Single IRB/Multi-Site Studies

Single IRB – Multi Site Studies

The National Institutes of Health (NIH) single IRB (sIRB) policy applies to most grants and contracts submitted to NIH on or after January 25, 2018 and that will involve multiple study sites (i.e., multi-site study) conducting non-exempt human subjects research.  A multi-site study means that the same research protocol procedures will be conducted at each site.  In the past, each study site would submit for and obtain IRB approval from the “local” site IRB.  The sIRB policy requires the use of a single IRB to review and approve the research protocol for all of the study sites. 

The NIH policy applies to domestic sites only and excludes awards involving foreign sites, career awards, training awards, and fellowship awards from this policy.  In addition, the policy does not apply to sites for which review by the proposed sIRB is prohibited by federal, tribal, or state law regulation or policy.

Important: 

  • The sIRB must be identified in the grant proposal. 
  • It is important to consult early in the grant preparation process with IRB staff and the collaborating study sites.

Resources:

NIH Single IRB Policy

NIH Frequently Asked Questions

Guidance about Single IRB Costs