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SBU Documents/Guidance

Common Terms

Authorization Agreement - a written agreement between two or more institutions that is used to document the delegation of IRB review responsibilities. This agreement may also be referred to as a reliance agreement or cede review agreement.

Cede review - the act of transferring IRB review and oversight.

Reviewing IRB - the IRB of record performing review on behalf of one or more institutions, also referred to as the single IRB and/or central IRB.

Relying Institution - the entity that agrees to rely upon the reviewing IRB.

Multi-Site Study - A multi-site study uses the same protocol to conduct non-exempt human research at more than one site.  

sIRB: -An sIRB (Single Institutional Review Board) is the selected IRB of record that conducts the ethical review for participating sites of the multi-site study.

External IRB/sIRB vs Local Review Responsibilities:

The image below depicts the different responsibilities of the external/sIRB compared to the local institution. 

 chart

Grant Application Information requirements for sIRB:

Required by NIH for Multi-Site Grant Applications
The NIH Single IRB Policy requires the following new information in grant applications for multi-site research submitted on and after January 25, 2018:

Human Subjects section

A Single IRB Plan should include the following elements:

  • Name of the sIRB of record
  • Indicate that: (1) All sites, including any added after award, agree to rely on the sIRB; (2) Sites will sign a reliance agreement that will include a communication plan; (3) Indicate who will maintain records of the reliance agreements

See details in Section 3.2 of the PHS Human Subjects and Clinical Trials Information Form Application Guide.

Budget and Budget Justification

Any IRB fees that will be charged as direct costs, and any personnel costs directly related to managing the IRB arrangements. See the PHS G.300 – R&R Budget Form for information about where in the budget form to put this information.