On July 12, 2016, PRIM&R hosted a webinar titled Navigating the New Reliance Agreement Landscape, presented by Tracy Ziolek, MS, CIP, and Emily Chi Fogler, Esq. This webinar highlighted the necessity for institutional review boards (IRBs) to adapt to new requirements related to multi-site research.
On June 21, 2016, the Office of Science Policy at the National Institutes of Health (NIH) released its final Policy on the Use of a Single Institutional Review Board for Multi-Site Research, which will take effect on May 25, 2017. This NIH policy and similar language in the Notice of Proposed Rulemaking (NPRM) for Revisions to the Common Rule stem from growing reliance on single IRB (sIRB) review in multi-site clinical research. Reliance agreements, which direct the respective responsibilities of an sIRB (or an institution or organization providing ethical review under 45 CFR Part 46) and any site relying on an sIRB’s review, have been used for some time. It stands to reason that reliance agreements will be used more and more frequently with the impending requirement that all NIH-funded, multi-site research rely on an sIRB for ethical review at all sites.
The NIH is supporting this requirement with its SMART IRB Platform, a resource for researchers to harmonize the process of utilizing a sIRB for multi-site research, and a sample reliance agreement.
The webinar detailed the different ways parties might operate under an sIRB reliance agreement. The main study team identifies the IRB of record (or sIRB) for all relying sites and submits a plan describing the use of an sIRB, how relying sites will adhere to the sIRB’s policies, and how communications between the sIRB and relying sites will be handled. This plan states the duties and responsibilities of all involved parties, and forms a general outline of a reliance agreement between the sIRB and individual relying sites.
Relying sites then review study progress at a local level. While the sIRB carries out initial and continuing reviews, a relying site bears other regulatory obligations, such as obtaining informed consent from subjects, overseeing the implementation of the approved protocol at that site, and reporting unanticipated problems and study progress to the sIRB. Relying sites also must communicate relevant information necessary for the sIRB to consider local context issues, including any state or local regulatory requirements during its deliberations.
The webinar stressed that flexibility and communication are necessary to support multi-site research that utilizes sIRBs. Reliance agreements should reflect the differing resources and responsibilities of each relying site and the sIRB. In turn, sIRBs and the IRBs at relying sites have to adapt their normal practices for the purposes of sIRB research. Communication from the relying site or sites is necessary to inform the sIRB about local researcher conflicts of interest, subject complaints, and adverse events related to the protocol. As an example of a best practice in communication, the webinar noted that study materials are sent to a relying site for a “local context review” so that the site may review the study with an eye to local regulatory requirements.
For institutions already involved in multi-site research, the new NIH mandate regarding the use of an sIRB may not require a significant change in practice; however, this webinar is a valuable resource for all institutions seeking to understand the NIH’s new policy and adapt to the new reliance agreement landscape.
By Seth Hall
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