Changes to the federal regulations governing the protection of human subjects participating in research (known as the Common Rule) were amended earlier this year. The changes to the Common Rule impact research conducted, supported, or regulated by the federal government. While many of the Common Rule changes go into effect in 2018, the single IRB requirement has a compliance date of January 20, 2020. Institutions engaged in National Institutes of Health (NIH) funded research must comply much earlier, however. The NIH has adopted a single Institutional Review Board (IRB) policy, which will apply to all NIH grant applications for multi-site research received on or after January 25, 2018 (NIH Policy).
This major change to the IRB policy requires that institutions located in the United States and engaged in cooperative research rely on a single IRB as the reviewing IRB for a particular study. Notably, there are exceptions to this rule for cooperative research where more than one IRB is required by law, and research for which any federal department or agency supporting or conducting the research determines that a single IRB is not appropriate. Notwithstanding the exceptions, the change to a single IRB will require participating institutions of multi-site studies to modify their approach to cooperative research. The use of a single IRB of record is intended to streamline the IRB review process and expedite the initiation of such studies. The NIH single IRB policy applies to domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subject research.
In an application to the NIH for funding, the applicant is expected to submit a plan describing the use of a single IRB that would be selected, identifying the single IRB where possible. However, where the IRB cannot be identified in advance, applications should include a statement indicating that award recipients will follow the NIH Policy and follow-up with information regarding a single IRB plan prior to initiating the protocol.
To facilitate reliance on a single IRB, the National Center for Advancing Translational Sciences has developed a SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement (Agreement). The Agreement allows participating institutions to cede IRB review to a reviewing IRB of another participating institution. The Agreement is open to participation by any institution that meets eligibility requirements and agrees to accept the terms and conditions of the Agreement through a joinder. The Agreement memorializes the respective authorities, roles and responsibilities of the reviewing IRB and the participating IRBs that are relying on the reviewing IRB. The Agreement is available at https://smartirb.org, which is a free platform for institutions and investigators to collaborate on IRB reliance for multi-site studies. The platform has a number of other tools and resources available to help institutions navigate implementation of the NIH Policy.