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Research & Development Committee Staff Chair: Alan J. Lesse, M.D. Contact: Janine Hilliard (716) 862-6525 Jan Giesler (716) 862-6021 The Research & Development Committee (R&D Committee) is the scientific review body for all research activities and is assisted by the Institutional Review Board. The R&D Committee reports to the Medical Center Director. The R&D Committee is responsible for assuring the scientific quality and appropriateness of all funded and unfunded research involving human participants, the protection of human participants, the welfare of animal research participants and laboratory safety.   Resources Office of Research Oversight (ORO) Registration of Clinical Trials Top of Page Institutional Review Board (IRB) Staff Chair: Jeffery Mador, M.D. Contact: Janine Hilliard (716) 862-6525 Jan Giesler (716) 862-6021 The Institutional Review Board (formerly the Human Studies Subcommittee) is a formally established IRB of the Research and Development (R&D) Committee. (M-3, Part 1, Chapter 2.02 and 3.01). The IRB is the committee that the VA has designated to prospectively review and monitor research involving human participants to protect the rights and welfare of the participants. The IRB reports its findings to the Research & Development (R&D) Committee.   Resources IRB Guidebook ** Declaration of Helsinki ** Food & Drug Administration (FDA) ** Office for Human Research Protections (OHRP) ** National Committee for Quality Assurance (NCQA) * VA Human Research Protection Accreditation Program (VAHRPAP) * Office of Research Oversight (ORO) Public Responsibility in Medicine & Research (PRIM&R) * Clinical Research and the HIPAA Privacy Rule * Ethical Issues in Research Involving Human Participants ** Top of Page WNYHS Subcommittee on Research Safety Staff Chair: Timothy Murphy, M.D. Contact: Sandra Martin-Thomas (716) 862-6528 The VAWNYHS Subcommittee on Research Safety reviews proposals involving toxic and/or hazardous chemicals, recombinant DNA or other potential biohazards in compliance with VHA Handbook 1200.8 (Safety of Personnel Engaged in Research). It assesses the impact of each agent on the safety of personnel working in research laboratories. Proposals involving the use of recombinant DNA or other potential biohazards may also be reviewed by the SUNYAB Biosafety Committee. Laboratory Safety Subcommittee Staff Chair: Carolyn Moronski Contact: Sandra Martin-Thomas (716) 862-6528 The Laboratory Safety Subcommittee reviews all research laboratory operations to establish that accepted safety standards are being met, and to recommend corrective action if necessary. Membership includes representatives from all major research laboratories. Investigators must certify that their employees are aware of correct safety procedures regarding the operation of equipment, reagent handling, usage, storage and disposal.   Resources Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) ** Report on Carcinogens ** Biosafety in Microbiological and Biomedical Laboratories (BMBL) 4th Edition ** Office of Research Oversight (ORO) Hazardous Waste Management Regulations * Top of Page Institutional Animal Care & Use Committee: Staff Chair: Mark Sands, MD Contact: Janine Hilliard (716) 862-6525 Jan Giesler (716) 862-6021 The VA Western New York Healthcare System in Buffalo recognizes the vital importance that animals fulfill in research. VAWNYHS is bound by federal mandates, specifically the Animal Welfare Act, the Public Health Service Policy, and the Department of Veterans Affairs, to maintain an oversight committee - the Institutional Animal Care and Use Committee (IACUC) - that reviews and regulates the care and use of animals for biomedical research and teaching. The IACUC (formerly the Animal Studies Subcommittee) reviews all research proposals involving live vertebrate animals for appropriateness, quality and availability of the animal models selected, humaneness of the proposed procedures, and optimal utilization of animals housed in the Veterinary Medical Unit. It has authority over operation of the Veterinary Medical Unit Facility (VMU). The IACUC reports to the Research and Development Committee. As part of quality assurance and a high standard of care, the IACUC adheres to the guidelines promulgated by the Office of Laboratory Animal Welfare (OLAW) and establishes its policies according to the Guide for the Care and Use of Laboratory Animals and the Department of Veterans Affairs Draft Handbook 1200.7, Use of Animals in Research. The Veterinary Medical Unit, with which the IACUC works closely, maintains FULL accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC, International) and has a letter of assurance of compliance on file with OLAW. Additionally the VAWNYHS animal care and use program maintains an Animal Welfare Assurance issued by OLAW (Assurance #A3087-01).   Resources How to Write an NIH Grant Application Involving Research Animals ** American Association of Laboratory Animal Science (AALAS) * Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) * NIH: Office of Laboratory Animal Welfare (OLAW) ** IACUC.org * Office of Research Oversight (ORO) Animal Research Training * Top of Page

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