China’s Ministry of Science and Technology released an ethical guideline for human genome editing research on Monday, establishing strict prohibitions on the use of edited germ cells, fertilized eggs, or human embryos for pregnancy and reproduction.

The guideline aims to regulate human genome editing research and promote healthy development in this field. It highlights the unpredictable risks and potential ethical, legal, and social issues associated with genome editing that could impact human dignity and well-being.

According to the guideline, any clinical research on germline genome editing is currently forbidden. Clinical research should only be considered if benefits and risks are fully understood, safety and efficacy issues are addressed, a broad social consensus is achieved, and the study undergoes rigorous assessment.

This announcement follows the 2018 incident involving He Jiankui, a genome-editing researcher at the Southern University of Science and Technology of China in Shenzhen, Guangdong Province. He claimed to have created the world’s first genetically modified humans and was subsequently sentenced to three years in prison in December 2019 for illegally conducting human embryo gene editing.

The guideline’s basic principles include enhancing human well-being, respecting human dignity, and safeguarding the fundamental rights and interests of research participants, including the right to information, privacy, and autonomy. It emphasizes the importance of carefully assessing conditions for human genome editing technologies and ensuring risk monitoring throughout the process with appropriate supervision.

Additionally, the guideline outlines principles of fairness, impartiality, openness, and transparency, and specifies general and special requirements for human genome editing research, which should be addressed at different stages of basic, preclinical, and clinical research.