WEKO3
アイテム
医薬品・医療機器・再生医療等製品の企業主導・医師主導治験における被験者健康被害補償：共通点・相違点と医法研ガイドライン適用性
https://repo.qst.go.jp/records/79834
https://repo.qst.go.jp/records/798342a3863bc-f11f-4951-b22e-4236f3010581
| 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 | 医薬品・医療機器・再生医療等製品の企業主導・医師主導治験における被験者健康被害補償：共通点・相違点と医法研ガイドライン適用性 | |||||
| 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× 小池, 竜司× 岡田, 潔× 鈴木, 千惠子× 星, 順子× 佐藤, 弥生× 村山, 敏典× 山本, 学× 渡邉, 裕司× Chieko, Kurihara× Ryuji, Koike |
|||||
| 抄録 | ||||||
| 内容記述タイプ | Abstract | |||||
| 内容記述 | Background：The ethical obligation to provide compensation for research-related harm has become a matter of common sense since the revision of the Declaration of Helsinki in 2013. The Japan Pharmaceutical Industry Legal Affairs Association (JPILA) provides detailed guidelines for compensation focusing particularly on sponsor-initiated clinical trials of drugs. Most of the guidelines are applicable in the cases of trials involving medical devices and regenerative medical products, as well as investigator-initiated trials. However, some aspects are specific to each category. Objective：To clarify commonalities and differences in the applicability of JPILA guidelines to each category of clinical trials. Method：A comparative study of clinical trial regulations and discussions among stakeholders engaged in different categories of clinical trials. Findings：Most of the JPILA guidelines can be applied to different categories of clinical trials. Notable differences among them, though, are as follows: (1) In the case of medical devices, the ‘Relief System for Adverse Health Effects’ for approved products is not applied; compensation for injured staff may be needed; and special consideration for implantable devices is required; (2) In the case of regenerative medicine, compensation for a cell or tissue donor should be considered; (3) In the case of an investigator-initiated trial, institutional policy development for trial-related injury is necessary. Conclusion：The findings of this study will contribute by enabling improvement in the compensation offered in each category of clinical trials, and will also help ensure equitable and fair compensation for injured trial participants regardless of the categories of clinical trial. |
|||||
| 書誌情報 |
臨床評価 巻 46, 号 2, p. 335-383, 発行日 2020-04 |
|||||
| 出版者 | ||||||
| 出版者 | 臨床評価刊行会 | |||||
| ISSN | ||||||
| 収録物識別子タイプ | ISSN | |||||
| 収録物識別子 | 0300-3051 | |||||
