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Single IRB Review and Local Context Considerations: A Scoping Review
Stephanie R Morain1, Megan K Singleton2, Kate Tsiandoulas3
1Associate professor in the Bloomberg School of Public Health's Department of Health Policy & Management and core faculty at the Berman Institute of Bioethics at Johns Hopkins University.
Ethics & Human Research
|June 30, 2024
Summary
Single IRB (sIRB) review for multisite studies faces challenges in considering local context. This review identifies goals and content for local context review, informing policy assessments and potential exceptions.
Area of Science:
- Human Subjects Research Ethics
- Clinical Trial Oversight
- Regulatory Compliance
Background:
- Federal policies now mandate single Institutional Review Board (sIRB) review for multisite studies.
- A key concern is how sIRBs address local context, with no consensus on its goals or scope.
- Disagreements exist regarding appropriate research for sIRB review.
Purpose of the Study:
- To identify and categorize the assumed goals of local context review in multisite research.
- To determine the proposed content and domains relevant to local context review.
- To understand concerns regarding research study exclusions from sIRB requirements.
Main Methods:
- Conducted a scoping review of published scholarship.
- Analyzed public comments on sIRB policies.
- Examined federal guidance documents related to sIRB review.
Main Results:
- Identified five assumed goals for local context review: participant protection, compliance, feasibility, research quality, and procedural justice.
- Grouped proposed content into four domains: participant characteristics, research team characteristics, institutional characteristics, and local laws.
- Found proposed exclusions from sIRB requirements based on protection and efficiency concerns.
Conclusions:
- The identified goals and content provide a framework for understanding local context in sIRB review.
- Findings can inform evaluations of sIRB policy implications.
- Results highlight areas for consideration when determining exceptions to sIRB mandates.
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