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Research Regulatory Compliance

  • 1st Edition - June 14, 2015
  • Latest edition
  • Editors: Mark A. Suckow, Bill Yates
  • Language: English

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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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

  • Edition: 1
  • Latest edition
  • Published: June 14, 2015
  • Language: English

About the editors

MS

Mark A. Suckow

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.
Affiliations and expertise
Private Consultant

BY

Bill Yates

Affiliations and expertise
University of Pittsburgh, Pittsburgh, PA, USA

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