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医師主導治験・医学系研究における健康被害補償に関する調査
https://repo.qst.go.jp/records/79836
https://repo.qst.go.jp/records/79836975d1814-3dfe-41c1-a8b6-00fb0bd1611f
| Item type | 学術雑誌論文 / Journal Article(1) | |||||
|---|---|---|---|---|---|---|
| 公開日 | 2020-04-09 | |||||
| タイトル | ||||||
| タイトル | 医師主導治験・医学系研究における健康被害補償に関する調査 | |||||
| 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 |
小池, 竜司
× 小池, 竜司× 栗原, 千絵子× 鈴木, 千惠子× 佐藤, 弥生× 星, 順子× 渡邉, 裕司× Kurihara, Chieko |
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| 抄録 | ||||||
| 内容記述タイプ | Abstract | |||||
| 内容記述 | Background: Risks associated with conducting clinical trials include occurrence of unintended AEs which could potentially cause health impairment of study participants. Therefore mechanisms by which patients are compensated for trial-related injury must exist; however, actual cases of managing such compensation has not enough surveyed, especially in the case of investigator-initiated clinical trial (IIT). Objectives: To find actual situation of managing compensation in IIT. Method: Web-based questionnaire survey in the fiscal year 2017, responded by the offices of institutional review board (IRB) for good clinical practice (GCP)-regulated study and of ethics committee (EC) for governmental guideline-regulated study. Findings: Main findings are as follows: (1) 5/21（24%）IRBs and 7/22（32%）ECs answered that they have a written institutional policy or procedure document; (2) 9/21（43%）IRBs and 1/22（5%）ECs answered that they have prepared a compensation-specific explanation sheet for research subjects, and 4/21（19%）IRBs and 1/22（5%）ECs have prepared such a document for the time when injury happens; (3) Only 1/21(5%) IRB and 2/22(9%)ECs answered that they have compensation-specific judge mechanism separately from IRB/EC; (4) Only a few number of institutions answered that they prepare for financial resource separately from insurance; (5) Several information about the cases of providing monetary compensation was obtained. Conclusion: Institutional operating procedures and information sheet for subject have not been enough prepared but several institutions have prepared them. Problem is that institutional mechanism to judge about the necessity of compensation have been rarely established. Further survey is needed to find actual situation of managing compensation cases in IIT. |
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| 書誌情報 |
臨床薬理 巻 50, 号 4, p. 157-166, 発行日 2019-08 |
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| ISSN | ||||||
| 収録物識別子タイプ | ISSN | |||||
| 収録物識別子 | 0388-1601 | |||||
| DOI | ||||||
| 識別子タイプ | DOI | |||||
| 関連識別子 | 10.3999/jscpt.50.157 | |||||
| 関連サイト | ||||||
| 識別子タイプ | URI | |||||
| 関連識別子 | https://www.jstage.jst.go.jp/article/jscpt/50/4/50_157/_article/-char/ja/ | |||||
