Less than a year after the first published paper on CRISPR-CAS9 gene drives, an undergraduate team in the international Genetically Engineered Machines (iGEM) competition were trying to create one for their project. While we within the iGEM Safety and Security Committee were caught off-guard by the project, our adaptive safety and security system enabled us to iterate a governance procedure and reflect on the larger changes other organizations might consider as research on gene drives and related biotechnologies continues.
Gene drives have already challenged governance systems. In this case study, we explore the International Genetically Engineered Machine (iGEM) competition’s experiences in gene drive-related research and lessons in developing, revising, and implementing a governance system. iGEM’s experiences and lessons are distilled into 6 key insights for future gene drive policy development in the United States: (1) gene drives deserve special attention because of their potential for wide-scale impact and remaining uncertainty about how to evaluate intergenerational and transboundary risks; (2) an adaptive risk management approach is logical for gene drives because of the rapidly changing technical environment; (3) review by individual technical experts is limited and may fail to incorporate other forms of expertise and, therefore, must be complemented with a range of alternative governance methods; (4) current laboratory biosafety and biosecurity review processes may not capture gene drive research or its components in practice even if they are covered theoretically; (5) risk management for research and development must incorporate discussions of values and broader implications of the work; and (6) a regular technology horizon scanning capacity is needed for the early identification of advances that could pose governance system challenges.
Millett, Piers, Tessa Alexanian, Megan J. Palmer, Sam Weiss Evans, Todd Kuiken, and Kenneth Oye. 2022. “iGEM and Gene Drives: A Case Study for Governance.” Health Security, January.