400-20: Research and Instruction Using Animal Subjects

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Overview

Ensures institutional compliance with all applicable federal and state laws and regulations and University policies governing the use of animals in research.

Purpose

The University has established policies on the use of animal subjects to promote their humane care and use in research and instruction and to ensure institutional compliance with all applicable federal and state laws and regulations and University policies governing the use of animals.

Definitions

The committee at UCSF appointed by the Chief Executive Officer and qualified through the experience and expertise of its members to oversee the institution’s animal program, facilities, and procedures. The committee shall consist of not less than 5 members and shall include at least:
● a Chairperson;
● one Doctor of Veterinary Medicine, with training or experience in laboratory animal science and medicine, who has direct or delegated program authority and responsibility for activities involving animals at the institution;
● one practicing scientist experienced in research involving animals;
● one member whose primary concerns are in a nonscientific area; and
● one individual who is not affiliated with the institution in any way other than as a member of the IACUC.

The entity at UCSF responsible for the acquisition, transportation, daily care, veterinary care, and housing of animals used in research.

Policy

  1. Compliance

    This policy is applicable to all research, research training, instructional, and biological testing activities involving live vertebrate animals conducted at UCSF or its facilities or affiliates, as defined in UCSF Assurance of Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals.

    1. UCSF complies with all applicable provisions of the Animal Welfare Act and Regulations (AWAR), the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals and other federal regulations and policies relating to the use of animals in research and instruction.
    2. UCSF is directed by the Guide for the Care and Use of Laboratory Animals.
    3. UCSF accepts responsibility for the care and use of animals involved in activities covered by the UCSF Assurance of Compliance with Public Health Service Policy on Humane Care and Use of Laboratory Animals. To fulfill this responsibility, UCSF makes every reasonable effort to assure that all individuals involved in the care and use of laboratory animals understand their individual and collective responsibilities for compliance with this assurance as well as all other applicable laws and regulations pertaining to animal care and use.
    4. UCSF grants or subcontracts Public Health Service supported activity involving the use of laboratory animals to another institution only when that institution has an approved UCSF Assurance of Compliance with Public Health Service Policy on Humane Care and Use of Laboratory Animals.
    5. UCSF maintains a program for activities involving animals in accordance with the Guide for the Care and Use of Laboratory Animals.
    6. UCSF Holds an Institutional PHS Assurance (#A3400-01)
    7. UCSF Holds an Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation (#001084)
  2. Institutional Animal Care and Use Committee

    UCSF has established an institutional animal care and use committee, called the Institutional Animal Care and Use Committee (IACUC) to oversee research using animal subjects.

    1. All research conducted on live animals, or on tissues collected from live animals must be covered by a protocol approved by IACUC. IACUC has sole approval authority.
    2. All personnel conducting procedures on live animals must be appropriately trained and approved by IACUC.
  3. Laboratory Animal Resource Center

    UCSF has established the Laboratory Animal Resource Center to oversee the acquisition, transportation, daily care, veterinary care and housing of animal research subjects.

Responsibilities

A. Associate Vice Chancellor, Ethics & Compliance

Acting as Institutional Official:

  1. Is responsible for compliance with federal and state regulations and statutes, and University policies on the care and use of animals in research and instruction.
  2. May disapprove applications that are approved by IACUC but may not approve an activity which has been disapproved by the IACUC.
  3. Appoints the members of the IACUC after consultation with appropriate constituencies.

B. Institutional Animal Care and Use Committee (IACUC)

In order to fulfill its charge, it is the responsibility of IACUC to:

  1. Review at least once every six months the UCSF program for humane care and use of animals;
  2. Inspect at least once every six months the UCSF animal care facilities, including satellite facilities;
  3. Make written recommendations to the Associate Vice Chancellor, Ethics and Compliance and Associate Vice Chancellor, Research regarding any aspect of the UCSF animal program, facilities, or personnel training;
  4. Review all applications for proposed use of live vertebrates for research and teaching;
  5. Ensure that personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures;
  6. Conduct continuing oversight of animal activities (post approval monitoring) to ensure the well-being of animals and to provide opportunities for refinement of research procedures;
  7. Notify investigators and appropriate UCSF officials in writing of its decision to approve or withhold approval of applications or modifications of ongoing activities;
  8. Review concerns involving the care and use of animals at UCSF;
  9. Suspend any activity found to be out of compliance with applicable laws or regulations or at variance with the relevant protocol approved by IACUC;
  10. Notify investigators, appropriate UCSF officials, and appropriate federal oversight agencies of any suspensions and the corrective actions taken when reinstatement of the approval occurs.

C. Laboratory Animal Resource Center

LARC reports to the Associate Vice Chancellor, Research. It is the responsibility of LARC to:

  1. Provide support for the acquisition of animal research subjects;
  2. Provide intra campus transportation for animal research subjects ;
  3. Provide animal husbandry for animals housed in LARC space;
  4. Develop and oversee animal health programs designed to detect, prevent or treat the outbreak of disease within the LARC managed animal facilities;
  5. Provide veterinary support to research procedures conducted on lab animals;
  6. Serve as a resource to the IACUC on all veterinary medical matters;
  7. Serve as the animal welfare experts for the IACUC and review research proposals for veterinary concerns;
  8. LARC Attending Veterinarian oversees all animal care and well-being. Attending Veterinarian or his/her designated associate veterinarian(s):
  • Advise investigators regarding the use of models for research projects, proper anesthetic techniques, and control of animal and human pathogens;
  • Conduct training programs for investigators, staff, and students in the proper care and use of animals;
  • Provide veterinary support to research procedures conducted on lab animals.
  • Provide veterinary care, when necessary, for animal research subjects.

Attending Veterinarian, or her/his designed associate veterinarian(s) have the authority to temporarily stop a study activity for animal well-being concerns pending IACUC action and review of the matter and has the authority to treat or remove an animal from study if deemed necessary.

D. Animal User Advisory Committee

The Animal User Advisory Committee is the committee of faculty and staff appointed by the Executive Vice Chancellor and Provost. The Animal User Advisory Committee members are responsible for:

  1. Assigning animal housing space;
  2. Review of the LARC budget and recharge rates.
  3. Review proposed LARC activities or initiatives that impact the general animal research community.

E. Principal Investigator

The principal investigator is responsible for:

  1. The continued ethical conduct of any research or instruction using live vertebrate animals, in compliance with the protocol as approved by IACUC;
  2. Submitting applications (initial, renewal, and modifications) and adverse events reports to allow sufficient time for review and processing; the PI may designate up to three alternates to submit changes or create initial protocols; the role of the IACUC Director or IACUC Veterinarian will also confer the ability to submit changes on behalf of the PI, however these individuals will only make changes upon a PI's request or consent.
  3. Ensuring that involved staff and students have been sufficiently trained and know how to handle and properly care for the species of animal being used in teaching or research;
  4. Ensuring that all personnel listed in an approved protocol have read, understand and are thoroughly familiar with all aspects of the study.

F. Department Chair

  1. Reviewing activities involving the use of animals in research and training within his or her department to determine that proper review and approval have been obtained;
  2. Ensuring that departmental review committees are established and maintained.

G. Departmental Review Committees

Departmental review committees are responsible for reviewing for scientific merit those IACUC applications that have not previously been reviewed and/or will not be reviewed in a competitive funding process.

H. Environmental Health and Safety and the Biosafety Committee

Environmental Health and Safety is responsible for ensuring that research on animals is conducted in a safe manner. The Biosafety Committee is responsible for approving research with biological agents conducted on animals, promulgating procedures for doing such research, and generally ensuring that such research complies with EH&S standards.