Single IRB Reliance
Revised Common Rule Cooperative Research Provision Compliance Date is January 20, 2020
As of January 20, 2020, According to the Revised Common Rule’s Cooperative Research Provision (45 CFR 46.114), all institutions located in the United States that are engaged in cooperative research conducted or supported by a Common Rule department or agency must rely upon approval by a Single IRB for the portion of the research conducted in the United States. For further information, click here.
E-IRB Abbreviated Applications (AA) for Ceded Review:
As of October 1, 2019, investigators will receive notification to submit an “Abbreviated Application (AA)” for their ceded research project in E-IRB after submitting the Reliance Registration/Request Form to email@example.com. The AA will provide prompts and links to requirements handled locally, not by the external IRB. There are many local ancillary processes independent from IRB review (e.g., conflict of interest, HIPAA, Investigational Drug Service, Institutional Biosafety Review). The AA will help investigators identify and keep up with these local requirements.
UK is a member of the following IRB Reliance Networks:
Submit a Reliance Request
If your research involves collaboration with any sites and/or personnel outside the University of Kentucky, then it is considered multisite research and IRB reliance issues will need to be addressed. This may include national multi-center trials as well local studies involving sites/personnel external to UK. If you would like to request that the University of Kentucky IRB (UK IRB) serve as the lead IRB for your study, or if you would like the UK IRB to defer review to another IRB, please complete the forms below and submit them to IRBReliance@uky.edu.
- IRB Reliance Request/Registration Form [PDF]
General inquiries/questions about IRB reliance and the University of Kentucky’s policies and procedures may also be submitted to: IRBReliance@uky.edu.
- Lead PI Checklist [PDF]
- Relying Institution PI Checklist [PDF]
- Principal Investigator Responsibilities When Other Institutions Are Relying on the UK IRB [PDF]
- Principal Investigator Reliance Assurance Statement [D149.0000] [PDF]
- IRB Application Instructions: Off-Site Research [HTML]
- OHRP's "Guidance on Engagement of Institutions in Human Subjects Research" [HTML]
- Sample Protocol for Reliance [PDF]
- Step-by-Step Guidance for University of Kentucky Investigators Requesting to Rely on an External IRB [PDF]