On 8 October 2023, the Ministry of Science and Technology of the People's Republic of China announced the above measures, which was formed on 7 September 2023 and will be in force on 1 December 2023, at the link below:

https://lnkd.in/gef3SXby

I have its machine English translation.

As a patent attorney having little knowledge on this, below are some of my observations:

  • Article 4 - the fields covered are life sciences, medicine, and artificial intelligence, specifically those in the appendix, which could be revised at any time.

  • Articles 7, 14 & 16 - the ethics (review) committee (the committee) shall have no less than 7 members, with each recognized meetings attended by at least 5 members, and decision should be reached by at least 2/3 of the attending members.

  • Article 9 - applications to the committee should include the following among many other things:

    1. Explanation on the necessity of the research.
    2. Informed consent form (for research involve human beings), source description materials of biological samples, data information, experimental animals.

  • Article 15 – the research should provide the following:

    1. Protection plan for the legitimate rights and interests of research participants such as compensation, injury treatment or compensation is reasonable, and special protection is given to vulnerable groups; the informed consent form provided is complete in contents.
    2. The use of experimental animals conforms to the principles of substitution, reduction, and optimization, the sources of experimental animals are legal and reasonable, and technical operation requirements such as breeding, use, and disposal comply with animal welfare standards.
    3. For activities involving data and algorithms, data collection, storage, processing, use and other processing activities, as well as research and development of new data technologies, etc. comply with relevant national data security and personal information protection regulations.

  • Article 43 – the committee should be registered through the National Science and Technology Ethics Management Information Registration Platform within 30 days of establishment.

  • Article 47 – there are liabilities.

  • A good thing that China starts talking about ethics.

  • Another problem to be solved by the compliance of a company doing research in China in the field of life sciences, medicine, and artificial intelligence. Have fun.

As said, I know very little about this, and will be grateful for any education from fellow readers.

关于印发《科技伦理审查办法（试行）》的通知_国务院部门文件_中国政府网

gov.cn

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