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 "the bible" 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 modifications to regulations, 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.
The IACUC Handbook has become "the Bible" for individuals serving 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 regulatory environment.
1. Origins of the IACUC
2. Circumstances Requiring an IACUC
3. Creation
of an IACUC- 4.Reporting Lines of the IACUC
5. General Composition of the
IACUC and Specific Roles of the IACUC Members
6. Basic IACUC Operations
7.
Frequency and Conduct of Regular IACUC Meetings
8. General Format of IACUC
Protocol Forms
9. Submission and Maintenance of IACUC Protocols
10. General
Concepts of Protocol Review11 Amending IACUC Protocols - Cecile Baccanale
12.Continuing Review of Protocols 13.Justification for the Use of Animals
14.
Justification of the Number of Animals to Be Used
15. Animal Acquisition and
Disposition
16. Animal Housing, Use Sites, and Transportation
17.
Considerations for Mitigation of Pain and Distress
18. Euthanasia19.
Surgery20.Custom Antibody Production and Blood Collection
21. Animals Used in
Agricultural Research and Teaching
22. IACUC Considerations for Research
Using Invertebrates
23. Occupational Health and Safety 24.Personnel Training
25. Disaster and Emergency Response Planning 26.Confidential and Proprietary
Information 27.General Concepts of the Program Review and Facility Inspection
28. Inspection of Animal Housing Areas 29.Inspection of Individual
Laboratories
30. Inspection of Surgery Areas
31. Assessment of Veterinary
Care
32. Research Animal Enrichment33. Adverse Events and Protocol
Noncompliance
34. Post approval Monitoring
35. The European Ethical Review
and Oversight Framework: Collaborative Issues 36.Ethical Review Framework in
Asia-Pacific Region: Collaborative Considerations 37.Proposed outline for
Operational Communications and Workflow
38. Reducing Regulatory Burden
39.Reproducibility and the Role of the IACUC
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 Partnerships 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.
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