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. 2025 Apr;22(2):248-254.
doi: 10.1177/17407745241290782. Epub 2024 Nov 25.

Ethical considerations for sharing aggregate results from pragmatic clinical trials

Stephanie R Morain  1   2 , Abigail Brickler  1 , Joseph Ali  1   3 , Patricia Pearl O'Rourke  4 , Kayte Spector-Bagdady  5   6 , Benjamin Wilfond  7 , Vasiliki Rahimzadeh  8 , Caleigh Propes  1   2 , Kayla Mehl  1 , David Wendler  9
Affiliations

Ethical considerations for sharing aggregate results from pragmatic clinical trials

Stephanie R Morain et al. Clin Trials. 2025 Apr.

Abstract

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.

Keywords: Pragmatic clinical trials; aggregate results; ethics.

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Conflict of interest statement

Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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