Single IRB review of multi-site studies is becoming increasingly common. The UAMS IRB has developed new procedures (and continues to review and refine them) to ensure adequate human subject protections AND regulatory compliance for sIRB studies. To facilitate to review of these studies, we ask that all study teams do the following:
- Complete the appropriate form (“Relying on an External IRB” or “UAMS is the IRB of Record”) available on the IRB’s website. Our nickname for this form is the “heads-up” form. It lets us know the multisite study is on its way, so we can start working on the related paperwork. This form should be submitted no later than when the study team begins creating the CLARA submission form.
- If UAMS is relying on an external IRB, please obtain a copy of whatever reliance agreement will be used, and provide it to the UAMS IRB as soon as possible. This document can be uploaded to the “form submitted “heads up” form (preferred) or emailed to irb@uams.edu. Note that the UAMS IRB’s preferred reliance agreement is the SMART IRB agreement. When that reliance agreement is used, there’s no need to send us the reliance agreement.
- If another IRB will be the overseeing the review, please let us know if you help completed any reliance-related forms, such as a local context form or communication plan. The versions of these forms used when the UAMS IRB is the IRB of record are available on our website.
- Check the UAMS IRB’s single/central IRB website often. We are constantly tweaking our procedures and related documents as we learn more about the sIRB process.