CRC Corner: How to Set Up a Reliance Agreement

A Reliance Agreement is a formal, written agreement in which the reviewing IRB agrees to serve as the IRB of Record for a Relying institution/site.  The signed agreement permits a single IRB to review human subject research activities for more than one site. Navigating the reliance agreement process can be complex, with many moving parts, so it’s important to follow each step carefully. When adding an outside site to a study where UVA is the IRB of record, the first step is to confirm that the external site’s local IRB is a member of SMART IRB. Next, check that the site is listed on the UVA IRB-approved protocol; if it isn’t, you’ll need to submit and receive approval for a modification before moving forward. Once that is complete, send the site the most current Reliance Agreement form from the UVA IRB website along with the latest UVA-approved consent form. The site should complete the form and return the consent with their required edits in tracked changes.

Once you receive these documents, review them carefully to ensure the information in the reliance agreement and changes made to the ICF match and that all site-specific details, such as PI information and other changes made to the ICF language, are correct. If the site prefers to use its own HIPAA privacy board, make sure the HIPAA language in the ICF is removed and the sites separate HIPAA form has been received. Once the review is complete, prepare the IRB submission with the reliance agreement, modification request, updated ICF, site PI credentials, and separate HIPAA form if applicable. Be sure to also include the UVA SOM Clinical Trials Unit approval for each site from Lori Elder lje5u@virginia.edu in the IRB Pro submission. Finally, save all of these submission documents and approvals along with your study files and share copies with the site for their records.

If you have any questions about this process or managing multisite studies, please contact somctumultisite@uvahealth.org.