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Paragraph 37 of the Declaration of Helsinki (DoH) issued by the World Medical Association (WMA) covers the clinical usage of unproven interventions. The 2024 amendment of the DoH added some provisions for ineligible patients to reconcile with ongoing clinical trials on the same intervention and warning against physicians’ continuous usage of unproven interventions to elude the burden to follow ethical principles. While the newly added provisions are right enough, our proposal to request continuous monitoring of safety and efficacy with accumulated data in clinical applications was not embraced by the WMA. This proposal was based on the policy of the World Health Organization (WHO), referred to as “monitored emergency use of unregistered and experimental intervention (MEURI),” which reflects the experiences of the Ebola outbreak and the COVID-19 pandemic. This chapter lays out this stringent monitoring policy as one of the core elements of physicians’ professional autonomy based on virtue ethics. Furthermore, in concert with the professional autonomy of physicians, it would contribute to establishing healthcare democratization.

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From Professional Freedom to Professional Autonomy: Ethical Principles for the Use of Unproven Interventions

  • 章节

  • 发表日期：

    2025年

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  • Takeo Saio,
  • Chieko Kurihara

摘要

Paragraph 37 of the Declaration of Helsinki (DoH) issued by the World Medical Association (WMA) covers the clinical usage of unproven interventions. The 2024 amendment of the DoH added some provisions for ineligible patients to reconcile with ongoing clinical trials on the same intervention and warning against physicians’ continuous usage of unproven interventions to elude the burden to follow ethical principles. While the newly added provisions are right enough, our proposal to request continuous monitoring of safety and efficacy with accumulated data in clinical applications was not embraced by the WMA. This proposal was based on the policy of the World Health Organization (WHO), referred to as “monitored emergency use of unregistered and experimental intervention (MEURI),” which reflects the experiences of the Ebola outbreak and the COVID-19 pandemic. This chapter lays out this stringent monitoring policy as one of the core elements of physicians’ professional autonomy based on virtue ethics. Furthermore, in concert with the professional autonomy of physicians, it would contribute to establishing healthcare democratization.