Research Policy Analysis and Coordination
18-400 University Policy on the Use of Animals in Research and Teaching
University policy on the use of laboratory animals in research and teaching, which was issued by Presidential Memorandum October 15, 1984, is restated in 18-410 through 18-440. (See Contract and Grant Memo for full text copy).
18-410 Basic Policy
The University of California recognizes the importance of the use of animals in its research and teaching programs. Animals are vital both for understanding basic biological processes and in developing treatment for human and animal diseases.
The University, committed to maintaining high standards for the care and use of animals in research and teaching, therefore adopts as its own principles the National Institutes of Health (NIH) "Principles for Use of Animals" (see 18-F21). The University, including its investigators and researchers, accepts responsibility for determining that research and teaching involving the use of animals fulfill these principles.
18-420 Applicability of Governmental Policies and Regulations to All Research
It is University policy that University practices for the procurement, housing and care of laboratory animals shall conform to the NIH Guide for the Care and Use of Laboratory Animals in Research (see 18-F22) and all requirements and all regulations issued by the United States Department of Agriculture (USDA), including regulations implementing the Animal Welfare Act (P.L. 89-544) as amended (see 18-F23). The Chancellor, Vice President or Director shall take appropriate action to meet such standards. The policy applies to all research and teaching irrespective of whether the research is funded from extramural or internal sources.
18-430 Responsibility for Policy Compliance and Implementation
The Chancellors, the Directors of the Department of Energy Laboratories, and the Vice President--Agriculture and Natural Resources are responsible for compliance with this policy in their institutions. They are authorized to take appropriate action for those activities under their jurisdiction to implement regulations required by all funding and regulatory agencies on the care and use of animals in research and teaching. Each Chancellor and Director and the Vice President shall establish implementing procedures including an animal research committee to assure adequate review of animal facilities, procedures, research and teaching protocols. The composition of the Committee is to be in accordance with current PHS policy requirements (see current requirements listed at 18-461.)
The Senior Vice President--Academic Affairs is responsible, on behalf of the President, for assuring University compliance with the policy and for developing any modifications or exceptions to policy as appropriate.
18-440 Aaalac Accreditation
All facilities in which animals are housed shall be fully accredited by the American Association for the Accreditation of Laboratory Animal Care (AAALAC) or the Chancellor, Vice President, or Director shall take appropriate action to achieve such accreditation.
[AAALAC certifies campus/Laboratory compliance with the provisions of the Animal Welfare Act and with additional standards of animal care, some of which are specified by federal agencies. Accreditation reviews are conducted every three years and include inspection of animal holding facilities and surgical facilities, review of animal protocols, veterinary inspection procedures, and animal census reports. Compliance requires submission of an annual report that includes a census of animals used in research and teaching.]
18-450 Animal Welfare Assurances
Campuses and Laboratories must satisfy PHS policy requirements for submission of written Animal Welfare Assurances acceptable to NIH. The specific instructions for preparation of such assurances are set forth in Chapter 1-43 of the HHS Grants Administration Manual. The assurance must include statements by the responsible institutional official (generally, the Chancellor or Laboratory Director) indicating (a) acceptance of the PHS "Principles for the Care and Use of Laboratory Animals", (b) implementation of the requirements of the Guide for the Care and Use of Laboratory Animals, and (c) compliance with the Animal Welfare Act and all other relevant Federal statutes and regulations on animal welfare. Other requirements of the Assurance are listed in a. through c. below.
a. Program for Animal Care and Use
The assurance must contain a description of the campus" or Laboratory's program for animal care and use, designating appropriate lines of authority and responsibility for administering the program along with ensuring compliance with PHS policy. It should also designate the veterinarian(s) qualified in laboratory animal medicine who will be responsible for supervising the housing, feeding, care, and use of all animals; the names, positions, titles, and credentials of the Animal Research Committee (ARC) members, the ARC Chairperson; and the responsible institutional official.
b. Institutional Status
The assurance must include a statement indicating that the campus or Laboratory has adopted one of the following options:
(1) Option 1
The campus or Laboratory is fully accredited by the American Association for Accreditation of Laboratory Animal Care (AAALAC).
(2) Option 2
The campus or Laboratory is not accredited by AAALAC but has conducted a self-assessment of its compliance with PHS policy (to be described in detail in the written assurance).
Any campus or Laboratory which has not received accreditation from AAALAC is required to submit an annual report to NIH which will become a part of its institutional assurance. In general, the contents of the annual report must cover a description of the nature and extent of adherence to the PHS policy, a description of deficiencies, if any, and a plan of action, including a specified time frame, for correcting all deficiencies. The annual report must also include the ARC recommendations for changes or improvements and be forwarded by the responsible campus or Laboratory official.
c. Submissions of Assurances, and Reports
In accordance with PHS policy, assurances, annual reports, changes in ARC membership, changes in the description of the institution's program or facilities for animal care or use, and reports on non-compliance with PHS policy are to be submitted to the Office for Protection from Research Risks (OPRR), National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland 20892. Each campus or Laboratory must submit a new and complete assurance to OPRR at least every 5 years. Changes in the ARC membership must be reported promptly to OPRR.
See 18-F23 for submission of certifications and reports to the U.S. Department of Agriculture that are required under the Animal Welfare Act.
18-460 Animal Research Committee and Other Institutional Requirements
As required under University policy, each Chancellor or Laboratory Director must designate an Animal Research Committee (ARC) to be responsible for carrying out the institution's animal subjects policies. The ARC must be established in accordance with current PHS policy requirements as presented in 18-461 through 18-465.
18-461 Composition of Committee Membership
The ARC shall consist of no fewer than five members with varying backgrounds. The composition of the ARC shall be consistent with current PHS policy. Among other things, the policy requires that at least one member shall be a licensed Doctor of Veterinary Medicine, with training or experience in laboratory animal science and medicine, who has direct or delegated program responsibility for activities involving animals at the institution; at least one practicing scientist experienced in research involving animals; at least one member whose primary vocation is in a nonscientific area; and one member shall be unaffiliated with the institution and not a member of the immediate family of a person who is affiliated with the institution.
18-462 Functions of the Animal Research Committee
The Animal Research Committee (ARC) appointed by the Chancellor or Laboratory Director is the principal advisory group on humane care and use of animals for the campus or Laboratory and to researchers who use animals. As necessary, the ARC will recommend to the Chancellor or Laboratory Director and other appropriate institutional officials, changes and improvements regarding the campus' animal program or facilities. (Annual reports to OPRR [required under Option 2, see 18-450 b.(2)] must include any ARC recommendations, as forwarded to the responsible institutional official).
a. Suspension of Research
Whenever the ARC determines that an activity involving animals is not in compliance with PHS policy or the Animal Welfare Act, the ARC may suspend the activity after review of the matter at a convened quorum with the suspension vote of a majority of the quorum present. The institutional official in consultation with the ARC should review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to OPRR.
b. Other Functions of the ARC
In the conduct of its duties, the ARC at a minimum shall:
(1) review at least annually the institution's program for humane care and use of animals'
(2) inspect at least annually all of the institution's animal facilities, including satellite facilities;
(3) review concerns involving the care and use of animals at the institution;
(4) make recommendations to the institutional official regarding any aspect of the institution's animal program, facilities or personnel training;
(5) review and approve, require modifications in (to secure approval) or withhold approval of those sections of applications or proposals related to the care and use of animals as specified in 18-463;
(6) review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities; and
(7) be authorized to suspend an activity involving animals in accord with specifications set forth in 18-462 a.
18-463 Review of Research Applications and Proposals by the ARC
Review and approval of the care and use of animals as set forth in all applications or proposals is required pursuant to PHS and University policies. The ARC shall approve the application or proposal only when the care and use of animals has been reviewed and found to comply with PHS and University policies and with the conditions of the campus' or Laboratory's institutional assurance.
The care and use of animals as set forth in applications and proposals must be reviewed at a convened meeting of at least a majority of the full membership of the ARC and must be approved by a majority of the full membership. Requirements of such review are listed in Chapter 1-43 of the PHS Grants Administration Manual and in Chapter 1-43 of the HHS Grants Administration Manual.
18-464 Information Required in Applications and Proposals Involving Use of Animals
Applications and proposals submitted that involve the care and use of laboratory animals shall contain the following information:
a. identification of the species and number of animals to be used;
b. rationale for involving animals, and for the appropriateness of the species and numbers to be used;
c. a complete description of the proposed use of the animals;
d. assurance that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals; and
e. a description of any euthanasia method to be used.
18-465 Records Retention, Inspection and Copying
Each campus or Laboratory shall maintain:
a. an assurance approved by the PHS;
b. minutes of ARC meetings, including records of attendance, activities of the committee, and committee deliberations;
c. records of applications, proposals and proposed significant changes in the care and use of animals and whether ARC approval was given or withheld;
d. records of any ARC reports and recommendations as forwarded to the institutional official; and
e. records of accrediting body determinations.
All records shall be maintained for at least three years; records that relate directly to applications, proposals, and propose significant changes in ongoing activities reviewed and approved by the ARC shall be maintained for the duration of the activity and for an additional three years after completion of the activity. All records shall be accessible for inspection and copying by authorized OPRR, PHS, and USDA representatives at reasonable times and in a reasonable manner.
With regard to projects funded by non-federal sponsors, ARC records shall also be retained and be accessible for inspection and copying by the sponsor in accordance with applicable law and University policy.
For rights of the public to inspect and copy University records, see Chapter 17.
18-466 Verification of ARC Approval by Contracts and Grants Officers
The ARC shall advise the responsible Contracts and Grants Officer of approval of the proposed care and use of animals on extramurally funded projects. The Contracts and Grants Officer shall be letter of verification inform the sponsor that the application or proposal has been reviewed and approved by the ARC in accordance with the campus' or Laboratory's institutional assurance. If conditional approval is granted by the ARC subsequent to the submission of the application or proposal, the letter of verification must also inform the sponsor of any modifications to the proposal or application, as prescribed by the ARC.