Ethical Review Guidelines for Life Sciences and Medical Research Involving Human Subjects in China
Announcement date: February 18, 2023, the competent authority is the National Health Commission (NHC).
The purpose of this regulation is to protect human life and health, uphold human dignity, respect and protect the legitimate rights and interests of research participants, promote the sound development of life sciences and medical research, and standardize the ethical review processes related to life sciences and medical research. This regulation is established based on the "Civil Code of the People's Republic of China," the "Basic Medical and Health Promotion Law of the People's Republic of China," the "Law on the Progress of Science and Technology of the People's Republic of China," the "Biosafety Law of the People's Republic of China," the "Regulations on the Management of Human Genetic Resources of the People's Republic of China," and others, in order to protect human life and health, uphold human dignity, respect and protect the legitimate rights and interests of research participants, promote the sound development of life sciences and medical research, and standardize the ethical review processes related to life sciences and medical research. 【Table of Contents】 ■ Chapter 1 General Principles ■ Chapter 2 Ethical Review Committee ■ Chapter 3 Ethical Review ■ Chapter 4 Informed Consent ■ Chapter 5 Supervision and Management ■ Chapter 6 Supplementary Provisions *For more details, please refer to the related links or feel free to contact us.
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Sakidoku Co., Ltd. is a research and consulting company that supports corporate overseas compliance based on public information such as policies, laws, and draft regulations, as well as related information from industry organizations. 【Features】 ■ Capable of conducting research in local languages from countries around the world ■ Able to address a wide range of regulatory fields and conduct complex investigations across multiple regulatory areas ■ Actively conducts inquiries and confirmations with regulatory authorities ■ Collaborates with major translation and interpretation service companies, large legal databases and service companies, specialized research and consulting firms, and law firms.
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