Research Regulatory Compliance

ISBN-13: 9780124200586 / Angielski / Twarda / 2015 / 344 str.

Suckow, Mark A. Yates, Bill

Opis

Research Regulatory Compliance offers the latest information on regulations and compliance in the laboratory. With the increasing complexity of regulations and need for institutional infrastructure to deal with compliance of animal use issues, as well as a requirement surrounding human subjects, this publication provides reputable guidance and information. The book is extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and is also a great asset for faculty or new researchers coming in to the laboratory environment. It will help prepare users for the deluge of regulatory and compliance issues they will face while conducting their scientific programs. The book is edited and authored by known leaders in the field of compliance and regulations, and contains extensive research on the topics. It represents the new standard for information in every laboratory.

• Provides a "one-stop," go-to resource for the many regulatory and compliance issues that affect laboratory study and research models
• Extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and also a great asset for faculty or new researchers coming in to the laboratory environment
• Focuses on United States regulations, covering both animal models and human subjects
• Written and edited by known leaders in the field of regulatory compliance who bring many years of collective experience to the book

Spis treści

1. Human Subjects Research Protections
2. Investigational New Drug and Device Exemption Process
3. The Institutional Animal Care and Use Committee
4. Biological Hazards and Select Agents
5. Radiological Hazards and Lasers
6. Controlled Substances: Maintaining Institutional Compliance
7. Export Controls and US Research Universities
8. Data Management and Research Integrity
9. Intellectual Property
10. Financial Conflicts of Interest in Research
11. Good Laboratory Practices (GLPs)
12. Human Embryonic Stem Cell Research Oversight: A Confluence of Voluntary Self-Regulation and Shifting Policy Initiatives

O autorze

Mark Suckow 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. He spent 8 years as a clinical laboratory animal veterinarian at Purdue University and then 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. Prior to coming to the University of Kentucky, he was Professor of Veterinary Population Medicine and Director, Research Animal Resources at the University of Minnesota. With an interest in cancer models, biomaterials models, and vaccines, Dr. Suckow has functioned as an independent and collaborative investigator and has published in refereed journals and has seven issued patents related to vaccine adjuvants and cancer vaccines. He has written or edited over 20 books on topics related to research and laboratory animal medicine. Further, he served as the 2006 President of the American Association for Laboratory Animal Science and the 2011 President of the American Society of Laboratory Animal Practitioners; and currently he serves on the AVMA Council on Research and is a member of the Council on Accreditation of AAALAC, International.