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Mandating Evidence-Based Informed Consent Practices: A Critical Engagement with IRB Leader Focus Group Findings
Meredith V Parsons1, Erin D Solomon2, Kari Baldwin3
1Staff scientist at the Bioethics Research Center at the Washington University School of Medicine.
Ethics & Human Research
|December 31, 2025
Summary
Mandating evidence-based informed consent practices is debated. While IRB leaders prefer education, research suggests mandates are needed for wider adoption, with manageable burdens.
Area of Science:
- Clinical Research Ethics
- Regulatory Science
Background:
- Evidence-based informed consent practices are underutilized in research.
- Current regulations (Common Rule) do not mandate these practices.
Purpose of the Study:
- To explore the feasibility and wisdom of mandating evidence-based informed consent practices.
- To assess institutional review board (IRB) leaders' perspectives on mandates.
Main Methods:
- Six focus groups with IRB leaders to gauge opinions on mandating informed consent practices.
- Literature review and analysis of existing study data.
Main Results:
- IRB leaders favor plain language and formatting but are skeptical of comprehension assessments.
- General opposition to federal/institutional mandates, preferring education.
- Authors argue mandates are necessary as education alone is insufficient.
Conclusions:
- IRBs should experiment with mandates for evidence-based informed consent practices.
- Institutional mandates can be implemented without significant delays or burden with proper support.
Keywords:
evidence‐based practicehuman research ethicsimplementation scienceinformed consentinformed consent mandatesinstitutional review board (IRB)research ethicsMore Related Videos
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