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Veterans Affairs Research and the IRB
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The University of Kentucky’s (UK) 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 Veterans Affairs (VA) establishes guidelines for responsibilities between the two entities. In addition, standard operating procedures (SOPs) have been established to further document the coordination between the UK IRB and the VA.
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 approvals are required before any research procedures can be implemented at the VA. The VA’s Research and Development Committee 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 "Committee Findings" section.
- If the requirement for documentation of informed consent has not been waived, all VA research protocols must include a VA-specific consent form ("VA Research Consent Form" - aka "VA 10-1086") containing the appropriate VA verbiage.
- 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.) Download 10-9012 Side 1 [PDF] ; Download 10-9012 Side 2 [WORD]
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 281-4927.
VA policy prohibits paying human subjects to participate in research when the research is integrated with a patient’s medical care and when it makes no special demands on the patient beyond those of usual medical care. Payment may be permitted, with IRB approval, in the following circumstances:
- When the study to be performed is not directly intended to enhance the diagnosis or treatment of the medical condition for which the volunteer subject is being treated, and when the standard of practice in affiliated non-VA institutions is to pay subjects in this situation.
- In multi-institutional studies, when human subjects at a collaborating non-VA institution are to be paid for the same participation in the same study at the same rate proposed.
- In other comparable situations in which, in the opinion of the IRB, payment of subjects is appropriate.
- When transportation expenses are incurred by the subject that would not be incurred in the normal course of receiving treatment and which are not reimbursed by any other mechanism. [VHA Handbook 1200.5, 7, 12.a., pg 21-22]
VA subjects cannot be charged for any research-related medical care and their insurance cannot be billed. Veteran subjects will not be required to pay for care received as subjects in VA research projects except if they are in an eligibility category that requires they pay a co-pay for medical services that are not part of the study. [VHA Handbook 1200.5 Appendix C, 2.a. (14)]
If specimens will be banked, genetic testing done, or a commercial product developed, VA policy must be followed [VHA Handbook 1200.5 Appendix C 2. b. (7)]. For details see the VHA Directive 2000-043 memo. The "Banking of Human Research Subjects’ Specimens,” November 6, 2000 document [online PDF] requires that all human biological specimens and linked clinical data collected as part of research projects conducted by VA investigators in VA facilities or approved off-site locations will be maintained at either VA-sponsored tissue banks or VA (ORD) approved tissue banks. Sites that may not be acceptable for storage of tissue specimens include non-academic, for-profit institutions, such as pharmaceutical or biotech companies.
Consent and/or Authorization by a Legally Authorized Representative for VA Research
The PI may obtain consent by a legally authorized representative only in situations where the prospective subject is incompetent or has impaired decision-making capacity, as determined and documented in the person’s medical record in a signed and dated progress note. The determination that a subject is incompetent or has an impaired decision-making capacity must be made by a legal determination or a determination by the practitioner, in consultation with the chief of service after appropriate medical evaluation that the prospective subject lacks decision-making capacity and is unlikely to regain it within a reasonable period of time.
In cases where the determination that a prospective subject lacks decision-making capacity is based on a diagnosis of mental illness, VA policy requires consultation with a psychiatrist or licensed psychologist.[For more information, see the UK ORI/IRB Informed Consent SOP, and the VHA Handbook 1200.5, Section 11 - Research Involving Human Subjects with Surrogate Consent]
VA Research Consent Form (VA 10-1086)
On October 30, 1992, the Veterans Affairs federal requirement (Veterans Health Administration Handbook 1200.5, July 15, 2003) dictated that informed consent obtained from VA patients being enrolled in research studies should be documented on a VA 10-1086 form. The VA enforces the use of the VA Research Consent form (VA 10-1086) for those studies approved to enroll VA patients in research. The consent form must conform to all VA requirements, including an appropriate VA-specific indemnification and notification clause. Use the VA 10-1086 consent template to ensure applicable VA verbiage is included.
VA Research Consent Form Template (VA 10-1086): [WORD] [RTF] [Revised 9/3/08]
Please note that this is a VA initiative. Studies that do not involve the enrollment of VA patients will not be affected. If you have questions about the VA research consent form, please contact the VA at 17-4927.