In the 2024 revision of the Declaration of Helsinki (DoH) by the World Medical Association (WMA), paragraph 33 on placebo-controlled trials was one of the focuses, but no meaningful amendments were made. Particularly, the discrepancy between the Council of International Organizations of Medical Sciences (CIOMS) guidelines and the DoH in terms of the acceptable risk for research participants in a placebo arm when there is a proven intervention was a key issue: the CIOMS defines “minor increase above minimal risk” while the DoH defines “no increase of serious or irreversible harm.” Although the Uruguayan Medical Union made a motion to amend it for consistency with the CIOMS, it was voted down. The concern is that vulnerable study participants may be disproportionately exposed to the risk defined to be “acceptable” by the 2024 DoH. This is against the principle of justice. Furthermore, the WMA states the fundamental (core) principle that the rights and interests of research participants take precedence over the goal of the research. The contradiction between this fundamental principle and the placebo clause must be resolved. The continuing debates over the placebo clause in the DoH are a testament to the commitment and aspiration of the global research ethics community seeking the highest ethical standards that simultaneously meet the demands of ethics and science.

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Justice and Equity of Placebo-Controlled Trials: What Has Changed?

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

摘要

In the 2024 revision of the Declaration of Helsinki (DoH) by the World Medical Association (WMA), paragraph 33 on placebo-controlled trials was one of the focuses, but no meaningful amendments were made. Particularly, the discrepancy between the Council of International Organizations of Medical Sciences (CIOMS) guidelines and the DoH in terms of the acceptable risk for research participants in a placebo arm when there is a proven intervention was a key issue: the CIOMS defines “minor increase above minimal risk” while the DoH defines “no increase of serious or irreversible harm.” Although the Uruguayan Medical Union made a motion to amend it for consistency with the CIOMS, it was voted down. The concern is that vulnerable study participants may be disproportionately exposed to the risk defined to be “acceptable” by the 2024 DoH. This is against the principle of justice. Furthermore, the WMA states the fundamental (core) principle that the rights and interests of research participants take precedence over the goal of the research. The contradiction between this fundamental principle and the placebo clause must be resolved. The continuing debates over the placebo clause in the DoH are a testament to the commitment and aspiration of the global research ethics community seeking the highest ethical standards that simultaneously meet the demands of ethics and science.