Editing Humanity: On the Precise Manipulation of DNA in Human Embryos

organisms.4 The engine at the core of this molecular revolution is a breakthrough, now commonly known as CRISPR-an acronym that refers to the system of Clustered, Regularly Interspaced, Short, Palindromic Repeats and CRISPR-associated (Cas) proteins.5 At the Human Genome Editing Summit, He Jiankui, a researcher from the Southern University of Science and Technology in Shenzhen, China, confirmed reports that he had performed genome editing on viable human embryos using CRISPR-Cas9.6 The experiments, which led to the birth of the world's first gene-edited babies, sought to edit a fragment of the CCR5 locus that encodes a protein receptor involved in HIV resistance in humans.7 He Jiankui performed the clinical trial in virtually complete secrecy, and his subsequent disclosure sent shock waves throughout the world.8 To be clear, He Jiankui's experiments to edit human embryos for clinical use were largely predictable.Another Chinese study published three years earlier amid similar controversy reported the first instance of human embryo editing to correct a genetic mutation.9 The distinction between that study and the one conducted by He Jiankui primarily concerns the quality of the embryos used.The former had experimented with embryos incapable of leading to a pregnancy, 10 whereas the latter edited healthy embryos that ultimately led to implantation in a woman's uterus and the live birth of twins.11 The logical leap between the two Chinese experiments was not large.After all, the same type of experiments had already been 97 N.C.L. REV.1147 (2019) 1160 NORTH CAROLINA LAW REVIEW [Vol.97flows from jurisprudence in the areas of procreative, parental autonomy, and-to some extent-privacy rights, but it is not absolute.38 hasten death.Id.This Article does not advocate that parents should assert a "right to try" GGE because there are no alternatives to conceiving a healthy child.To the contrary, this Article extensively links the FDA's role in establishing the safety and efficacy of drugs and biological products to the GGE context.See discussion infra Part I.This Article argues, however, that once safety and efficacy of select GGE interventions are established, which probably will occur at some point in the near future, the government likely cannot categorically ban access to the technology.Unlike the distribution of unapproved drugs, research in human embryos is legal-at least when performed without the use of public funds.Drug manufacturers may not legally test unapproved drugs without FDA oversight, but little currently prevents geneticists, fertility specialists, and other researchers from continuing to test, refine, and develop GGE technologies for use in early-stage embryos.See, e.g., Hong Ma et al., Correction of a Pathogenic Gene Mutation in Human Embryos, 548 NATURE 413, 413 (2017) (correcting pathogenic heritable mutations in human embryos via GGE).This marks a fundamental distinction between the right-to-try cases and GGE technologies.Scientists in the United States and abroad are conducting research in human and animal embryos to address current limitations of genome-editing technologies, which will lead to more precise genome-editing tools to make GGE safe and effective.At some point in the future, the only impediment to clinical use of GGE may be the current legislative ban on FDA review of Investigational New Drug Applications and Biologic Licensing Applications for GGE purposes.See infra Section I.D.But such a ban may not withstand the pressures of rapid and continuous scientific advances that lead to precise, safe, and effective GGE.38.This Article builds upon the influential scholarship of the late John A. Robertson, who was a pioneer in the fields of law, bioethics, and reproductive rights.Throughout various works, Robertson proposed that "principles of reproductive freedom and family autonomy appear to support a presumptive liberty right to obtain and use genetic information in making reproductive decisions."John A. Robertson, Genetic Selection of Offspring Characteristics, 76 B.U. L.

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