IRB Application Instructions: Off-Site Research

Introduction

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 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:

  • Principal Investigator Responsibilities When Other Institutions Are Relying on the UK IRB [PDF];
  • IRB Reliance Request/Registration Form [PDF];
  • General Information Sheet: IRB Reliance Requests [WORD]

Specific Non-UK sites with additional requirements

Cardinal Hill Hospital:

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.

Fayette County Public Schools:

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 Dr. Billy Buchanan. 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 Grants, Research, Accountability, & Data (GRAD)

Research and Data Requests at Fayette County Public Schools: Process and Requirements

GitHub Repository containing FCPS research request process/information

If you have any questions about conducting research in FCPS, please contact the GRAD office at data.research@fayette.kyschools.us.

Jefferson County Public Schools:

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.

Scott County Public Schools:

Research conducted within the Scott County school system requires review and documentation of approval by Ken Bicknell, Assistant Superintendent of Student Learning. The documentation of approval must be submitted to the IRB. You may call either at (502) 570-3036 or contact Meocha Williams by e-mail at meocha.williams@scott.kyschools.us.

Shriners Hospital for Children:

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 Rebecca Davis, Research Operations Manager at Shriners Hospitals for Children Medical Center – Lexington at rfdavis@shrinenet.org or (859) 268-5705.

Research Conducted in Subject's Home:

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.

Letters of Support & Local Context

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:

  • Please submit general inquiries to: IRBReliance@uky.edu
  • TBD, ORI Reliance Point of Contact/Medical Full Review protocols, (859) 218-1501
  • Joe Brown, ORI Reliance Point of Contact, (859) 257-9084

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:

  1. Agreement of the institution’s administration for the study to be conducted at that site;
  2. Review of the project by someone at the facility with respect to the issues of appropriateness for its human subject population, and adequacy of the facility to perform the procedures as approved by the UK IRB (if applicable).

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:

  1. Agreement of the institution’s administration for the study to be conducted at that site;
  2. Review of the project by someone at the facility with respect to the issues of appropriateness for its human subject population, and adequacy of the facility to perform the procedures as approved by the UK IRB. For FDA regulated research, the non-UK institution attests to, or provides verification of, site’s adequacy to execute the clinical protocol requirements (e.g., equipment, emergency/specialized care, test article security/accountability);
  3. Written confirmation that the facility personnel have the appropriate expertise to carry out the research procedures as reviewed and approved by the IRB.For FDA regulated research, the non-UK institution attests to, or provides verification of, appropriate qualifications of applicable clinical investigators (e.g., credentials, licensure, training, expertise, experience, and/or inspection history);
  4. Assurance that personnel from the facility who are involved in data collection have appropriate training in human subject research protection.
  5. A fully executed IRB Authorization Agreement (IAA) or Individual Investigator Agreement (IIA), which can be determined at the discretion of UK’s Reliance Team and/or the UK IRB, in conjunction with the non-UK institution.

*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.