a Centre of Genomics and Policy , McGill University , Montreal , QC , Canada.
b Faculties of Law and Pharmacy & Pharmaceutical Sciences , University of Alberta , Edmonton , AB , Canada.
Account Res. 2019 May;26(4):257-264. doi: 10.1080/08989621.2019.1617138. Epub 2019 May 17.
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.
“CRISPR 婴儿”的诞生再次引发了围绕基因编辑的伦理、法律和社会影响的争论。尽管贺建奎博士的研究是在临床试验的背景下进行的，但他的研究似乎违反了中国的规定和标准伦理程序，以及国际公认的研究和生物伦理标准。正是在这种情况下，我们对中国在这种情况下的法规执行问题进行了评论。我们认为，中国的法规确实符合国际公认的标准。然而，问题仍然存在，中国可以通过哪些方式加强和更新其监管框架，以更好地应对新兴技术带来的利益和挑战，明确清晰的执行机制，并规定伦理审批标准。
