Gene Editing and Risk Assessment: Application to IBC Review

Gene editing technologies have been used for decades by scientists in the field of molecular genetics and recombinant DNA technology. Recently, with the discovery of CRISPR-Cas 9 gene editing, this field has expanded, and the ease to manipulate genes has changed significantly. There are multiple methods for editing genes, and many times they are used together. Biosafety officers, although experts in safety and bio-risk assessment, may need additional information in regards to the scientific and technical side of this new technology in order to understand the risks of a protocol more completely in order to provide adequate risk management recommendations. This course is designed to provide a brief, but detailed, overview of basic gene editing technologies such as plasmid based systems, RNA interference, viral vectors, CRISPR Cas9 technology and gene drives. After brief discussion of these technologies, participants will review a proposed project as it may be presented to the IBC. They will be expected to review, discuss risks and benefits, and should be able to propose alternative ways for the research to be conducted in a safer manner. The goal of this course is to provide the participants with comprehensive background knowledge of various gene editing and recombinant DNA technologies in common use, to better enable them to ask the pertinent questions during protocol review. Additional detail on off-targeting issues, and streamlined protocol exercises will be offered.