National policies to oversee inheritable genetic modifications research

This chapter presents recommendations for regulating research related to inheritable genetic modifications (IGM). In producing these recommendations, we analyzed current limits that have the potential to apply to IGM, including rules promulgated by the Recombinant DNA Advisory Committee (RAC) of the National Institutes of Health (NIH), federal human subject protections, Food and Drug Administration (FDA) regulations that apply to somatic cell gene transfer trials, and state laws that might apply to IGM. Our analysis includes comparisons with historical approaches to somatic cell gene transfer and the flaws in those approaches. Several of our recommendations, in fact, are derived from flaws in previous regulatory models that should be remedied in establishing a review mechanism for IGM. Our work on these recommendations benefited from and was informed by our participation in the AAAS working group process.