Single IRB (sIRB) Review for Multi-Site Cooperative Research

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Overview

The General Implementation date for the Revised Common Rule went into effect January 19, 2018. As part of the Revised Common Rule, the regulations require that Federally-funded or supported non-exempt cooperative research studies (that is, studies involving more than one institution) must rely on the use of a single reviewing IRB for the portion(s) of the research being conducted in the U.S.

Which Studies Are Subject to the Single IRB Review Requirement?

The implementation date for this provision of the Revised Common Rule is January 20, 2020, meaning all non-exempt multi-site cooperative research studies supported, conducted and/or funded by a Federal department / agency which were approved on or after January 20, 2020 are subject to this requirement and must be compliant with these provisions on or before this date (unless the study qualifies for one of the exceptions described below). Studies approved prior to January 20, 2020 are not required to comply with the Single IRB review mandate; however, it may be advantageous to do so, depending on the nature of the research. Applicants for federal funding of multi-site cooperative research must include a plan for Single IRB review as part of their funding application submission.

Which IRB Serves as the Single IRB?

The regulations allow for some flexibility in the designation of the sIRB. In some situations, the sIRB may be designated by the Federal sponsor supporting this research; in the event that the Federal sponsoring agency does not designate a specific IRB to serve as the sIRB, the lead institution supporting the research will typically serve as the sIRB. 

Exceptions to the Single IRB Review Requirement

The Office for Human Research Protections (OHRP) outlines several specific exceptions to the sIRB requirement; sIRB compliance will not be required in the following situations involving research conducted or supported by the Dept. of Health and Human Services (HHS):

  • Protocols initially approved by at least 1 IRB between January 21, 2019 and January 20, 2020
  • Protocols initially approved by at least 1 IRB before January 21, 2019, and for which an institution has determined and an IRB or institution has documented that the research will comply with the 2018 Requirements
  • Protocols for which an NIH exception determination was issued on or before January 20, 2020, regardless of when at least 1 IRB reviews and approves a specific cooperative research protocol

In certain situations, specific state / federal / tribal laws may require the use of more than one reviewing IRB; in these situations, the sIRB requirement may be suspended. Additionally, the Federal agency sponsoring the research may determine that the use of an sIRB may not be appropriate, given the specifics of the research project. In this case, the use of an sIRB may be suspended with PI providing documentation supporting the determination made by the Federal agency sponsor.

Research that has been given a determination of Exempt status is also not subject to the sIRB requirements; investigators at each institution are responsible for seeking their own independent Exempt determination(s) for research to be conducted at their site. 

Process for Initiating Single IRB Review

sIRB review of eligible non-exempt multi-site cooperative research is handled through the IRB Authorization Agreement process. Researchers will need to determine which IRB will be serving as the sIRB of record. Once the sIRB has been designated, signed Authorization Agreement(s) will need to established prior to the initiation of the collaborative research. For more information on how the Authorization Agreement process is handled, please see our guidance on IRB Authorization Agreements.

Resources

Revised Common Rule's Cooperative Research Provision (45 CFR 46.114)

Determination of Exception for Certain HHS-Conducted or -Supported Cooperative Research Activities Subject to the 2018 Requirements

Guidance: IRB Authorization Agreements for Human Subjects Research