Practice-Based Research Networks Ceding to a Single Institutional Review Board: A Report From the INSTTEPP Trial and...

Area of Science:

• Health Services Research
• Clinical Trials
• Regulatory Science

Background:

• Cooperative research projects historically required multiple Institutional Review Boards (IRBs) for approval, leading to redundancies.
• Federal regulations now permit cooperative IRB review and the ceding of authority to a single lead IRB to streamline the process.
• Practice-based research networks (PBRNs) often engage multiple sites, necessitating efficient IRB oversight.

Purpose of the Study:

• To delineate the process of achieving IRB approval for a multi-site clinical trial using a single lead IRB.
• To describe the cooperation and personnel effort involved in the IRB ceding process for the INSTTEPP trial.
• To highlight the benefits of a centralized IRB review for multi-site research.

Main Methods:

• The Implementing Networks' Self-management Tools Through Engaging Patients and Practices (INSTTEPP) clinical trial involved 4 PBRNs and 16 family physician offices.
• Four academic institution IRBs and four external IRBs from family practice offices ceded their review authority to a single lead IRB.
• The process involved establishing the lead IRB as the IRB of record for all participating sites.

Main Results:

• Ceding IRB authority to a lead IRB was successfully accomplished for the INSTTEPP trial.
• Subsequent IRB modifications and continuing reviews were managed by the lead IRB.
• This streamlined process saved time for all participants and kept the clinical trial on schedule.

Conclusions:

• Centralized IRB review through ceding authority significantly improves efficiency in multi-site research.
• The IRB ceding process, as demonstrated by the INSTTEPP trial, is a viable strategy for managing cooperative research projects.
• Adoption of lead IRB models can facilitate timely completion of clinical trials involving PBRNs.