Ensuring National Biosecurity

Ensuring National Biosecurity

Institutional Biosafety Committees

1st Edition - January 29, 2016

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  • Editors: Carole Baskin, Alan Zelicoff
  • Paperback ISBN: 9780128018859
  • eBook ISBN: 9780128018606

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Description

Ensuring National Biosecurity: Institutional Biosafety Committees reviews the various responsibilities and associated challenges Institutional Biosafety Committees (IBCs) face and proposes changes that may help improve this system and increase national biosecurity and worker safety. In recent years IBCs in academic and other institutions have been tasked with increasing levels of responsibility, overseeing work with recombinant genetic material and hazardous agents. IBC members often lack the training to effectively ensure that the work performed is truly safe for scientists and the general community, and so increasingly rely upon the expertise of the researchers themselves. With the proposed US dual-use research policies soon to be implemented, this strain may increase. This book provides readers with the necessary information to be able to enhance national biosecurity within the US, EU, Australia, New Zealand, Japan and more. Ensuring National Biosecurity is as an invaluable reference for biosafety professionals or for researchers who need to understand the regulatory landscape that impacts their research.

Key Features

  • Examines and assesses the current state of Institutional Biosafety Committees (IBCs)
  • Collates contributions from world-renowned experts in fields as diverse as research compliance, law and astrobiology
  • Reflects an international perspective on regulatory biosecurity and biosafety

Readership

Professional life scientists, environmental health and safety professionals, public health researchers, policy makers

Table of Contents

  • 1. Laboratory biosecurity in the United States: Evolution and regulation

    • Abstract
    • Introduction
    • Historical origins of biosecurity
    • Elements of modern laboratory biosecurity
    • Key legislation in biosecurity (or how Congressional intent defines biosecurity)
    • Legislation and its implementation through “rule-making”
    • Historical origins of current biosecurity regulations
    • Recent Executive Orders (EOs) affecting laboratory biosecurity
    • Some important documents from professional and ad hoc groups
    • Legislation, deliberation and executive exhortation become regulation
    • What might the future bring?
    • Summary
    • References

    2. US federal oversight of biological materials and the IBC

    • Abstract
    • Introduction
    • The early days of recombinant DNA research
    • Components of an IBC
    • Regulatory agencies and oversight
    • National institutes of health, environmental protection agency, and federal drug administration
    • IBC oversight of the SAP
    • Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA PATRIOT Act) Act of 2001
    • U.S. Congress. Public Health Security and Bioterrorism Preparedness and Response Act of 2002
    • National Research Council (NRC)
    • National Science Advisory Board for Biosecurity (NSABB)
    • NSABB – US policy for oversight of life sciences DURC 2012 and how it affects IBCs
    • Seven experiments of DURC
    • 2012 – Current events on dual use research
    • 2012 US policy for oversight of life sciences DURC
    • The policy for institutional DURC oversight
    • October 2014, US Government announces moratorium on gain of function research
    • Conclusion
    • References

    3. Challenges with biocontainment facilities – building, maintaining and testing

    • Abstract
    • Introduction
    • Regulatory requirements and design guides
    • Design considerations and challenges
    • Biosafety level 2 and animal biosafety level 2 facilities
    • Biosafety level 3 and animal biosafety level 3 facilities
    • References

    4. Challenges faced by senior administration of academic institutions

    • Abstract
    • Introduction
    • Regulatory requirements
    • Roles and responsibilities
    • Models of coordination
    • References

    5. Overcoming regulatory gaps in biological materials oversight by enhancing IBC protocol review

    • Abstract
    • Introduction
    • Functions of an IBC
    • Standardizing the IBC review process
    • Regulatory gaps
    • Conclusions
    • References

    6. Dual use research

    • Abstract
    • Historical issues
    • Emergence of dual use research concepts/issues
    • Review of the process for rulemaking and oversight
    • US Government response
    • Other institutions (NIH, academic)
    • Approaches by institutions for review of dual use research
    • Other models
    • Future of biosecurity implementation
    • Proposed regulation burdens
    • Antithesis of science for good/misuse
    • Communication, protection versus dissemination
    • Necessary partnerships (US Government, funding agencies, PIs, institutions)
    • International cooperation
    • Conclusions
    • Acknowledgment
    • References

    7. Emerging technologies and bio-threats

    • Abstract
    • The role of the Institutional Biosafety Committee: risk assessment and protection of the community through (dis)approval of proposed scientific activities
    • Risk assessment of emerging technologies or biothreats
    • A possible role of the IBC: efficacy considerations and resource allocation decisions as representatives of the public interest
    • The role of the IBC: risk communication and mediating the “science conversation” with members of the public
    • References

    8. Animal biosafety

    • Abstract
    • Animals and biosafety
    • Risk assessment, risk groups, and biosafety levels
    • Transgenic animal models
    • Regulatory reporting
    • Select agents and toxins
    • Conclusions
    • References

    9. Crop security: Current priorities and perspectives in public sector institutional review

    • Abstract
    • Introduction
    • What is crop biosecurity?
    • Prevention, protection, and accountability
    • Risks, challenges, and opportunities in institutional oversight
    • Conclusion
    • References

    10. Select agent program impact on the IBC

    • Abstract
    • Introduction and background
    • Challenges and options
    • Summary remarks
    • References

    11. Biosecurity challenges for the IBC: An exploration of the roles and responsibilities of Institutional Biosafety Committees in the age of terrorism and biosecurity, now and for the future

    • Abstract
    • Introduction
    • Overview of security issues relevant to the IBC
    • Overview of current IBC roles
    • Defining biosecurity
    • Adapting/expanding the expertise of the IBC to address biosecurity
    • Challenges in applying biosecurity to research programs
    • A path forward: a “BMBL” for biosecurity
    • Summary and recommendations
    • References

    12. IBCs – A cornerstone of public trust in research

    • Abstract
    • Introduction
    • Evolution of an oversight framework – Asilomar and beyond
    • The NIH Guidelines as a dynamic oversight framework
    • The NIH Guidelines today
    • IBCs as the linchpin in our framework of biosafety oversight
    • Current scope of responsibilities
    • Importance of partnerships for promoting IBC excellence
    • NIH’s role in supporting IBCs
    • The NIH IBC site visit program
    • Lessons learned from the site visit program
    • Impact of the site visit program
    • Institutional roles in supporting IBCs
    • The future face of IBCs
    • Research on highly pathogenic agents
    • Oversight of dual use research of concern
    • Conclusion
    • Acknowledgments
    • References

    13. Strengthening the role of the IBC in the 21st century

    • Abstract
    • Introduction
    • IBC review of DURC
    • The increasing burden of regulatory review
    • Regulatory compliance for research institutions: an unfunded mandate
    • References

Product details

  • No. of pages: 270
  • Language: English
  • Copyright: © Academic Press 2016
  • Published: January 29, 2016
  • Imprint: Academic Press
  • Paperback ISBN: 9780128018859
  • eBook ISBN: 9780128018606

About the Editors

Carole Baskin

After her veterinary training in North Carolina, Carole R. Baskin, DVM, MSc, CPIA completed a Master’s Of Science in Physiology & Immunology of the Ohio State University under the mentorship of Kenneth W Hinchcliff, BVSc, PhD, DACVIM, and now Dean, Faculty of Veterinary Science at the University of Melbourne. She went on to a residency in comparative medicine at the University of Washington and did a concurrent post-doc in the laboratory of Michael G. Kate, Ph.D., with a focus on virology and animal models of infectious diseases, including non-human primate models of Highly Pathogenic Avian Influenza and the 1918 pandemic flu. This experience fostered her growing interest and expertise in research compliance and regulations. After an assistant professorship at the Biodesign Institute in Arizona and a Directorship of Scientific Programs at Science Foundation Arizona, she is now Associate Professor at the Institute for Biosecurity of Saint Louis University.

Affiliations and Expertise

Associate Professor, Environmental and Occupational Health, Saint Louis University, MO, USA; Deputy Director, Institutional Animal Care and Use Committee (IACUC), St Louis University, St. Louis, MO, USA

Alan Zelicoff

Affiliations and Expertise

Professor, Environmental and Occupational Health and Epidemiology, St. Louis University, St. Louis, MO, USA

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