692 Pages 5 B/W Illustrations
by CRC Press

Ever since its establishment by USDA regulation in the mid-1980s, the Institutional Animal Care and Use Committee (IACUC) has evolved as the premier instrument of animal welfare oversight within research institutions in the United States. As biomedical research continuously grows, the role and impact of the IACUC has increased in scope and complexity. The IACUC Handbook has become an invaluable resource for individuals when the time comes for them to serve on their institution’s IACUC. It provides a foundation for understanding and implementing the many and varied responsibilities of this committee.

This fourth edition comprehensively addresses the significant changes in the pertinent regulatory environment and interpretation of applicable federal laws, regulations, and policies. It includes regulatory updates, as well as best practices, and new chapters on basic IACUC operations; animals used in agricultural research and teaching; invertebrates; pandemic and disaster planning; the Pacific Rim ethical review framework; operational communications and workflow; reduction of regulatory burden; and research reproducibility and role of the IACUC. It also adds new authors and editors widely respected in the field. 

An essential resource for IACUC members, university administrators and compliance personnel, laboratory animal veterinarians, and scientific investigators whose work involves animal research, this new edition ensures the book's continued acceptance as the standard reference in the field.

Chapter 39 of this book is freely available as a downloadable Open Access PDF at http://www.taylorfrancis.com under a Creative Commons (CC-BY) 4.0 license.

Dedication

Preface

Acknowledgement to Authors of Earlier Editions

About the Editors

List of Contributors 

Abbreviations

Survey Methods and Statistics

1 Origins of the IACUC

Neera V. Gopee

 

2 Circumstances Requiring an IACUC  

Marcy Brown and Deborah Frolicher

 

3 Creation of an IACUC

Marcy Brown and Deborah Frolicher

 

4  Reporting Lines of the IACUC

Marcy Brown and Deborah Frolicher

 

5 General Composition of the IACUC and Specific Roles of the IACUC Members

William G. Greer and Erin Czarniak

 

6 Basic IACUC Operations

Jennifer A. Klahn and Joanne L. Zahorsky-Reeves

 

7 Frequency and Conduct of Regular IACUC Meetings

Sreekant Murthy

 

8 General Format of IACUC Protocol Forms

William G. Greer and Lauren Danridge

 

9 Submission and Maintenance of IACUC Protocols

Anna Hampton

 

10 General Concepts of Protocol Review

John F. Bradfield, Ernest D. Prentice, Gwenn S. F. Oki, and Michael D. Mann

 

11 Amending IACUC Protocols 

Cecile Baccanale

 

12 Continuing Review of Protocols

John F. Bradfield, Ernest D. Prentice, and Gwenn S. F. Oki

 

13 Justification for the Use of Animals

Kristina Cataline and Larry Carbone

 

14 Justification of the Number of Animals to Be Used

Ed J. Gracely

 

15 Animal Acquisition and Disposition

Deborah Mook, Michael J. Huerkamp, and David R. Archer

16 Animal Housing, Use Sites, and Transportation

Robin Crisler and Karen Rogers

 

17 Considerations for Mitigation of Pain and Distress

Emily L. Miedel and F. Claire Hankenson

 

18 Euthanasia

Debra L. Hickman

 

19 Surgery

Szczepan W. Baran and Marcel Perret-Gentil

 

20 Custom Antibody Production and Blood Collection

Noé Tirado-Muñiz

 

21 Animals Used in Agricultural Research and Teaching

Bart Carter, Vickie Jarrell, and Rose Gillesby

 

22 IACUC Considerations for Research Using Invertebrates

Stuart Leland and Alan Gelperin

23 Occupational Health and Safety

Robin Lyn Trundy and Susan Stein Cook

 

24 Personnel Training

Melissa C. Dyson, Tara Martin, and Kiirsa Pokryfke

 

25 Disaster and Emergency Response Planning

Kevin Prestia, JoAnn Henry, and Jennifer Pullium

 

26 Confidential and Proprietary Information

Tracy M. Heenan and Thomas A. Leach

 

27 General Concepts of the Program Review and Facility Inspection

Joseph D. Thulin and Kenneth P. Allen

 

28 Inspection of Animal Housing Areas

Christine A. Boehm and Carolyn M. Malinowski

 

29 Inspection of Individual Laboratories

Neil S. Lipman and Scott E. Perkins

 

30 Inspection of Surgery Areas

Scott E. Perkins and Neil S. Lipman

 

31 Assessment of Veterinary Care

Carolyn M. Doerning and Bernard J. Doerning

32 Research Animal Enrichment

Kathryn Bayne and Jennifer N. Camacho

 

33 Adverse Events and Protocol Noncompliance

Stacy L. Pritt and Madeline Budda

 

34 Post approval Monitoring

Ron E. Banks

 

35 The European Ethical Review and Oversight Framework: Collaborative Issues

Javier Guillén

 

36  Ethical Review Framework in Asia-Pacific Region: Collaborative Considerations

Sonja T. Chou and Dewi K. Rowlands

 

37 Proposed outline for Operational Communications and Workflow

Natalie Mays, Tanise Jackson, and Jennifer Klahn

 

38 Reducing Regulatory Burden

Sally Thompson-Iritani, Elaine Kim, and Aubrey Schoenleben

 

39  Research Reproducibility and the Role of the IACUC

Mark J. Prescott, Esther J. Pearl, Nathalie Percie du Sert, and Penny S. Reynolds

Biography

Mark Suckow, DVM, is currently located at the University of Kentucky where he serves as Associate Vice President for Research, Attending Veterinarian, and Professor in the Department of Biomedical Engineering. He received his DVM from the University of Wisconsin in 1987 and subsequently completed a post-doctoral residency in laboratory animal medicine at the University of Michigan in 1990. Following eight years as a clinical laboratory animal veterinarian at Purdue University, Dr. Suckow then spent 17 years at the University of Notre Dame where he served as Director of the Freimann Life Science Center and later as Associate Vice President for Research Compliance. With an interest in cancer models, biomaterials, and vaccines, Dr. Suckow has worked as an independent and collaborative investigator, and he has published on these topics in refereed journals. Dr. Suckow is a Past President of the American Association for Laboratory Animal Science (2006) and the American Society of Laboratory Animal Practitioners (2011). In addition, he served on the AVMA Council on Research from 2014-2020 (Chair from 2016-2018); is a Diplomate of the American College of Laboratory Animal Medicine; and is a member of the Council on Accreditation of AAALAC, International. 

Sreekant Murthy, PhD, is a professor of medicine, adjunct professor of biomedical engineering, and senior associate vice provost for research compliance (retired) at Drexel University. He recently joined Rowan University, Glassboro, New Jersey, as their chief research compliance officer. He earned his doctoral degree from Philadelphia College of Pharmacy, currently known as University of Sciences, Philadelphia. As a faculty member he simultaneously chaired two IACUCs in the same institution for five years. As the senior associate vice provost, he managed research compliance in human subject research, animal welfare, institutional biosafety committee, radiation safety, and research integrity. He has been the institutional official for the IACUC since 2006. At Rowan University, he continues to be responsible for all aspects of research compliance, research integrity, and export control.

Julie Sharp, DVM, is the Director of the Institutional Animal Care and Use Program (IACUP) at University of California San Francisco. Leading the IACUP staff, she works with Institutional Animal Care and Use Committee (IACUC) in pursuit of their mission of “Advancing Health Worldwide” by promoting humane care and use of animal research subjects. In this role, she collaborates with faculty and research staff to facilitate their research endeavors while focusing on program and process improvements to reduce regulatory and administrative burden. Dr. Sharp has been deeply involved in animal care and use programs at both public and private academic medical centers since 2003, holding animal welfare leadership positions with the Duke University Medical Center, the Institute for Medical Research at Durham Veterans Affairs Medical Center, the University of Pennsylvania, and the Research Foundation for the SUNY Downstate Health Sciences University. She also served on the Board of Directors of the IACUC Administrators Association and actively participates with the Federal Demonstration Partnership’s Compliance Unit Standard Procedures project, as part of the 21st Century Cures Act. Dr. Sharp earned her Doctor of Veterinary Medicine degree from North Carolina State University and her Bachelor of Science degree in Molecular Biology from Westminster College. She is a Certified Professional IACUC Administrator, a Diplomate of the American College of Laboratory Animal Medicine, and serves as an AAALAC International ad hoc Specialist.

Troy M. Hallman, M.S., V.M.D., D.A.C.L.A.M, serves as the Director of the Office of Animal Research Support at Yale University. Earlier, he served as the Director of the Office of Animal Welfare and a clinical laboratory animal veterinarian at the University of Pennsylvania. Dr. Hallman completed a master's degree in zoology from the University of British Columbia in 1997.  He received his veterinary medical degree from the University of Pennsylvania in 2000 and completed a post-doctoral residency program in laboratory animal medicine at the University of Pennsylvania in 2002. He has been a Diplomate of the American College of Laboratory Animal Medicine since 2008. Dr. Hallman currently serves as a member of the AAALAC Council on Accreditation. His expertise includes regulatory oversight of veterinary, biomedical and agricultural programs, and laboratory animal welfare regulations and guidance.