Approaches to ethical review of life sciences and medical research involving humans

At the same time, the Measures stipulate that the right to know and the autonomy to participate in the research of research participants or their guardians shall be respected and protected, and the use of deception, inducement, coercion and other means shall not be allowed to make research participants or their guardians agree to participate in the research, and the unconditional withdrawal of research participants or their guardians shall be allowed at any stage. In the special chapter on Informed consent, it is further stipulated that if the study participants are persons without or with limited capacity for civil conduct, they shall obtain the written informed consent of their guardians. In addition to obtaining the guardian's consent, the researcher should also inform and obtain the consent of the study participants within the scope of their understanding.

7. How do the Measures and the Measures for the Ethical Review of Biomedical Research Involving Humans apply?

In order to strengthen the legal construction of ethical review of biomedical research involving humans in medical and health institutions and clarify legal responsibilities, the former National Health and Family Planning Commission revised the normative document "Measures for Ethical Review of Biomedical Research Involving Humans (Trial Implementation)" issued by the former Ministry of Health in 2007. In the form of departmental regulations, the "Measures for the Ethical Review of Biomedical Research Involving Humans" (former Order No. 11 of the Health and Family Planning Commission) was issued in 2016. Order No. 11 applies to medical and health institutions at all levels and of all types that carry out biomedical research involving humans, and details administrative penalties for violations.

With the continuous increase of investment in scientific and technological innovation and the development of biotechnology, universities and research institutes are increasingly involved in human life science and medical research. The CPC Central Committee and The State Council attach great importance to safeguarding the rights and interests of research participants, and actively promote the construction of a unified ethical review system. To this end, the NHC, together with the Ministry of Education, the Ministry of Science and Technology, the Bureau of Traditional Chinese Medicine and other relevant departments, formulated the "Measures" to provide a unified ethical review system for medical and health institutions, universities, research institutes and other relevant research to follow, and clearly defined the division of supervision and inspection departments.

The main institutional framework, ethical review methods, informed consent, etc. of the Measures and Decree No. 11 are generally consistent, and some provisions are refined and improved in combination with the requirements of new laws and regulations issued by the State and the actual conditions of universities and research institutes. Within a certain period of time, the specific ethical review practices of institutions may be guided by the Measures; For violations of ethical review in medical and health institutions, health administrative departments at all levels may deal with them on the basis of Order No. 11. The Committee will conduct an in-depth summary of the parallel situation of the Measures and Order 11, and start the revision of Order 11 in a timely manner to further improve supervision. Any other institution violating the provisions shall be dealt with by its superior competent department in accordance with its administrative subordination.

8. Compared with the "Measures for the Ethical Review of Biomedical Research Involving Humans", what are the adjustments to the "Measures for the Ethical Review of Life Sciences and Medical Research Involving Humans"?

The Measures for Ethical Review of Life Science and Medical Research Involving Human Beings adhere to the basic principles and institutional framework of the Measures for Ethical Review of Biomedical Research involving Human beings, including: first, adhere to the main responsibility of institutions, requiring institutions to establish ethical review committees to conduct ethical review of life science and medical research involving human beings; Second, adhere to the two pillars of informed consent and ethical review; The third is to follow internationally recognized ethical norms and adhere to basic ethical requirements. At the same time, combined with the actual situation, it has been optimized and perfected, and put forward a unified follow for different research subjects to carry out life science and medical research involving people.

(1) Expand the scope of application of ethical review, and clarify the regulatory responsibilities of departments in accordance with administrative affiliations. Expand "biomedical research involving people" to "life science and medical research involving people", and bring life science research involving people into the scope of management. Expand the management objects to include medical and health institutions, universities, research institutes, etc., and clarify the regulatory responsibilities of ethical review in accordance with administrative affiliations.