Research Regulatory Compliance - 1st Edition - ISBN: 9780124200586, 9780124200654

Research Regulatory Compliance

1st Edition

Editors: Mark Suckow Bill Yates
eBook ISBN: 9780124200654
Hardcover ISBN: 9780124200586
Imprint: Academic Press
Published Date: 8th July 2015
Page Count: 344
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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

Details

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

About the Editor

Mark Suckow

Director, Research Animal Resource, University of Minnesota, St. Paul, MN, USA

Affiliations and Expertise

Executive Director, Research Animal Resource, University of Minnesota, St. Paul, MN, USA

Bill Yates

Affiliations and Expertise

University of Pittsburgh, Pittsburgh, PA, USA