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CIOMS生物医学研究指針の改訂 ─ グローバル・ヘルスと研究の価値 ─
https://repo.qst.go.jp/records/56034
https://repo.qst.go.jp/records/560348842a7e6-d433-477f-ad4a-68517a8c1ab7
| Item type | 一般雑誌記事 / Article(1) | |||||
|---|---|---|---|---|---|---|
| 公開日 | 2017-04-25 | |||||
| タイトル | ||||||
| タイトル | CIOMS生物医学研究指針の改訂 ─ グローバル・ヘルスと研究の価値 ─ | |||||
| 言語 | ||||||
| 言語 | jpn | |||||
| 資源タイプ | ||||||
| 資源タイプ識別子 | http://purl.org/coar/resource_type/c_6501 | |||||
| 資源タイプ | article | |||||
| アクセス権 | ||||||
| アクセス権 | metadata only access | |||||
| アクセス権URI | http://purl.org/coar/access_right/c_14cb | |||||
| 著者 |
栗原, 千絵子
× 栗原, 千絵子× 齊尾武郎× 栗原 千絵子 |
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| 抄録 | ||||||
| 内容記述タイプ | Abstract | |||||
| 内容記述 | Purpose：To provide an explanatory overview of the draft revision of International Ethical Guidelines for Biomedical Research Involving Human Subjects submitted by the CIOMS (Council for International Organizations of Medical Science) for public consultation from September 2015 to March 1, 2016. Methods：Narrative, non-systematic review of literature on research ethics. Results：We identified nine topics where major changes were proposed in the draft: (1) social value of research; (2) choice of control in clinical trials; (3) biobank and data archive; (4) treatment and compensation for research-related harms; (5) research in disaster situations; (6) implementation research; (7) use of online information; (8) research ethics committees and review; and (9) public accountability. Discussion and Conclusion：Though logical constructions and ethical considerations of this proposed draft are still premature, there are significant changes worth noting. These changes shall provide the ethical foundation for research aiming at global health, focusing on critical issues of public health, such as an Ebola outbreak; earthquakes; tsunamis; and military conflicts, as well as research using new technologies for the analysis of large amounts of data or whole genome sequence. Most importantly, CIOMS argues that ethical justification of health-related research involving human subjects is derived from its social value, which must be generated only from scientifically valid research; and that placebo control is ethically acceptable when it does not cause more than a minor increase above minimal risk. Both of these arguments are in marked contrast to the 2013 version of the Declaration of Helsinki as CIOMS raises the ante of science and ethics as well as requiring researchers to balance science and ethics, involving a more difficult trade off. |
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| 書誌情報 |
臨床評価 巻 43, 号 2, p. 613-28, 発行日 2016-01 |
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| ISSN | ||||||
| 収録物識別子タイプ | ISSN | |||||
| 収録物識別子 | 0300-3501 | |||||
