UK Office of Research Integrity

Off-Site Research - IRB Application Instructions

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 topic "Off-Site Research" on the IRB Survival Handbook web page for details on the requirements for conducting off-site research including, but not limited to:

  • ORI's Off-site Research Guidance;
  • Principal Investigator Responsibilities When Other Institutions Are Relying on the UK IRB;
  • IRB Reliance Request/Registration Form.

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 review by Michael Owen and documentation of his approval submitted to the IRB. You may contact Mr. Owen by e-mailing michael.owen@fayette.kyschools.us or calling (859) 381-4245. See also FCPS, "Research Policy and Process for Application and Application" [PDF].

Jefferson County Public Schools:

Research conducted within the Jefferson County school system requires review by the Data Management and Research Office (DMRO)[PDF]. Documentation of DMRO approval must be submitted to the IRB. Requests for review by the DMRO 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 either Matt Thompson or Rick Culross, EdD. The documentation of approval must be submitted to the IRB. You may call either at (502) 863-3663 or contact Matt Thompson by e-mail at matthew.thompson@scott.kyschools.us or Rick Culross at rick.culross@scott.kyschools.us.

Shriners Hospital for Children:

The University of Kentucky has a Cooperative Agreement in place to serve as the IRB of record for Shriners Hospital for Children. No additional materials are needed for submissions to conduct research at this location.

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:

  • Amy Kolasa, Off-Site Research Coordinator/Medical Full Review protocols, (859) 257-9425;
  • Joanne Hines, Medical Expedited protocols, (859) 257-7467;
  • Andrew Hedrick, Non-Medical Full and Expedited protocols, (859) 257-1639.

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.

*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.

 

 

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