Using Central or External IRBs
The OHSU IRB allows the use of a Single or Central IRB. This meets the requirements under the National Institutes of Health (NIH) Policy on the Use of a Single IRB (sIRB) for Multi-Site Research and the Cooperative Research (§45 CFR Part 46.114(b)) requirements of the Revised Common Rule (effective January 20th, 2020). Until that date, the only studies required to utilize a Central IRB are studies subject to the NIH sIRB Policy.
The OHSU IRB typically will NOT agree to be Reviewing IRB (i.e., the Single or Central IRB) for multi-site studies. There are other IRBs setup to specifically function as a Reviewing IRB for multi-site studies. OHSU study teams should plan to use an External IRB as the Reviewing IRB, even when OHSU is the Lead Site or the OHSU PI is the overall Lead PI of the study.
Waiving Oversight to an External IRB
To waive oversight to an External IRB, there must be an agreement between the two institutions. The agreement can either be an IRB Authorization Agreement (IAA) or a Memorandum of Understanding (MOU). The SMART IRB Agreement is a commonly used MOU.
Submit your study in the OHSU eIRB system so the OHSU IRB can ensure institutional requirements are met:
- Agree to Rely on the External IRB
- OHSU required consent language
- Training requirements
- Ancillary reviews
- Process any agreements that need signatures
Before the study may start both the External IRB and the OHSU IRB Office must sign off on the study.
Applicability of the NIH sIRB Policy
The NIH sIRB Policy applies to studies that meet these criteria:
- Studies funded by competing NIH grants (new, renewal, revision, or resubmission), contracts, or cooperative agreements submitted on or after 1/25/2018.
- Multi-site studies with domestic (US) sites conducting the identical protocol.
For questions about whether this policy applies to your study, contact your NIH Program Officer, your OPAM departmental contact, or see the NIH Single IRB Policy for Multi-site Research website.
General reliance or waived study questions:Email IRBReliance@ohsu.edu.
Pre-submission study-specific questions:Use the Send Comment function in the eIRB and list “IRB Reliance” in the additional e-mail notification recipients section.
Post-submission study-specific questions:
Send to the assigned IRB Coordinator by using the Add Comment function in the eIRB and checking the box for IRB Coordinator.