Cooperative Research Projects
Cooperative research projects are those projects covered by this policy that involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy.
45 CFR 46.114(b)(1) states that any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States.
Note: Effective January 25, 2018, the National Institutes of Health mandated the use of single IRBs as a contingency for funding of multi-center studies.
IRB Reliance Agreements
A reliance agreement (i.e. IAA’s, IIA, etc.) is an agreement between two or more institutions that allows an institution’s IRB to rely on another, unrelated institution’s IRB for review of human subjects’ research. A reliance agreement comes in multiple formats, with the most common being Institutional Authorization Agreements (IAA), Memorandum of Understanding (MOU), and Master Reliance Agreement (MRA). An Investigator working at multiple institutions, each having their own IRB, may decide to have one IRB serve as the IRB of record for some or all participating sites. This practice is commonly referred to as ceded review, reliance agreements, or deferral of IRB oversight.
In some cases, the Radford University IRB will either serve as the reviewing IRB (IRB of Record) or will cede oversight (rely upon) of the research activity to another equally qualified institution’s IRB. Each individual IRB will indicate which agreement format is appropriate for a specific study.
Under a Master Agreement with Carilion Clinic effective Fall 2020, Radford University cedes authority for IRB review for students with IRB projects involving students and/or patients at Carilion Clinic. These human subjects research projects will undergo the Carilion Clinic's IRB review process with a Carilion Clinic faculty member as PI for the project. Following approval of the IRB protocol, a copy of the IRB approved protocol, approval letter, and corresponding documents shall be sent to Radford’s Research Compliance Office for documentation purposes.
For other collaborative projects please contact the Research Compliance Office for the IRB Authorization Agreement (IAA) to be completed. Submission of the completed IAA along with a copy of the IRB-approved protocol, approval letter, and corresponding approved materials from your University's IRB or Exemption letter received is needed. The IRB Office will review the submitted documents and contact you either for any more information that might be required or with approval information that you may begin your project.