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Dr. Carrie Wolinetz is NIH’s Associate Director for Science Policy, and writes about biomedical research policy issues on her blog, Under the Poliscope.
Research involving human participants is key to improving public health and advancing medicine. Oversight of such research by institutional review boards (IRBs) both protects research participants and promotes ethical science. IRB review and approval is a critical step in initiating the start of a research project and for multi-site studies, NIH is taking an important step to help streamline the process.
Today, NIH is issuing the NIH Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research (sIRB Policy) in both the Federal Register and the NIH Guide to Grants and Contracts. The sIRB policy establishes the expectation that a single IRB of record will be used to conduct ethical reviews for domestic sites of multi-site, non-exempt human subjects research protocols that are funded by NIH. The goal is to promote effective IRB review of multi-site research proposals while eliminating the unnecessary repetition of those reviews across sites. In developing the policy, NIH considered input from a range of stakeholders who commented on a 2014 draft version. The comments are discussed in the preamble to the final policy, and a compilation of the public comments are available on the NIH Office of Science Policy (OSP) website.
This move to a single IRB model also presents a unique opportunity to harmonize the standards and agreements used in clinical research. The NIH National Center for Advancing Translational Sciences (NCATS), through its Clinical and Translational Science Awards (CTSA) Program, convened experts across the nation to develop a “single IRB reliance model” for multi-site clinical studies. This model, the NCATS “Streamlined, Multisite, Accelerated Resources for Trials” (or “SMART”) IRB Reliance Platform, provides investigators and clinical research review networks with a flexible and user-friendly toolkit. Several CTSA-supported institutions have already adopted this platform leading the goal to have all CTSA institutions use the SMART IRB Reliance Platform. More information about SMART IRB is available on the NCATS website.
To give the research community ample time to prepare for this change, the NIH is providing a long lead time before the policy takes effect on May 25, 2017. In addition to the SMART IRB Reliance Platform, guidance on implementation of the sIRB policy is available, such as how costs may be charged to NIH awards. Information and resources, such as FAQs, will be posted to the NIH OSP website, as they are developed. NIH will continue to add information to this page prior to the policy implementation date.
We look forward to working with our stakeholders to facilitate implementation, and welcome input on additional information or clarifications that may be helpful. We also encourage you to read a statement published today by NIH Director Francis Collins on the importance of this issue.
For further questions or additional information about the policy, we invite you to contact us at SingleIRBpolicy@mail.nih.gov.
The scientific and ethical advantages of the SMART IRB policy will undoubtedly strengthen the quality and impact of NIH-funded clinical research. However, it may be useful to collect feedback from PIs who currently interact with NIH Institute ethics review panels regarding their clinical trials, as this information may facilitate appropriate “streamlining” of the new policy. I have heard colleagues who lead NIH-funded extramural clinical trials remark that their Institutes’ ethics review panels have made significant demands regarding change in study design and even modification of Specific Aim content. Whereas these suggestions are appropriate in the context of peer review, they have been put forward by personnel who lack the scientific background to make such demands. In several cases, the progress of this clinical research has suffered (and dollars wasted). I strongly suggest that the SMART IRB policy protect the patients’ ethical rights as well as the peer-reviewed scientific content of the clinical research.