Management, Practices, and Compliance

Page 1

CRC Press

MANAGEMENT, PRACTICES, AND COMPLIANCE

Taylor & Francis Group

Bestseller! Bestseller!

The Care and Feeding of an IACUC

The IACUC Handbook

The Organization and Management of an Institutional Animal Care and Use Committee

Second Edition Edited by

Jerald Silverman University of Massachusetts Medical School, Worcester, USA

Mark A. Suckow

M. Lawrence Podolsky Consultant, Belmont, California, USA

University of Notre Dame, Indiana, USA

Victor Lukas

Sreekant Murthy Drexel University, Philadelphia, Pennsylvania, USA

”The IACUC Handbook is an interesting interactive handbook with a unique format that introduces a complex subject of rules, policy, and guidelines for an animal care program and the committee given the task of oversight of that program and offers interpretation into those guidelines. …easy to read, complete with a multitude of reference material …useful to any new IACUC members or members of IACUC who have additional questions regarding policies and regulations concerning animal programs at their or other institutions.” —Sandra L. Jex, DVM, ALN Magazine

“This book remains a valuable source of practical information issues facing IACUCs, and I highly recommend it for the libraries of all those who are part of an IACUC or contribute to IACUC support.” —Rebecca S. Schwiebert, D.V.M., American Journal of Veterinary Medicine

Established by U.S. Department of Agriculture regulation in the 1980s, the Institutional Animal Care and Use Committee has evolved as the premiere instrument of animal welfare supervision for institutions in the United States. The IACUC Handbook provides a foundation for those attempting to understand and implement the various responsibilities of this committee. This edition features comprehensive updates for all pertinent federal laws, regulations, and policies. It incorporates revised suggestions from experienced professionals in the field to guide IACUC members on best-practice compliance. With concise, easy-to-find information, it remains a reference of choice for researchers and professionals.

Contents Origins of the IACUC. Circumstances Requiring an IACUC. Creation of an IACUC. Reporting Lines of the IACUC. General Composition of the IACUC and Specific Roles of the IACUC Members. Frequency and Conduct of Regular IACUC Meetings. General Format of IACUC Protocol Forms. Submission and Maintenance of IACUC Protocols. General Concepts of Protocol Review. Amending IACUC Protocols. Continuing Review of Protocols. Justification for the Use of Animals. Justification for the Number of Animals to be Used. Animal Acquisition and Disposition. Animal Housing and Use Sites. Pain and Distress. Euthanasia. Surgery. Antigens, Antibodies, and Blood Collection. Occupational Health and Safety. Personnel Training. Academic Freedom and Proprietary Information. General Concepts of the Facility Inspection and Program Review. Inspection of Animal Housing Areas. Inspection of Individual Laboratories. Inspection of Surgery Areas. Assessment of Veterinary Care. Laboratory Animal Enrichment. Animal Mistreatment and Protocol Noncompliance. Post –Approval Monitoring. Appendices: Animal Welfare Act; Animal Welfare Act Regulations; Health Research Extension Act of 1985; Health Service Policy on Humane Care and Use of Laboratory Animals; U.S. Government Principles for the Utilization and Care of Vertebrate Animals in Testing, Research, and Training Catalog no. 4010, October 2006, 680 pp. ISBN: 978-0-8493-4010-9, $89.95 / £57.99

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Edited by

Legacy Clinical Research & Technology, Portland, Oregon, USA

"… pertinent…well written…a valuable addition to the library of any facility…Perhaps the greatest value in this book is its potential as a part of a training program for IACUC members." —Contemporary Topics in Laboratory Animal Science

In 1987, the Scientists Center for Animal Welfare, in cooperation with the American Association for Laboratory Animal Science, published a compilation of presentations made at five regional workshops on effective operation of IACUCs. In the decade since this compilation was published, nearly all of the 18 consensus recommendations developed by the workshop participants and the Center's Board of Trustees have either been incorporated into the AWA regulations or have been voluntarily adopted by institutions using animals subjects. This work superbly illustrates the progress and advances the animal-using communities have made in implementing these and other improvements in their animal care and use programs.

Contents IACUC: The Hub of Communication Formation and Composition of an IACUC IACUC Records and their Management IACUC Issues in Academia Forms and Notices (Annotated) Running an IACUC: One Chair's Perspective The IACUC's Role in Education and Training The IACUC and Laboratory Animal Resources The Role of the IACUC in Assessing and Managing Pain and Distress in Research Animals IACUC from a Principal Investigator's Perspective The Literature Search for AlternativesEthics and Quandaries Acronyms and Abbreviations Appendix 1: IACUC Resources Appendix 2: Training Resources Appendix 3: Directions for Alternatives to Animal Testing Appendix 4: Major Data Bases Appendix 5: Where to Contact USDA Appendix 6: Internet Sources of Interest to IACUCs Appendix 7: Associations and Related Organization Appendix 8: Guidelines for Blood Sample Withdrawal Appendix 9: Volume Guidelines for Compound Administration Appendix 10: Euthanasia Guide Catalog no. 2580, March 1999, 216 pp. ISBN: 978-0-8493-2580-9, $97.95 / £66.99

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MANAGEMENT, PRACTICES, AND COMPLIANCE The COST Manual of Laboratory Animal Care and Use

Managing the Laboratory Animal Facility

Refinement, Reduction, and Research

Second Edition

Edited by

University of Massachusetts Medical School, Worcester, USA

CRC Press Taylor & Francis Group

Jerald Silverman

Bryan Howard Former Director of Animal Welfare, University of Sheffield, UK

Timo Nevalainen University of Kuopio, Finland

Gemma Perretta Italian National Research Council, Santa Maria di Galeria, Italy

COST Action B-24 established four working groups to research and discuss issues relevant to laboratory animal science. These included the housing of animals, environmental needs, refinement of procedures, genetically modified animals, and cost-benefit analysis. Based on the groups’ findings, The COST Manual of Laboratory Animal Care and Use: Refinement, Reduction, and Research provides a consensual European view of best practices for individuals and institutions caring for and working with laboratory animals. This book focuses on reduction and refinement strategies and includes insightful contributions from 44 experts drawn from various EU countries. Addressing the most commonly used mammalian species—rats, mice, and rabbits—each chapter of the book follows a similar structure: • Objectives outline the breadth of the chapter’s coverage • Key Factors summarize the central issues that underpin good practice • Questions Unresolved close each chapter, identifying areas of uncertainty and prompting investigations directed at advancing knowledge and application within relevant fields This manual is the reference sure to be found in the labs of those responsible for the care and welfare of animals and those overseeing and conducting activities related to the use of animals for scientific purposes.

Contents Design and Oversight of Laboratory Animal Facilities Housing and Care of Laboratory Animals Animal Needs and Environmental Refinement Ethical Evaluation of Scientific Procedures: Recommendations for Ethics Committees

“I am pleased that Dr. Silverman has put out a second edition. I felt … that he was talking directly to me—in his folksy style of presentation—about any one of the facility issues I’ve faced over the years. The not-so-hypothetical Great Eastern University from his Lab Animal column is again used to help us address those management scenarios that we see each and every day. For myself, I will assign reading the sections on per diem in my lab animal management class to help my students better understand this oft times difficult topic. As well, Jerry has offered many insights and approaches to help both the new and experienced lab animal manager… .” —Bruce W. Kennedy, Compliance Associate, Research & Graduate Studies, California State Polytechnic University

A guide to providing high-quality management of laboratory animal facilities in a financially sound manner, this book promotes a basic understanding of management and leadership concepts in laboratory animal science. While retaining the focus of its predecessor, this edition contains more than 100 more pages of new and expanded material. It includes an entirely new chapter on leadership, a greatly expanded chapter on the management of human resources, a new appendix on productivity goals and measurements, and a revised appendix on how to calculate per diem rates.

Features • Explains several environmental factors that can influence a manager’s choice of goals and strategies • Addresses the most important aspects that go into creating a good working environment, including communication and trust in the workplace • Discusses how to manage existing and potential funds and how to establish per diem rates • Covers day-to-day time management, specifically planning, controlling, and organizing time • Explores the traits of leaders and relates the basics of management to leadership

Contents

Reduction by Careful Design and Statistical Analysis Animal Models: Selecting and Preparing Animals for a Study Creation of Genetically Modified Animals Management of Genetically Modified Rodents Impact of Handling, Radiotelemetry, and Food Restriction Basic Procedures: Dosing, Sampling and Immunisation

The Organizational Environment The Management of Human Resources Managing Financial Resources Management of Information Resources Time Management

Imaging Techniques

Leadership

Anaesthesia and Analgesia Use of Humane Endpoints to Minimise Suffering

Appendix 1: Productivity Goals and Measurements Appendix 2: Setting Per Diem Rates

Euthanasia

Appendix 3: Hiring the Right Person

Education, Training and Competence Animal Experimentation and Open Communication Catalog no. K11184, October 2010, 439 pp. ISBN: 978-1-4398-2492-4, $89.95 / £57.99

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The Basics of Managing a Laboratory Animal Facility

Appendix 4: Training Catalog no. 55569, July 2008, 328 pp. ISBN: 978-1-4200-5556-6, $79.95 / £49.99

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MANAGEMENT, PRACTICES, AND COMPLIANCE

CRC Press Taylor & Francis Group

New!

Bestseller!

Animal Welfare in Animal Agriculture

Management of Laboratory Animal Care and Use Programs

Husbandry, Stewardship, and Sustainability in Animal Production

Edited by

Edited by

Mark A. Suckow

Wilson G. Pond

University of Notre Dame, Indiana, USA

Cornell University, Ithaca, New York, USA

Fred A. Douglas Purdue University, West Lafayette, Indiana, USA

Robert H. Weichbrod National Eye Institute, Bethesda, Maryland, USA

The management of biomedical research using animals has become increasingly complex due to new technology, increased regulatory oversight, and recognition of the need for animals free of disease and distress. Within this changing environment, individuals charged with the management of laboratory animal facilities have a substantial responsibility to the institution, the public, and the animals. Management of Laboratory Animals Care and Use Programs provides both factual and theoretical information drawn from the substantial experience of authors who are noted experts in the field. This book provides individuals with the basic knowledge and information necessary to meet typical professional challenges. A co-publication with the American Association for Laboratory Animal Science, this valuable book serves as the text for the Certified Manager Animal Resources (CMAR) exam.

Features • Provides a comprehensive overview of laboratory animal management • Stresses theory as well as practical applications • Assembles the works of recognized authorities in the field

Fuller W. Bazer Texas A&M University, College Station, USA

Bernard E. Rollin Colorado State University, Fort Collins, USA

Through a multidisciplinary approach, this book takes readers on a journey through the complex maze of issues that surround animal welfare today. After providing historical background on industrialized agriculture, the text links current and historical uses of animals and our views toward them with the concept of sustainable agriculture, addressing the role that welfare plays in this subject. International contributors present their views on what constitutes genuine animal welfare and how it is attained. They discuss such topics as the environmental issues involved in industrial animal agriculture as well as the multiple uses of animals in developing and developed nations.

Features • Investigates the use of animals for food and fiber production and for biological products used in human and animal health • Presents a variety of viewpoints and approaches to animal welfare from a diverse group of distinguished scientists and animal welfare experts • Summarizes the findings of the PEW Foundation Commission Report and contains a thorough analysis of the controversial aspects of this report

• Co-published with the American Association of Laboratory Animal Science

• Includes a conceptual and practical discussion of the environmental issues involved in industrial animal agriculture

Contents

Abridged Contents:

People: A Most Valuable Resource

The Role of Animals in Society

Education and Training Programs

Perspectives on Emergence of Contemporary Animal Agriculture in the Mid-Twentieth Century Contributions of Farm Animals to Society: Food, Fiber, Leather, Pharmaceutical and Biomedical Products, and Draft Power

Personal Leadership Skills Professional Ethics

Contributions of Animals in Agricultural Research and in Service Functions for Individuals and in Other Specialized Activities

Animal Health and Medicine Regulatory Compliance

Treatment of Animals

Quality Management Standard Operating Procedures and Policies, Physical Plant

Socio-Ethical Concerns about Animal Agriculture: Review of the 2008 PEW Foundation Commission Report Defining Animal Welfare: Varying Viewpoints and ApproachesImplementing Effective Practices and Programs to Assess Animal Welfare

Fiscal Management Grants and Contracts Utilization of Information Technology

Animal Welfare: Synthesizing Contemporary Animal Agriculture Engineering and Animal Comfort and Social Responsibility

Hazard and Risk Management

Sustainable Plant and Animal Agriculture for Animal Well-Being

Disaster Management

Symbiosis of Plants, Animals, and Microbes

Facility Security Public Relations

Food Safety Issues in Animal Source Foods Related to Animal Health and Welfare

Catalog no. 2287, November 2001, 408 pp. ISBN: 978-0-8493-2287-7, $99.95 / £63.99

Catalog no. K12159, December 2011, c. 320 pp. ISBN: 978-1-4398-4842-5, $89.95 / £57.99

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