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Post-trial access as the norm of ethics in health research was established by the World Medical Association (WMA) in the 2000 version of the Declaration of Helsinki (DoH), as the right of study participants to continued access to the best-proven interventions if needed after the completion of trial participation. However, due to pressure from regulators, industries, and researchers who argued difficulties with implementation, this principle in the DoH has been downgraded and it became the merely item in the protocol and informed consent form. In its 2024 revision, small improvements were made, reflecting discussions at WMA’s meetings as the voices of resource-limited regions were heard but there was a failure to reinstate the past achievement of 2000. This chapter carefully examines the small improvements made in the post-trial provisions and other relevant paragraphs of the 2024 DoH, to implement post-trial access as health is one of the fundamental human rights. In conclusion, post-trial access must be guaranteed to (1) study participants, (2) study host community, and (3) all those in need in the global community.

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Post-trial Access as a Fundamental Right to Health: What Has Changed in the Implementation Principles?

  • 章节

  • 发表日期：

    2025年

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  • Chieko Kurihara,
  • Dirceu Greco,
  • Ames Dhai,
  • Takeo Saio

摘要

Post-trial access as the norm of ethics in health research was established by the World Medical Association (WMA) in the 2000 version of the Declaration of Helsinki (DoH), as the right of study participants to continued access to the best-proven interventions if needed after the completion of trial participation. However, due to pressure from regulators, industries, and researchers who argued difficulties with implementation, this principle in the DoH has been downgraded and it became the merely item in the protocol and informed consent form. In its 2024 revision, small improvements were made, reflecting discussions at WMA’s meetings as the voices of resource-limited regions were heard but there was a failure to reinstate the past achievement of 2000. This chapter carefully examines the small improvements made in the post-trial provisions and other relevant paragraphs of the 2024 DoH, to implement post-trial access as health is one of the fundamental human rights. In conclusion, post-trial access must be guaranteed to (1) study participants, (2) study host community, and (3) all those in need in the global community.