WEKO3
アイテム
米国における臨床試験規則と研究対象者保護規制
https://repo.qst.go.jp/records/48817
https://repo.qst.go.jp/records/488179822cacc-d21e-44cc-b90b-c8029e46d4aa
| Item type | 学術雑誌論文 / Journal Article(1) | |||||
|---|---|---|---|---|---|---|
| 公開日 | 2018-04-26 | |||||
| タイトル | ||||||
| タイトル | 米国における臨床試験規則と研究対象者保護規制 | |||||
| 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 | journal 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× 栗原 千絵子 |
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| 抄録 | ||||||
| 内容記述タイプ | Abstract | |||||
| 内容記述 | Background：In the United States (U.S.), human subject protection regulations, called “Common Rule”, were fully revised in January, 2017. Meanwhile, as for the clinical trial regulations under the Food, Drug and Cosmetic Act, a new regulation to require clinical trial information including its results information to be submitted to publicly available database was implemented on January 18, 2017. In Japan, a new law for clinical research was established in April 2017 and will be implemented in a year. Objective：To overview U.S. research regulations to identify key information for the Japanese research community to find the way how to manage the new law for clinical research. Method：Narrative, non-systematic literature review. Results：U.S. regulations for clinical trial were established in the 1960s responding to the Thalidomide drug disaster and established since this era with the framework now internationally known to be Good Clinical Practice, along with the investigational new drug (IND) application system. Additionally, new regulations requiring clinical trial registration are prominent as they make detailed results open to the public. U.S. regulations for human subject protection were established in the 1970s for governing federally funded research. Most important changes are (1) to define “broad consent” which makes possible secondary use of bio-specimen and information of humans; (2) to make informed consent document of clinical trial open to the public; (3) to make it mandatory to rely on a single IRB (institutional review board) for multi-center study. Conclusion：It is useful to learn U.S. research regulations from the above-mentioned points to find the best way to manage the new Japanese law for clinical research. |
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| 書誌情報 |
臨床評価 巻 45, 号 2, p. 455-480, 発行日 2017-08 |
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