Title: |
Research with Vertebrate Animals |
Publication date: |
7/7/2021 |
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, 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
[email protected]
(510) 486-5867
Title: |
Research with Vertebrate Animals |
Publication date: |
7/7/2021 |
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:
- 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
- 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 |
|
Animal Welfare and Research Committee (AWRC) |
|
Attending Veterinarian |
|
Institutional Official for animal welfare |
|
Human and Animal Regulatory Committees (HARC) Staff |
|
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 |
Web site |
|
n/a |
Animal Welfare and Research Committee Protocol Personnel Form (PPF) |
Form |
n/a |
Charter |
|
n/a |
Compliance document |
I. Contact Information
Animal Welfare and Research Committee
Human and Animal Regulatory Committees Office
[email protected]
(510) 486-5867
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 |
7/7/2021 | 1.1 | G. Fuentes-Creollo | Periodic review: contact info and implementing docs updates. No policy changes. | Contact info; H. | Minor |
DOCUMENT INFORMATION
Title: |
Research with Vertebrate Animals |
Document number |
03.02.003.000 |
Revision number |
1.1 |
Publication date: |
7/7/2021 |
Effective date: |
10/3/2013 |
Next review date: |
7/7/2024 |
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
- Public Health Service Policy on Humane Care and Use of Laboratory Animals, 2002
- Guide for the Care and Use of Laboratory Animals, Eighth Edition
Implementing Documents
Document Number |
Document Title |
Type |
n/a |
Web site |
|
n/a |
Animal Welfare and Research Committee Protocol Personnel Form (PPF) |
Form |
n/a |
Charter |
|
n/a |
Compliance document |