On February 18, 2023, the National Health and Wellness Committee and other four departments jointly issued the "Measures for Ethical Review of Life Sciences and Medical Research Involving People", which came into force as of the date of promulgation.
First, why the "Measures" were issued.
Adhere to the concept of "people-oriented, life first", in order to protect people's life and health, safeguard personal dignity, respect and protect the legitimate rights and interests of research participants, and promote the healthy development of life science and medical research, standardize the ethical review of life science and medical research involving people.
According to the Civil Law of People's Republic of China (PRC), the Law of People's Republic of China (PRC) on Basic Medical Care and Health Promotion, the Law of People's Republic of China (PRC) on Scientific and Technological Progress, the Law of People's Republic of China (PRC) on Biosafety and the Regulations of People's Republic of China (PRC) on the Management of Human Genetic Resources, these Measures are formulated.
Second, research involving human life sciences and medicine, including what research.
The life science and medical research involving people as mentioned in the Measures refers to the following research activities that take the human body as the research object or the biological samples and information data of users (collectively referred to as research participants) as the research object:
1, using physical, chemical, biological, traditional Chinese medicine and other methods to study human reproduction, growth, development, aging activities.
2, the use of physics, chemistry, biology, traditional Chinese medicine and psychology and other methods to study human physiology, psychological behavior, pathological phenomena, disease etiology and pathogenesis, as well as disease prevention, diagnosis, treatment and rehabilitation activities.
3, the use of new technologies or new products in human experimental research activities.
4. Activities of collecting, recording, using, reporting or storing biological samples and information data (including health records and behaviors). ) and other scientific research materials related to human life sciences and medical problems.