Problem Statement
Within five years, our healthcare system has expanded to include a tertiary-care teaching hospital, four community acute-care hospitals, two regional behavioral health centers and a home care system, a statewide clinical laboratory operation and physical therapy/rehabilitation network, and a primary care physician practice group. The system underwent reorganization into regions and service lines. The new structure consolidated resources and decision-making to efficiently execute essential strategies.
We established a centralized IRB by consolidating the individual committees from three partner institutions. The objectives of centralizing IRB functions were to apply one set of Association for the Accreditation of Human Research Protections Program-accredited standard operating procedures, decrease administrative burden and duplicative review, simplify submissions, and track the entire research portfolio using an electronic platform.
Program Description
We received support from system leadership and developed an implementation plan: assessing volume, capacity, resources, existing redundant protocol reviews, and establishing a timeline. We enlisted support and input from all IRB offices and institutional officials. Plenary meetings were conducted to establish trusting relationships, provide familiarity with processes, procedures, and personnel, identify roles and responsibilities, and provide updates and feedback on progress.
The System Central IRB was established with its own IORG and federal wide assurance (FWA), with two IRB panels registered with the Office for Human Research Protections. Each partner institution continues to maintain a FWA for funding purposes with a designation of reliance on the System IRB as the primary external IRB of record, with written IAAs among partner institutions to support this reliance.
Oversight for all protocols previously under the auspices of the partner hospitals was transferred to the System Central IRB. This effort largely was made possible by the implementation of a new, fully electronic research submission and management solution. It allowed for continuous oversight of all protocols with no lapse in IRB approval or protection of human subjects.
Evaluation
We eliminated 75 duplicative reviews. Investigators are now able to request a single IRB review for multi-site protocols. Taking time to “get to know” each other and establish a trusting relationship allowed for this smooth, successful transition in a relatively short time period.
Future Suggestions and Take Home Message
Centralizing has allowed a broader view of the scope of our research and more timely evaluations and changes. We’ve identified the need to add a third IRB panel and have begun participating in the National Cancer Institute Central IRB initiative. Investments in supporting infrastructure and forging trusting relationships have been keys to successful implementation of a centralized IRB system.