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

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

Front Med (Lausanne)

Ethics Working Group of International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP), Woerden, Netherlands.

Published: September 2024

AI Article Synopsis

  • * The paper explores key aspects, including ethical reforms for including vulnerable participants to ensure diversity and the necessity of social value, especially for those in need.
  • * It also discusses the requirements for promoting the inclusion of vulnerable groups, such as reevaluating placebo-controlled trial norms and post-trial access, and suggests directions for reforming research ethics to enhance social value and global health equity.

Article Abstract

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 " However, this proposal has been withdrawn and the relationship between the two concepts has not been clarified.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

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11442373PMC
http://dx.doi.org/10.3389/fmed.2024.1432267DOI Listing

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