Institutional Review Board Use of Outside Experts: What Do We Know?

Area of Science:

• Bioethics
• Research Administration

Background:

• Institutional Review Boards (IRBs) are authorized to consult external experts for research reviews exceeding internal expertise.
• Current understanding of the utilization of outside experts by IRBs is limited, with no dedicated empirical studies.
• This knowledge gap has significant implications for the quality of IRB reviews and research oversight.

Purpose of the Study:

• To examine the current practices, rationale, and challenges associated with IRB consultation of outside experts.
• To identify gaps in the literature regarding the use of external expertise in research ethics review.
• To propose an agenda for future empirical research on IRB external consultation.

Main Methods:

• A comprehensive review of regulations and standards governing IRB use of outside experts.
• An examination of the needs, strategies, challenges, and concerns related to external expert consultation.
• Identification of critical gaps in existing literature.

Main Results:

• Regulations permit IRBs to seek external expertise for specialized research reviews.
• There is a lack of empirical data on the specific circumstances, reasons, and methods of IRB expert consultation.
• The effective use of external expertise is crucial for balancing participant protection and research advancement.

Conclusions:

• IRB reliance on external expertise is vital for reviewing complex research protocols.
• Further empirical research is needed to understand and optimize the process of IRB external consultation.
• Addressing these gaps will enhance IRB effectiveness in safeguarding research participants.