TABLE 2.

Recommended Requirements for Potential Clinical Trials of Heritable Genome Editing by NAS/NAM Report on Human Genome Editing (25)

• Absence of reasonable alternatives; • Restriction to preventing a serious disease or condition; • Restriction to editing genes that have been convincingly demonstrated to cause or to strongly predispose to that disease or condition; • Restriction to converting such genes to versions that are prevalent in the population and are known to be associated with ordinary health with little or no evidence of adverse effects; • Availability of credible preclinical and/or clinical data on risks and potential health benefits of the procedures; • Ongoing, rigorous oversight during clinical trials of the effects of the procedure on the health and safety of the research participants; • Comprehensive plans for long-term, multigenerational follow-up that still respect personal autonomy; • Maximum transparency consistent with patient privacy; • Continued reassessment of both health and societal benefits and risks, with broad ongoing participation and input by the public; and • Reliable oversight mechanisms to prevent extension to uses other than preventing a serious disease or condition.