NIH’s Single IRB Policy to Impact Non-NIH Funded Clinical Trials Too 
[Posted on: Thursday, July 21, 2016]

Last month, NIH announced the final policy for IRB review of multi-site clinical trials funded by NIH. Starting next May, all multi-site clinical trials funded by NIH must use a single IRB for all sites. This creates a new paradigm for IRB review of clinical trials aimed to reduce the redundancy and cost of IRB review. The goal of this policy is the address common complaint regarding multiple IRBs reviewing the same protocol with minor differences in opinion leading to unnecessary administrative work for the trial operations. NIH is the largest funding agency for clinical trials and defines IRB policies for all US government Agencies. It is likely this policy will be adopted widely across all trials funded by the US government. As has been the experience with other NIH policies, over a short time, this policy is expected to be adopted for all clinical trials, even those not funded by NIH by creating an industry-wide gold standard for IRB review of clinical trials. Traditionally, multi-site trials could have multiple site-specific IRBs reviewing the same protocol, each giving comments minor and major that require amending the protocol and informed consent multiple times. Additionally, some IRBs, particularly those at large academic centers, could take much longer to review the study specific documents delaying the trial at the linked site. Some institutions insisted on using local IRB to allow participation in clinical trials. With this policy it could become hard, if not impossible, for institutions to demand that all trials be reviewed by their IRBs. Under the current policy, sponsors must create a written plan describing the criteria for selection of a single IRB for their multi-site trial. The selected IRB must have authorization agreements with the study sites. Local IRBs can do additional review if desired but will not be considered as the deciding IRB and NIH funds cannot be used to pay for the additional reviews. The policy will have several intended and a few unintended consequences. Review by one IRB should make it easy to simultaneously initiate all sites participating in a given trial. This should also reduce the number of IRB reviews needed, and speed-up adverse event report submissions, review of safety events across multiple sites, and informed consent reviews. Reduction in administrative burden of submitting same document to multiple IRBs, and follow-up of each review, should free-up resources for other purposes. It should also provide consistency of review across all sites, better deviation management, and easier project management. Larger central IRBs will likely benefit the most as they have the resources and experience to review multi-site trials. Smaller local IRBs will likely diminish operations or close operations. Sponsors can evaluate multiple IRBs and pick the one with most experience in the given trial, and ability for speedier review. IRBs will likely need to compete for business eliminating monopolies where sponsors were locked with institutional IRBs they had to work with despite complaints. The policy applies to US-based sites only but NIH policies have a significant respect with equivalent organizations in other countries. We may be seeing the beginning of a global policy for IRB review of clinical trials.