A Qualitative Study of Non-Affiliated, Non-Scientist Institutional Review Board Members

Abstract

In addition to outlining criteria for the approval of human subjects research, federal regulations provide guidance regarding local institutional review board (IRB) membership. IRBs are mandated to include “at least one member whose primary concerns are in nonscientific areas” and “at least one member who is not otherwise affiliated with the institution.” Often a single individual serves both of these roles simultaneously. Although there have been calls for increased representation of lay community members on IRBs, little is known regarding their experiences or their perceptions of human subject protections and the IRB process. Using an ethnographic interview approach, this study seeks to gain a perspective from non-affiliated, non-scientist (NA/NS) IRB members about the process in which they participate. Findings suggest a need for clarification regarding whom NA/NS IRB members represent. They also suggest that NA/NS IRB members’ experiences could be improved by an increased show of respect from the IRB chair, other members, and staff; efforts to make participation more convenient for these volunteer members; and training tailored specifically to NA/NS members. Further research on this important and understudied topic is needed to determine best practice and policy recommendations.

Keywords:

• human subjects protection
• Institutional Review Boards
• IRB membership/composition
• non-scientist IRB members
• non-affiliated IRB members
• community IRB members

Acknowledgment

The author would like to thank Dr. James M. DuBois for his encouragement and guidance.

Notes

¹Information about registered IRBs is publicly available on the OHRP website (http://www.hhs.gov/ohrp/).

²Contact information for IRB administrators and IRB chairs is publicly available on institutional websites.

³Saturation is defined as “data adequacy” and operationalized as collecting data until no new information is obtained.

45 C.F.R. 46 (2005).

President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (President’s Commission). (1983). Implementing Human Research Regulations: Second biennial report on the adequacy and uniformity of federal rules and policies, and of their implementation for the protection of human subjects