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Variability in Institutional Board Review for a Multisite Assessment of Resident Professionalism
Judith A Linden1,2, Jeffrey I Schneider1,2, Andrea Cotter1,2
11 Boston Medical Center, MA, USA.
Summary
Institutional Review Board (IRB) review for studies involving medical residents, who are vulnerable participants, showed significant variation across institutions. Common concerns included potential resident coercion and confidentiality breaches, impacting research oversight.
Area of Science:
- Medical Education Research
- Clinical Research Ethics
Background:
- Medical residents are trainees and employees, posing unique ethical considerations as research participants.
- Institutional Review Board (IRB) oversight for research involving residents can be complex and inconsistent.
Purpose of the Study:
- To analyze the variability in Institutional Review Board (IRB) review processes for educational research involving medical residents.
- To identify common concerns and barriers encountered during IRB review for resident research.
Main Methods:
- The study examined data from 19 university-affiliated sites participating in the Assessment of Professional Behaviors Study (2009-2011).
- IRB review categories (exempt, expedited, full board), informed consent requirements, and submission-to-approval timelines were analyzed.
Main Results:
- IRB review pathways varied significantly, with 71% requiring written informed consent.
- Review times ranged from 1 to 7 months, with most taking 1-2 months.
- Key concerns identified were potential resident coercion and loss of confidentiality.
Conclusions:
- Significant variability exists in local IRB review for educational research involving medical residents.
- Addressing concerns about resident coercion and confidentiality is crucial for ethical research conduct.
- Standardized IRB review guidelines may be beneficial for studies involving vulnerable trainee populations.
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