Research Compliance: A Faculty Handbook
Research Using Animal Subjects
The University of California (UC), Berkeley is committed to ensuring the humane care and use of all animals associated with its research and teaching programs and devotes considerable resources to carrying out this responsibility. As a premier research institution, Berkeley maintains a lively mix of research and teaching activities involving the use of animals across the full spectrum of scientific endeavor. The animal care and use program assists the campus in achieving its academic mission and commitment to public service by providing humane care and use of animals, facilitating research and education programs, and assuring compliance with applicable federal and state regulations, policies, and guidelines. UC Berkeley is a USDA-registered research facility, maintains a Public Health Service (PHS) Animal Welfare Assurance, and has been fully accredited by the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC) continuously since 1994. UCB maintains full compliance with the U.S. Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy), the National Research Council’s Guide for the Care and Use of Laboratory Animals and the U.S. Department of Agriculture’s Animal Welfare Act Regulations regarding the care and use of animals in a research setting.
Berkeley policies are designed to ensure compliance with federal law, regulations, and professional guidelines.
The Office of Laboratory Animal Care (OLAC)
OLAC is an academic service unit responsible for managing a centralized program of laboratory animal care. OLAC provides daily animal husbandry, veterinary care, provision of research services, surgical/anesthesia assistance and monitoring, purchase of all live vertebrates, purchase and disbursement of controlled substances, and training of research and technical personnel who use vertebrate animals in research or teaching. OLAC’s Guide to Services publication is a wealth of information about the services this unit provides. The Guide to Services is available in hard copy from the OLAC office or may be accessed on the OLAC website.
The Institutional Animal Care and Use Committee (ACUC)
ACUC is a federally mandated Chancellor’s advisory committee responsible for oversight and evaluation of the campus’s overall animal care and use program. Its functions include evaluation of the program; inspection of animal facilities and animal-study areas; submission of reports to responsible institutional officials; review of proposed uses of animals in research, testing, or education; and receipt and review of concerns involving the care and use of animals. The ACUC has the authority to approve, require modification in, or withhold approval of any proposed project, and to suspend any ongoing project that it determines is not being conducted in compliance with applicable laws, regulations, and guidelines. The Office for Animal Care and Use (OACU) administratively supports the ACUC in managing the overall animal care and use program.
The Review Process for Studies Using Animals
The Animal Use Protocol
Principal Investigators (PIs) are directly responsible for the humane treatment of animals used in their research, the training of all personnel using animals, and for compliance with all applicable laws, regulations, and guidelines, as well as University policies regarding live vertebrate animals. Before undertaking any activity involving live vertebrate animals, PIs must submit an Animal Use Protocol (AUP), describing the proposed activities in detail, to the ACUC for review and approval. Protocol forms, monthly submission deadlines, and other useful information are available on the ACUC website. It is also the responsibility of the PI to ensure that all personnel listed on the AUP receive the required training in animal care and use and are enrolled in the Animal Occupational Health and Safety Program (AOHSP) prior to the start of any animal activity.
The AUP describes all uses of live vertebrate animals proposed by an individual PI for a three-year period. For investigators with multiple research projects, the AUP presents a cumulative description of all proposed animal species, numbers, and procedures to be used during the three-year period. The AUP must be reviewed and approved by the ACUC before the acquisition, housing, or use of animals. Detailed information about the AUP is posted on the ACUC website.
Training For Personnel Who Work With Animals
U.S. Animal Welfare Act Regulations and PHS Policy require institutions to provide training for all personnel engaged in animal research. This includes PIs, technicians, laboratory personnel, research fellows, students, and visiting scientists. Further information about training is posted on the ACUC website.
The Animal Occupational Health and Safety Program (AOHSP)
The AOHSP is another component of UC Berkeley’s animal care and use program. The AOHSP is coordinated by the Occupational Health Clinic (OHC) and University Health Service, Tang Center. The requirements of the AOHSP are based on the guidelines of the National Research Council’s Guide for the Care and Use of Laboratory Animals, and Occupational Health And Safety in the Care and Use of Research Animals. Detailed information about the AOHSP is posted on the ACUC website.
The Committee on Animal Research Space Assignment (CARSA)
CARSA reviews and recommends plans for accommodating animal housing space requests. CARSA is composed of academic senate members who are animal users and non-animal users, the Director of OLAC, the Chair of the ACUC, and the Associate Vice Chancellor for Research. CARSA is advisory to the Vice Chancellor for Research, who has authority to make animal research space assignments. Animals cannot be housed without an approved AUP; however, approval of an AUP does not guarantee that animal housing space will be available for the proposed project. OLAC is responsible for the management of animal housing space on campus, and assigns space when it is available. If appropriate and adequate space is not available, the request for space is forwarded to CARSA for review.
Questions about animal subjects? Where to get answers:
For advice about protocols or applicable laws, policies or regulations related to the use of vertebrate animals:
Office for Animal Care and Use (OACU)
Telephone: (510) 642-8855
Web site: http://acuc.berkeley.edu/
For advice about the acquisition and care of animals:
Office of Laboratory Animal Care (OLAC)
Telephone: (510) 642-9232
Web site: http://www.olac.berkeley.edu/