– Executive Summary

The purpose of this thesis was to analyze the potential threat synthetic biology can produce when it is combined with advanced technology regarding dual-use research, dual-use research of concern, and ultimately gain-of-function research. Gain-of-function research, when combined with synthetic biology, has the potential to create new organisms or enhance current organisms with increased transmissibility and potentially, lethality.[1] While gain-of-function research in synthetic biology does have significant potential for benefit to mankind, there is also risk, which has brought controversy globally.[2] Furthermore, there is lack of cooperation worldwide in the various aspects regulating dual-use research of concern and gain-of-function research, which can be attributed in part to ethical and morality issues to suspicious motivations of foreign countries.[3]

This thesis used a future scenarios research method comparing previous epidemics and pandemics with a theoretical virus with both high transmissibility and high lethality. To this end, this thesis conducted an evaluation of scientific research documents from around the world. Much of this data validates the benefits of gain-of-function research but acknowledges the concern for unintended consequences.[4] Additional secondary research sources included scholar and peer reviewed research articles, theses, and dissertations. Along with these scholarly articles, such primary sources as government policies and policy papers were evaluated for current status and capabilities for research regulation.

The findings of this thesis reveal that synthetic biology and technology are fast out-pacing the ability and capability of academia and government agencies to adequately regulate and control emerging research with limited understanding of biological engineering.[5] The scenario indicated that a pandemic with high transmissibility and lethality would be devastating to society ultimately ending with societal collapse. The findings with analysis on current conditions internationally point to significant vulnerabilities that could prove disastrous for humanity. First, there is lack of consistency on terminology associated with definitions of gain-of-function as well as safety and security protocols designed to regulate research.[6] Second, there is no uniform agreement on what constitutes gain-of-function research and what risks should be adopted.[7] Third, biosecurity is expensive and previous regulations no longer adequately apply to current research.[8] Fourth, dual-use research of concern can be used nefariously for the development of weapons of mass destruction.[9] And finally, synthetic biology aligned with technology, can pose a significant threat to the United States when applying accountability and stipulations for research when foreign countries neglect ethical and moral implications and can potentially gain innovative and economic advantage over America.[10]

These findings identify vulnerabilities not only to the United States but also the global community. This thesis offered several recommendations for risk management that provide the benefits of gain-of-function research while reducing the vulnerabilities that could lead to unintended consequences. First, dual-use research of concern and gain-of-function research should be reevaluated by scientists and researchers that includes a diverse group of stakeholders outside the scientific community. Second, international cooperation must be ironclad among countries on funding and research. Third, multiple stakeholders should provide insight and input on scientific research. Fourth, there needs to be universal agreement on terminology of what constitutes dual-use research of concern and gain-of-function research. Fifth, a global consensus must be established on research guidelines. Sixth, there should be no foreign aid or funding for gain-of-function research outside of the continental United States. The seventh and final recommendation is that there needs to be consistent and uniform governance and regulation concerning BSL laboratories globally. These recommendations provide a more secure and safe environment for with the pursuit of research in synthetic biology.

Ultimately, this thesis reveals that inconsistencies across the globe allow an uncertain and unacceptable risk to humanity and the environment. Consistent, universal regulations governing synthetic biology and its technological development will allow benefits to the human race while reducing risks.

[1] Gigi Kwik Gronvall, Synthetic Biology: Safety, Security, and Promise (Baltimore, MD: Health Security Press, 2016), 87.

[2] Max Kozlov, “Risky ‘Gain-of-Function’ Studies Need Stricter Guidance, Say Us Researchers,” Nature 605, no. 7909 (May 2022): 203–4, https://doi.org/10.1038/d41586-022-01209-w.

[3] National Academies of Sciences, Engineering, and Medicine, Dual Use Research of Concern in the Life Sciences: Current Issues and Controversies (Washington, DC: The National Academies Press, 2017), 8,60, https://doi.org/10.17226/24761; Gronvall, Synthetic Biology, 143.

[4] National Research Council et al., Perspectives on Research with H5N1 Avian Influenza: Scientific Inquiry, Communication, Controversy: Summary of a Workshop (National Academies Press, 2013), 47, https://books.google.com/books?hl=en&lr=&id=7lWfAwAAQBAJ&oi=fnd&pg=PA1&dq=perspectives+on+research++with+h5n1&ots=2VfiOToLEx&sig=opmHC59zxBUSuGTLX-Hvm4K7sBQ#v=onepage&q=perspectives%20on%20research%20%20with%20h5n1&f=false.

[5] Jing Li et al., “Advances in Synthetic Biology and Biosafety Governance,” Frontiers in Bioengineering and Biotechnology 9 (2021): 173, https://doi.org/10.3389/fbioe.2021.598087.

[6] Gronvall, Synthetic Biology, 92.

[7] Todd Kuiken, Oversight of Gain of Function Research with Pathogens: Issues for Congress, vol. R47114 (Washington, DC: Congressional Research Service, 2022), https://crsreports.congress.gov/product/pdf/R/R47114.

[8] Benjamin D Trump et al., “Building Biosecurity for Synthetic Biology,” Molecular Systems Biology 16, no. 7 (July 1, 2020): e9723, https://doi.org/10.15252/msb.20209723.

[9] Piers D. Millett, “Gaps in the International Governance of Dual-Use Research of Concern,” in Dual Use Research of Concern in the Life Sciences: Current Issues and Controversies, ed. National Academies of Sciences, Engineering, and Medicine (Washington, DC: National Academies Press, 2017), 15, https://nap.nationalacademies.org/resource/24761/Millett_Paper_011717.pdf.

[10] Marcus A. Cunningham and John P. Geis, “A National Strategy for Synthetic Biology,” Strategic Studies Quarterly: SSQ 14, no. 3 (Fall 2020): 49–80, https://www.proquest.com/docview/2441884694/abstract/1D4AAF014B474C92PQ/1; Jeffrey Mervis, “When Should U.S. Research Be Stamped ‘Top Secret’? NSF Asks For a New Look at the Issue,” Science, June 2022, https://www.science.org/content/article/when-should-u-s-research-be-stamped-top-secret-nsf-asks-new-look-issue.

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