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Suggested Citation:"Bibliography." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

Bibliography

AL-Hmoud, N. 2016. Comments. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 11. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_-1A6gBHZTYN.

Bates, S., and J. Holroyd. 2012. Human Factors That Lead to Non-Compliance with Standard Operating Procedures. Health and Safety Executive Research Report RR919. Available at: http://www.hse.gov.uk/research/rrpdf/rr919.pdf.

Callahan, M. 2016. Exportation of GOF Policy to International Stakeholders: Case Studies from Recent Events. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 11. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

Casagrande, R. 2016. Risk and Benefit Analysis (RBA) of Gain-of-Function Research: Gaps and Future Considerations. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 10. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

CDC and NIH (Centers for Disease Control and Prevention and National Institutes of Health). 2007. Biosafety in Microbiological and Biomedical Laboratories, 5th ed. (L. Casey Chosewood and Deborah E. Wilson, eds.). Washington, DC: U.S. Government Printing Office.

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Coglianese, C. 2015. Listening, Learning, Leading: A Framework for Regulatory Excellence. Phiadelphia, PA: Penn Program on Regulation. Available at: https://www.law.upenn.edu/live/files/4946-pprfinalconvenersreport.pdf.

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Suggested Citation:"Bibliography." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

Cotton-Barratt, O., S. Farquhar, and A. Snyder-Beattie. 2016. Beyond Risk-Benefit Analysis: Pricing Externalities for Gain-of-Function Research of Concern. Policy Working Paper [Revision 0.9]. Future of Humanity Institute, University of Oxford. Available at: http://globalprioritiesproject.org/wp-content/uploads/2016/03/GoFv9-3.pdf.

Cox, T. 2016. Using Risk Benefit Analysis to Improve GOF Research Decisions. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 10. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

Davidson, E. M., R. Frothingham, and R. Cook-Deegan. 2007. Practical Experiences in Dual-Use Review. Science 316:1432-1433.

Draghia-Akli, R. 2016. Gain of Function/Dual Use: EU Perspective. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 10. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

EASAC (European Academies Scientific Advisory Council). 2015a. Gain-of-Function: Experimental Applications Relating to Potentially Pandemic Pathogens. EASAC Policy Report 27. Halle (Saale), Germany: EASAC. Available at: http://www.easac.eu/fileadmin/PDF_s/reports_statements/Gain_of_Function/EASAC_GOF_Web_complete_centred.pdf.

EASAC. 2015b. Summary of EASAC Launch Event on Gain of Function. Available at: http://www.easac.eu/fileadmin/PDF_s/reports_statements/Gain_of_Function/Summary_of_EASAC_launch_event_on_Gain_of_Function_FINAL.pdf.

Epstein, G. 2016. NSABB Working Group Proposal. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 10. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

European Society for Virology. 2013. Letter to the President of the European Commission. October 16. Available at: http://wp.eusv.eu/wp-content/uploads/2015/10/ESV-letteron-Gain-of-function_GOF_research-in-Virology.pdf.

FDA (Food and Drug Administration). 2013. Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making. PDUFA V Plan (FY 2013-2017). Available at: http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf.

Fineberg, H. 2016. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 10. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

Finkel, A. M. 2016. Solution-Focused Risk/Benefit Assessment (RBA) for Gain-of-Function Research. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 10. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

Fisher, R. 2016. A Regulator’s Perspective. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 11. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

Foundation for Vaccine Research. 2013. Letter to the President of the European Commission. December 18. Available at: http://www.nature.com/polopoly_fs/7.14586!/file/vaccine%20foundation%20letter.pdf.

Frothingham, R. 2016. Lesson Learned from Thirteen Years of Gain-of-Function Research Reviews. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 10. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

Suggested Citation:"Bibliography." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

Fukuda, K. 2016. International Policy Landscape. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 10. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

GAO (Government Accountability Office). 2009. High-Containment Laboratories: National Strategy for Oversight Is Needed. GAO-09-574. Washington, DC: U.S. Government Printing Office.

Gao, G. F. 2016. Comments. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 11. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

GEC (German Ethics Council). 2014. Biosecurity: Freedom and Responsibility of Research. Opinion. Berlin: Deutscher Ethikrat. Available at: http://www.ethikrat.org/files/opinionbiosecurity.pdf.

Gryphon Scientific. 2015. Risk and Benefit Analysis of Gain of Function Research. Draft Final Report. Takoma Park, MD: Gryphon Scientific. Available at: http://osp.od.nih.gov/sites/default/files/Risk%20and%20Benefit%20Analysis%20of%20Gain%20of%20Function%20Research%20-%20Draft%20Final%20Report.pdf.

Gryphon Scientific. 2016. Risk and Benefit Analysis of Gain of Function Research: Final Report—April 2016. Takoma Park, MD: Gryphon Scientific. Available at: http://www.gryphonscientific.com/wp-content/uploads/2016/04/Risk-and-Benefit-Analysis-of-Gain-of-Function-Research-Final-Report.pdf.

Handelsman, J. 2016. Opening Remarks. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 10. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

Haynes, A. B., T. G. Weiser, W. R. Berry, S. R. Lipsitz, A-H. S. Breizat, E. P. Dellinger, T. Herbosa, S. Joseph, P. L. Kibatala, M. C. M. Lapitan, A. F. Merry, K. Moorthy, R. K. Reznick, B. Taylor, and A. A. Gawande. 2009. A surgical safety checklist to reduce morbidity and mortality in a global population. New England Journal of Medicine 360(5):491-499.

HHS (Department of Health and Human Services). 2012. A Framework for Guiding U.S. Department of Health and Human Services Funding Decisions About Research Proposals with the Potential for Generating Highly Pathogenic Avian Influenza H5N1 Viruses That Are Transmissible Among Mammals by Respiratory Droplets. Available at: http://www.phe.gov/s3/dualuse/Documents/funding-hpai-h5n1.pdf.

Holdren, J. P., and L. Monaco. 2014. Enhancing Biosafety and Biosecurity in the United States. August 18. Available at: http://www.whitehouse.gov/sites/default/files/microsites/ostp/enhancing_biosafety_and_biosecurity_19aug2014_final.pdf.

Huising, R. 2016. Laboratory Safety and Security: Organizational and Cultural Factors. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 11. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

Huising, R., and S. S. Silbey. 2011. Governing the Gap: Forging Safe Science Through Relational Regulation. Regulation & Governance 5(1):14-42.

Huntley-Fenner, G. 2016. The Lack of Human Reliability Data Is a Barrier to the Attainment of the NSABB’s Risk Reduction Objectives. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 11. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

Suggested Citation:"Bibliography." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

IDSA (Infectious Disease Society of America). 2016. Comments to the NSABB Working Paper on Evaluating the Risks and Benefits of Gain-of-Function Studies to Formulate Policy Recommendations. Submitted to NSABB February 23. Available at: http://www.idsociety.org/uploadedFiles/IDSA/Policy_and_Advocacy/Current_Topics_and_Issues/Support_for_Medical_Education_and_Research/Letters/IDSA%20Comments%20to%20the%20NSABB%2002222016.pdf.

Kerr, L. 2016. The HHS Framework for Review of Certain Avian Influenza Experiments. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 10. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

Klitzman, R. 2015. The Ethics Police?: The Struggle to Make Human Research Safe. New York: Oxford University Press.

Leung. G. 2016. Comments. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 11. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

Lipsitch, M., D. A. Relman, and T. V. Inglesby. 2016. COMMENTARY: Six policy options for conducting gain-of-function research. CIDRAP Newsletter. March 8. Available at: http://www.cidrap.umn.edu/news-perspective/2016/03/commentary-six-policyoptions-conducting-gain-function-research.

Moreno, J. 2016. Presentation. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 11. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

Morgan, K. 2016. Informing the Policy Framework. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 10. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

NIH (National Institutes of Health). 2013. NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. Available at: http://osp.od.nih.gov/officebiotechnology-activities/biosafety/nih-guidelines.

NRC (National Research Council). 2004. Biotechnology Research in an Age of Terrorism. Washington, DC: The National Academies Press.

NRC. 2015. Potential Risks and Benefits of Gain-of-Function Research: Summary of a Workshop. Washington, DC: The National Academies Press.

NSABB (National Science Advisory Board for Biosecurity). 2015a. Working Paper Prepared by the NSABB Working Group on Evaluating the Risks and Benefits of Gain-of-Function Studies to Formulate Policy Recommendations. December 23. Available at: http://osp.od.nih.gov/sites/default/files/NSABB%20WG%20Working%20Paper%20on%20Gain-of-Function%20Studies%2012-23-2015_0.pdf.

NSABB. 2015b. Framework for Conducting Risk and Benefit Assessments of Gain-of-Function Research: Recommendations of the National Science Advisory Board for Biosecurity. Available at: http://osp.od.nih.gov/sites/default/files/resources/NSABB_Framework_for_Risk_and_Benefit_Assessments_of_GOF_Research-APPROVED.pdf.

Potter, P. 2016. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 10. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

Schneider, C. E. 2015. The Censor’s Hand: The Misregulation of Human-Subject Research. Cambridge, MA: MIT Press.

Suggested Citation:"Bibliography." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

Schoch-Spana, M. 2016. Public Deliberation and Gain-of-Function Research Policy: Putting It into Practice. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 11. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

Selgelid, M. J. 2015. White Paper: Gain-of-Function Research: Ethical Analysis. Available at: http://osp.od.nih.gov/sites/default/files/Gain-of-Function%20Research%20Ethical%20Analysis%20White%20Paper%20by%20Michael%20Selgelid_0.pdf.

Selgelid, M. J. 2016. Comments. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 11. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

Settembre, E. 2016. Influenza Vaccine Production Considerations. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 11. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

Stanley, S. L., Jr. 2016. NSABB Report: Preliminary Findings and Draft Recommendations About Gain-of-Function Research. Presentation and Discussion at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 10. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

ter Meulen, V. 2016. Gain of Function Research: Advice from EASAC. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 10. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

U.S. Government. 2015. Report of the Federal Experts Security Advisory Panel. Available at: http://www.phe.gov/s3/Documents/fesap.pdf.

Vöneky, S. 2016. The German Ethics Council Report. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 10. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

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Wolinetz, C. D. 2016. The Gain-of-Function Deliberative Process. Presentation at Gain-of-Function—The Second Symposium, National Academies of Sciences, Engineering, and Medicine, Washington, DC, March 10. Available at: https://www.youtube.com/playlist?list=PLuTGMA3A_-175RgOxOwYyy_1A6gBHZTYN.

Suggested Citation:"Bibliography." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

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Suggested Citation:"Bibliography." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 87
Suggested Citation:"Bibliography." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 88
Suggested Citation:"Bibliography." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 89
Suggested Citation:"Bibliography." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 90
Suggested Citation:"Bibliography." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 91
Suggested Citation:"Bibliography." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 92
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On March 10-11, 2016, the National Academies of Sciences, Engineering, and Medicine held a public symposium on potential U.S. government policies for the oversight of gain-of- function (GOF) research. This was the Academies’ second meeting held at the request of the U.S. government to provide a mechanism to engage the life sciences community and the broader public and solicit feedback on optimal approaches to ensure effective federal oversight of GOF research as part of a broader U.S. government deliberative process.

The first symposium, held in December 2014, examined the underlying scientific and technical questions surrounding the potential risks and benefits of GOF research involving pathogens with pandemic potential. The second symposium focused on discussion of the draft recommendations regarding GOF research of a Working Group of the National Science Advisory Board for Biosecurity. This report summarizes the key issues and ideas identified during the second symposium.

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