In the past few years, new regulations and policies have been announced and implemented to address the challenges of conducting clinical trials involving multiple research sites. Chief among these requirements is the use of a designated single (or central) IRB (sIRB) for multisite research, which we’ll discuss below. Here’s where the regulations currently stand:

NIH Single IRB Policy

The first of the sIRB mandates to be announced, the NIH Single IRB 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 that all federally funded research would, with little exception, use an sIRB of record, and it prompted many institutions to seek partnerships with external IRBs.

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.

The 21st Century Cures Act

This bill was passed by Congress on December 13, 2016, and included the requirement for the US government to reduce “duplication of effort” in human subject protections, suggesting centralized IRB review as one way to do that. This bill also eliminates the term “local” from “institutional review board” references in the regulations governing device studies, aligning device regulations with established drug research regulations and explicitly allowing for sIRB review of multisite device studies.

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

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

A New Age of sIRB

These regulations reflect the continued progression of multisite clinical research towards centralized human subject protection review, with the understanding that single IRB review reduces administrative burden and provides clearer guidance and oversight of human subject protections

The research and regulatory environment is evolving, and single IRB review is the new standard for multisite research. It’s no longer an option, so now is the time to work together and figure out best practices. In this new paradigm, communication is the key to success.

In need of an sIRB partner? Advarra has served as sIRB for thousands of industry-sponsored and federally funded multisite studies and works with over 3,000 institutions and hospital systems. Benefit from our existing processes, procedures, and resources, including budget planning support for grant applications. Contact us to get started.

 

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