China releases ethical guidelines to regulate human genetic data research

China’s Ministry of Science and Technology has released ethical guidelines regulating human genetic data research. The rules aim to ensure genetic privacy, protect participants’ rights, and promote the use of genomics for public benefit.

According to the guidelines, human genetic data refers to various types of information obtained from biological samples such as cells, tissues, organs, bodily fluids, and secretions that directly reflect human genetic information. With the rapid advancement of gene sequencing, omics technologies, and genetic data analysis methods, research involving human genetic data provides crucial scientific support for biomedical research, disease prevention, and precision medicine.

However, due to its unique characteristics—including ease of identification, familial and group associations, and intergenerational impacts—human genetic data and related research can raise complex ethical, legal, and social issues.

The guidelines state that scientific activities involving human genetic data must adhere to core principles of enhancing welfare, respecting autonomy, controlling risks, avoiding harm, preventing misuse, and ensuring fairness and equality. Such activities should aim to improve human health, enhance disease prevention and treatment, and strengthen public interest and human welfare.

Scientific rationality, legitimate objectives, and the minimum necessary approach must be applied while respecting and protecting each individual’s rights and legitimate interests. The guidelines also stress that all parties involved in human genetic data research must strengthen genetic privacy protection, ensuring data mining and usage do not violate privacy. Appropriate privacy measures must be implemented throughout the research and technology development process based on data sensitivity and risk levels.