Center for Medical Ethics and Health Policy Staff Publications

Language

English

Publication Date

4-1-2025

Journal

Clinical Trials

DOI

10.1177/17407745241290782

PMID

39587730

PMCID

PMC11991889

PubMedCentral® Posted Date

4-12-2025

PubMedCentral® Full Text Version

Author MSS

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

Humans, Pragmatic Clinical Trials as Topic, Informed Consent, Information Dissemination, Clinical Trials as Topic, Decision Making, Ethics, Research, Pragmatic clinical trials, ethics, aggregate results

Published Open-Access

yes

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