Realigning gene editing with clinical research ethics: What the “CRISPR Twins” debacle means for Chinese and international research ethics governance

Abstract

ABSTRACT The announcement of the “CRISPR babies” reignited the debate surrounding the ethical, legal and social implications of germline gene editing. Despite having been conducted in the context of a clinical trial, Dr. Jiankui He’s research appears to have violated both Chinese regulations and standard ethical procedures, as well as internationally accepted research and bioethical standards. It is within this context that our commentary surrounding the question of the enforceability of Chinese regulations in such a case. We argue that Chinese regulations do align with internationally accepted standards. Yet, the question remains, in what ways can China strengthen and update its regulatory framework to better address the benefits and challenges associated with emerging technologies, delineate clear enforcement mechanisms and specify criteria for ethics approval.