The draft note of clarification or revision on the Declaration of Helsinki paragraph 30 and Japanese guidelines for clinical research

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  • ヘルシンキ宣言第30条の注記または改訂案と日本における「臨床研究に関する倫理指針」

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Paragraph 30 of the Declaration of Helsinki by the World Medical Association (WMA) embodies one important ethical principle, i. e. that at the conclusion of the study, every patient in the study should be assured of access to the best proven prophylactic, diagnostic, and therapeutic methods identified by the study. This sentence was included in the Declaration's 2000 revision as a result of intensive international debate on clinical trials in several developing countries, funded and initiated by various research groups from the industrialized countries. However, a small group in WMA is trying to upset this principle by attempting to revise Paragraph 30 or adding a note of clarification to it. In Japan, where there are no legally-binding regulations for medical research involving human subjects at large, a set of administrative guidelines on clinical research was developed in 2002 and released in July 2003. But in the process, there was not enough discussion on this principle, although the same text was included in the guidelines. Considering the recent Japanese situation, clinical trials initiated by Japanese pharmaceutical industries and conducted in Asian countries have significantly increased because of the low cost in these countries, and that trials in small clinics in Japan have been encouraged by national policy, it is necessary for Japanese researchers and society to catch up such with the world-wide discussion on clinical research.

Journal

  • Bioethics

    Bioethics 14 (1), 83-90, 2004

    Japan Association for Bioethics

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