Assessing the Impact of Global Human Genome Editing Governance Reports: The Persistence of Value-Based Norms

Abstract: After the 2018 news from China of the birth of twins from genome-edited embryos, several prestigious international bodies (most notably the National Academies and Royal Society and the WHO) issued reports proposing ethical and governance guidelines for various applications of human genome editing (HGE). This paper assesses the discernable effects of these reports on “hard” law—treaties, laws, and regulations--and the “softer” realm of norms and practices of research and clinical medicine. Our analysis, which focus on both heritable and somatic genome editing, compares U.S. and international laws, regulations, and other governance documents before and after the principal HGE reports. We also draw on interviews with professionals who participated in preparing those reports, with emphasis on the compromises that were made to arrive at the final versions. Preliminary findings reveal few causal connections between the reports and any specific hard-law reforms. Nonetheless, the reports were and remain highly significant because they mirror, publicize, and thus reinforce a widely shared set of ethical values that have developed over the last decade or more in the scientific community. These values are increasingly reflected in, for example, the U.S. FDA’s evolving practices in applying existing law to the assessment of HGE-based therapies and the standards applied by funders, journals, and university hiring and tenure committees in evaluating HGE research. The publicity given to the reports will help to ensure that—even in the absence of new hard law--the values they embody will set a continuing standard for HGE practice.

Jean Cadigan – Social Medicine – UNC-CH; Gail Henderson, PhD – Professor, UNC-CH; Greg Inamine – Law – UNC-CH; Alexandra Robinson – Public Policy – UNC-CH; Hayley Stancil – Law – UNC-CH