A single IRB (sIRB) is the IRB of record that oversees all clinical trial sites participating in a multi-site study.
Effective January 25, 2018, the NIH will require the use of a sIRB for the review of non-exempt, multi-site, domestic, human subjects research protocols funded by the NIH.
Additionally, under the new Final Rule governing human subjects protections approved by the DHHS in January, 2017, most U.S. government funded cooperative studies that meet the criteria for non-exempt “human subjects research”, and involve more than one site, will also require sIRB review. This requirement goes into effect January 20, 2020.
Some other networks, companies and foundations may also require sIRB review.
MUSC has created a Reliance Intake Form. You must submit your request for reliance using this form before making any commitment in your grant application that MUSC is willing to serve as the sIRB. MUSC IRB is required to review and approve your request before providing you with a letter of support and additional instructions for your grant application.
Once you have received confirmation from MUSC IRB, the next steps are available on the MUSC IRB Reliance website.
Once you have completed the Reliance Intake Form, and you have been notified that MUSC IRB agrees to enter into a reliance agreement, you will be provided a letter of support as well as template language to include in your grant application. The template language will describe how MUSC IRB is prepared to serve as a sIRB.
The NIH policy requires that a “communication plan” be included in your grant application/proposal. The applicant/offeror is expected to submit a communication plan describing the use of an sIRB that will be selected to serve as the IRB of record for all study sites. The plan should include a statement confirming that participating sites will adhere to the sIRB Policy and describe how communications between sites and sIRB will be handled.
In addition, a budget for sIRB fees will be required as part for the grant application.