Research with Animals

Title:	Research with Animals
Publication date:	8/1/2024
Effective date:	8/1/2024

BRIEF

Policy Summary

All Berkeley Lab research involving vertebrate or cephalopod 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, when applicable.

Who Should Read This Policy

Employees, affiliates, visitors, and subcontractors whenever they propose or conduct research that involves vertebrate or cephalopod animals (or covered 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
[emailprotected]
(510) 486-6005

Title:	Research with Animals
Publication date:	8/1/2024
Effective date:	8/1/2024

POLICY

A. Purpose

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

B. Persons Affected

Berkeley Lab employees, affiliates, visitors, and subcontractors whenever they propose or conduct research that involves vertebrate or cephalopod animals (or covered 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

This policy does not include the use of invertebrate animals other than cephalopods at this time.

D. Policy Statement

All Berkeley Lab research involving vertebrate or cephalopod animals must be conducted in accordance with the PHS Policy, the Guide for the Care and Use of Laboratory Animals, and the Animal Welfare Act, when applicable. This requirement derives from Department of Health and Human Services’ policy and federal law.

To ensure that this requirement is met:

All use of vertebrate and cephalopod animals or their specimens for Berkeley Lab research, including work done elsewhere in support of our research, must be reviewed by the HARC Office to determine the requirements necessary to maintain compliance.
All protocols for research involving live vertebrate or cephalopod animals performed at or funded through Berkeley Lab must be submitted to and formally approved by the AWRC prior to initiation, and
All work with vertebrate and cephalopod 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 , 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 and other staff, 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 Strategic Partnership Office 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 AWRC 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
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 covered 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 Office of Laboratory Animal Welfare 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	HARP Account Request Form	Form
n/a	Animal Welfare and Research Committee Website	Website

I. Contact Information

Animal Welfare and Research Committee
Human and Animal Regulatory Committees Office
[emailprotected]
(510) 486-6005

J. Revision History

Date	Revision	By whom	Revision Description	Section(s) affected	Change Type
1/2/2012		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
8/1/2024	2	K. MIller	Periodic review: added cephalopod animals. Title changed from Research with Vertebrate Animals to Research with Animals	All	Major

DOCUMENT INFORMATION

Title:	Research with Vertebrate Animals
Document number	03.02.003.000
Revision number	2
Publication date:	8/1/2024
Effective date:	8/1/2024
Next review date:	7/31/2029
Policy Area:	Human and Animal Subjects Research
RPM Section (home)	Conduct of R&D
RPM Section (cross-reference)	none
Functional Division	Research Compliance Office
Prior reference information (optional)	PUB-3000, Chapter 22, Section 22.3

Source Requirements Documents

Public Health Service Policy on Humane Care and Use of Laboratory Animals, 2002
Guide for the Care and Use of Laboratory Animals, Eighth Edition

FAQs

What is an example of refinement in animal research? ›

Examples of refinement include ensuring the animals are provided with housing that allows the expression of species-specific behaviours, using appropriate anaesthesia and analgesia to minimise pain, and training animals to cooperate with procedures to minimise any distress.

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What are the 3 R's in animal research? ›

Definition: The Three Rs principle was launched in the early 1960s by two English biologists, Russel and Burch in their book “The Principle of Humane Experimental Technique”. The 3 Rs stand for Replacement, Reduction and Refinement.

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What are the 4 R's of animal research? ›

The 4 R concept, alternatives are Reduction, Refining, Replacement and Reproduction. By these one can save some percentage of animals and maintain biodiversity in nature. Refining means simply purifying the process of dissection and experiments done on animals.

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Is there an IRB for animal research? ›

The IRB reviews research that involves human participants. Research involving animals must be reviewed by the Institutional Animal Care and Use Committee (IACUC) before it begins.

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What are some examples of refinement? ›

With refinement, things and people become more acceptable: the sugar's refinement makes it appropriate to serve at a fancy party, and your refinement makes you a perfect guest there. the process of removing impurities (as from oil or metals or sugar etc.)

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Which is an example of refinement? ›

Refinement refers to modifications of husbandry or experimental procedures that minimize or eliminate animals' pain and distress and improve their welfare. A few examples of refinement are anesthetics and analgesics, humane animal handling, environmental enrichments, and humane endpoints.

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Is it OK to use animals for research? ›

There are several reasons why the use of animals is critical for biomedical research: Animals are biologically very similar to humans. In fact, mice share more than 98% DNA with us! Animals are susceptible to many of the same health problems as humans – cancer, diabetes, heart disease, etc.

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What is the Russell and Burch replacement concept? ›

Authors Russell and Burch define a replacement technique as “any scientific method employing non-sentient material which may in the history of experimentation replace methods which use conscious living vertebrates.” Scientists should seek to replace animals in experiments with alternatives whenever possible.

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What are the 5rs in animal research? ›

Effectively communicating the 5R's (replace, reduce, refine, reuse, and rehabilitate) of research ethics, biomedical waste, personalized medicines and the rest.

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What are the four animal models used in animal research? ›

The four model animals chosen primarily on the basis of their convenience for genetic analysis are C. elegans, Drosophila, zebrafish, and mice. All are relatively small, easy to maintain in large populations in the laboratory, and have short generation times, which allow for rapid analysis of breeding experiments.

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What are the basic or general principles of animal research? ›

Among the basic principles generally accepted in our culture, three are particularly relevant to the ethics of research using animals: respect for life, societal benefit and nonmaleficence.

What regulates animal research? ›

The USDA licenses research facilities and conducts annual, unannounced inspections. Violations are punished with fines, cease-and-desist orders, and license suspension or revocation. Protects all vertebrate animals (including fish, reptiles, rats, mice, and birds) used in research funded by the Public Health Service.

Who approves animal research? ›

Institutional Animal Care and Use Committees

The AWA and the PHS Policy both require that proposals for research involving animals must be reviewed and approved in advance by an Institutional Animal Care and Use Committee (IACUC).

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Does NIH fund animal testing? ›

Every NIH-funded activity involving live vertebrate animals must describe in their NIH grant application: How it is scientifically important, hypothesis driven, and relevant to public health. What specific animals and how many will be involved as well as why they were selected.

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What is an example of a refinement objective? ›

Refinement objective.

Ex. “By the end of the conference, the teacher will be able to explain how she plans for the pacing of a lesson that provides sufficient time for each segment and provides for a clear closure.” This objective includes specific language from the 'Lesson Structure and Pacing' indicator.

Research with Animals - RPM (2024)