Continuing Reviews: I am the PI for a protocol and another institution is relying on the UVa IRB-HSR. What do I need to consider at the time of continuing review? Unanticipated problems: I am a PI for a protocol at UVa but we have relied on another IRB. If an unanticipated problem has occurred with one of my subjects, who do I report it to? Consent I am the PI for a protocol and another institution is relying on the UVa IRB-HSR. Do they use a UVa consent? Answers 1. What is a Reliance Agreement? A reliance agreement (also called an IRB Authorization Agreement) is a document signed by two or more institutions engaged in human subjects research that permit one or more institutions to cede review to another IRB. The signed agreement permits a single IRB to review human subject research activities for more than one site. 2. What is the purpose of a Reliance Agreement? A reliance agreement avoids duplicate IRB initial review and continued oversight when multiple IRBs have jurisdiction for the same multi-site research protocol. Once the agreement is executed, it can lessen the administrative burden and regulatory oversight of multiple institutions’ IRBs. 3. Are Reliance Agreements accepted by all institutions? Institutions vary as to whether they will utilize reliance agreements. Many institutions will decide if they will allow a reliance agreement based on the research protocol being reviewed. Some institutions have standing arrangements to utilize other IRBs for specific types of research. From a regulatory perspective, federal regulations allow for reliance agreements to be used for multi-site research. 4. Does the University of Virginia IRB-HSR utilize Reliance Agreements? Yes, UVa has both agreed to allow other institutions to rely on the IRB-HSR and it has also agreed to cede review to other IRBs outside of UVa.
Continuing Reviews: I am the PI for a protocol and another institution is relying on the UVa IRB-HSR. What do I need to consider at the time of continuing review? Unanticipated problems: I am a PI for a protocol at UVa but we have relied on another IRB. If an unanticipated problem has occurred with one of my subjects, who do I report it to? Consent I am the PI for a protocol and another institution is relying on the UVa IRB-HSR. Do they use a UVa consent? Answers 1. What is a Reliance Agreement? A reliance agreement (also called an IRB Authorization Agreement) is a document signed by two or more institutions engaged in human subjects research that permit one or more institutions to cede review to another IRB. The signed agreement permits a single IRB to review human subject research activities for more than one site. 2. What is the purpose of a Reliance Agreement? A reliance agreement avoids duplicate IRB initial review and continued oversight when multiple IRBs have jurisdiction for the same multi-site research protocol. Once the agreement is executed, it can lessen the administrative burden and regulatory oversight of multiple institutions’ IRBs. 3. Are Reliance Agreements accepted by all institutions? Institutions vary as to whether they will utilize reliance agreements. Many institutions will decide if they will allow a reliance agreement based on the research protocol being reviewed. Some institutions have standing arrangements to utilize other IRBs for specific types of research. From a regulatory perspective, federal regulations allow for reliance agreements to be used for multi-site research. 4. Does the University of Virginia IRB-HSR utilize Reliance Agreements? Yes, UVa has both agreed to allow other institutions to rely on the IRB-HSR and it has also agreed to cede review to other IRBs outside of UVa.
IRB_Reliance_Agreements-Frequently_Asked_Questions.docx