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Research Regulatory Compliance
A “one-stop” resource for information, compliance standards, and regulations surrounding research models, covering not only human subjects, but also animal models.
Mark A. Suckow (Edited by), Bill Yates (Edited by)
9780124200586, Elsevier Science
Hardback, published 11 August 2015
344 pages
23.4 x 19 x 2.4 cm, 0.91 kg
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.
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
Subject Areas: Pharmacology [MMG], Diabetes [MJGD], Clinical trials [MBGR1]
