Reliance on a Single IRB
Using a Central IRB (CIRB) or Single IRB of Record outside of UVA: There are certain instances where a UVA study can be reviewed by an IRB outside of UVA. In that case the outside IRB may be referred to as a "Central IRB", the "Single IRB of Record", or the "Reviewing IRB". This requires a written agreement between IRBs called a "reliance agreement" and is only permitted in certain instances for expedited or full board studies. In some cases, the UVA IRB-HSR will still serve as the HIPAA privacy board, which means they retain some responsibilities for the study. Please note that IRB reliance agreements only cover IRB review; Institutional reviews (ancillary non-IRB reviews such as pharmacy reviews, radiation safety committee reviews, clinical trial agreement reviews, etc.) still need to be conducted at each institution. Please note that UVA has an IRB Reliance Agreement with SMART IRB and is willing to rely on any non-UVA IRB that also has an IRB Reliance Agreement with SMART IRB (is a member of SMART IRB). # Using UVA IRB-HSR as a Single IRB of Record for a multi-center study: In some cases, the UVA IRB-HSR can serve as the Central/Single/Reviewing IRB of record for a study. * Number of Relying Institutions: The IRB-HSR is only able to serve as the single IRB of Record for a study that will include less than 10 sites. For studies involving more than 10 sites, the IRB-HSR is available to provide consultation in choosing the single IRB of Record. * Grant Proposals: You will need written approval from the IRB-HSR if you intend to propose the IRB-HSR as the single IRB of Record for a multi-site study in your grant proposal. If the IRB-HSR agrees to serve as the single IRB, you will be provided with language describing the IRB-HSR to include in your grant proposal. You will also need to obtain an initial agreement from all sites to rely on the IRB-HSR prior to submitting the grant proposal. A formal IRB reliance agreement document with each relying site will be obtained at a later date. * Budget: see NIH Guidance: Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-site Research. * UVA will not be charging any additional fees to non-UVA sites to serve as their IRB of Record, however you should check with the relying institutions to determine if they charge an administrative review fee that you would need to include in your budget. * Data Coordinating Center: Utilizing a single IRB of Record adds additional responsibilities for the overall PI of the study. These responsibilities may be handled by the overall PI or a Data Coordinating Center. UVA SOM CTO has experience serving as the Data Coordinating Center and is available to carry out these additional duties for you. * IRB Review Process: The study team will need to write a protocol that will be used by all sites. Therefore the protocol template provided by Protocol Builder will not be appropriate. The IRB-HSR suggests study teams use templates provided by the NIH. These may be found on the IRB-HSR website. Also note that protocol writing assistance is available from the SOM CTO. * Submit the protocol first to the IRB-HSR for the UVA site. Once approved the study team should submit modifications to add each site. Further details can be found on the "Visit Website" link provided on this page.