Contract and Grant Manual

PROTECTION OF RESEARCH SUBJECTS

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Table of Contents

18-100 INTRODUCTION

18-200 UNIVERSITY POLICY ON THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH

18-210 BASIC POLICY

18-220 APPLICABILITY OF GOVERNMENTAL REGULATIONS AND POLICIES TO ALL RESEARCH

18-230 RESPONSIBILITY FOR COMPLIANCE

18-240 REVIEW BY THE OFFICE OF THE GENERAL COUNSEL

18-250 HUMAN SUBJECTS INSTITUTIONAL ASSURANCE REQUIREMENTS

18-251 Statement of Principles

18-252 Designation of IRBs and Membership

18-253 Written Procedures to be Followed by IRBs

18-254 Submission of Assurances and Changes in IRB Membership

18-260 THE HUMAN SUBJECTS INSTITUTIONAL REVIEW BOARD (IRB)

18-261 Composition of Committee Membership

18-262 Responsibilities and Functions

18-270 OTHER INSTITUTIONAL REQUIREMENTS

18-271 Cooperative Research

18-272 Records Retention, Inspection and Copying

18-273 Verification of IRB Approval by Contracts and Grants Officers

18-300 UNIVERSITY POLICY FOR MEDICAL TREATMENT OF HUMAN SUBJECTS FOR INJURIES RESULTING FROM PARTICIPATION IN RESEARCH

18-310 PROVISIONS OF MEDICAL TREATMENT OR REIMBURSEMENT OF MEDICAL COSTS

18-320 CONDITIONS OF THE UNIVERSITY'S OBLIGATION TO PROVIDE MEDICAL TREATMENT

18-330 PREFERENCE OF LOCATION FOR MEDICAL TREATMENT

18-340 DESIGNATION OF CONTACT PERSON OR OFFICE

18-350 FUNDING SOURCE FOR PAYMENT OF MEDICAL CLAIMS

18-360 COMPENSATION OF HUMAN SUBJECTS FOR INJURY

18-400 UNIVERSITY POLICY ON THE USE OF ANIMALS IN RESEARCH AND TEACHING

18-410 BASIC POLICY

18-420 APPLICABILITY OF GOVERNMENTAL POLICIES AND REGULATIONS TO ALL RESEARCH

18-430 RESPONSIBILITY FOR POLICY COMPLIANCE AND IMPLEMENTATION

18-440 AAALAC ACCREDITATION

18-450 ANIMAL WELFARE ASSURANCES

18-460 ANIMAL RESEARCH COMMITTEE AND OTHER INSTITUTIONAL REQUIREMENTS

18-461 Composition of Committee Membership

18-462 Functions of the Animal Research Committee

18-463 Review of Research Applications and Proposals by the ARC

18-464 Information Required in Applications and Proposals Involving Use of Animals

18-465 Records Retention, Inspection and Copying

18-466 Verification of ARC Approval by Contracts and Grants Officers

18-999 RELATED UNIVERSITY REFERENCES

PROTECTION OF RESEARCH RISKS, GENERAL--EXTERNAL REQUIREMENTS

EXTERNAL REQUIREMENTS--FEDERAL

None

EXTERNAL REQUIREMENTS--STATE

None

HUMAN SUBJECTS--EXTERNAL REQUIREMENTS

EXTERNAL REQUIREMENTS--FEDERAL

18-F11 Belmont Report

18-F12 Federal Regulations on the Protection of Human Research Subjects

18-F13 Informed Consent

EXTERNAL REQUIREMENTS--STATE

18-S01 Experimental Subject's Bill of Rights

EXTERNAL REQUIREMENTS--INTERNATIONAL

18-X01 The Declaration of Helsinki

18-X02 Nuremberg Code

ANIMAL SUBJECTS--EXTERNAL REQUIREMENTS

EXTERNAL REQUIREMENTS--FEDERAL

18-F21 Public Health Service Policy on Humane Care and Use of Laboratory Animals

18-F22 NIH Guide for the Care and Use of Laboratory Animals

18-F23 Animal Welfare Act

EXTERNAL REQUIREMENTS--STATE

None


18-100 INTRODUCTION

The University is committed to the principle of protecting the rights of human subjects participating in research and related activities. The University has established policies and administrative procedures which comply with governmental regulations applicable to human research subjects. In addition, the University is committed to maintaining high standards for the care and use of animals in research and teaching and has adopted policies and procedures which conform to governmental regulations on the humane care and use of laboratory animals.

18-200 UNIVERSITY POLICY ON THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH

University policy on the protection of human subjects in research, which was issued by Presidential Memorandum, September 2, 1981, is restated in part in 18-210 through 18-240. (See Contract and Grant Memo for full text copy).

18-210 BASIC POLICY

The University of California is committed to the ethical principles for the protection of human subjects in research set forth in the Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The University recognizes and accepts responsibility, which it shares with its investigators and other researchers, for determining that research involving human subjects fulfills these ethical principles.

The basic ethical principles outlined in the Belmont Report which guide the Institutional Review Board's deliberations and decision-making include respect for persons, beneficence, and justice. A summary of these principles follows:

a. Respect for persons dictates that researchers must obtain informed consent from all human subjects invited to participate in research. In order to respect subject autonomy, the consent process includes giving subjects full and comprehensible information about the research and providing a clear assurance of the subjects' voluntary participation.

b. Beneficence is the essence of concern for the well-being of subjects, and requires that the risk of harm to subjects is the least possible, and that the sum of benefits to the subject and the importance of the knowledge to be gained so outweigh the remaining harm as to waive a decision to allow this risk.

c. Justice requires that the selection of human subjects should be fair and equitable and that the risks and benefits of research should be distributed among subjects in a fair and equitable manner, with particular concern for subjects whose personal status or condition--as children, prisoners, patients, impoverished persons--places them in a vulnerable or dependent position. See 18-F11 for further details on the Belmont Report.

18-220 APPLICABILITY OF GOVERNMENTAL REGULATIONS AND POLICIES TO ALL RESEARCH

It is University policy that the regulations of the Department of Health and Human Services (HHS), set forth in 45 CFR Part 46, are applicable to all research involving human subjects, as defined by these regulations, for which the University is responsible, regardless of the source of funding or whether the research is funded. In the case of conflict between regulations of the funding or regulatory agency and HHS, the more restrictive regulations shall prevail. The University is also obligated by law to adhere to the regulations of the Food and Drug Administration (21 CFR Parts 50 and 56) governing projects involving investigational new drugs [within the meaning of 21 U.S.C. sections 355(i) or 357(d)], or investigational new devices [within the meaning of 21 U.S.C. section 360(g)]. See 18-F12 for a summary of these federal regulations.

18-230 RESPONSIBILITY FOR COMPLIANCE

The Chancellors, the Senior Vice President--Academic Affairs, the Vice President--Agriculture and Natural Resources, and the Directors of the Department of Energy Laboratories are responsible for compliance with the University's policies applicable to human subjects. They are authorized to take appropriate action to implement the human subjects regulations of all funding or regulatory entities covering activities under their jurisdiction. In developing implementing procedures for research, the Chancellors, Vice Presidents and Directors shall establish a process for determining whether an activity constitutes research under the regulations and whether the research activity is exempt from formal review. As a minimum, such a process should provide for some form of consultation with investigators.

18-240 REVIEW BY THE OFFICE OF THE GENERAL COUNSEL

When significant legal issues are identified by investigators or Institutional Review Boards in connection with a specific research proposal, they shall be forwarded to the Office of the General Counsel for review. The assurances developed to implement government regulations shall also be forwarded to the Office of the General Counsel to assure that legal requirements are met.

18-250 HUMAN SUBJECTS INSTITUTIONAL ASSURANCE REQUIREMENTS

It is University policy that each campus and Laboratory comply with current Department of Health and Human Services policy requirements to provide written assurances acceptable to the Office for Protection from Research Risks, National Institutes of Health, Department of Health and Human Services. The specific instructions for preparation of such assurances are set forth in 45 CFR Part 46.103. The assurance must include statements of the responsible campus or Laboratory official (generally, the Chancellor or Laboratory Director) which certify (a) the institution's discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution, regardless of source of funding, (b) the designation of one or more Institutional Review Boards (IRBs) established in accordance with HHS requirements, including a list of the IRB members identified by name and qualifications, and (c) the written procedures which the IRBs will follow. Detailed requirements of these elements and other assurance requirements are presented in 18-251 through 18-254.

18-251 Statement of Principles

The assurance must contain a statement of principles governing the campus' or Laboratory's discharge of its responsibilities for protecting the rights and welfare of human subjects in research and may include an appropriate existing code, declaration, or statement of ethical principles, or a statement formulated by the campus itself. The University has adopted and incorporated the Belmont Report (see 18-210 and 18-F11) as its basic statement of ethical principles in its human subjects policy. Refer to 18-X01, Declaration of Helsinki and 18-X02, Nuremberg Code, as other examples of universally accepted statements of ethical principles concerning human subjects in research.

18-252 Designation of IRBs and Membership

The assurance must designate one or more IRBs to be responsible for carrying out the campus' or Laboratory's human subject policies, for which there has been provided sufficient resources for meeting space and staff to support the IRB's review and recordkeeping duties. The assurance must also contain a list of the IRB members identified by name; earned degree; indication of experience such as board certifications, licenses, etc., sufficient to describe each member's chief anticipated contributions to IRB activities; and the employment relationship with the institution.

18-253 Written Procedures to be Followed by IRBs

The assurance must include the written procedures which the IRB will follow for conducting its initial and continuing review of research and for reporting its findings and actions to investigators and the institution. The assurance should discuss the IRB verification procedures, methods for insuring prompt reporting of changes in a research activity, and the reporting of unanticipated problems involving risks to subjects and others.

18-254 Submission of Assurances and Changes in IRB Membership

In accordance with HHS policy, assurances and changes in IRB membership are to be submitted to the Office for Protection from Research Risks, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland 20892. See 18-240 concerning University requirement for General Counsel review of assurances prior to submission to HHS.

18-260 THE HUMAN SUBJECTS INSTITUTIONAL REVIEW BOARD (IRB)

As discussed in 18-252, each campus and Laboratory must designate one or more IRBs to be responsible for carrying out the institution's human subjects policies. The IRB must be established and function in accordance with current HHS policy requirements as summarized in 18-261 through 18-262.

18-261 Composition of Committee Membership

Each campus or Laboratory is to appoint one or more IRBs in accordance with prescribed HHS policy. The IRB shall consist of no fewer than five members with varying backgrounds, some of whom should possess the professional competence to review specific research and teaching activities. The composition of the IRB shall be consistent with current HHS requirements which specify that:

a. Each IRB shall include at least one member whose primary concerns are in nonscientific areas; for example: lawyers, ethicists, members of the clergy.

b. Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.

No IRB may consist entirely of men or entirely of women, or entirely of members of one profession. Also, no IRB may have a member participating in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. An IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of complex issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.

18-262 Responsibilities and Functions

The responsibilities and functions of the IRB are to be consistent with current HHS requirements. The primary duties are summarized as follows:

a. Review and Approval of Proposed Research Projects

The IRB has the responsibility to review, approve, disapprove, and when necessary require the PI to modify proposed research involving human subjects at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. Expedited review procedures involving research with minimal risk are to be in compliance with current HHS requirements. Research activities which are exempt from the regulations are specified in Section 46.101(b), 45 CFR Part 46, Subpart A.

The IRB is responsible for notifying investigators and the responsible Contracts and Grants Officer in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the proposed research activity is disapproved, the IRB shall include in its written notification a statement of the reasons and provide the investigator an opportunity to respond in person or in writing.

An IRB shall require documentation of informed consent or may waive documentation in accordance with current HHS policy (Refer to 18-F13, "Informed Consent" and Section 46.117, 45 CFR Part 46, Subpart A).

An IRB has a responsibility to conduct continuing review of research covered by University policy and HHS regulations appropriate to the degree of risk, but no less than annually, and should have authority to observe or have a third party observe the consent process and the research as appropriate.

b. Reporting of Noncompliance

The IRB also has the responsibility for reporting to appropriate institutional officers and to the Secretary of HHS any serious or continuing noncompliance by investigators with the requirements and determinations of the IRB.

c. IRB Authority to Suspend or Terminate Research

The IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. The IRB's action of suspension or termination shall be reported promptly to the investigators, appropriate institutional officers, and the Secretary of HHS.

18-270 OTHER INSTITUTIONAL REQUIREMENTS

18-271 Cooperative Research

When the University contracts or subcontracts research to a cooperating institution, the University as a grantee or prime contractor is committed to and remains responsible for safeguarding the rights and welfare of human subjects. The University may use joint review, seek reliance upon the review of the qualified IRB at the cooperating institution, or undertake other appropriate arrangements aimed at protecting the rights of human subjects in research.

18-272 Records Retention, Inspection and Copying

a. Records Retention

In accordance with the provisions under current HHS regulations, the University keeps and maintains systems of records and documentation (i.e., minutes, correspondence, approved consent documents, et al) of IRB activities. IRB records relative to research funded by Federal agencies or regulated by FDA are generally required to be retained for at least 3 years after completion of the research.

General Counsel recommends longer retention periods for IRB and academic research records pertaining to children as subjects, (seven years after the children reach the age of majority [18 in California]) and for records pertaining to in vitro studies or pregnant women (25 years).

b. Inspection and Copying

The IRB records under Federally-funded or regulated projects shall be accessible for inspection and copying by authorized representatives of HHS/FDA and the Federal sponsor at reasonable times and in a reasonable manner. In the case of projects funded by non-Federal sponsors, IRB records shall be retained and be accessible for inspection and copying by the sponsor in accordance with applicable law and University policy. If required to negotiate inspection, access or copying provisions for IRB or other academic research records under a non-Federal agreement, Contracts and Grants Officers should contact the Coordinator of Information Practices and Special Projects in the Office of the President, who is responsible for policy review of such matters. As a matter of University policy, privacy of records and access to records are governed by the Federal Privacy Act, the State Public Records Act, and the State Information Practices Act. (Refer to Business and Finance Bulletin RMP-8, "Legal Requirements on Privacy of and Access to Information").

For rights of the public to inspect and copy University records, see Chapter 17 of this manual.

18-273 Verification of IRB Approval by Contracts and Grants Officers

In accordance with 18-262 above, the IRB shall advise the responsible Contracts and Grants Officer of IRB approval of an application or proposal to an extramural sponsor involving the use of human subjects.

For HHS applications and proposals the responsible Contracts and Grants Officer shall comply with submission of HHS Form 596 (or equivalent verification form) to indicate that the application or proposal has been reviewed and approved by the IRB in accordance with the campus' or Laboratory's (and when applicable, the cooperating institution's) approved HHS General Assurance(s). For non-HHs applications or proposals, the verification of IRB approval shall be submitted in accordance with the individual sponsoring agency's prescribed format and timing requirements.

If conditional approval is granted by the IRB subsequent to the submission of the application or proposal, the sponsor must be informed of any modifications to the proposal or application, as prescribed by the IRB.

18-300 UNIVERSITY POLICY FOR MEDICAL TREATMENT OF HUMAN SUBJECTS FOR INJURIES RESULTING FROM PARTICIPATION IN RESEARCH

University policy for medical treatment of human subjects for injuries resulting from participating in research, which was issued by Presidential Memorandum, January 19, 1979, is restated in part in 18-310 through 18-340. (See Contract and Grant Memo for full text copy).

18-310 PROVISION OF MEDICAL TREATMENT OR REIMBURSEMENT OF MEDICAL COST

The University of California will provide to any injured subject any and all medical treatment reasonably necessary for any injury or illness which a human subject suffers as a direct result of participation in an authorized University activity covered by University policy on the protection of human subjects in research or reimburse the subject for the costs of such treatment, except when the injury or illness is a consequence of a medical research procedure which is designed to benefit the subject directly.

18-320 CONDITIONS OF THE UNIVERSITY' OBLIGATION TO PROVIDE MEDICAL TREATMENT

The obligation of the University undertaken in paragraph 18-310 shall be subject to the following conditions:

a. It must be demonstrated that the injury resulted directly from participation in the specified activity.

b. Written notification of any such injury is to be given to the University by the human subject within a reasonable time after discovery.

c. Any claim for reimbursement is to be supported by appropriate documentation.

18-330 PREFERENCE OF LOCATION FOR MEDICAL TREATMENT

It is the preference of the University that the medical treatment available under this policy be provided at a University of California medical facility.

18-340 DESIGNATION OF CONTACT PERSON OR OFFICE

Chancellors and other chief administrators, as appropriate, shall designate an individual or office as a contact for inquiries about implementation of this policy.

18-350 FUNDING SOURCE FOR PAYMENT OF MEDICAL CLAIMS

It is recognized that the University's policy to provide medical treatment for injured subjects establishes a potential unfunded liability exposure for the University. This is distinct from the University's Professional and Medical Liability Self-Insurance program. The decision on an appropriate fund source with respect to a claim for medical expenses will be made on a case-by-case basis. When it can be ascertained that the claim can be treated as an allowable cost to the organization or entity financing the research, the University, as a matter of policy, shall seek to pass along the cost of the claim to the research sponsor.

18-360 COMPENSATION OF HUMAN SUBJECTS FOR INJURY

Except for claims arising from demonstrated negligence on the part of the University, the University's current policy does not provide for compensation of injured subjects through payments for lost wages, cost of pain and suffering, or additional expenses beyond those of medical care. Any compensation claims received for reimbursement of costs and expenses beyond the provision of medical care and not covered under the University's Professional and Medical Liability Self-Insurance program (malpractice) must be handled on a case-by-case basis in consultation with the Office of General Counsel of The Regents and the Office of the Senior Vice President--Academic Affairs.

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

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.

18-999 RELATED UNIVERSITY REFERENCES

  • Presidential Memorandum dated September 2, 1981, University Policy on the Protection of Human Subjects in Research

  • Business and Finance Bulletin RMP-8, Legal Requirements on Privacy of and Access to Information

  • Presidential Memorandum dated January 19, 1979, University Policy for Medical Treatment of Human Subjects for Injuries Resulting from Participation in Research

  • Presidential Memorandum dated October 15, 1984, University Policy on the Use of Animals in Research and Teaching

  • Contract and Grant Memo 86-21, Protection of Research Subjects--Source Documents (8/21/86)

    HUMAN SUBJECTS

    EXTERNAL REQUIREMENTS--FEDERAL

    18-F11 Belmont Report, "Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research"

    PURPOSE

    The Belmont Report summarizes the basic ethical principles identified by the National Commission in the course of its deliberations as mandated by the National Research Act of July 12, 1974 (P.L. 93-348).

    It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects.

    APPLICABILITY

    The University of California has determined that the findings of the Belmont Report will apply to all human subject activities regardless of funding source for which the University is responsible.

    SUMMARY OF PROVISIONS

    The summary of the provisions appears in 18-210.

    UNIVERSITY POLICY IMPLEMENTATION AND PRIMARY UNIVERSITY RESPONSIBILITY

    By Presidential policy memo dated September 2, 1981 the University of California adopted the ethical principles for the protection of human subjects set forth in the Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (see 18-210).

    Primary responsibility for implementation is shared by Chancellors, Laboratory Directors, Institutional Review Boards, and Principal Investigators. The primary responsibility for judging or ascertaining if an extramural program or application falls under the provisions of the University's basic human subjects policy and has received the approval by the IRB rests with the Contracts and Grants Officers. For Office of the President activities and for policy review and compliance, the responsibility rests with the Senior Vice President--Academic Affairs or the Vice President--Agriculture and Natural Resources, as appropriate.


    HUMAN SUBJECTS

    EXTERNAL REQUIREMENTS--FEDERAL

    18-F12 Federal Regulations on the Protection of Human Research Subjects

    IDENTIFICATION

    The Department of Health and Human Services (HHS) has issued regulations pursuant to the National Research Act (P.L. 93-348), which are codified in the Code of Federal Regulations under 45 CFR, Part 46.

    There are four Subparts to Part 46 of the Code of Federal Regulations:

    Subpart A - Basic HHS Policy for Protections of Human Research Subjects

    Subpart B - Additional Protections Pertaining to Research, Development, and Related Activities Involving Fetuses, Pregnant Women, and Human In Vitro Fertilizations

    Subpart C - Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects

    Subpart D - Additional Protections for Children Involved as Subjects in Research

    The Food and Drug Administration has issued regulations pursuant to the Federal Food, Drug and Cosmetic Act, which are codified in the Code of Federal Regulations under 21 CFR, Parts 50 and 56.

    PURPOSE

    To protect the rights and welfare of human subjects involved in biomedical and behavioral research which is supported by the Department of Health and Human Services.

    APPLICABILITY

    Federal regulations codified under 45 CFR, Part 46, are applicable to HHS grants and contracts supporting biomedical or behavioral research, development, and related activities which involve human subjects.

    a. Relation to Other Federal Agencies: 45 CFR, Part 46 also applies to human subject research supported by funds from the DOD, Commerce, Energy, HUD, Justice, Agriculture, State, Transportation, Treasury, EPA, USF, VA, USIA, the Consumer Product Safety Commission, the Civil Service Commission, and NASA, which have all adopted 45 CFR, Part 46, in whole or in part, by reference.

    b. Applicability of Governmental Regulations and Policies to All University Research: University policy in 18-220 extends the regulations set forth in 45 CFR, Part 46 to all University research involving human subjects, regardless of funding source.

    Federal Regulations codified under 21 CFR, Parts 50 and 56 are applicable to clinical investigations regulated by the Food and Drug Administration.

    LEAD AGENCY FOR INTERPRETATION OF GUIDANCE

    Office for Protection from Research Risks (OPRR), Office of the Director, National Institutes of Health, is the lead agency responsible for:

    a. interpreting the regulations for administrators, and for grantee and contractor institutions; and

    b. responding to requests for clarification and guidance on ethical issues raised in connection with biomedical or behavioral research involving human subjects.

    SUMMARY OF PROVISIONS/REQUIRED COMPLIANCE MECHANISM

    a. Description: Grantees or contractors requesting or receiving HHS support for activities involving human subjects are required to submit written assurance of compliance with regulations calling for institutional review of all activities involving human subjects, conducted or supported by the institution. Assurances are evaluated by OPRR. Grantees or contractors are also required to submit certification of review and approval of each activity involving human subjects to be supported by HHS.

    Applications or proposals involving human subjects submitted to HHS are also evaluated for compliance by HHS and are subject to review and approval by appropriate Councils or Committees or other bodies as required by law. On the basis of any such evaluations, the Secretary of HHS may take further action or impose additional restrictions which in the judgment of the Secretary are necessary to protect human subjects.

    The awarding agency is responsible for resolving any problems or questions raised in the review procedure.

    b. Penalties for Non-Compliance: No activity involving human subjects can be supported or conducted by HHS without prior certification of review and approval by an institutional review board established in accordance with an assurance approved by HHS and concurred with by an official authorized to act on behalf of the recipient institution.

    If an institution has failed materially to comply with respect to a particular grant or contract, the Secretary of HHS may terminate or suspend the grant or contract. In addition, the Secretary, in making any future awards, may take into account the previous record of an institution in discharging its responsibilities for the protection of the rights and welfare of human subjects in research at the institution, whether or not HHS funds were involved.

    c. Burden of Proof: Written documentation in the form of an institutional assurance of compliance, approved and on file with OPRR and in the form of certification of review and approval of specific activities, is evidence of compliance. Monitoring of compliance is initiated on the basis of any indication of failure to protect the rights and welfare of subjects or of questions or complaints directed to OPRR. In the case of monitoring, the burden of proof of compliance falls on the recipient institution. The judgment of the Secretary of HHS is the final basis for determining compliance or non-compliance.

    PRIMARY UNIVERSITY RESPONSIBILITY

    Primary responsibility for implementation of 45 CFR, Part 46 and related Federal regulations governing the protection of human subjects is shared by Chancellors, Laboratory Directors, Institutional Review Boards, and Principal Investigators. For Office of the President activities and for policy review and compliance, the responsibility rests with the Senior Vice President--Academic Affairs or the Vice President--Agriculture and Natural Resources, as appropriate.

    UNIVERSITY POLICY IMPLEMENTATION

    University policy implementation is located in 18-220.


    HUMAN SUBJECTS

    EXTERNAL REQUIREMENTS--FEDERAL

    18-F13 Informed Consent

    IDENTIFICATION

    45 CFR, Part 46, Subpart A (Section 46.116); and 21 CFR, Part 50 (Sections 50.20 and 50.25).

    PURPOSE

    To establish standards and compliance mechanisms for legally effective informed consent to permit the prospective subject or the representative sufficient opportunity to consider whether or not to participate as a subject in research without coercion or undue influence.

    APPLICABILITY

    Refer to 18-F12, "Applicability"

    SUMMARY OF PROVISIONS

    DOCTRINE OF INFORMED CONSENT

    a. DEFINITION

    Informed consent means the knowing consent of an individual (or of a legally authorized representative when a vulnerable or dependent person is to be involved) to his or her participation in a research activity without coercion or undue influence. Consent information, oral or written, must be expressed with words and in a language which are understandable to the subject or the representative. The text of the consent information must not involve any exculpatory language through which the subject is made to waive, or to appear to waive, any legal rights, including release of the University or its agents from liability for negligence. All subjects or their authorized representatives must receive a copy of any consent document which has been completed by them.

    b. SUMMARY OF BASIC ELEMENTS OF INFORMED CONSENT

    (1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

    (2) A description of any reasonably foreseeable risks or discomforts to the subject;

    (3) A description of any benefits to the subject or to others which may reasonably be expected from the research;

    (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

    (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

    (6) For research involving more than minimal risk, an explanation as to whether any compensation or any medical treatments are available if injury occurs and, if so, what they consist of or where further information may be obtained;

    (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject (see University policy for Medical Treatment of Human Subjects for Injuries Resulting from Participation in Research at 18-300); and

    (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

    Additional elements of Informed Consent to be used when appropriate are summarized in section 46.116 (b), 45 CFR, Part 46, Subpart A and section 50.25(b), 21 CFR, Part 50.

    c. DOCUMENTATION OF INFORMED CONSENT

    Section 46.117, 45 CFR Part 46, Subpart A and section 50.27, 21 CFR, Part 50 require that informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative, with a copy given to the person signing the form. Section 46.117 of the HHS regulations permits waiver by the IRB of documentation for purpose of confidentiality when requested by the subject, or if the research presents no more than minimal risk or of harm and involves no procedures for which written consent is normally required.

    The FDA does not permit waiver of documentation by the IRB.

    PRIMARY UNIVERSITY RESPONSIBILITY AND UNIVERSITY POLICY IMPLEMENTATION

    Refer to 18-F12, "Primary University Responsibility" and "University Policy Implementation."


    HUMAN SUBJECTS

    EXTERNAL REQUIREMENTS--STATE

    18-S01 EXPERIMENTAL SUBJECT'S BILL OF RIGHTS

    IDENTIFICATION

    Health and Safety Code, Section 24172

    APPLICABILITY

    Medical Experiments

    Under California Health and Safety Code, Section 27172, all persons requested to take part in a "medical experiment" or any person asked to consent on behalf of another person's participation in a "medical experiment" must be given a copy of a specific bill of rights in a language in which the person is fluent. Health and Safety Code section 27176 provides for civil and criminal sanctions for researchers who do not comply with section 27172.

    Medical experiment is defined in the law as:

    a. the severance or penetration or damaging of tissues of a human subject or the use of a drug or a device as defined in the California Health and Safety Code, use of electromagnetic radiation, heat or cold, or use of a biological substance or organism, in or upon a human subject in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of such subject or otherwise directly benefiting such subject;

    b. the investigational use of a drug or device licensed by the Federal Food and Drug Administration or the California Department of Health Services (when the study is being conducted under California law); or

    c. withholding medical treatment from a human subject for any purpose other than maintenance or improvement of the health of such subject.

    In preparing protocols for research projects covered by this law, the Institutional Review Board (IRB) may request that investigators indicate their intention to distribute the bill of rights to their prospective subjects, and add the following notice to their proposed written consent forms: "I acknowledge receiving and reading the Medical Research Subject's Bill of Rights," or words to this effect.

    SUMMARY OF PROVISIONS

    Under the Experimental Subject's Bill of Rights, any person who is asked to consent to participate as a subject in a medical experiment or who is asked to consent on behalf of another, has the following rights:

    a. To be told what the study is trying to find out.

    b. To be told about what will happen in the study and whether any of the procedures, drugs or devices is different from what would be used in standard medical practice.

    c. To be told about the risks, side effects or discomforts of the things that may happen to the subject.

    d. To be told if the subject can expect any benefit from participating and, if so, what the benefit might be.

    e. To be told what other choices are available and how they may be better or worse than being in the study.

    f. To be allowed to ask any questions concerning the study both before agreeing to be involved and during the course of the study.

    g. To be told what sort of medical treatment is available if any complications arise.

    h. To refuse to participate at all, either before or after the study is started. This decision will not affect any right to receive the standard medical care.

    i. To receive a signed and dated copy of the consent form and the Subject's Bill of Rights.

    j. To be allowed to decide to consent or not to consent to participate without any pressure being exerted by the investigators or others.

    PRIMARY UNIVERSITY RESPONSIBILITY

    The primary responsibility for implementing the requirements under this law are to be assumed by Principal Investigators engaged in "medical experiments" as defined by the law. The responsibility is also shared by the IRB which has a responsibility to review research involving human subjects in compliance with prescribed University policy and applicable law.

    In accordance with 18-262 c., the IRB has authority to suspend or terminate research that is not being conducted in accordance with prescribed human subject requirements.

    UNIVERSITY POLICY IMPLEMENTATION

    There is no specific University policy relating to Health and Safety Code section 24172.


    HUMAN SUBJECTS

    EXTERNAL REQUIREMENTS--INTERNATIONAL

    18-X01 THE DECLARATION OF HELSINKI

    (Adopted by the 18th World Medical Assembly, Helsinki, Finland, 1961, and as revised by the 29th World Medical Assembly, Tokyo, Japan, 1975).

    "Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects"

    ISSUING ORGANIZATION

    World Medical Association

    10 Columbus Circle

    New York, New York 10019

    PURPOSE

    The Declaration, comprised of recommendations, was issued to establish standards of proper and responsible conduct of human experimentation in research.

    APPLICABILITY

    The standards established by the recommendations require voluntary adoption by medical doctors engaged in biomedical research involving human subjects. The recommendations are useful in helping to guide Institutional Review Boards' deliberations and decision making responsibilities.

    SUMMARY OF PROVISIONS

    Full text copies of the Declaration are distributed by Contract and Grant Memo.

    PRIMARY RESPONSIBILITY

    Primary responsibility for determining whether the Standards and recommendations under the Declaration of Helsinki should be adopted for use rests with Chancellors, Laboratory Directors, Institutional Review Boards, and Investigators.

    UNIVERSITY POLICY IMPLEMENTATION

    Although the University's basic human subjects policy has specifically adopted only the Belmont Report as its statement on ethical principals, the use of other universally accepted declarations, codes, principles or even Statements formulated by campuses or laboratories are permissible.


    HUMAN SUBJECTS

    EXTERNAL REQUIREMENTS--INTERNATIONAL

    18-X02 "NUREMBERG CODE"

    ISSUING ORGANIZATION

    Nuremberg Military Tribunals: U.S. v. Karl Branch

    USA REFERENCE

    Trials of War Criminals Before the Nuremberg Military Tribunals, Vol. II, pp. 181-82; U.S. Government Printing Office 1949. (Text from which the "Nuremberg Code" is derived).

    PURPOSE

    The Code was established as a result of the outcome of World War II to establish the proper and responsible conduct of human experimentation in research.

    APPLICABILITY

    The standards established by the Code require voluntary adoption. The standards prescribed by the Code are useful in helping to guide Institutional Review Boards' deliberations and decision making responsibilities.

    SUMMARY OF PROVISIONS

    Full text copies of the Code are distributed by Contract and Grant Memo.

    PRIMARY RESPONSIBILITY

    Refer to 18-X01

    UNIVERSITY POLICY IMPLEMENTATION

    Refer to 18-X01


    ANIMAL SUBJECTS

    EXTERNAL REQUIREMENTS--FEDERAL

    18-F21 Public Health Service Policy on Humane Care and Use of Laboratory Animals

    IDENTIFICATION

    Vol. 14, No. 8, NIH guide for Grants and Contracts, June 25, 1985; Chapter 1-43, "Animal Welfare", HHS Grants Administration Manual; and Chapter 1-43, "Animal Welfare", PHS Grants Administration Manual

    PURPOSE/APPLICABILITY

    The purpose of the Policy, as revised, effective December 31, 1985, is to describe the responsibility of institutions for establishing and maintaining proper measures to ensure the appropriate care and use of all animals involved in research, research training, and biological testing activities supported by the Public Health Service (PHS). The policy is applicable to all PHS-supported activities involving animals, whether the activities are performed at an awardee institution or any other institution. Through University policy implementation at 18-420 the PHS policy applies to all University research and teaching irrespective of whether the research is funded from extramural or internal sources.

    SUMMARY OF PROVISIONS

    Humane care and use of animals in PHS-awarded projects is the responsibility of investigators and institutions receiving awards. The policy prescribes that no award will be made to any institution for use of animals or animal facilities unless a responsible official of that institution has submitted an acceptable assurance to the Office of Protection from Research Risks, National Institutes of Health, PHS, and until the institutional animal care and use committee has reviewed and approved those sections of applications for PHS funds that relate to the care and use of animals. Other pertinent provisions of the Policy are summarized in the University's basic policy issuance at 18-450 through 18-465. Full text of the Policy is published in the NIH Guide and in the PHS and HHS Grants Administration Manuals.

    PRIMARY UNIVERSITY RESPONSIBILITY

    Primary responsibility for assurance that University practices for the care and use of animals conform to the PHS Policy on Humane Care and Use of Laboratory Animals is shared by Chancellors, Laboratory Directors, Animal Research Committees, and investigators utilizing animals in their research or other activities. Primary responsibility for policy review rests with the Senior Vice President--Academic Affairs.

    UNIVERSITY POLICY IMPLEMENTATION

    University implementation of this policy is located at 18-410 through 18-440.


    ANIMAL SUBJECTS

    EXTERNAL REQUIREMENTS--FEDERAL

    18-F22 NIH Guide for the Care and Use of Laboratory Animals

    IDENTIFICATION

    NIH Publication No. 85-23, Revised 1985, NIH Supplement Guide for Grants and Contracts, Vol. 14, No. 8, June 25, 1985, Special Edition

    PURPOSE

    The purpose of the Guide is to assist scientific institutions in using and caring for laboratory animals in ways judged to be professionally appropriate. The recommendations are based on scientific principles, expert opinion, and experience with methods and practices that have proved to be consistent with high quality animal care. The Guide conforms to the prescribed standard for animal care required by the Animal Welfare Act and is the accepted primary reference on standards on animal care for the scientific community.

    APPLICABILITY

    The Guide is implemented under University policy in 18-420 and applies to all University practices and activities involving the procurement, housing, and care of animals.

    SUMMARY OF PROVISIONS

    The Guide provides information and recommendations for the care and use of animals under four broad areas:

    a. Laboratory Animal Management

    (1) Housing

    (2) Sanitation

    (3) Husbandry

    b. Laboratory Animal Quality and Health

    (1) Veterinary Care

    (2) Multiple Survival Surgery

    (3) Genetics

    (4) Nomenclature

    (5) Environmental Factors affecting Laboratory Animals

    c. Institutional Policies

    (1) Monitoring the Care and Use of Animals

    (2) Veterinary Care

    (3) Personnel Qualifications

    (4) Personal Hygiene

    (5) Occupational Health

    (6) Experimentation Involving Hazardous Agents

    d. Physical Plant

    (1) Functional Areas

    (2) Service Areas in Relation to the Total Size of the Animal Facility

    (3) Physical Relationship of Animal Facilities to Research or Teaching Labs

    (4) Construction Guidelines

    (5) Asceptic Surgery

    (6) Large Domestic Animals

    (7) Special Facilities for Conducting Animal Research with Hazardous Agents

    (8) Space Recommendations for Laboratory Animals

    PRIMARY UNIVERSITY RESPONSIBILITY

    Primary responsibility for assurance that University practices for the housing and care of animals conform to the NIH Guide for the Care and Use of Laboratory Animals in Research is shared by Chancellors, Laboratory Directors, Animal Research Committees, and investigators utilizing animals in their research or other activities. Primary responsibility for policy review rests with the Senior Vice President--Academic Affairs.

    UNIVERSITY POLICY IMPLEMENTATION

    The University policy implementation of the Guide is located in 18-420.


    ANIMAL SUBJECTS

    EXTERNAL REQUIREMENTS--FEDERAL

    18-F23 Animal Welfare Act

    IDENTIFICATION

    Title 7 United States Code, section 2131 et seq.

    Regulations and standards implementing this requirement have been published and subsequently amended on several occasions and are contained in Title 9, Code of Federal Regulations, Subchapter A, Parts 1, 2, 3.

    PURPOSE

    To ensure that Federally established minimum standards for the humane care and handling of warmblooded animals are observed by common carriers, intermediate handlers, research facilities, dealers, exhibitors, and other users of animals falling under the purview of the Animal Welfare Act, and to prohibit the cruel practice of holding animal fighting events.

    APPLICABILITY

    Applicable to: All research, teaching, testing or experimentation using warmblooded animals where Federal funds or commerce are involved, including Federal, State, local government, academic, industrial, or private entities. All persons involved in buying, selling, transporting or holding warmblooded animals for purposes of research, exhibition or for use as pets at the wholesale level. All persons involved in live animal transportation. Persons involved in prohibited animal fighting ventures.

    Under the provisions of the Animal Welfare Act (as amended) the care of animals housed by "research facilities" (includes universities, medical schools, hospitals and other research centers) is regulated by the U.S. Department of Agriculture. The Secretary of Agriculture has been authorized to promulgate regulations to ensure that animals intended for experimentation in "research facilities" are provided humane care and treatment. (The Act does not cover the "design, outlines, guidelines, or performance of the actual research experimentation" to be carried out or determined by the Principal Investigator of a research project). Implementing rules and regulations are published in the Code of Federal Regulations, Title 9, Subchapter A--Animal Welfare, Parts 1, 2 and 3. All amendments to the rules and regulations are periodically published in the Federal Register under the heading, Department of Agriculture, Animal and Plant Health Inspection Services.

    Excluded from Coverage: Individual pet owners, members of breed fanciers selling at retail only, certain retail pet stores, rodeos, purebred animal shows, birds, rats, mice, domestic farm animals.

    SUMMARY OF PROVISIONS

    a. Registration Requirement

    In accordance with the provisions under the Act the University has registered as a "research facility" with the U.S. Department of Agriculture, Area Veterinarian in Charge, State of California. The registration No. 9344 is under the University's legal corporate name, The Regents of the University of California, and covers the operation of all research facilities of the University. As a registrant under the Act, the University has agreed to comply with all applicable standards under the Act. The "registration" with the Department of Agriculture should not be confused with, and does not substitute for, the "accreditation" process administered by AAALAC (see 18-440).

    b. Compliance Mechanism

    Compliance is attained by making periodic unannounced inspections of USDA licensees and registrants and making written reports of such inspections. Unannounced inspections are made of each licensee or registrant as frequently as needed to bring them into full compliance with the Act, its standards, and regulations.

    (1) Penalties for Non-Compliance: Penalties for non-compliance are based on the severity of the situation. In severe instances of non-compliance, penalties include a cease and desist order, 21-day summary license suspension, license suspension which remains in effect until full compliance is gained, $1,000 civil penalty, and license revocation. In less severe instances, a letter of warning is usually issued unless the licensee or registrant has a history of noncompliance.

    (2) Burden of Proof: The burden of proof lies with the Federal Government to show recipient noncompliance. This is done most typically by recorded inspection reports. Photographs, witness affidavits and other investigatory measures are undertaken as circumstances dictate.

    c. Records and Inspection

    In accordance with the provisions under the Act, the University is required to keep and maintain systems of records on various live animals which it acquires and to follow authorized retention schedules on such records as promulgated by the Secretary of Agriculture (see 18.465).

    The University is required during ordinary business hours to permit Veterinary Services representatives, and other Federal officers or employees designated by the Secretary of Agriculture to examine records required to be kept pursuant to the Act, to make copies of such records, and to inspect University facilities, property and animals.

    d. Reports Required Under the Animal Welfare Act

    Compliance requirements under the Act include submission by campuses and Laboratories of an animal census on the total numbers of laboratory animals used in research and teaching; assurance on the humane treatment of animals regarding the minimizing or eliminating of pain during an experiment; and certification by the institutional Veterinarian that rules pursuant to the Act are being followed. The Act requires that each campus or Laboratory shall submit the report signed by a "legally responsible official" to the Veterinarian in Charge for the State of California, on or before December 1 of each calendar year covering the previous Federal fiscal year of October 1 through September 30.

    e. Veterinarian in Charge for the State of California

    The cognizant USDA office having oversight responsibilities for the University's compliance with the Animal Welfare Act is as follows:

    U.S. Department of Agriculture
    Animal and Plant Inspection Service
    83 Scripps Drive
    Sacramento, California 95825
    Attention: Area Veterinarian in Charge

    (916) 484-4891

    This office has responsibility for carrying out the U.S. Department of Agriculture's regulations under the Animal Welfare Act for the State of California, including requirements for audit, inspections, and receipt of annual reports.

    PRIMARY UNIVERSITY RESPONSIBILITY

    For policy review and satisfying the registration requirements, the primary responsibility rests with the Senior Vice President--Academic Affairs who has registered the University under its legal corporate name, The Regents of the University of California. For satisfying all other requirements and standards under the Act (including maintenance of specified records systems, submission of annual reports, and upholding prescribed standards on humane care and treatment of animals), the responsibility is shared by Chancellors, Laboratory Directors, Animal Research Committees, and Investigators utilizing animals in their research.

    UNIVERSITY POLICY IMPLEMENTATION

    By Presidential policy memo dated October 15, 1984, the University's basic policy on the use of animals in research and teaching provides 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 (DHEW 78-23), reprinted in 1980 (DHEW 80-23 or succeeding editions) (see 18-F09), all requirements of the United States Department of Agriculture (USDA), and all regulations issued by the USDA implementing the Animal Welfare Act (P.L. 89-544) as amended...."