Single IRBs and IRB Authorization Agreements

Both the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) permit an IRB the option to rely on the review of another IRB. When this is the intention, the institutions enter into an agreement often referred to as an IRB Authorization Agreement. These agreements are executed between a Reviewing IRB and one or more Relying Institutions and delineate the roles and responsibilities of the involved parties. The agreements can be for a single research study or for multiple studies (e.g., a Master Reliance Agreement). The National Institutes of Health (NIH) and some funding agencies have increasingly encouraged the designation of one IRB to serve as the Reviewing IRB for all participating sites in multicenter research studies.

Effective January 25, 2018, the NIH has mandated that all domestic sites participating in a non-exempt, multi-site research study (where study activities outlined in a single protocol are carried out at multiple institutions) use a single IRB (sIRB).

Effective January 20, 2020, OHRP will require a sIRB for all domestic sites participating in a non-exempt, cooperative research study (two or more institutions coordinate to complete a portion of the research outlined in a specific protocol).

Instructions for Requesting a Reliance Determination

Please email the completed Reliance Request Form along with a copy of the grant proposal, if applicable, to your IRB Office. If needed for a grant proposal, please submit the request at least one (1) week before the grant submission deadline.
Researchers at University Park and all other campus locations except Penn State’s College of Medicine and Penn State Health please contact:
Office for Research Protections (ORP) IRB
Email irb-orp@psu.edu and indicate "Single IRB" in the subject line.
 
Researchers at the Penn State College of Medicine and Penn State Health please contact:
Human Subject Protection Office
Email hspo@pennstatehealth.psu.edu and indicate "Single IRB-NIH" in the subject line.
 

Once reviewed and the reliance determination made, your IRB Office will provide you with a letter of support that describes the selected sIRB and Penn State’s willingness to rely on this IRB OR serve as the reviewing IRB.

NOTE: Penn State’s IRB Offices CANNOT guarantee their willingness to support the use of the sIRB that has been selected without prior consultation and agreement documented in a letter of support.

Learn More

To learn more about single IRB review and authorization agreements, please see our frequently asked questions page.