It refers to the “Measures for Ethical Review of Life Science and Medical Research Involving Human Beings” (hereinafter the “Measures”, 涉及人的生命科学和医学研究伦理审查办法), published on 18 Feb. 2023.
The Measures is released by China’s National Health Commission, Ministry of Education, Ministry of Science and Technology, and National Administration of Traditional Chinese Medicine.
The Measures aims to strike a balance between safeguarding human dignity, protecting the rights of researchers and promoting the development of life science and medical research.
Life science and medical research involving human beings refers to the following research activities carried out with biological samples and information data with human beings as subjects or users:
- Activities of research on human reproduction, growth, development and senescence;
- Activities of research on human physiological and psychological behaviors, pathological phenomena, etiology and pathogenesis of diseases, as well as prevention, diagnosis, treatment and rehabilitation of diseases;
- Activities of experimental research on human beings; and
- Activities of collecting, recording, using, reporting or storing biological samples, information data (including health records, behaviors, etc.) on life science and medical problems involving human beings.
Institutions conducting life science and medical research involving human beings shall establish ethical review committees to conduct ethical reviews of the aforementioned research activities.
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Contributors: CJO Staff Contributors Team