Key lessons and strategies for implementing single IRB review in the Trial Innovation Network

Abstract

The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. The Network’s single IRB (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This has generated several lessons learned that can benefit the national clinical research enterprise, as we work to improve the conduct of clinical trials. These lessons include distinguishing the roles of the single IRB from institutional Human Research Protections programs, establishing a consistent sIRB review model, standardizing collection of local context and supplemental, study-specific information, and educating and empowering lead study teams to support their sites.

Stakeholder Reflections on Implementing the National Institutes of Health's Policy on Single Institutional Review Boards

“…To address many of these challenges, the SMART IRB Harmonization Committee has developed resources to promote alignment of sIRB policies and processes and adoption of common forms, practices, and workflows 16 . Johnson et al suggest the following as successful strategies in the implementation and operation of sIRBs in the National Center for Advancing Translational Sciences’ Trial Innovation Network: distinguishing the roles of the sIRB from those of institutional human research protections programs, establishing consistent steps in the sIRB review process, standardizing collection of local information, and providing education to and setting expectations with lead study teams and sites 17 . Additionally, CTTI previously published a guide to support communication between relying sites and sIRBs 18 along with recommendations and resources for implementing the sIRB model and addressing barriers to using sIRBs for multicenter clinical trials 19…”

Using single IRB consultations to meet the educational needs of investigative teams

“…Our findings are consistent with the literature that describes both perceived and experienced challenges of SIRB review. Others have cited the challenge researchers and institutions can experience when trying to differentiate the roles of the IRB from the HRPP [ [3] , [4] , [5] , [8] , [9] , [10] , [11] , [12] , [13] ] as well as the difficulty navigating unfamiliar IT platforms [ [13] , [14] , [15] ]. Our results show that these challenges are a reality and that SIRB consults may be an avenue for reducing challenges.…”

“…One challenge with the implementation of SIRB review is the lack of preparedness or experience of investigative teams to secure SIRB review for all sites in multi-center studies [ [3] , [4] , [5] ]. Because the use of SIRB review has not been previously required, many investigative teams are most familiar with the IRB at their home institution, and do not have practical experience working with a variety of IRBs for their projects.…”

Implementation of single IRB review for multisite human subjects research: Persistent challenges and possible solutions

“…It is now over 4 years since the implementation of the NIH sIRB policy and more than 2 years since the effective date of the Common Rule requirement. Yet, significant challenges with the implementation of sIRB remain [4][5][6][7]. The leadership of SMART IRB has organized an "Emerging Issues" annual workshop in which leaders in human participant protections gather to discuss sIRB review.…”

“…Yet, significant challenges with the implementation of sIRB remain. [4][5][6][7] The leadership of SMART IRB has organized an "Emerging Issues" annual workshop in which leaders in human participant protections gather to discuss sIRB review. The theme of the 2022 workshop was to identify "persistent barriers and future solutions to the success of single IRB."…”