著者
田代 志門
出版者
日本医学哲学・倫理学会
雑誌
医学哲学 医学倫理 (ISSN:02896427)
巻号頁・発行日
vol.25, pp.21-29, 2007-10-18 (Released:2018-02-01)

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.
著者
諸岡 了介 相澤 出 田代 志門 桐原 健真 藤本 穣彦 板倉 有紀 河原 正典
出版者
島根大学
雑誌
基盤研究(B)
巻号頁・発行日
2013-04-01

本研究プロジェクトでは、ケア実践との関連において現代日本における死生観の実態を明らかにすべく、各種の質的調査や、思想史的・宗教史的考察、海外事情の研究といった分担研究を集約しながら、在宅ホスピスを利用した患者遺族を対象とした大規模な調査票調査を実施した。調査票調査では、宮城県・福島県における在宅ホスピス診療所6カ所の利用者2223名に依頼状を送付して、663通の回答が得られた。その分析から、在宅療養時の患者や家族の不安感やニーズの詳細とともに、宗教的関心に経済的・社会的関心が絡み合った死生観の具体相が明らかにされた。
著者
田代 志門
出版者
日本保健医療社会学会
雑誌
保健医療社会学論集 (ISSN:13430203)
巻号頁・発行日
vol.26, no.2, pp.21-30, 2016

本稿では、現代的な死にゆく過程の成立をある医師の個人史と重ねて整理し、それが以下の3段階から形成されていることを明らかにした。まず、病院での死が当たり前となり、死にゆく過程が医療の管理下に置かれるようになること。次にその過程で「一分一秒でも長く生かす」ことの正しさが疑われるような局面が表面化すること。最後にこうした難しい局面においては、本人が死の近いことを知ったうえで、主体的に「生き方」を選択するという規範が支持されるようになること。これにより、「自分の死が近いことを認識している人間が残された生をどう生きるべきか思い悩む」という実存的問題が「発見」され、それが医療スタッフの経験する困難にも質的変化をもたらした。以上の変化を受けて、医療社会学には専門家による「生き方の道徳化」を批判的に検討しつつも、現代的な死にゆく人役割の困難さの内実に迫る研究に取り組むことが求められている。
著者
田代 志門
出版者
日本医学哲学・倫理学会
雑誌
医学哲学医学倫理 (ISSN:02896427)
巻号頁・発行日
no.25, pp.21-29, 2007-10-18

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.