Reliance and Single IRB Review for Multi-site Research

IRB Reliance is when two or more institutions in a multisite or collaborative study rely on one IRB, the “Reviewing IRB”, to review, approve and monitor human subjects research (HSR) procedures conducted by investigators affiliated with the institutions. In such cases, the responsibility for IRB review has been ceded by each Relying Institution.

A reliance agreement must be in place before reliance procedures, such as submission of a protocol for review or review by the Reviewing IRB for a Relying Institution, can commence. The Columbia Reliance Request Form is the primary mechanism by which investigators inform the Columbia Human Research Protection Office (HRPO) about proposed reliance situations, after which relevant decisions can be made, e.g., whether reliance is appropriate and which institution will serve as the Reviewing IRB.

A Single IRB (sIRB) is an IRB that is responsible for review, approval and oversight of all, or sometimes only all domestic sites, that are participating in multi-site research. HSR supported by HHS funding is generally subject to a requirement for sIRB review for all domestic sites.

For other than HHS funded research, Columbia generally prefers to not enter into a reliance relationship. Exceptions to this general approach are made on a case-by-case basis for:

• Collaborative non-exempt HSR with closely affiliated institutions such as Weill Cornell Medical Center and the New York State Psychiatric Institute
• Multi-site non-exempt HSR for which a sponsor, network or consortium requires a sIRB.

Consult with the HRPO if a reliance situation is proposed that is not HHS funded.

HHS sIRB Requirements

Federal Requirements for sIRB Review

1. The Common Rule (45 CFR 46, Subpart A) 2018 Requirements for Cooperative Research at 45CFR 46.114 (effective for research initially approved on or after January 20, 2020)
   • Common Rule criteria for sIRB review:
     • Two or more domestic sites
     • Non-exempt human subjects research and research requiring Limited IRB Review
     • Protocol initially approved by an IRB on or after January 20, 2020
2. The NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research (effective January 25, 2018) describe requirements for use of a single IRB for certain federally-funded multi-site studies.
   • NIH criteria for sIRB review:
     • Two or more domestic sites
     • Non-exempt human subjects research
     • Grant application submitted on or after January 25, 2018
     • Same protocol conducted at each site
       • Protocols that address the same research questions, involve the same methodologies, and evaluate the same outcomes are considered to be the “same research protocol.”
       • 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.” 
3. The single IRB review requirements in the revised Common Rule are not the same as the requirements in the NIH policy.

If you are preparing a grant application for HHS funding, you should immediately complete the CU Reliance Request Form if either of these requirements in Section A apply to your research. For questions while completing this reliance request, please contact Tasha Isles Smith, Senior IRB Specialist – Liaison at [email protected]

It is not acceptable to indicate in the grant application that CU is willing to serve as the Reviewing IRB or is willing to rely on an external IRB without receiving confirmation from the HRPO. A letter of support with the HRPO determination as to whether reliance is required and which IRB is proposed to serve as the Reviewing IRB will be provided and should be included in your grant application. 

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Basic reliance concepts:

• Some applications for NIH or other federal funding for multicenter studies will require reliance on a sIRB and some will not; this must be assessed by the HRPO at the time of the grant application for requirements to be met efficiently when funding is awarded or a Just-in-Time notification is received. This could be for a grant or contract, for initial funding or for continued funding.  The requirement for sIRB Review may not have applied at the time of initial funding but may apply at the time of grant renewal.
• Columbia may decide in certain situations to serve as the sIRB when Columbia is the applicant organization and a federal requirement for sIRB Review applies. An independent IRB may be contracted to serve as the sIRB, particularly when there are more than three non-Columbia sites involved. In certain situations, the IRB at one of the study sites may serve as the sIRB.
• When the NIH Policy became effective, a sIRB plan was required to be provided in the grant submission for all grant applications to which the NIH sIRB policy applies. This requirement has since been eliminated, but it is recommended for planning purposes that a sIRB plan be prepared by the PI for all situations for which a federal requirement for sIRB review applies. A template sIRB plan can be found here. 
• The NIH Policy required that each collaborating institution that would be engaged in the research must concur with reliance on a sIRB at the time of grant application and, when the proposed sIRB has already been designated, concur with reliance on that sIRB. Concurrence was to be documented, e.g., by a letter or email of support for reliance on a sIRB or the designated sIRB. Written concurrence is no longer a common request.
• A cost estimate for the sIRB review must be included in the grant application. HRPO staff will provide the estimate when Columbia is proposed to serve as the sIRB.
• Both the NIH Policy and the Common Rule 2018 Requirements permit limited exceptions to the sIRB requirement.
• These sIRB requirements apply only for federally-funded research. Although Columbia applies federal regulations for the protection of human subjects in research to all research conducted by Columbia, the federal sIRB requirements do not apply to non-federally funded research because the federal funding agency must approve the designation of the sIRB and this would not be possible when there is no federal agency providing funding.

The Columbia University sIRB Process for HHS grants provides guidance in completing the request form, for when Columbia is the Applicant Organization and will be the sIRB and for when Columbia will be relying on a non-Columbia IRB for sIRB review.

The following documents are used to explain or facilitate reliance:

sIRB Request & Review Workflow v2a: This document describes the processes for requesting approval for a reliance situation and IRB review.

Local context form for reliance on external IRB: This form is required to be completed collaboratively by the Columbia study team and HRPO staff and submitted to the external Reviewing IRB, when the Reviewing IRB does not provide a local context form.

Cover page for WCG Reliance: This form is required to be completed collaboratively by the Columbia study team and HRPO staff and submitted to the WCG IRB (formerly WIRB), when the WCG IRB will serve as the Reviewing IRB.

Tips for Creating a Rascal Tracking Protocol for CU Research Submitted to an External IRB

FAQs

What is the difference between a central IRB and a single IRB? Both are designed to help streamline IRB review, and the terms are sometimes used interchangeably. In general:

• A Central IRB is the IRB of record that provides the ethical review for all sites participating in more than one multi-site study. The sites are usually in a network, consortium or particular program.
• A Single IRB is the IRB of record, selected on a study-by-study basis, which provides the ethical review for all sites participating in a multi-site study.

Note: At Columbia the same request form and process is used for requesting either a central IRB or a single IRB.