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POLICY BRIEF article

Front. Med.
Sec. Regulatory Science
Volume 11 - 2024 | doi: 10.3389/fmed.2024.1432267

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

Provisionally accepted
Chieko Kurihara Chieko Kurihara 1*Dirceu Greco Dirceu Greco 2Ames Dhai Ames Dhai 3Kotone Matsuyama Kotone Matsuyama 4Varvara B. Baroutsou Varvara B. Baroutsou 5
  • 1 Kanagawa Dental University, Yokosuka, Japan
  • 2 School of Fine Arts, Federal University of Minas Gerais, Belo Horizonte, Mato Grosso, Brazil
  • 3 Other, Johannesburg, South Africa
  • 4 Department of Health Policy and Management, Nippon Medical School, Tokyo, Japan
  • 5 International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine, Woerden, Netherlands

The final, formatted version of the article will be published soon.

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 However, this proposal has been withdrawn and the relationship between the two concepts has not been clarified.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

    Keywords: Vulnerability, social value, post-trial access, global health, Declaration of Helsinki

    Received: 13 May 2024; Accepted: 28 Aug 2024.

    Copyright: © 2024 Kurihara, Greco, Dhai, Matsuyama and Baroutsou. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Chieko Kurihara, Kanagawa Dental University, Yokosuka, Japan

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.