Description of the Research
In an attempt to streamline the oversight of multicenter clinical trials, our IRB conducted a pilot study, from June to December 2012 to compare local versus independent IRB review, assessing both the efficiency and quality of the review processes. This pilot involved 43 multicenter, industry-sponsored clinical trials, for which the sponsor had previously arranged for IRB review of the trial by an independent central IRB (I/C IRB). Results of the pilot project support continued reliance on 14 I/C IRBs for industry-sponsored, multicenter clinical trials; we adopted the central reliance program as part of its routine practice.
In preparation for the official October 2013 launch, our office prepared and disseminated guidance documents for completing the I/C IRB’s registration documents and provided educational sessions to promote ease of working with the central independent IRBs. Despite our extensive preparation and university outreach, a multitude of barriers soon became apparent. Institutional reviews surrounding conflicts of interest, Health Insurance Portability and Accountability Act (HIPAA), and clinical trial agreement negotiations were the leading cause of delays in providing institutional finalization of reliance approval. Investigators repeatedly encountered situations in which University-approved subject injury language was not accepted by sponsor. Coordinators became middlemen for contractual negotiations between the institution and sponsor and/or Contract Research Organization (CRO). Once finalized, study personnel experienced delays in the dissemination of approved documents (e.g., consents and HIPAA authorization documents) from the sponsor and/or CRO, preventing submission to the I/C IRB.
A review of year one data identified that nearly 93% of our studies were repeatedly deferred to only six of the 14 IRBs. The remainder of the deferred studies were limited to three departments, none of which stipulated the use of the designated I/C IRB as a requirement for site participation. Based on this information, we revised our policy to allow reliance on the top six I/C IRBs. In addition, the guidance documents were revised based on feedback from investigators and collaborating offices.
Ensuing implementation of the revised policy, the following improvements were noted: Better communication with collaborating offices; improved investigator understanding of the reliance process; and improved turn-around time. The December 2014 National Institutes of Health (NIH) draft guidance mandating the use of a single IRB for NIH-funded/supported multi-site studies illuminates the directional shift to utilizing central IRBs. Our work demonstrates that, with continued evaluation and improvement, this program can be a viable option for academic medical centers.