New Requirements and Improvement Suggestion for the Protection of Vulnerable Groups in Ethical Review Measures for Life Science and Medical Research Involving Humans
10.12026/j.issn.1001-8565.2023.10.08
- VernacularTitle:《涉及人的生命科学和医学研究伦理审查办法》对保护弱势群体的新要求及改进建议
- Author:
Zengrui ZHANG
1
;
Ruilin DING
2
;
Juyi WAN
3
;
Jiyin ZHOU
4
Author Information
1. Ethics Committee of Clinical Research, the Affiliated Hospital of Southwest Medical University, Luzhou 646000, China
2. Phase I Clinical Trial Ward, the Affiliated Hospital of Southwest Medical University, Luzhou 646000, China
3. Department of Cardiovascular Surgery, the Affiliated Hospital of Southwest Medical University, Luzhou 646000, China
4. Research Center Clinical Medicine, the Second Affiliated Hospital of Army Medical University, Chongqing 400037, China
- Publication Type:Journal Article
- Keywords:
Life Science and Medical Research Involving Humans;
Vulnerable Groups;
Ethics Committee
- From:
Chinese Medical Ethics
2023;36(10):1110-1115
- CountryChina
- Language:Chinese
-
Abstract:
In February 2023, the National Health Commission, together with the Ministry of Science and Technology, the Ministry of Education, and the State Administration of Traditional Chinese Medicine issued the Ethical Review Measures for Life Science and Medical Research Involving Humans, which emphasizes that research participants involving vulnerable groups such as children, intellectual disabilities, and mental disabilities should be given special protection. This paper expounded the current situation of protecting vulnerable groups from six aspects: inadequate protection of vulnerable groups by relevant laws and regulations, unclear definition of vulnerable groups, insufficient supervision by relevant departments, insufficient review ability of ethics committee to satisfy the protection of vulnerable groups, difficulty in fair inclusion of vulnerable groups, and the need to improve the ethical awareness of researchers and vulnerable groups. This paper also analyzed the new requirements for the protection of vulnerable groups in the Ethical Review Measures for Life Science and Medical Research Involving Humans from the following three aspects: expanding attention to potentially vulnerable research participants, paying more attention to the consent of research participants without or with limited capacity for civil conduct, and re-informed consent after the improvement of civil capacity level. Finally, suggestions on strengthening the protection of vulnerable groups were put forward from six aspects: improving the relevant legal system, clarifying the category of vulnerable groups, strengthening the implementation by regulatory departments, establishing a research participant protection system by research institutions, improving the ethical review capacity of ethics committees, formulating review guidelines by industry associations, and strengthening the education and training of all parties, so as to minimize the risk of vulnerable groups participating in clinical research and boost the quality and speed of clinical research in China.
