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REQUIREMENTS AND POLICIES MANUAL

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Research with Vertebrate Animals

    Title:

    Research with Vertebrate Animals

    Publication date:

    10/3/2013

    Effective date:

    10/3/2013

    BRIEF

    Policy Summary

    All Berkeley Lab research involving vertebrate animals must be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, the Guide for the Care and Use of Laboratory Animals, and the Animal Welfare Act.

    Who Should Read This Policy

    • Employees, affiliates (formerly known as "guests"), visitors, and subcontractors whenever they propose or conduct research that involves vertebrate animals (or vertebrate-animal-derived materials such as antibodies or tissues)
    • The Institutional Official for animal welfare, members of the Institutional Animal Care and Use Committee (IACUC) known at Berkeley Lab as the Animal Welfare and Research Committee (AWRC), and the staff of the Human and Animal Regulatory Committees (HARC) Office

    To Read the Full Policy, Go To:

    The POLICY tab on this wiki page

    Contact Information

    Animal Welfare and Research Committee
    Human and Animal Regulatory Committees Office
    HARC@lbl.gov
    (510) 486-5399

    Title:

    Research with Vertebrate Animals

    Publication date:

    10/3/2013

    Effective date:

    10/3/2013

    POLICY

    A. Purpose

    All Berkeley Lab research involving vertebrate animals must be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, the Guide for the Care and Use of Laboratory Animals, and the Animal Welfare Act.

    B. Persons Affected

    • Berkeley Lab employees, affiliates (formerly known as "guests"), visitors, and subcontractors whenever they propose or conduct research that involves vertebrate animals (or vertebrate-animal-derived materials such as antibodies or tissues)
    • The Institutional Official for animal welfare; members of the Institutional Animal Care and Use Committee (IACUC) known at Berkeley Lab as the Animal Welfare and Research Committee (AWRC); and the staff of the Human and Animal Regulatory Committees (HARC) Office, which supports the AWRC

    C. Exceptions

    Not applicable

    D. Policy Statement

    All Berkeley Lab research involving vertebrate animals must be conducted in accordance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy), the Guide for the Care and Use of Laboratory Animals, and the Animal Welfare Act. This requirement derives from Department of Health and Human Services policy and federal law.

    To ensure that this requirement is met:

    1. All protocols for research involving vertebrate animals performed at or funded through Berkeley Lab must be submitted to and formally approved by the Animal Welfare and Research Committee prior to initiation and
    2. All work with vertebrate animals must follow the approved protocol

    The Laboratory can terminate research that is not conducted in accordance with AWRC decisions, conditions, and requirements, or that has been associated with pain or distress beyond the level anticipated in the protocol and/or unanticipated experimental outcomes.

    E. Roles and Responsibilities

    Role

    Responsibility

    Researchers using animals
    (including employees, affiliates (formerly known as "guests"), visitors, and subcontractors who propose or conduct research that involves animals or animal-derived material such as antibodies or tissues)

    • Safeguard the welfare of animals used in their research
    • Complete required Ethical Training for researchers at LBNL
    • Develop protocols for and obtain AWRC approval
    • Ensure that staff working under the protocol(s) are trained
    • Follow approved protocols, file renewals in a timely fashion, and promptly report problems to the AWRC

    Animal Welfare and Research Committee (AWRC)

    • Establishes and maintains an Animal Welfare Assurance with the U.S. Department of Health and Human Services Office of Laboratory Animal Welfare
    • Conducts a semiannual facility inspection and animal welfare program review
    • Reviews research proposals to ensure the protection of animals used in research
    • Monitors ongoing animal research
    • Educates Berkeley Lab researchers using animals as needed
    • Reports unanticipated problems and adverse events to the Institutional Official and Laboratory Director
    • Recommends changes in Laboratory policy relevant to research-animal welfare to the Institutional Official
    • Certifies to funding agencies and/or the Office of Sponsored Partnerships & Industry Partnerships that research has been reviewed and approved by the Institutional Animal Care and Use Committee

    Attending Veterinarian

    • Oversees all activities involving animals at Berkeley Lab
    • Conducts routine inspections and monitors ongoing animal research
    • Consults with and provides training for animal care and research staff as needed
    • Serves as a member of the IACUC
    • Temporarily suspends or interrupts research that is not conducted in accordance with AWRC decisions, conditions, and requirements or that has been associated with unexpected experimental failure or suffering to animals
    • Recommends changes in Laboratory policy relevant to research animal welfare to the AWRC and/or the Institutional Official

    Institutional Official for animal welfare

    • Signs the Animal Welfare Assurance on behalf of the Laboratory
    • Receives the semiannual inspection and program review report from the AWRC
    • With the AWRC Chair, signs the annual report to the Office of Laboratory Animal Welfare
    • Appoints members to the AWRC
    • Suspends or terminates research that is not conducted in accordance with AWRC decisions, conditions, and requirements or that has been associated with unexpected failure or suffering to animals
    • Approves changes in Laboratory policy relevant to research involving animals
    • Ensures support to the AWRC, the Attending Veterinarian and the HARC Office sufficient to carry out their responsibilities

    Human and Animal Regulatory Committees (HARC) Staff

    • Facilitate and support the AWRC, researchers, and the Institutional Official in carrying out their responsibilities
    • Oversees the Human/Animal Research Protocol Management System (HARP)

    F. Definitions/Acronyms

    Term

    Definition

    Animal

    Any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes.

    PHS Policy

    Public Health Service Policy on Humane Care and Use of Laboratory Animals; the implementing guidance for federally funded research involving animals

    Guide for the Care and Use of Laboratory Animals

    The Guide is published by the National Research Council of the National Academies and defines the framework for a compliant animal care and use program.

    Animal Welfare Act

    Public Law 89-544, 1966, as amended, (P.L. 91-579, P.L. 94-279, and P.L. 99-198) 7 U.S.C. 2131 et seq.; the federal law regulating the treatment of animals in research, exhibition, transport, and by dealers

    Institutional Animal Care and Use Committee (IACUC)

    A board or committee authorized by a federal assurance to review research involving animals. The AWRC is the Berkeley Lab Institutional Animal Care and Use Committee.

    Institutional Official for animal welfare

    The Berkeley Lab official who signs the Animal Welfare Assurance, committing the institution to following the Public Health Service (PHS) Policy on Humane Care and Use of Animals

    Animal Welfare Assurance

    The written, binding agreement submitted to the Department of Health and Human Services in which the institution commits to complying with regulations governing the use of animals in research and stipulates the procedures through which compliance will be achieved

    Human/Animal Research Protocol Management System (HARP)

    The system housing online "smart" forms that lead researchers through protocol application, renewal, modification, and adverse/unexpected event reporting processes

    G. Recordkeeping Requirements

    Responsible Party

    Record

    Animal Welfare and Research Committee (AWRC)

    Conducts a semiannual facility inspection and animal welfare program review, and reports the outcome to the Institutional Official

    Institutional Official and AWRC Chair

    Reports annually to the PHS Office of Laboratory Animal Welfare on the status of the animal welfare program

    H. Implementing Documents

    Document Number

    Document Title

    Type

    n/a

    Human/Animal Research Protocol Management System (HARP)

    Web site

    n/a

    Animal Welfare and Research Committee Short Renewal Form 

    Form

    n/a

    Animal Welfare and Research Committee Protocol Personnel Form (PPF)

    Form

    03.02.002.001

    Research with Human and Animal Subjects

    Program

    n/a

    Animal Welfare and Research Committee Charter

    Charter

    n/a

    Animal Welfare Assurance

    Compliance document

    I. Contact Information

    Animal Welfare and Research Committee
    Human and Animal Regulatory Committees Office
    HARC@lbl.gov
    (510) 486-5399

    J. Revision History

    Date

    Revision

    By whom

    Revision Description

    Section(s) affected

    Change Type

    1/2/2012

    0

    C. Byrne

    Brief for wiki

    All

    Minor

    10/3/2013

    1

    C. Byrne

    Policy for wiki

    All

    Minor

    DOCUMENT INFORMATION

    Title:

    Research with Vertebrate Animals

    Document number

    03.02.003.000

    Revision number

    1

    Publication date:

    10/3/2013

    Effective date:

    10/3/2013

    Next review date:

    10/3/2013

    Policy Area:

    Human and Animal Subjects Research

    RPM Section (home)

    Conduct of R&D

    RPM Section (cross-reference)

    none

    Functional Division

    OIA

    Prior reference information (optional)

    PUB-3000, Chapter 22, Section 22.3

    Source Requirements Documents

    • Title 7 U.S.Code, Chapter 54, Transportation, Sale and Handling of Certain Animals, The Animal Welfare Act 

    Other Driving Requirements

    Implementing Documents

    Document Number

    Document Title

    Type

    n/a

    Human/Animal Research Protocol Management System (HARP)

    Web site

    n/a

    Animal Welfare and Research Committee Short Renewal Form 

    Form

    n/a

    Animal Welfare and Research Committee Protocol Personnel Form (PPF)

    Form

    03.02.002.001

    Research with Human and Animal Subjects

    Program

    n/a

    Animal Welfare and Research Committee Charter

    Charter

    n/a

    Animal Welfare Assurance

    Compliance document

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