Ethical examination on the vulnerability of medical research participants in the context of the new era
10.12026/j.issn.1001-8565.2026.08.02
- VernacularTitle:新时代语境下对医学研究参与者脆弱性的伦理审视
- Author:
Jing YANG
1
;
Lianghui MA
1
;
Yongchuan CHEN
2
Author Information
1. Medical Ethics Committee， Chongqing University Central Hospital/Chongqing Emergency Medical Center， Chongqing 400014， China
2. Department of Pharmacy， the First Affiliated Hospital， Army Medical University， Chongqing 400038， China
- Publication Type:Journal Article
- Keywords:
Declaration of Helsinki;
vulnerability of participant;
concept change;
ethical examination
- From:
Chinese Medical Ethics
2026;39(8):991-997
- CountryChina
- Language:Chinese
-
Abstract:
The focus on the vulnerability of participants always occupies an important position in medical research. The connotation and extension of vulnerability continue to evolve with changes in times and the expansion of ethical considerations. In the 2024 revision of the Declaration of Helsinki， the description of vulnerability has also undergone significant changes. Clarifying the historical background， scope， significance， and impact of these changes is of positive importance for protecting the rights and interests of medical research participants. By reviewing the changes in the description of vulnerability across successive versions of the Declaration of Helsinki， this paper analyzed the connotation of vulnerability in the context of the new era from three aspects of fixed， contextual， and dynamic factors， and summarized the historical evolving characteristics. It also explored the reasons for the changes in the category of vulnerability from four aspects regarding medicine， society， cognition， and ethics， and weighed the changes in special protection mechanisms such as research design， subject recruitment， ethical review， and adjustment of protective measures in medical research practice. These aimed to ensure that the rights and interests of vulnerable individuals， groups， and communities were fully considered and protected in the changing times.
