How to Determine When a Single IRB (sIRB) is Required

• The Single IRB Mandates
• NIH Definitions
• Exceptions to Single IRB Review Requirements
• Additional Responsibilities if sIRB is Required

The Single IRB Mandates

All new multi-site federally funded projects must use a single IRB (sIRB). For existing studies, you might have an sIRB due to competing renewal.

There are two rules that determine whether a single IRB is required for your federally funded study.

1.       Revised Common Rule at 45 CFR 46

The revised federal Common Rule’s single IRB requirement went into effect January 21, 2020 (a year later than the rest of the revised rule).  This requirement relates to collaborative, non-exempt human research that involves multiple institutions. This applies to all federally funded or supported research (with the exception of Department of Justice funded projects).

2.       National Institutes of Health (NIH) Policy

For protocols that were approved prior to January 21, 2020, the revised Common Rule does not require a sIRB. However, the NIH sIRB policy may still apply. The NIH Policy applies to new and competing grant renewals submitted to the NIH on or after January 25, 2018 that involve multi-site, non-exempt human research. This means for ongoing research protocols that were approved without utilizing a sIRB, the NIH may require you to transfer all your sites to a sIRB at the time of renewal.

 The information below is designed for studies that must comply with either of the above mandates.

• NIH Definitions
• Exceptions
• Requirements
• Identify the sIRB

NIH Definitions

Multi-site
“Multi-site” means that the same research procedures (i.e., protocol) are being conducted at one or more U.S. sites and that each site is under the control of a local participating investigator. This typically involves a lead site that receives the grant or contract directly from NIH and that then establishes a subaward or subcontract to each participating site. The research could be a clinical trial, an observational study, or a basic clinical research study.

Same Research Protocol
Protocols that address the same research questions, involve the same methodologies, and evaluate the same outcomes are considered to be the “same research protocol.” Additionally, sites that are accruing research participants for studies that are identical, except for variations due to local context consideration, would be considered to be conducting the “same research protocol.” If a study involves a separate site for study coordination or coordination of data and statistical analyses and the site is conducting the same protocol as the other participating sites, then all sites would be expected to rely on the designated single IRB.

At The Time of New or Competing Grant Renewal
If you are unsure whether a project you are proposing is subject to the NIH single IRB requirement, work with the NIH program officer. You can also contact the IRO Director for help in determining whether sIRB is required.

Exceptions to Single IRB Review Requirements

Types of Research

The mandates do not apply to exempt human research, nor to research that is determined to be not human research.

Types of Sites

The mandates do not apply to the following types of participating sites in multi-site research:

• Fred Hutch does not review for Veteran’s Affairs (VA) sites, so you must request an exception to the single IRB requirement from the NIH.
• International sites (even if domestic sites of the same study are subject to sIRB requirements)
• Sites involving tribal nations
• Sites for which review by the proposed sIRB is prohibited by a federal, tribal, or state law, regulation, or policy

Note that a study may involve sites that must comply with the policy and other sites that are not required to comply.

Other Exceptions to Single IRB Review Requirements

In October 2020, OHRP issued an exception to the sIRB review requirements for research conducted during the Coronavirus Disease (COVID-19) Public Health Emergency declared by the Secretary of HHS. Funding agencies supporting the research must approve the use of this exception. The NIH has confirmed that its use of this exception will be rare.

In November 2019, OHRP issued an exception for all HHS-funded research subject to the Common Rule Single IRB requirement and that was approved by an IRB prior to January 21, 2020. This means that at least one IRB has approved any part of the study. This exception does not apply if the study must comply with the NIH multi-site policy.

The NIH has established a process by which it will consider other requests for exceptions from its multi-site policy if there is a compelling justification, but it has stated that exceptions will be rarely granted. If you believe that your study should be excepted, work with the NIH program officer to identify how to request an exception.

The Common Rule mandate allows funding agencies to make exceptions; however, at this time to our knowledge, there is no formal process established for requesting an exception from non-NIH funding agencies. If you believe that your study should be excepted from the Common Rule requirement, you may be able to work with the federal agency’s program officer to identify how to request an exception.