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Disentangling informing participants from obtaining their consent
Patricia Pearl O'Rourke1, Joseph Ali2,3, Judith Carrithers4
1Harvard Medical School, Harvard University Boston Massachusetts USA.
Learning Health Systems
|October 31, 2025
Summary
Even when research consent is waived for pragmatic trials, informing participants is valuable. Communicating study details respects individuals and enhances engagement, even without risk or consent requirements.
Area of Science:
- Clinical Trials
- Bioethics
- Research Ethics
Background:
- Pragmatic clinical trials in routine care often meet criteria for waiving research consent.
- This waiver may lead to the assumption that no participant communication is necessary beyond risk notification.
Purpose of the Study:
- To explore ethical justifications for providing information to participants in trials with waived consent.
- To identify methods for communicating study information when consent is not obtained.
Main Methods:
- Ethical analysis was conducted by the NIH Collaboratory Ethics and Regulatory Core working group.
- Examples of trials illustrating communication methods were provided.
Main Results:
- Communicating information supports respect for persons, participant understanding, engagement, and trust.
- Methods include letters, email, flyers, posters, and clinician conversations.
- Feasibility and cost must be balanced against the benefits of informing participants.
Conclusions:
- Providing information to participants should be the default for trials with a waiver of research consent.
- This practice promotes ethical goals and participant trust, irrespective of consent requirements.
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