脆弱性、社会价值和公平分享研究成果：超越 "安慰剂 "和 "获取 "的争论

IF 3.1 3区医学 Q1 MEDICINE, GENERAL & INTERNAL

Frontiers in Medicine Pub Date : 2024-09-18 DOI:10.3389/fmed.2024.1432267

Chieko Kurihara, Dirceu Greco, Ames Dhai, Kotone Matsuyama, Varvara Baroutsou

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引用次数: 0

摘要

研究参与者的脆弱性是《赫尔辛基宣言》2024 年修订版的一个重要主题，其中建议纳入 "社会价值"。"然而，这一提议已被撤回，这两个概念之间的关系也未得到澄清。本文试图阐明：(1) 近期为促进多样性而对弱势研究参与者的伦理包容所进行的改革；(2) 社会价值是每个人，尤其是弱势者和最需要帮助者的先决条件；(3) 促进弱势参与者包容的要求，尤其是对安慰剂对照试验和试验后准入规范的审查；(4) 最后，为实现社会价值和公平的全球健康而进行的研究伦理改革的方向。

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Vulnerability, social value and the equitable sharing of benefits from research: beyond the placebo and access debates

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 ” However, this proposal has been withdrawn and the relationship between the two concepts has not been clarified.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.

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来源期刊

Frontiers in Medicine Medicine-General Medicine

CiteScore

5.10

自引率

5.10%

发文量

3710

审稿时长

12 weeks

期刊介绍： Frontiers in Medicine publishes rigorously peer-reviewed research linking basic research to clinical practice and patient care, as well as translating scientific advances into new therapies and diagnostic tools. Led by an outstanding Editorial Board of international experts, this multidisciplinary open-access journal is at the forefront of disseminating and communicating scientific knowledge and impactful discoveries to researchers, academics, clinicians and the public worldwide. In addition to papers that provide a link between basic research and clinical practice, a particular emphasis is given to studies that are directly relevant to patient care. In this spirit, the journal publishes the latest research results and medical knowledge that facilitate the translation of scientific advances into new therapies or diagnostic tools. The full listing of the Specialty Sections represented by Frontiers in Medicine is as listed below. As well as the established medical disciplines, Frontiers in Medicine is launching new sections that together will facilitate - the use of patient-reported outcomes under real world conditions - the exploitation of big data and the use of novel information and communication tools in the assessment of new medicines - the scientific bases for guidelines and decisions from regulatory authorities - access to medicinal products and medical devices worldwide - addressing the grand health challenges around the world