The IACUC Handbook, Third Edition PDF
Preview The IACUC Handbook, Third Edition
Lab Animal Science Silverman Suckow Murthy T h e I “For the experienced reader and novice alike, this book provides a wealth The A of useful information and insight into the collective experience and wisdom of the numerous expert editors and authors. Both NIH/OLAW and APHIS/AC commend the authors and editors for their outstanding efforts and for moving the biomedical research community forward in its formulation of I ACUC best practices and commonly accepted professional guidance in this C complex arena.” —From the Introduction by Dr. Patricia A. Brown, Director of the Office of Laboratory Animal Welfare Dr. Chester A. Gipson, Deputy Administrator, USDA/APHIS/Animal Care U Ever since its establishment by USDA regulation in the mid-1980s, the Institutional Animal Care and Use Committee (IACUC) has evolved as the HANDBOOK premier instrument of animal welfare oversight within research institutions in C 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 Third Edition them to serve on their institution’s IACUC. It provides a foundation for under- standing and implementing the many and varied responsibilities of this committee. H This Third Edition comprehensively addresses the significant changes in the A pertinent regulatory environment and interpretation of applicable federal laws, N regulations, and policies. It provides multiple references and commentary on the new edition of the Guide for the Care and Use of Laboratory Animals, the D new AVMA Guidelines for the Euthanasia of Animals: 2013 Edition, and the B Office of Laboratory Animal Welfare’s Frequently Asked Questions. The Third Edition also features an updated survey of IACUC practices from institutions O around the United States, offering wisdom gained from their experience. In addition, it includes a chapter that provides an international perspective on O Edited by how animal welfare reviews can function in other countries. K Jerald Silverman Mark A. Suckow Third Sreekant Murthy Edition K15383 The I ACUC HANDBOOK Third Edition The I ACUC HANDBOOK Third Edition Edited by Jerald Silverman Mark A. Suckow Sreekant Murthy Boca Raton London New York CRC Press is an imprint of the Taylor & Francis Group, an informa business CRC Press Taylor & Francis Group 6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487-2742 © 2014 by Taylor & Francis Group, LLC CRC Press is an imprint of Taylor & Francis Group, an Informa business No claim to original U.S. Government works Version Date: 20150505 International Standard Book Number-13: 978-1-4987-0371-0 (eBook - PDF) This book contains information obtained from authentic and highly regarded sources. Reasonable efforts have been made to publish reliable data and information, but the author and publisher cannot assume responsibility for the validity of all materials or the consequences of their use. The authors and publishers have attempted to trace the copyright holders of all material repro- duced in this publication and apologize to copyright holders if permission to publish in this form has not been obtained. If any copyright material has not been acknowledged please write and let us know so we may rectify in any future reprint. Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, reproduced, transmitted, or utilized in any form by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying, microfilming, and recording, or in any information storage or retrieval system, without written permission from the publishers. For permission to photocopy or use material electronically from this work, please access www.copyright.com (http://www.copy- right.com/) or contact the Copyright Clearance Center, Inc. (CCC), 222 Rosewood Drive, Danvers, MA 01923, 978-750-8400. CCC is a not-for-profit organization that provides licenses and registration for a variety of users. For organizations that have been granted a photocopy license by the CCC, a separate system of payment has been arranged. Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identifica- tion and explanation without intent to infringe. Visit the Taylor & Francis Web site at http://www.taylorandfrancis.com and the CRC Press Web site at http://www.crcpress.com Contents 1. Origins of the IACUC ............................................................................................................1 Harry Rozmiarek 2. Circumstances Requiring an IACUC ...............................................................................11 Marcy Brown and Mary Jo Shepherd 3. Creation of an IACUC ..........................................................................................................23 Marcy Brown and Mary Jo Shepherd 4. Reporting Lines of the IACUC ..........................................................................................39 Marcy Brown and Mary Jo Shepherd 5. General Composition of the IACUC and Specific Roles of the IACUC Members .......45 Christian E. Newcomer and William G. Greer 6. Frequency and Conduct of Regular IACUC Meetings .................................................73 Sreekant Murthy 7. General Format of IACUC Protocol Forms .....................................................................97 Christian E. Newcomer and William G. Greer 8. Submission and Maintenance of IACUC Protocols ....................................................111 Kathy Laber and Alison C. Smith 9. General Concepts of Protocol Review ............................................................................139 Ernest D. Prentice, Gwenn S. F. Oki, and Michael D. Mann 10. Amending IACUC Protocols ............................................................................................177 Angela M. Mexas and Diane J. Gaertner 11. Continuing Review of Protocols .....................................................................................199 Gwenn S. F. Oki and Ernest D. Prentice 12. Justification for the Use of Animals ...............................................................................211 Larry Carbone 13. Justification of the Number of Animals to Be Used ....................................................237 Ed J. Gracely 14. Animal Acquisition and Disposition .............................................................................253 Michael J. Huerkamp, Larry Iten, and David R. Archer 15. Animal Housing, Use Sites, and Transportation .........................................................299 Robert M. Bigsby and Robin Crisler 16. Pain and Distress ................................................................................................................317 Alicia Z. Karas and Jerald Silverman 17. Euthanasia ............................................................................................................................377 Peggy J. Danneman 18. Surgery ..................................................................................................................................417 Lester L. Rolf Jr. 19. Antigens, Antibodies, and Blood Collection ................................................................447 Harold F. Stills Jr. 20. Occupational Health and Safety .....................................................................................461 Robin Lyn Trundy and Susan Stein Cook 21. Personnel Training .............................................................................................................483 Howard G. Rush and Melissa C. Dyson 22. Confidential and Proprietary Information ...................................................................503 Marilyn J. Chimes and Priya Sankar 23. General Concepts of the Program Review and Facility Inspection .........................539 Joseph D. Thulin and Kenneth P. Allen 24. Inspection of Animal Housing Areas ............................................................................573 Christine A. Boehm and Debra L. Hickman 25. Inspection of Individual Laboratories ...........................................................................591 Neil S. Lipman and Scott E. Perkins 26. Inspection of Surgery Areas.............................................................................................603 Scott E. Perkins and Neil S. Lipman 27. Assessment of Veterinary Care .......................................................................................617 Mark A. Suckow and Bernard J. Doerning 28. Laboratory Animal Enrichment ......................................................................................657 Kathryn Bayne and Jennifer N. Camacho 29. Animal Mistreatment and Protocol Noncompliance ..................................................685 Jerald Silverman 30. Postapproval Monitoring ..................................................................................................719 Ron E. Banks 31. The European Ethical Review Framework: Collaborative Issues ............................751 Javier Guillén
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