研究と診療を区別する二つのモデル : ヘルシンキ宣言からベルモント・レポートへ

抄録

The purpose of this paper is to clarify the logical construction of Robert J. Levine's model for the distinction between research and therapy. Levine's model has been adopted in well-known ethical guidelines such as the Belmont Report (1979) and the CIOMS guidelines (1993). Levine introduced into research ethics two theoretical models, the intent-based model and the approval-based model, for the distinction between research and therapy. He also recommended that physician-investigators deal with "innovative therapy" as research, which should be reviewed by IRBs. Levine criticized two assumptions which were largely shared in the medical community in the 1960's. Some physician-investigators thought that it was impossible to distinguish research from therapy because all medical practice was in a sense experimental. Others thought we should distinguish therapeutic research from non-therapeutic research and that the former can be conducted according to relatively relaxed standards. This was also the standpoint of the Declaration of Helsinki in 1964. These assumptions interfered with effective regulation of clinical research. Levine's model introduced a new perspective into research ethics and became a foundation of the contemporary regulation of clinical research. The purpose of this paper is not only to reconstruct past discussion and share its heritage but also to obtain suggestions for the regulation of clinical research in Japan.