Regulatory Toxicology, Second Edition

Maintaining its user-friendly approach, The Care and Feeding of an IACUC: The Organization and Management of an Institutional Animal Care and Use Committee, Second Edition is a handy guide for members of the laboratory animal community looking for a concise, descriptive introduction to what an IACUC is all about and how it operates. The book covers training programs and discusses professional certifications for IACUC administrative and animal care staff. It provides pointers to principal investigators, discusses interactions between IACUCs and other compliance panels, and addresses occupational health and safety programs and the role they play in the overall animal care and use program.

This new edition of a bestseller contains new information on international regulations regarding animal subject research and the requirements for an ethics panel review. It discusses outside collaborations, interinstitutional memorandums of understanding, and the differences in regulations between countries. The book also includes a new chapter exploring semiannual program reviews, semiannual inspections, and postapproval monitoring. The contributors provide updated information on the protocol submission process, electronic protocol management systems, and records management-including the essential elements of the protocol form and how to complete it.

The book also delves deeply into bioethics. It discusses how IACUCs can ensure that each proposal to use animals in research includes an ethical review with a harm-benefit analysis weighing the expected advancements in human and animal health against the potential harm inflicted to the animal. Also included is a chapter on how to survive a regulatory inspection or an accreditation site visit.

All interpretations of the regulations have been reviewed by staff at the NIH Office of Laboratory Animal Welfare (OLAW), the Animal Welfare Information Center (AWIC), and USDA APHIS/Animal Care (AC) for consistency and compliance with the PHS Policy and the USDA Animal Welfare Act Regulations (AWAR).

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