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Research Regulatory Compliance
1st Edition - June 14, 2015
Editors: Mark A. Suckow, Bill Yates
Language: English
Hardback ISBN:9780124200586
9 7 8 - 0 - 1 2 - 4 2 0 0 5 8 - 6
eBook ISBN:9780124200654
9 7 8 - 0 - 1 2 - 4 2 0 0 6 5 - 4
Research Regulatory Compliance offers the latest information on regulations and compliance in the laboratory. With the increasing complexity of regulations and need for instituti…Read more
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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
Researchers, administrators, institutional officials, and technicians working in laboratories using animal and human subjects.
Preface
Chapter 1. Human Subjects Research Protections
1. Introduction
2. Historical Perspectives
3. Key Regulatory Agencies and Mandate
4. Common Challenges
5. Current Influences Shaping the Future of Human Research Subject Protection
Chapter 2. Investigational New Drug and Device Exemption Process
1. Introduction
2. Historical Perspectives [1]
3. Relevant Regulatory/Oversight Agencies, Regulations, and Guidance Documents
4. Regulatory Mandates
5. Key Personnel and University Committees Designated to Implement Regulatory Mandates
6. Common Compliance Challenges
7. Addressing Noncompliance
Chapter 3. The Institutional Animal Care and Use Committee
1. Introduction
2. Regulatory History
3. Relevant Regulatory and Oversight Laws, Regulations, and Guidance Documents
4. Key Regulatory Mandates for the Institutional Animal Care and Use Committee
5. Key Personnel and Committees Designated to Implement Regulatory Mandates
6. Common Compliance Challenges
7. Addressing Noncompliance
8. Final Comments
Chapter 4. Biological Hazards and Select Agents
1. Introduction
2. Historical Perspectives
3. Relevant Regulatory/Oversight Agencies, Regulations, and Guidance Documents
4. Key Regulatory Mandates
5. Key Personnel and University Committees Designated to Implement Regulatory Mandates
6. Common Compliance Challenges
7. Addressing Noncompliance
Chapter 5. Radiological Hazards and Lasers
1. Introduction
2. Historical Perspectives
3. Relevant Regulatory/Oversight Agencies, Regulations, and Guidance Documents
4. Key Regulatory Mandates
5. Key Personnel and University Committees Designated to Implement Regulatory Mandates
3. Relevant Regulatory/Oversight Agencies, Regulations, and Guidance Documents
4. Key Regulatory Mandates
5. Key Personnel and University Committees Designated to Implement Regulatory Mandates
6. Common Compliance Challenges
7. Addressing Noncompliance
Chapter 7. Export Controls and US Research Universities
1. Summary
2. Key Definitions
3. Introduction
4. Historical Perspectives
5. Relevant Regulatory/Oversight Agencies, Regulations, and Guidance Documents
6. Regulatory Mandates
7. Key Personnel and University Committees
8. Common Compliance Challenges
9. Addressing Noncompliance
Chapter 8. Data Management and Research Integrity
1. Introduction
2. Historical Perspectives
3. Relevant Regulatory/Oversight Agencies, Regulations, and Guidance Documents
4. Key Regulatory Mandates
5. Key Personnel and University Committees Designated to Implement Regulatory Mandates
6. Common Compliance Challenges
7. Addressing Noncompliance
Chapter 9. Intellectual Property
1. Summary
2. Key Personnel and University Committees Designated to Implement Regulatory Mandates
3. Common Compliance Challenges
4. Addressing Noncompliance
Chapter 10. Financial Conflicts of Interest in Research
1. Introduction
2. Historical Perspectives
3. Relevant Regulatory/Oversight Agencies, Regulations, and Guidance Documents
4. Key Regulatory Mandates of the 2011 Public Health Service Regulation
5. Key Personnel and University Committees Designated to Implement Regulatory Mandates
6. Common Compliance Challenges
7. Addressing Noncompliance
8. End-of-Chapter Notes
Chapter 11. Good Laboratory Practices (GLPs)
1. Introduction
2. Historical Perspectives
3. Relevant Regulatory/Oversight Agencies
4. Key Regulatory Mandates
5. Key Personnel
6. Common Compliance Challenges
7. Addressing Noncompliance
Chapter 12. Human Embryonic Stem Cell Research Oversight: A Confluence of Voluntary Self-Regulation and Shifting Policy Initiatives
1. Introduction
2. Historical Perspectives
3. Relevant Regulatory Agencies and Oversight Laws, Regulations, and Guidance Documents in Effect Today
4. Key Regulatory Mandates
5. Key Personnel and University Committees Designated to Implement Regulatory Mandates
6. Common Compliance Challenges
7. Addressing Noncompliance and Anticipating Emerging Compliance Issues
Index
No. of pages: 344
Language: English
Edition: 1
Published: June 14, 2015
Imprint: Academic Press
Hardback ISBN: 9780124200586
eBook ISBN: 9780124200654
MS
Mark A. Suckow
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.
Affiliations and expertise
Associate Vice President for Research, Attending Veterinarian, University of Kentucky, USA.
BY
Bill Yates
Affiliations and expertise
University of Pittsburgh, Pittsburgh, PA, USA
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