Abstract
A central problem for the international governance of heritable germline gene editing is that there are important differences in attitudes and values as well as ethical and health care considerations around the world. These differences are reflected in a complicated and diverse regulatory landscape. Several publications have discussed whether reproductive uses would be legally permissible in individual countries and whether clinical applications could emerge in the context of regulatory gaps and gray areas. Systematic comparative studies that explore issues related to the governance of this technology from different national and international perspectives are needed to address the lack of knowledge in this area. In this research report, we contribute to filling this gap by presenting views of stakeholders in the United Kingdom on challenges to the governance of heritable genome editing. We present findings from a multistakeholder study conducted in the United Kingdom between October 2016 and January 2018 and funded by the Wellcome Trust. This research included interviews, literature analysis, and a workshop. We involved leading U.K. scientists, in vitro fertilization clinicians, and representatives from regulatory bodies, patient organizations, and other civil societal organizations, as well as fertility companies. Part one of this article explores stakeholder perceptions of possible global developments in heritable genome editing and associated risks and governance challenges. Part two presents a range of policy options that were generated during the workshop in relation to the challenges discussed in part one.
Highlights
The organizing committee of the Hong Kong summit declared, for example, the need for “a rigorous, responsible translational pathway toward” “clinical trials of germline editing” that establishes international “standards for preclinical evidence and accuracy of gene modification, assessment of competency for practitioners of clinical trials, [and] enforceable standards of professional behavior.”[8]. This statement was criticized, by both scientists and social scientists because it deemphasized the commitment to a “broad societal consensus” that was evident in the NASEM and Nuffield Council reports and in other publications.[9]
A group of scientists and ethicists working with the geneticist Eric Lander, for instance, demanded the adoption of a temporary global moratorium on all clinical uses of human germline editing, arguing that the decision to move toward clinical applications should not be made by the scientific or medical community, but by societies as a whole.[10]
The World Health Organization responded to the news of the genetically modified babies in China by setting up a new advisory committee to develop global standards for the governance and oversight of human genome editing, aiming to work toward a strong international governance framework.[11]
Summary
BY ACHIM ROSEMANN, ADAM BALEN, BRIGITTE NERLICH, CHRI STI N E HAU SK ELLE R, MA RGA RE T SL EEBOOM-FAUL K NE R, SA RA H H A RT L E Y, XINQING ZHANG, AND NICK LEE. Several publications have sought to develop a broad, comparative understanding of existing regulatory conditions in different countries[13] and to sample international legal and regulatory frameworks that may influence the governance of clinical applications in this field.[14] Other articles have explored the social and ethical dimensions of this technology in relation to a variety of topics, such as the interests and rights of people with disabilities;[15] reproductive autonomy;[16] the history of eugenics and racism;[17] the gendered, ethnic, and socioeconomic dimensions of genome editing;[18] the consequences of gene editing for future generations;[19] and challenges related to informed consent.[20] Other work has compared existing regulatory frameworks for basic and preclinical research as well as potential reproductive applications of human genome editing.[21] A central point of discussion in these studies was whether reproductive uses would be legally permissible in individual countries and whether clinical applications could emerge in the context of regulatory gaps and gray areas.[22]. The first theme is issues related to the situation and well-being of fertility patients
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