Ensuring National Biosecurity

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