Kurihara Chieko, Greco Dirceu, Dhai Ames, Matsuyama Kotone, Baroutsou Varvara
Kanagawa Dental University, Yokosuka, Japan.
Ethics Working Group of International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP), Woerden, Netherlands.
Front Med (Lausanne). 2024 Sep 17;11:1432267. doi: 10.3389/fmed.2024.1432267. eCollection 2024.
The vulnerability of research participants is a critical topic for the 2024 revision of the Declaration of Helsinki, with the proposal to include "social value. " However, this proposal has been withdrawn and the relationship between the two concepts has not been clarified. This paper attempts to clarify: (1) the recent reform for the ethical inclusion of vulnerable study participants to promote diversity; (2) the social value, prerequisite for everyone, especially for those who are vulnerable and the most in need; (3) the requirements for promoting the inclusion of vulnerable participants, in particular the review of the norms for placebo-controlled trials and post-trial access; (4) finally, the direction of research ethics reform to achieve social value and equitable global health.
研究参与者的脆弱性是《赫尔辛基宣言》2024年修订版的一个关键议题，其中提议纳入“社会价值”。然而，该提议已被撤回，且这两个概念之间的关系尚未厘清。本文试图阐明：（1）近期为将脆弱研究参与者纳入伦理考量以促进多样性所做的改革；（2）社会价值，这是每个人的前提条件，尤其是对那些脆弱且最有需求的人而言；（3）促进纳入脆弱参与者的要求，特别是对安慰剂对照试验规范及试验后获取情况的审查；（4）最后，实现社会价值和全球健康公平的研究伦理改革方向。
