Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance

Abstract

The revised Common Rule requires using a single institutional review board (sIRB) for U.S.‐based, multisite, nonexempt, federally conducted or supported research with human participants. The 21st Century Cures Act directs the Department of Health and Human Services (HHS) to harmonize differences between HHS and the U.S. Food and Drug Administration (FDA) regulations governing research with humans. Anticipating that the FDA may update its 2006 centralized IRB guidance, we conducted interviews with 34 stakeholders engaged in FDA‐regulated clinical research to identify benefits and challenges of using sIRBs and to gather recommendations for revising the FDA's guidance. The main benefits were consistency and standardization, speed and efficiency, and streamlining and simplification. The main challenges were uncertainty at local institutions, including addressing local context; decreased timeliness of the research review process; variable processes; and insufficient communication. Several recommendations for FDA guidance focused on the local context and communication plans. Findings suggest that the sIRB review process may be gaining efficiency although challenges remain.

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.…”

Demonstration Project: Transitioning a Research Network to New Single IRB Platforms

“…This was not unique to the CPCCRN network; uncertainties and misunderstandings about roles of the sIRB and local HRPP programs are among the most common ongoing concerns about sIRB review. 8 Communicating the value of standardization. The need to standardize HRPP specific requirements is critical.…”

“…It was important to reinforce that HRPPs still retained the ability to conduct local reviews and notify the sIRB if site requirements need to be adjusted, even after a reliance decision was initiated. This was not unique to the CPCCRN network; uncertainties and misunderstandings about roles of the sIRB and local HRPP programs are among the most common ongoing concerns about sIRB review 8 …”

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."…”