Reassess the Law and Ethics of Heritable Genome Editing Interventions: Lessons for China and the World.

Abstract

The current ethical and legal standards for human subjects research do not adequately address human gene editing technologies, because scientific advancements in this field have outpaced regulatory policy. The Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technique allows the rewriting of life's code, but is fraught with scientific and ethical quandaries. In particular, the genetic alteration of human embryos in vitro in China has caused worldwide repercussions. It is hard to predict the long-term effects of proposed edits, which raises an inquiry about whether it is appropriate for humans to purposely alter any aspect of their genetic future. Genome editing is moving too quickly for processes of critical reflection, such as law and regulation, to keep pace. The ethical, legal and social implications of the use of these technologies in humans remain uncertain. The resultant tension within the existing framework calls into question the underlying values on which moral and legal norms repose. This article explores the implications for law, ethics, regulation and health policy. Balancing potential benefits against the risk of unintended harms will shape perspectives on whether and how to use these technologies. Responsible engagement with decision makers and stakeholders, among other things, will promote transparency, confer legitimacy, and improve policy making.