New requirements of the Declaration of Helsinki for inclusion and protection of vulnerable participants and recommendations for their implementation in China
10.3760/cma.j.cn113565-20250311-00061
- VernacularTitle:《赫尔辛基宣言》对纳入和保护脆弱研究参与者的新要求及其在我国的落实建议
- Author:
Jue WU
1
;
Qin HE
;
Jiyin ZHOU
Author Information
1. 四川泰康医院 科研教学部，成都 610213
- Publication Type:Journal Article
- Keywords:
Helsinki Declaration;
Vulnerability;
Participants;
Ethics review
- From:
Chinese Journal of Medical Science Research Management
2025;38(4):291-297
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To study the revised content of the 2024 version of the Helsinki Declaration on vulnerability and the responsible inclusion of vulnerable participants, and to provide suggestions for improving regulations and ethics review in China. Methods:We analyzed the requirements of the Declaration of Helsinki and the preconditions for the inclusion of vulnerable groups, sorted out the international ethical principle and the relevant vulnerability provisions of China's laws and regulations, and proposed feasible recommendations for the inclusion and protection of vulnerable participants in China.Results:The Helsinki Declaration had been revised many times to involve the inclusion and protection of vulnerable participants, especially the Helsinki Declaration in 2024 for the first time proposed that vulnerability may originate from fixed or situational and dynamic factors, and vulnerability was no longer applicable to the traditional entire vulnerable group, and stipulated the prerequisites for the inclusion of vulnerable participants, because paying attention to " vulnerable groups" would affect the judgment of individual vulnerability, and should focus on the views and priorities of vulnerable individuals. Investigators and ethics committees should strengthen the identification and protection of vulnerable participants. The international ethical guidelines and China′s regulations had content on vulnerability, but there was a lack of consensus on the inclusion and protection of vulnerable participants. Conclusions:Feasible recommendations for the inclusion and protection of vulnerable participants in China include improving the relevant regulations on the inclusion of vulnerable participants in medical research, setting ethics review standards for vulnerable participants at the national level, strengthening the construction of ethics committees and training on the topic as well as clarifying key points of ethics review to maintain impartiality and avoid the misuse of vulnerable participants.
