Research on the extraterritorial regulatory experience of human germline genome editing
10.12026/j.issn.1001-8565.2024.10.04
- VernacularTitle:人类生殖系基因编辑的域外监管经验研究
- Author:
Yawen ZOU
1
;
Yingshi TAO
Author Information
1. 上海科技大学人文科学研究院,上海 201210
- Keywords:
human germline;
genome editing;
extraterritorial regulation
- From:
Chinese Medical Ethics
2024;37(10):1146-1153
- CountryChina
- Language:Chinese
-
Abstract:
Researching the extraterritorial regulatory experience of human germline genome editing (HGGE) has important reference significance for improving China's genome editing governance framework.Taking the United Kingdom (UK) and the United States (US) as examples,they already have relatively mature practices in terms of regulatory agencies,laws and regulations,and multi-group participation.The UK incorporates germline genome editing into the regulatory scope of assisted reproduction through the Human Fertilization and Embryology Authority (HFEA),while the US is mainly responsible for regulation by the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).The experience of both countries shows that the regulatory framework for HGGE requires a regulatory agency with a clear division of responsibilities,as well as classified management and timely adjustment and revision of outdated laws and regulations to cope with development and ethical challenges of technology.Additionally,the authors believe that drawing on the consultation of various international and national organizations and increasing public participation is crucial to establishing correct values.It is recommended that China should clarify the regulatory responsibilities of institutions,formulate prove effective provisions of legal and regulatory,and promote multi-party dialogue and public participation.
