Research Regulatory Compliance

Research Regulatory Compliance

1st Edition - June 14, 2015

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  • Editors: Mark Suckow, Bill Yates
  • eBook ISBN: 9780124200654
  • Hardcover ISBN: 9780124200586

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Description

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.

Key Features

  • 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

Readership

Researchers, administrators, institutional officials, and technicians working in laboratories using animal and human subjects.

Table of Contents

    • 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
      • 6. Common Compliance Challenges
      • 7. Addressing Noncompliance
      • 8. Conclusion
    • Chapter 6. Controlled Substances: Maintaining Institutional Compliance
      • 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 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

Product details

  • No. of pages: 344
  • Language: English
  • Copyright: © Academic Press 2015
  • Published: June 14, 2015
  • Imprint: Academic Press
  • eBook ISBN: 9780124200654
  • Hardcover ISBN: 9780124200586

About the Editors

Mark 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.

Bill Yates

Affiliations and Expertise

University of Pittsburgh, Pittsburgh, PA, USA

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