Single IRB Reliance
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]
University of Kentucky (UK) Single IRB Frequently Asked Questions (FAQs)
- What is a Single IRB?
A single IRB is when one institution engaged in human subject research agrees to be the reviewing IRB for another institution for a cooperative study. Single IRB is mandated when institutions located within the US are engaged in cooperative research conducted or supported by a Common Rule department or agency. Generally, UK should be the IRB for any studies in which a UK investigator is the Principal Investigator. List of the common rule departments or agencies [HTML]
Can I Use a Single IRB if My Study is Not Funded?
Studies that are not federally funded are reviewed on a case-by-case basis.
Please contact UK’s Reliance Team if you want to use a single IRB for a non-funded study.
Some of the items that are considered for non-federally funded studies include:
- Risk of the project,
- Sponsor’s requirement for single IRB,
- Accreditation status,
- The number of sites and the research activities conducted for the project.
- Do all multi-site studies require a single IRB?
Not all multi-site studies require a single IRB. Though there are exceptions, the following is less likely to require a single IRB:
- Exempt research,
- Research that is being conducted under research training awards,
- If a single IRB is unable to meet the needs of a specific population, especially if there are federal, tribal, or state laws surrounding research involving the population,
- If the research sites are only international.
- When Should I Contact UK Reliance Team for My Project?
- You want an external IRB to be the reviewing IRB,
- You want UK to serve as the reviewing IRB for a multi-site study,
- You are transferring your project to UK or want to work with your previous institution on a project,
- You or your colleagues are transferring to another institution and want to continue to work on the project,
- You have reliance questions about a project.
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 firstname.lastname@example.org. 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.