Advances in gene editing have recently received significant scientific and media attention. Gene editing, especially CRISPR-Cas9, has revived multiple longstanding ethical debates, including debates related to parental autonomy, health disparities, disability perspectives, and racial and economic inequalities. Germline, or heritable, gene editing generates several newer, neglected bioethical debates, including those about the shared human germline and whether there is a "line" that humans should not cross.
This Article addresses several interrelated ethical and legal questions related to germline gene editing. Those questions address why, if at all, germline gene editing needs to be regulated and, if germline gene editing needs to be regulated, whether it can be regulated under existing law. Ultimately, this Article finds that germline gene editing should and can be regulated under existing law; however, the current federal-centric regime is not the optimal way to regulate this subset of gene editing.
Instead, this Article argues that germline gene editing should be regulated like traditional assisted reproductive technology, such as in vitro fertilization, instead of as an exceptional, federally-regulated medical product. Doing so would reduce regulatory barriers in access to innovation, and the technique would be subject to a significantly less burdensome and less federally dominated regime than it is today. Additionally, this Article's proposed regulatory treatment of germline gene editing would increase access to the technique and remove the federal government, which is prone to regulate based on social and political views,from the practice of medicine, in order to allow access to a procedure that could improve or save many lives.
51 Seton Hall Law Review 735-813 (2021)
Lewis, Myrisha S., "Is Germline Gene Editing Exceptional?" (2021). Faculty Publications. 2028.