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IRB Application: Additional Study Materials

Section 4
FORM R.  Veteran Affairs Research and the UK IRB

The University of Kentucky's Medical Institutional Review Board (IRB) serves as the IRB of record for research involving recruitment of human subjects (e.g., patients, staff, volunteers) from the Veterans Affairs Medical Center (VAMC) or uses VA resources (e.g., funds, equipment, space, VA personnel). A Memorandum of Understanding (MOU) between UK and the VA establishes guidelines for responsibilities between the two entities.

The Medical IRB is charged with protection of the rights and welfare of the individuals enrolled as subjects in research. The VAMC also has a Research and Development Committee (R&DC) which reviews protocols falling under VA purview for scientific merit. Both IRB and VA R&DC Committee's approvals are required before any research procedures can be implemented at the VA. The VA's R&DC will not consider an application without prior UK Medical IRB review and approval.

In order for the IRB to consider approval for a protocol falling under the VA's purview, the following materials and details must be included in the IRB application submission:

  • VA Form 10-1223 Report of Subcommittee on Human Studies.  The PI should fill in the project/program title, PI name, and VAMC name at the top of this form.  (The IRB/ORI staff will complete the remainder of the form, which is attached to the IRB approval letter when issued to the PI.);
  • If the requirement for documentation of informed consent has not been waived, all VA research protocols must include a VA-specific consent form (VA 10-1086);
  • All VA studies must have " UK/V:" at the beginning of the study title (for internal tracking purposes);
  • For investigational drug studies, a VA Form 10-9012, Investigational Drug Information Record. (ORI staff send the form to the VA after obtaining the IRB Chair or designee's signature.)
If you are proposing research involving VA facilities, patients, or resources, please mark the appropriate selection(s) in the space provided on the General Information Sheet [Section 1, Form A].

University Kentucky researchers who utilize VA facilities, recruit VA patients for UK studies, or who have joint appointments must complete mandatory education in any area applicable to the research being conducted. These VA requirements are in the following areas: Human Subjects, Animal Care and Use, Occupational Health and Safety, Hazardous Materials Management, Radiation Safety, Fire and Safety, and Data Security. For specific information, contact the VA Research Service Office at 859-281-4927. 

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