Research Regulatory Compliance

Erscheinungsjahr 2015
ISBN: 978-0-12-420058-6
Verlag: Elsevier Science

Buch, Englisch, 344 Seiten, Format (B × H): 191 mm x 236 mm, Gewicht: 930 g

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.

Autoren/Hrsg.

Suckow, Mark A

Yates, Bill

Fachgebiete

• Interdisziplinäres Wissenschaften Wissenschaften: Allgemeines Wissenschaftliches Arbeiten, Studientechnik
• Sozialwissenschaften Pädagogik Berufliche Bildung Wissenschaftliches Arbeiten, Studientechnik

Inhaltsverzeichnis

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

Über Autor(innen)

Suckow, Mark A
Mark A. Suckow is a private consultant in laboratory animal medicine and Professor (Emeritus) in Biomedical Engineering at the University of Kentucky where he previously served as Attending Veterinarian and Associate Vice President for Research. He received his DVM from the University of Wisconsin and subsequently completed a post-doctoral residency in laboratory animal medicine at the University of Michigan. Dr. Suckow has 35 years of experience in laboratory animal medicine, regulatory compliance, and animal facility management. With an interest in the use of animal models for cancer research, vaccinology, and biomaterials development, Dr. Suckow has published greater than 115 papers 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 he currently serves as an emeritus member of the Council on Accreditation of AAALAC, International and as Editor in Chief for the Journal of the American Association for Laboratory Animal Science.