Performance Measures for Institutional Review Boards

This dissertation was comprised of two papers that explored performance measures for institutional review boards (IRBs). The first paper was a review of advisory, regulatory, accreditation and empirical literature focused on IRB performance; it examined historical efforts to evaluate IRBs since their inception and confirmed that empirically based definitions of IRB performance and mechanisms to systematically evaluate IRB performance are limited. The second paper was an exploratory descriptive study exploring IRB quality measures. Ten IRB members from a large urban AAHRPP-accredited research institution with approximately 80 IRB members were recruited to participate in semi-structured telephone interviews. IRB members were asked to describe their processes for completing protocol reviews, identify characteristics of a quality protocol review and reflect on their role in human subject protection. IRB members also were asked to share their considerations and recommendations for IRB quality measures. Eight served as scientist members and two served as non-scientist members. Member characteristics reflected variation in education; professional background and specialty expertise; and IRB role, experience and length of service. This variation was important and encouraged a wide perspective and view for exploring IRB quality measures. The study identified tools facilitating protocol reviews and challenges that IRB members reported regarding protocol review completion. The study’s finding regarding different evaluative methods and steps used by IRB members to review protocols made a unique contribution to existing literature on IRB performance; it encouraged innovative changes in IRB protocol review processes and deliberations and improvement of IRB member orientation and workload. The study’s other unique and important contribution was the exploration of IRB quality measures from the perspective of IRB members. IRB members described quality measures that focused on enhancement of human subject protection, relationships with investigators, and IRB member education, mentoring and peer review. The study offered a beginning framework for the development of IRB quality measures.