Gene Drive 101: A Basic Guidance Resource for Biosafety Professionals

Biosafety risk assessment and containment framework strategies for research involving gene drives pose a challenge, as there are no published guidelines or regulatory information yet written specifically addressing biosafety and gene drive use. Since the risk is more at an ecologic population level than an individual risk to the researcher, this further confounds the typical risk assessment process, which traditionally places emphasis on evaluating biosafety risks to the user and how the agent is spread among permissible hosts. We also realize that many of the publications currently available for gene drive biosafety are written with the assumption that readers have a good grasp of molecular biology and genetics. We have good reason to believe that this assumption is neither correct nor justified among all biosafety professionals. Our goal here is to create a resource that would offer a basic primer on gene drive technology while providing enough resources to start the risk assessment process of a gene drive proposal. We developed several questions and answers that we believe will make tackling the biosafety aspects of a gene proposal less formidable.