were enrolled without their consent. This article explores the ethical dimensions that can inform decision-making about sharing aggregate results from pragmatic clinical trials, and provides recommendations for that sharing. A central insight is that healthcare institutions—as key partners for the conduct of pragmatic clinical trials—must also be key partners in decision-making about sharing aggregate pragmatic clinical trial results. We conclude with insights for future research. pubtype: Academic Journal doctype: tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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