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研究対象者の権利と補償：−グローバル臨床試験を視野に入れた国際比較と今後の課題
https://repo.qst.go.jp/records/57942
https://repo.qst.go.jp/records/57942f0e86187-0bc5-4630-bd51-506c8d719374
| Item type | 一般雑誌記事 / Article(1) | |||||
|---|---|---|---|---|---|---|
| 公開日 | 2011-07-27 | |||||
| タイトル | ||||||
| タイトル | 研究対象者の権利と補償：−グローバル臨床試験を視野に入れた国際比較と今後の課題 | |||||
| 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× 栗原 千絵子 |
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| 抄録 | ||||||
| 内容記述タイプ | Abstract | |||||
| 内容記述 | Objectives:To identify characteristics of compensation frameworks for research-related injuries of human subjects of clinical trials, in Japan and other parts of the world, and clarify future perspectives. Method:Narrative, non-systematic review of regulations and literature concerning compensation programs for research-related injuries of Japan, United States (US), and European, Asian, and African countries, and additional interview surveys. Results:(1) There is a substantial diversity in the national frameworks for compensation for researchrelated injuries. (2) Analysis of cost-effectiveness and feasibility of insurance program is difficult when it is managed as a private and/or voluntary system. (3) The compensation guidelines of the Japan Pharmaceutical Industry Legal Affairs Association provide a high level of human subject protection compared with the world situation. The compensation guidelines of the Association of British Pharmaceutical Industries, which is similar to the Japanese guidelines, seem to work as global standards to some extent. On the other hand, the compensation policy development and implementation is insufficient in comparison with the international standards and those in the US and other Asian countries. Conclusion:A publicly established framework would work better for cost-effective analysis toward fairness of compensation for research-related injuries. Additionally, a global consensus for fairness and equality of compensation should be reached through more international discussion on this topic. |
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| 書誌情報 |
臨床評価 巻 39, 号 1, p. 31-62, 発行日 2011-07 |
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| ISSN | ||||||
| 収録物識別子タイプ | ISSN | |||||
| 収録物識別子 | 0300-3051 | |||||
