Ethical considerations for sharing aggregate results from pragmatic clinical trials.

Autor:	Morain SR; Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA.; Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA., Brickler A; Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA., Ali J; Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA.; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA., O'Rourke PP; Retired., Spector-Bagdady K; Center of Bioethics and Social Sciences in Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.; Department of Obstetrics and Gynecology, University of Michigan Medical School, Ann Arbor, MI, USA., Wilfond B; Treuman Katz Center for Pediatric Bioethics, Seattle Children's Hospital, Seattle, WA, USA., Rahimzadeh V; Center for Medical Ethics & Health Policy, Baylor College of Medicine, Houston, TX, USA., Propes C; Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA.; Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA., Mehl K; Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA., Wendler D; Department of Bioethics, NIH Clinical Center, Bethesda, MD, USA.
Jazyk:	angličtina
Zdroj:	Clinical trials (London, England) [Clin Trials] 2024 Nov 25, pp. 17407745241290782. Date of Electronic Publication: 2024 Nov 25.
DOI:	10.1177/17407745241290782
Abstrakt:	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. Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Databáze:	MEDLINE
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