Institutional Review Board Use of Outside Experts: A National Survey
Kimberley Serpico1, Vasiliki Rahimzadeh2, Luke Gelinas3
1Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
AJOB Empirical Bioethics
|June 24, 2022
Summary
Many institutional review boards (IRBs) utilize outside experts for specialized knowledge, but their engagement is infrequent. Further research is needed to optimize the use of these experts for high-quality research reviews.
Area of Science:
- Research Ethics
- Clinical Trial Oversight
- Regulatory Science
Background:
- Institutional Review Boards (IRBs) face inherent limitations in expertise due to manageable board sizes.
- Regulations permit IRBs to engage external experts for specialized reviews.
- Current understanding of IRB utilization of outside experts remains limited.
Purpose of the Study:
- To characterize the utilization of outside experts by U.S. Institutional Review Boards (IRBs).
- To identify the frequency, reasons, and methods of engaging external expertise in IRB reviews.
- To understand the perceived impact of outside expert consultation on the review process.
Main Methods:
- A national survey of U.S. IRBs was conducted.
- The study employed a descriptive, cross-sectional design.
- Data were collected on the engagement patterns and perceived value of outside experts.
Main Results:
- 55.4% of surveyed IRBs reported using outside experts.
- Outside experts were typically consulted less than monthly, often annually.
- The primary reason for consultation was a lack of specific scientific expertise within the IRB (69.6%).
- Most IRBs (91.5%) perceived a positive impact on the review process from using outside experts.
Conclusions:
- While over half of IRBs use outside experts, their engagement is infrequent.
- The optimal level and type of outside expert involvement require further investigation.
- Exploring barriers and community perspectives, such as through Community Advisory Boards, could enhance IRB review quality.
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