Governance of Human Genome Editing

Although the first genetically modified animal was created in the 1970s, it was not until very recently that genome editing methods became precise and efficient enough to allow for applications beyond fundamental research. Similar to all medical applications, the use of genome editing in promoting human health, either by restoring normal function in disease or preventing the perpetuation of hereditary diseases, comes with its own set of benefits, risks, ethical issues, and societal implications. Recognizing the concerns with human gene editing, the National Academy of Sciences (NAS) and the National Academy of Medicine (NAM) created the Committee on Human Gene Editing: Scientific, Medical, and Ethical Considerations. This committee was charged to report on various aspects of human genome editing, including whether or not the current regulatory framework provided adequate oversight and to provide guiding principles on the regulation of human gene editing. In the final report (2017), the committee made a clear distinction between genome editing in somatic cells (non-heritable changes) versus germline editing (heritable changes) and concluded that ethical norms and current regulatory framework developed for human clinical trials, gene transfer research, and gene therapy were appropriate for the management of the former, while the latter had different technical and societal ramifications and required more research compared to current standards for authorizing clinical trials. The committee recommended the following guiding principles for the governance of human genome editing: promoting well-being, transparency, due care, responsible science, respect for persons, fairness, and translational cooperation.

In November 2018, a scientist made the announcement that he had successfully edited the genome of two baby girls during the embryonic stage. The work was performed without regulatory oversight and has yet to be verified independently. Experts argue that the health benefit conferred by the modified genome did not outweigh the risk (which may be characterized as the risk of having unknown risks) or meet any unmet medical needs in this case. Clearly, many of the global guiding principles in the governance of human genome editing recommended by the NAS and NAM were not applied. Interestingly, despite the public outcry, as of Dec 14, an online survey shows that approximately 18% of the readers of the pertinent Nature news article consider this "an appropriate use of gene-editing technology".

As pointed out in the NAS and NAM report: "Public input and engagement are important elements of many scientific and medical advances. This is particularly true with respect to genome editing for potential applications that would be heritable... Meaningful engagement with decision makers and stakeholders promotes transparency, confers legitimacy, and improves policy-making... There are many ways to engage the public in these debates..." This MeetUp session may well be one of them.