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Ethical considerations for sharing aggregate results from pragmatic clinical trials
Stephanie R Morain1,2, Abigail Brickler1, Joseph Ali1,3
1Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA.
Clinical Trials (London, England)
|November 26, 2024
Summary
Sharing aggregate results from pragmatic clinical trials (PCTs) presents unique ethical challenges. Healthcare institutions must partner in decision-making to ensure responsible dissemination of PCT findings to participants and clinicians.
Area of Science:
- Bioethics
- Clinical Trials Research
- Health Services Research
Background:
- Existing literature addresses sharing aggregate results with research participants.
- Pragmatic clinical trials (PCTs) introduce unique ethical and logistical considerations for result sharing.
- PCTs may involve patient-subjects and clinicians, broadening the scope of result dissemination.
Purpose of the Study:
- To explore the ethical dimensions of sharing aggregate results from PCTs.
- To provide recommendations for sharing aggregate results in PCTs.
- To highlight the role of healthcare institutions in PCT result sharing decision-making.
Main Methods:
- Ethical analysis of PCT characteristics impacting result sharing.
- Exploration of implications for patient-subjects and clinicians.
- Consideration of PCTs conducted under a waiver of informed consent.
Main Results:
- PCTs complicate result sharing due to broader stakeholder involvement (patient-subjects and clinicians).
- Waivers of informed consent in PCTs present unique challenges for result dissemination.
- Healthcare institutions are crucial partners in deciding how to share PCT aggregate results.
Conclusions:
- Ethical frameworks for sharing aggregate results must adapt to the complexities of PCTs.
- Collaborative decision-making involving healthcare institutions is essential for responsible PCT result sharing.
- Future research should further investigate best practices for disseminating PCT findings.
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