On 8 July 2024, China's Ministry of Science and Technology (MOST) released a comprehensive set of ethical guidelines for human genome editing research, including a ban on clinical research involving germline genome editing. This key regulatory development aims to address ethical concerns and ensure responsible conduct in genetic science.
Key elements of the guidelines and ban
1. Ban on germline genome editing
The guidelines impose a strict ban on clinical research involving germline genome editing, which refers to genetic modifications that can be inherited by future generations. This decision comes in the wake of global controversy and ethical debates, particularly following past incidents of unauthorised gene editing in embryos. The ban underscores China's commitment to ethical standards and the precautionary principle in genetic research. Researchers are prohibited from conducting any experiments that could result in heritable genetic changes, thus preventing potential long-term consequences and ethical dilemmas associated with germline modifications.
2. Enhanced ethical oversight and governance
The guidelines call for the establishment of specialised ethics committees at research institutions to review and approve all genome editing research proposals. These committees are tasked with ensuring that research adheres to stringent ethical standards and does not involve prohibited practices, such as germline editing.
3. Focus on informed consent and subject protection
The guidelines emphasise the importance of obtaining informed consent from all participants in genome editing studies. Researchers must provide clear and comprehensive information about the research, including aims, methods, potential benefits, and risks. This is crucial in protecting the rights and autonomy of research subjects.
4. Transparency and international collaboration
Recognising the global nature of scientific research, the guidelines call for transparency in genetic research, adherence to international ethical standards and collaboration with international research bodies.
The 2024 ethical guidelines for human genome editing research, along with the explicit ban on germline genome editing, reflect China's proactive stance in addressing the ethical challenges posed by rapid advancements in genetic science. By prohibiting germline editing and focusing on ethical oversight, informed consent, and international collaboration, China hopes to navigate the complexities of genetic research while safeguarding human health and rights.
The original publication can be found here (Chinese only).
For more information on these ethical guidelines and the ban, contact your CMS client partner or these CMS experts.
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