Ethical, Legal, Social and Governance Issues in Non-Traditional Genetics and Genomics

A large and highly heterogeneous group of individuals conducts genetic and genomic research outside of traditional corporate and academic settings. They can be an important source of innovation, but their activities largely take place beyond the purview of existing regulatory systems for promoting safe and ethical practices. Historically the gene-targeting technology available for non-traditional biology (NTB) experiments has been limited, and therefore they have attracted little regulatory attention. New techniques such as CRISPR-cas9, however, may create a need for alternate governance approaches. The investigators will explore whether alternate governance approaches might be needed and, if so, what governance approaches would be most likely to enable non-traditional experiments to be conducted safely and ethically. To accomplish this overall objective, the project will identify current types of NTB activities and those likely in the near future; consider the risks and benefits of current and near-term NTB; conduct a policy analysis of the current governance approach and potential alternate approaches; disseminate a preliminary report of their findings to stakeholders, and incorporate their feedback into a final report that they will disseminate through peer-reviewed publications, formal presentations to scientific, legal, bioethics, and policy conferences, policy briefs, and presentations to NTB community labs, meetings, and conferences.