The ability to construct, synthesize, and edit genes and genomes at scale and with speed enables, in synergy with other tools of engineering biology, breakthrough applications with far-reaching implications for society. As SARS-CoV-2 spread around the world in early spring of 2020, researchers rapidly mobilized, using these tools in the development of diagnostics, therapeutics, and vaccines for COVID-19. The sharing of knowledge was crucial to making rapid progress. Several publications described the use of reverse genetics for the de novo construction of SARS-CoV-2 in the laboratory, one in the form of a protocol. Given the demonstrable harm caused by the virus, the unequal distribution of mitigating vaccines and therapeutics, their unknown efficacy against variants, and the interest in this research by laboratories unaccustomed to working with highly transmissible pandemic pathogens, there are risks associated with such publications, particularly as protocols. We describe considerations and offer suggestions for enhancing security in the publication of synthetic biology research and techniques. We recommend: (1) that protocol manuscripts for the de novo synthesis of certain pathogenic viruses undergo a mandatory safety and security review; (2) that if published, such papers include descriptions of the discussions or review processes that occurred regarding security considerations in the main text; and (3) the development of a governance framework for the inclusion of basic security screening during the publication process of engineering biology/synthetic biology manuscripts to build and support a safe and secure research enterprise that is able to maximize its positive impacts and minimize any negative outcomes.
Mackelprang, Rebecca, Katarzyna P. Adamala, Emily R. Aurand, James C. Diggans, Andrew D. Ellington, Samuel Weiss Evans, J. L. Clem Fortman, et al. 2022. “Making Security Viral: Shifting Engineering Biology Culture and Publishing.” ACS Synthetic Biology 11 (2): 522–27. https://doi.org/10.1021/acssynbio.1c00324.
Background
The Security Working Group of the Engineering Biology Research Consortium (EBRC), of which I’m a part, was taken aback by the recent publication of a Nature Protocols paper outlining step-by-step procedures for creating new variants of SARS-CoV-2, and were trying to work out how to respond. Do we argue for retraction? Do we not say anything in fear of making the paper more of a security concern by raising its visibility? In the end, we decided on writing a piece critiquing the oversight processes we have in place for potential novel security concerns in the life sciences, focusing on the publication stage, and making the set of recommendations noted above.