2nd Edition 2002 arena/olaw institutional Animal Care and Use Committee Guidebook



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2nd Edition



2002





ARENA/OLAW
Institutional Animal

Care and Use

Committee Guidebook

This Guidebook is provided for informational purposes only.

It neither establishes nor reflects a change in PHS Policy on

Humane Care and Use of Laboratory Animals.
Table of Contents

Foreword v

Editorial Board vii


Contributing Authors viii

Office of Laboratory Animal Welfare (OLAW) x

Abbreviations and Acronyms xi


Sections



A. The IACUC 1

A.1. Timeline, Background and History 3


A.2. Authority, Composition and Functions 11


A.3. Operation and Administration 19

A.4. Training for Members 27

A.5. Legal Concerns 31
B. Oversight of the Animal Care and Use Program 35

B.1. Program and Facility Review 37

B.2. Animal Environment, Housing and Management 43

B.2.a. General 43

B.2.b. Animal Environment 44

B.2.c. Husbandry 45

B.2.d. Facility Maintenance 48

B.2.e. Emergency, Weekend and Holiday Care 49

B.2.f. Behavioral Management for Laboratory Animals 49

B.3. Role of the Veterinarian 53


B.4. Occupational Health and Safety 59

B.5. Personnel Training and Education 65

B.6. Emergency Preparedness 71

B.6.a. Security and Crisis Management 71

B.6.b. Disaster Planning 74
C. Review of Proposals 83
C.1. Fundamental Issues 85

C.2. Protocol Review Criteria 97

C.2.a. Alternatives – Replacement, Reduction

and Refinement 97

C.2.b. Euthanasia 101

C.2.c. Humane Endpoints 103

C.2.d. Minimization of Pain and Distress 109

C.2.e. Personnel Qualifications 114

C.2.f. Veterinary Review and Consultation 117

C.3. Other Protocol Review Considerations 121

C.3.a. Agricultural Research 121

C.3.b. Antibody Production 125

C.3.c. Breeding Colonies 130


C.3.d. Field Studies 134

C.3.e. Hazardous Materials 138

C.3.f. Instructional Use of Animals 142

C.3.g. Surgery 145

C.3.h. Transgenic Animals 148

C.4. Monitoring of Approved Protocols 153


D. Evaluation of Animal Care and Use Concerns 157
E. Recordkeeping and Communications 167

E.1. Recordkeeping and Reporting 169


E.2. Communications 179



Appendices 181

Appendix A. Resources 183


Appendix B. Office of Laboratory Animal Welfare

Organizational Chart 191

Appendix C. Mandatory IACUC Issues Identified



During AAALAC International Site Visits 193

Appendix D. Recommendations of the 2000 AVMA



Panel on Euthanasia 195

Appendix E. Federal and State Permits Required



for Field Studies 199

Appendix F. U.S. Government Principles for the Utilization



and Care of Vertebrate Animals Used in

Testing, Research and Training 209

List of Tables by Section



A.2. Table A. Comparison of IACUC

Membership Requirements 14

A.2. Table B. Federally Mandated Functions of the IACUC 17

B.5. Table A. General Training Objectives 68

B.6. Table A. Examples of Categories of Emergencies 79

B.6. Table B. Core Functions of an Animal Facility 80


C.1. Table A. Regulatory Criteria Applicable to Protocol

Review as Defined in PHS Policy and

USDA Regulations 86

C.2.a. Table A. Methods for Reduction of Numbers

of Animals Used 98

C.2.c. Table A. Examples of Humane Endpoints for Studies

with Potential Lethality 107

C.2.d. Table A. Definitions of Terminology Related to

Pain and Distress 112


C.2.d. Table B. Signs of Acute Pain 112

C.2.d. Table C. Signs, Degree, and Length of Surgically

Produced Pain 113

E.1. Table A. Federal Requirements: Recordkeeping 174

E.1. Table B. Federal Requirements: Assurance

and Registration 175


E.1. Table C. Federal Requirements: Report of

Semiannual Evaluations 176

E.1. Table D. Federal Requirements: Annual Report 177

E.1. Table E. Federal Requirements: Suspensions

and Noncompliance 178



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Foreword
The original OPRR/ARENA IACUC Guidebook was published in 1992 and has served as a useful resource to the animal research community. This revised edition, the ARENA/OLAW IACUC Guidebook, continues to support the fundamental principle on which the animal care and use program is based: self-regulation with oversight. It clearly demonstrates the increased role of the Institutional Animal Care and Use Committee (IACUC) in ensuring the ethical and sensitive care and use of animals in research, teaching and testing.
This Guidebook is the product of an ARENA-established editorial board of knowledgeable individuals who have IACUC experience and are familiar with the evolution of IACUC issues and relevant documents published during the past decade. Sections from the original document have been updated, and new sections added to incorporate state of the art knowledge regarding the functioning of IACUCs and institutional animal care and use programs. This Guidebook does not create new or different interpretations of the PHS Policy on Humane Care and Use of Laboratory Animals, legislation, or USDA animal regulations.
The most current knowledge and understandings were sought through dis-tinguished authors with experience and expertise. New references, resources and contemporary scientific and “road tested” guidance have been incorporated. For example, the emphasis of the 1996 edition of the Guide for the Care and Use of Laboratory Animals on performance goals as opposed to engineering approaches is a theme that resonates throughout. Other new reports, such as the 1997 Occupational Health and Safety in the Care and Use of Research Animals and the 1998 The Psychological Well-Being of Nonhuman Primates, both published by the National Research Council have offered new insights and approaches that are reflected herein. The AVMA Panel on Euthanasia also published new guidelines in 2001.
Additional knowledge and changing trends in research have mandated broader and deeper coverage of topics in this Guidebook. New topic areas include training IACUC members, disaster planning, managing breeding colonies, and the use of transgenic animals. New federal requirements and

directives have been incorporated, and feedback from the field during the past ten years has resulted in emphasis on topics such as the role of the nonaffiliated member, the application of the three R’s (reduction, refinement and replacement) of alternatives, and the development of humane endpoints.


It is with a great sense of gratitude and respect for my colleagues who served on the editorial board and to the 30 authors who generously shared their time and expertise that I submit this document to the Office of Laboratory Animal Welfare. I would especially like to express my appreciation to the Project Director, Carol Wigglesworth, and her colleagues in NIH’s OLAW who gave untold hours of editing and guidance to make this project not only possible, but also enjoyable. ARENA also gratefully acknowledges the technical review for consistency with the provisions of the USDA animal welfare regulations provided by Dr. Ron DeHaven, Deputy Administrator, Animal Care, APHIS, and his headquarters staff. This has truly been a labor of love by many dedicated individuals in the animal research community and I feel honored to have been a part of this effort.
Marky Pitts

Chair, Editorial Board


Editorial Board



Marky Pitts, Chair

Director, Animal Subjects Program

University of California, San Diego

La Jolla, CA


Kathryn Bayne, M.S., Ph.D., D.V.M.

Co-Chair


Associate Director

AAALAC International

Rockville, MD
Lynn C. Anderson, D.V.M.

Senior Director

Comparative Medicine

MERCK Research Laboratories

Rahway, NJ




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