• Institutional Animal Care and Use Committee (IACUC)
• Research & Development Committee (R&D)
• Subcommittee on Research Safety (SRS)

CFBRE - (Cincinnati Foundation for Biomedical Research & Education)
The Cincinnati Foundation for Biomedical Research and Education (otherwise known as CFBRE) is a non–profit corporation of the VA that was established in 1991 by Congressional mandate under the authority of Circular 10–89–99, dated September 21, 1989. The CFBRE non–profit Federal tax ID number is 31–1347969. Meetings of the board take place at least two times each year.

GCRC - (General Clinical Research Center)
The overall mission of the VA GCRC is to provide a site for the study of adults with complex medical or psychiatric disorders.
The VA GCRC was started in November 2002 as a joint venture between the University of Cincinnati College of Medicine, the Cincinnati VA, and VISN 10. This unit was designed to provide space, specialized research equipment, and experienced staff to support clinical investigators on the UC, VA, and CCHMC campuses. Since its inception the VA GCRC has expanded steadily and now supports more than 20 ongoing projects by researchers from Psychiatry, Cardiology, Endocrinology, Pharmacology, Pulmonary Medicine, Neurology, and Immunology. These projects are funded by NIH, the VA, and foundation grants as well as through collaborations with industry. Beyond its research endeavors the VA GCRC also provides support for teaching and clinical care activities.
The VA GCRC consists of 3,000 square feet of dedicated research space located on the 4th floor of the Cincinnati VAMC. Included in this space are two monitored rooms; a fully equipped cardio–pulmonary physiology laboratory with radiographic capability and equipment for noninvasive cardiac assessments; an exercise laboratory with a metabolic cart; a sleep laboratory; an investigational pharmacy; a phlebotomy and sample processing laboratory with refrigerated centrifuge; a nurses station; and 5 outpatient exam rooms. In addition, the GCRC has additional space for storage, including –70° and –20° C freezers, in an adjacent building at the VAMC.
The VA GCRC is staffed five days a week by two research nurses and two research assistants. The VA GCRC has administrative staff that can assist researchers with grant submission and preparation, budgets, regulatory issues, scheduling and managing of research visits, and medical support. For information on any VA GCRC issues (usage costs, submission dates, services, etc.) or to schedule a tour of the VA GCRC, please contact Amelia T. Nasrallah, VA GCRC Administrator at 513-558-2226 .
Studies conducted in the VA GCRC must have the approval of the UC IRB and the VA Research Committees. Investigators may submit their protocol to the VA GCRC SAC (Scientific Advisory Committee) for R&D, which holds monthly meetings on the last Friday of each month to review protocols submitted to the VA GCRC.
The VA GCRC offers an annual research award (Ursich Research Award) to help support young investigators conducting research at the VA GCRC.

Purchasing
To purchase supplies or equipment from a VA funded grant, you will need the following forms:

• Forms: Account Status Report Instructions
• Purchasing Instructions
• Research Order Form

To obtain these forms electronically please send your request to Tim Roth .
Turn in orders to the Research Service Administrative Office (Building 1, Room B–420), or fax to 513-475-6415.
For questions regarding purchases from a VA grant, please contact Tim Roth, Budget Analyst, at 513-475-6342 or email Tim Roth

Mandatory Computer Training
All Principal Investigator’s & their Research Staff (including Study Coordinator's a& Data Entry Personnel) are required to take mandatory computer training prior to beginning any research at the Cincinnati VAMC. For instructions on completing training requirements, contact Stephanie Zazycki at 513.861.3100, ext. 4080, or email Stephanie .

IACUC - Institutional Animal Care and Use Committee

Request IACUC forms packet via E-MAIL

The Institutional Animal Care and Use Committee (IACUC) is responsible for maintaining high standards in all animal research conducted at the Cincinnati VA Medical Center or by VA personnel with VA funding located off–site. All use of animals in research at this facility, regardless of species, must be reviewed by the Veterinary Medical Officer or Consultant, and approved by the IACUC and R&D Committees. Animal care and use is subject to the provisions of the Animal Welfare Act as amended; the facility must maintain accreditation by the American Association for the Accreditation of Laboratory Animal Care (AAALAC). The R&D Committee cannot alter an adverse report or recommendation (e.g., a protocol disapproval by the IACUC). IACUC meetings are held monthly, the third Tuesday at 1:30 p.m., in the Research Service Conference Room. Additional meetings may be held, at the call of the Chairman.
The IACUC must inspect the Animal Facility at least every six months. This inspection will include a review of the full physical facilities (including all animal care and procedure/surgical areas) and operating procedures. The report must be maintained on file for at least three years. A copy of the report must be forwarded through the R&D Committee and Medical Center Director to Central Office.
The IACUC must review and approve, require modifications in or withhold approval of all research involving the use of any animals, if such research is to be conducted at the VAMC or is supported by VA funds. The protocols to be reviewed must include a completed “Animal Component of Research Protocol” and an in depth summary of the total proposed research study. A full justification for the use of the animal model, to include why alternative, less sentient models cannot be used, must be a part of the submission. Evaluations by the IACUC are based on standards promulgated by the USDA as authorized by the Animal Welfare Act and the Public Health Service “Guide to the Care and Use of Animals.” The IACUC must evaluate the research as to appropriateness, quality and availability of the selected animals, the humaneness and appropriateness of procedures proposed and conditions surrounding animal subject use before and throughout the study, as well as the adequacy and availability of essential animal research facility support.
The IACUC must monitor experimental animal procedures particularly when a high potential exists for producing pain or distress in animal subjects. The IACUC must review annually the animal component of all continuing projects. This review will be performed in the anniversary month of the IACUC approval.
Suspension of Projects: The IACUC will suspend any research project, upon notification of conditions of animal care, treatment or practices that violate the PHS “Guide.”

R & D - Research & Development Committee

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Research and Development (R&D) Committee is responsible for maintaining high standards throughout the facility’s research and development program and supporting the patient care mission in the VA. All funded and unfunded research and development activities involving the staff, patients and resources of this VAMC are within its purview. The Committee meets on the second Tuesday of each month at 1:30 p.m. or otherwise as needed at the call of the Chairman. Quorum (majority) must be present to conduct business.
The R&D Committee will be responsible for:
1. Assuring the continuing high quality of the facility's research and development program. Planning and developing broad objectives of the research and development program so that it supports the patient care mission of the facility. Determining the extent to which the research and development program has met its objectives,
2. Evaluating critically the quality, design, desirability and feasibility of each new research and development proposal, continuing research or development project, application for funding, manuscript to be submitted for publication or other reporting activity to assure maintenance of high scientific standards, protection of human subjects, proper use of animals and adequate safety standards,
3. Working closely with the University of Cincinnati (UC) and VA Central Office (VACO) on an ongoing basis to ensure that the facility’s research program is in compliance with federal and other regulations, and meets the criteria for certification. Focus areas include human subjects (e.g., Institutional Review Board {IRB}); animals (e.g., Institutional Animal Care and Use Committee {IACUC}); safety (e.g., Subcommittee on Research Safety {SRS}); administration of grants and contracts; scientific misconduct; intellectual property and identifying problems and recommending solutions,
4. Reviewing and approving the research and development budgetary requests of the facility,
5. Recommending policies on the recruitment and development of personnel supported by research and development funds,
6. Reviewing the minutes of the executive board meetings of the Cincinnati Foundation for Biomedical Research and Education (CFBRE), the non–profit corporation,
7. Reviewing the minutes of the Clinical Research Unit/General Clinic Research Center Steering Committee/Advisory Board,
8. Advising the Director on the recommendation to the Assistant Chief Medical Director for Research and Development of candidates for the position of Associate Chief of Staff for Research and Development,
9. Fulfilling such other functions as may be specified by the facility Director.

SRS - Subcommittee on Research Safety

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The Subcommittee on Research Safety (SRS) is responsible to the Medical Center Director, through the Research and Development Committee, for maintaining oversight of safety issues in research laboratories. This includes a review of all research applications for funding that will be conducted at the VA facility or by VA personnel with VA funding located off–site. The SRS is responsible to review all research activities involving biological, chemical, physical and radiation hazards for compliance with all applicable regulations, policies and guidelines prior to commencement. The committee meets on the first Tuesday of each month at 10:30 a.m. or otherwise as needed at the call of the Chairperson.
The SRS Committee is responsible for:
1. Reviewing all research activities involving biological, chemical, physical and radiation hazards for compliance with all applicable regulations, policies and guidelines prior to submission for funding. This includes a review of all research applications for funding that will be conducted at the VA facility or by VA personnel with VA funding located off–site,
2. Providing written notification of the results of the SRS review to the R&D Committee, the Research Office and the PI,
3. Annually reviewing all active research protocols involving biological, chemical, physical and radiation hazards regarding of funding status or source. The date of the continuing review will be based on the date of SRS approval,
4. Coordinating all safety–related activities in research laboratories including mandatory and non–mandatory training, safety inspections, accident reporting and liaison activities with all facility safety committees and officials. Coordinating follow–up evaluations to ensure that deficiencies cited during inspections are permanently and effectively alleviated,
5. Reporting operational problems or violations of directives to the Research Office within 30 days of occurrence or detection unless the SRS determines that a report has been previously filed by the PI,
6. Identifying need for health surveillance of personnel involved in individual research projects. If appropriate, SRS will advise the R&D Committee and Employee Health Practitioner on the need for such surveillance,
7. Maintaining adequate documentation of all SRS activities and forwarding minutes to the Research Office,
8. Assuring that all laboratory personnel receive annual research specific safety training,
9. Holding SRS meetings at least quarterly,
10. Ensuring coordination with other regulatory programs or committees such as the Radiation Safety Committee and Environmental and Hospital Infection Control Committee,
11. Annually evaluating the effectiveness of the laboratory’s Chemical Hygiene Plan and making necessary revisions,
12. When appropriate, requesting the appointment of an ad hoc committee consisting of members with appropriate expertise, to investigate and report on occupational injuries, illnesses and adverse environmental events,
13. Review and approve a policy for the preservation of employee medical and OSHA exposure records (paragraph 6.c., 29 CFR 1910.1020) and environmental records (i.e., hazardous waste, air monitoring),
14. Upon request, cooperating with appropriate medical center personnel to review the quantity and type of hazardous waste generated by each PI annually. Providing technical assistance in the reduction of the quantity of waste and/or recycling programs, where appropriate.