Governing nonconventional genetic experimentation.

ABSTRACT

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 genomic research has been limited, and therefore these activities have attracted little regulatory attention. New technologies such as CRISPR/Cas9, however, give nonconventional experimenters more extensive gene editing abilities at an unprecedented level of accessibility. The affordability and accessibility of these powerful technologies are raising questions about whether the current largely laissez-faire governance approach is adequate. This article recommends steps to enhance self-governance, including establishing umbrella organizations to represent community interests, creating a community IRB modelled on the DIYBio Ask a Safety Expert Service, and adopting an ethical obligation to report rogue experiments.