Research activities conducted at performance sites that are not owned or operated by the University of Kentucky (UK) or at sites that do not fall under the UK IRB’s authority are subject to special procedures for coordination of research review. Additional information is required.
See the Single IRB Reliance web page for details on the requirements for conducting off-site research including, but not limited to:
Research being conducted at Cardinal Hill Hospital requires approval by the Cardinal Hill Hospital Scientific Review Committee (SRC). A copy of the SRC approval letter should be included in your application. A cooperative review agreement (IRB Authorization Agreement) may also need to be completed. This determination is made on a case-by-case basis in consultation with the ORI staff.
Research conducted within the Fayette County school system requires initial approval by a district co-sponsor and final approval from Dr. Shanshan Wang and/or Carl Hayden. Documentation of approval by the co-sponsor is submitted to the IRB as the required letter of support. Once secured, final Fayette County Public Schools approval documentation must be submitted as a post IRB-approval modification. You may contact Dr. Wang by e-mailing shanshan.wang@fayette.kyschools.us or calling (859) 381-4290.
For further information please see:
FCPS Office of School Improvement
FCPS External Research Requests
GitHub Repository containing FCPS research request process/information
If you have any questions about conducting research in FCPS, please contact the Office of School Improvement at data.research@fayette.kyschools.us.
Research conducted within the Jefferson County school system requires review by the JCPS Institutional Review Board (IRB). Documentation of JCPS approval must be submitted to the IRB. Requests for review by the JCPS IRB can be submitted on their Data Request Management System (DRMS) website.
Research conducted with faculty, staff, and/or students from the Kentucky Community & Technical College System (KCTCS) requires initial communication with KCTCS to obtain the required letter of support. Once secured, final KCTCS approval documentation must be submitted as a post IRB-approval Modification Request (MR) before any research activities can be initiated. Please contact Anthony Pinson (anthony.pinson@kctcs.edu, 859-256-3389) to discuss your project, their review process, and how to obtain the initial letter of support from KCTCS.
Research conducted within the Scott County school system requires review and documentation of approval by Stephanie Emmons, Assistant Superintendent of Student Learning. The documentation of approval must be submitted to the IRB. You may contact Stephanie Emmons by e-mail at stephanie.emmons@scott.kyschools.us.
The University of Kentucky IRB is no longer the relied upon IRB for research taking place in the Lexington Shriners Hospital for Children. Investigators interested in conducting research at the Lexington Shriners Hospital for Children should contact Shelby White, Research Program Manager at Shriners Hospitals for Children Medical Center – Lexington at Shelby.White@shrinenet.org or (859) 268-5705.
If your research project involves seeing a patient/subject in their home (e.g., research-related medical intervention), please contact UK Legal at (859) 323-1161 to determine if a Kentucky notice requirement applies to your study.
Research activities conducted at performance sites that are not owned or operated by the University of Kentucky, at sites that are geographically separate from UK, or at sites that do not fall under the UK IRB’s authority are subject to special procedures for the coordination of research review. The term off-site research designates research meeting any one of these criteria. An off-site institution or facility may be domestic or international and may or may not have its own IRB.
Research procedures should not be initiated at an off-site location prior to IRB review of the appropriate documentation for that site.
Step 1: Determine if the non-UK institution is “engaged” in the human subject research activity.
An institution becomes “engaged” in human subjects research when its employees or agents (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes (45 CFR 46.102(d),(f)). Examples of engagement are included in the OHRP Guidance Document, “Engagement of Institutions in Research”.
If you have questions about conducting human subjects research with non-UK sites and personnel, please contact the following individuals in ORI for assistance:
Step 2: Determine additional requirements for engaged vs. non-engaged non-UK institutions.
A. If the non-UK institution IS NOT engaged in the research:
Submit a letter from the appropriate administrator of the non-UK institution (on the facility’s letterhead stationery), that addresses the following items:
B. If the non-UK institution IS engaged in the research AND UK will serve as the relied-upon IRB for oversight of the project*:
Submit a letter from the appropriate administrator of the non-UK institution (on the facility’s letterhead stationery), that addresses the following items:
*If the participating non-UK site has its own IRB and that IRB will review and approve the protocol for its own location, then you may submit a copy of the IRB approval from that site in place of a letter of support & local context.