Too Many Rationales, Not Enough Reason: A Call to Examine the Goals of Including Lay Members on Institutional Review...

Area of Science:

• Bioethics
• Public Health Policy
• Research Ethics

Background:

• Numerous commissions and scholarly articles recommend increasing lay members on Institutional Review Boards (IRBs).
• Qualitative studies reveal lay IRB members often experience role confusion and ambiguity.
• Lack of clarity on unique contributions hinders effective recruitment and training strategies for these members.

Purpose of the Study:

• To articulate the unique contributions of lay (nonscientist, unaffiliated) members to Institutional Review Boards (IRBs).
• To provide historical context for the necessity of diverse IRB membership.
• To establish a foundation for improving IRB recruitment, training, and composition.

Main Methods:

• Historical analysis of IRB regulations, policies, and commentaries.
• Review of scholarly literature and commission reports on IRB composition.
• Synthesis of qualitative findings on lay IRB member experiences.

Main Results:

• Historical review reveals a consistent rationale for including nonscientist and unaffiliated perspectives.
• Lay members offer unique insights into community values and participant perspectives.
• Articulating these unique contributions provides a basis for targeted recruitment and training.

Conclusions:

• Clearly defining the distinct roles and contributions of lay IRB members is essential.
• This definition supports arguments for increasing their numbers and optimizing their integration.
• Effective utilization of lay members enhances the ethical review process and public trust in research.