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Your Guide to sIRB Mandates

In the past several years, Health and Human Services (HHS) Office of Human Research Protections (OHRP), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH) have announced and/or implemented new regulations to address the challenges of conducting clinical trials involving multiple research sites.

Chief among these requirements is the use of a designated single institutional review board (sIRB) for multisite research (also known as a central IRB [cIRB]). Here’s where the regulations currently stand:

NIH Single IRB Policy

The first of the sIRB mandates announced was the NIH Single IRB Policy. This policy requires domestic awardees and domestic sites conducting NIH-funded multisite research to be overseen by a single IRB of record.

This rule was announced on June 21, 2016, with a compliance date of January 25, 2018. This policy was the forerunner of the later HHS decision mandating all federally funded research would, with little exception, use an sIRB of record. This policy change prompted many institutions to seek partnerships with external IRBs.

The 21st Century Cures Act

This bill was passed by Congress on December 13, 2016, and included the requirement for the U.S. government to reduce “duplication of effort” in human subject protections, suggesting centralized IRB review as one way to do so.

This bill also eliminates the term “local” from “institutional review board” references in the regulations governing device studies, aligning device regulations with established regulations for drug studies and explicitly allowing for sIRB review of multisite device studies. Additionally, it requires differences between the HHS and FDA human subject protection regulations be harmonized, or consistent, “to the extent practicable.”

Final Revisions to the Common Rule

The long-discussed revisions to the Federal Policy for the Protection of Human Subjects, also known as the Common Rule, mandates sIRB oversight for cooperative research. Per 45 CFR 46.114, “cooperative research projects are those projects covered by [the Common Rule] that involve more than one institution.”

The sIRB compliance date for cooperative research went into effect on January 20, 2020, and requires single IRB review for virtually all federally funded multisite research. Click here for more information on the HHS compliance requirements.

FDA Initiatives

FDA has long supported sIRB review for multisite research, releasing the guidance document Using a Centralized IRB Review Process in Multicenter Clinical Trials in 2006. This guidance has led many industry sponsors to require sIRB review for their multisite studies.

In September 2022, FDA released two Notices of Proposed Rulemaking (NPRMs) intended to partially harmonize existing FDA regulations with the Common Rule, in keeping with requirements set forth by the 21st Century Cures Act. Specifically, the NPRM titled “Institutional Review Boards; Cooperative Research” recommends any U.S.-located institution conducting cooperative research be required to rely on sIRB oversight for the research being conducted in the U.S. (with certain exceptions).

These changes are currently under review by the public and industry, and no word is yet available regarding if and when the proposals might become final rules.

Other sIRB Initiatives

The IRB reliance networks SMART IRB and IRB Reliance Exchange were developed to help support single IRB review. Enacted through separate NIH grants, these networks and tools establish a master IRB reliance agreement among member IRBs. A document exchange platform is designed to support and streamline the sIRB process for the sIRB and relying institutions alike.

Additionally, therapeutically focused research networks are moving toward requiring sIRB review for the studies conducted by their member sites.

An Age of sIRB

These regulations and policies reflect the continued progression of multisite clinical research towards centralized human subject protection review, with the understanding that sIRB review reduces administrative burden on investigators, sites, and sponsors and provides clearer guidance and oversight of human subject protections.

The research and regulatory environment continues to evolve, and sIRB review is the new standard for multisite research. Now is the time to work with external and fellow institutional IRBs and figure out the best way to implement the sIRB requirements. In this new paradigm, communication and partnership are the keys to success.

Note: This article was originally published February 5, 2020, and has been updated to include new and clarifying information.

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