Will Northwestern University’s IRB serve as the IRB of Record for another institution or site?
On a case-by-case basis, Northwestern University’s IRB may serve as the Single IRB (sIRB) or IRB of Record for a Multi-Site Study, Collaborative Study, or an individual investigator. The IRB Office reviews and determines if it is appropriate in alignment with the requirements outlined in “SOP: Northwestern University serving as IRB of Record (HRP-093).”
The IRB Office has a Single IRB Consultation process to aid research teams in identifying the best route to sIRB compliance. There are several ways for Northwestern University and its researchers to comply with the revised Common Rule Single IRB mandate for cooperative research and the NIH sIRB mandate, such as 1) the Use of a Central (Commercial) IRB, 2) Northwestern University serving as the IRB of Record, or 3) Another academic IRB (from one of the participating sites) serving as IRB of Record. As a part of the Single IRB Consultation process, which includes determining the appropriate route, the IRB Office will provide a Letter of Support for one of the three options above. The IRB of Record is not determined based on which institution is the primary grant recipient.
Please also refer to the IRB Office’s Single IRB webpage for detailed information about the consultation process, how to submit a request for a Letter of Support for federal funding proposals, and an overview of the criteria that the IRB Office takes into consideration when determining whether it is appropriate for Northwestern to serve as the IRB of Record.