Single Institutional Review Board (sIRB)

Certain research supported by the Federal Government mandates a single IRB for review of multi-site and collaborative research activities.  This guidance may be used to identify when a sIRB is required.

Single Institutional Review Board (sIRB)

Effective Date: January 25, 2018

sIRB is mandated by the NIH and the revised Common Rule for the following types of non-exempt research:  

The NIH Single IRB Policy for Multi-Site Research

Applies to: NIH funded studies in which two or more sites are using the same research protocol to conduct the same human subject research activities at each site. These will typically be clinical trials, but can include observational studies. 

Exceptions to the Requirement: International sites, or sites involving tribal nations.

Details:Single IRB Policy for Multi-site Research

The NIH single IRB policy does not apply to studies conducted under career development, research training or fellowship awards.  

The Common Rule’s Cooperative Research Provision

Effective Date: January 20, 2020

Applies to: Federally funded cooperative research projects receiving initial IRB approval on or after January 20, 2020.  That is, studies that involve more than one institution conducting research with human subjects (regardless of if each institution is not carrying out the same human subject research activities).

Reviewing IRB: will be identified by the Federal department or agency supporting or conducting the research OR proposed by the lead institution (subject to the acceptance of the Federal department or agency supporting the research).

Exceptions to the Requirement: International sites, sites involving tribal nations, or studies that received initial IRB approval prior to January 20, 2020.

Details: The Revised Common Rule’s Cooperative Research Provision

Single IRB Help

• Stony Brook requires completion of a request in order to determine whether or not a study qualifies for Single IRB review and agree to be the sIRB or rely on the chosen IRB of Record.

• Currently SBU IRB will only cede review or serve as the single IRB for federally funded research studies in order to comply with the Single IRB mandate.

Guidance to Determine if a Study Qualifies for a sIRB and Process to Request SBU rely on an External IRB. (Click here for External sIRB flow chart).

Steps to Request SBU IRB as the sIRB (Click here for SBU sIRB Flow Chart).

Investigators should contact the Reliance Administrator in the Office of Research Compliance early in the multi-site grant/contract process to discuss possible sIRB options.