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人を対象とする研究に関する倫理規程・標準業務手順書について : 分子イメージング臨床研究及びトランスレーショナルリサーチの推進基盤
https://repo.qst.go.jp/records/45481
https://repo.qst.go.jp/records/454814682ce32-10b6-4b10-9777-9c51080cf9ff
| Item type | 学術雑誌論文 / Journal Article(1) | |||||
|---|---|---|---|---|---|---|
| 公開日 | 2009-04-16 | |||||
| タイトル | ||||||
| タイトル | 人を対象とする研究に関する倫理規程・標準業務手順書について : 分子イメージング臨床研究及びトランスレーショナルリサーチの推進基盤 | |||||
| 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× 福島, 芳子× 谷内, 一彦× その他× 栗原 千絵子× 福島 芳子× 谷内 一彦 |
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| 抄録 | ||||||
| 内容記述タイプ | Abstract | |||||
| 内容記述 | In this article we introduce the ethicalregulations and standardized operating procedure(SOP)for research involving humans, which we developed for the Association for Promoting Drug Development(APDD),in order to assure compliance with the Ethical Guidelines for Clinical Research, issued by the Ministry of Health, labvor and Welfare(MHLW) in 2003, revesed in July 2008, and to be implemented in April 2009. The main additional requrements in the 2009 revision fo MHLW guidelines are :(1) Registration of Clinical research with invasive interventions to one of the defined public databases :(2) Compensation for subjects'injury related to research :(3)adverse events reporting;(4) education for the researchers and ethics committee members ;(5)Information disclosre of ethics committees and adverse events. On the other hand , outsoricing of wthical review and abbreviated process in obtaining informed consent has become acceptable. The regulations and the SOP we developed to assure compliance with such requirements have the following characteristics;(1) The requirements in the three governmental guidelines for each of fwnwrix epidemiological, and clinical research are combined;(2)Investigational brochures (IB) to be attached to the protocol and additional research review for safe dosage of radioisotopes are defined ; and (3) The univormed formats for the registered clinical trials under the pharmaceutical Affaires Low are revised and applied for non-registered clinical research under the govermental ethical guidelines. This set of regulations and SOP would promote well-controlled conduct of molecular imaging and translational clinical research, including the microdosing approach, and compiance with governmental guidelines which have become ore effective regulations in this recent revision. |
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| 書誌情報 |
臨床評価 巻 36, 号 3, p. 747-784, 発行日 2009-04 |
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| ISSN | ||||||
| 収録物識別子タイプ | ISSN | |||||
| 収録物識別子 | 0300-3051 | |||||
