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A1.0100 OVERVIEW OF UK RESEARCH ENVIRONMENT - page 19 / 23

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A1.0050

documents, standardizing IRB policies and investigator training requirements, and developing mechanisms for coordination of multiple IRBs in the state-wide region.

A1.2050 VETERANS AFFAIRS MEDICAL CENTER RESEARCH AND DEVELOPMENT COMMITTEE

As a teaching facility affiliated with the UK Colleges of Medicine and Dentistry, the Lexington Veterans Affairs Medical Center (VAMC) coordinates closely with UK in ensuring human research protections. The VAMC Research and Development Committee serves the VAMC in an advisory capacity in the development and operation of the research program. Among broad functions designed to ensure the high quality of the facility’s program are specific responsibilities for evaluating the quality, design, desirability, and feasibility of each new research and development proposal, continuing research or development project, application for funding, or other activity to assure maintenance of high scientific standards and protection of human subjects.

Through a memorandum of understanding, the UK Medical IRB reviews Lexington VAMC research involving human subjects. All proposals submitted for VAMC or extra-VAMC research funds which involve human subjects must satisfy the regulations of both institutions and comply with the relevant legal and regulatory requirement of the VA, DHHS, and of other governmental agencies. The decisions of the UK IRB are binding on the VAMC, as they are for UK. The VAMC Associate Chief of Staff for Research and Development or designee serves as a non- voting ex officio member of the UK Medical IRB and provides the IRB with recommendations during the review of VAMC protocols. The VA Research Compliance Officer conducts ongoing quality assurance initiatives and also serves as ex officio member of the UK Medical IRBs. VA employees also serve as members of the UK Medical IRB.

A1.2100 INSTITUTIONAL RESOURCES

Allocation of institutional resources to support effective functioning of the UK HRPP is the responsibility of the VPR. The ORI assesses the needs of the IRB and its support infrastructure on a continual basis. The ORI submits requests to the VPR for budgetary support and resource allocation to meet the needs identified during regular review of the volume and nature of the research being conducted and the protocols being reviewed by the IRB.

The VPR receives and processes requests for overload payments for IRB chairs of the Medical and Nonmedical IRB committees, the costs of meals for IRB members and staff during meetings, travel and other professional development costs for IRB members to attend professional meetings, and any additional special project needs.

In addition, various units reporting to the VPR provide the resources necessary to support IRB operations. Administrative and Fiscal Affairs (AFA) provides budget support for ORI personnel salaries and fringe benefits, communications costs, copying, and selected office and supply expenses. The Office of Research Information Services (Research IS) handles requests for computer and technology resources to support the IRB and ORI staff. The VAMC provides travel support for ORI staff members to attend professional meetings. The ORI budget covers additional basic operating costs including education for ORI staff, supplies, office furniture, education materials, and selected equipment.

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