Risk-based protection of participants in un-notified clinical trials No-fault Compensation & Informed Consent-

对未经通知的临床试验参与者进行基于风险的保护无过失补偿

基本信息

批准号：
21590592
负责人：
MURAYAMA Toshinori
金额：
$ 3万
依托单位：
Kyoto University
依托单位国家：
日本
项目类别：
Grant-in-Aid for Scientific Research (C)
财政年份：
2009
资助国家：
日本
起止时间：
2009 至 2011
项目状态：
已结题

来源：
https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-21590592/
关键词：
臨床試験・倫理無過失補償

项目摘要

Un-notified clinical trials to the authorities are still allowed in Japan, other than IND/IDE trials. The Ethical Guidelines for Clinical Studies, the only regulation for those, were fundamentally revised and enacted in April 2009, which obligate researchers to take measures on compensation such as insurance in clinical trials to assess pharmaceuticals or medical devices.Since casualty insurance companies have not accumulated know-how to estimate the risk of un-notified trials besides IND/IDE trials, compensation insurance remains inadequate in quality.In order to overcome the situation, we have set a working group of'Risk-based protection of trial participants in un-notified clinical trials' among academic clinical institutes and a casualty company. The working group has investigated legal restriction for insurance, medical expense reduction system in the academic hospital, and an academic guideline for compensation in researcher-initiated un-notified clinical trials.

除 IND/IDE 试验外，日本仍然允许未经当局通知的临床试验。唯一的法规《临床研究伦理指南》于 2009 年 4 月进行了根本性修订并颁布，要求研究人员在临床试验中对药品或医疗器械进行评估时采取保险等补偿措施。除了 IND/IDE 试验之外，赔偿保险的质量仍然不足。为了克服这种情况，我们成立了一个“基于风险的未通知试验参与者保护”工作组。已通知学术临床机构和伤亡公司之间的临床试验。工作组研究了保险的法律限制、学术医院的医疗费用减免制度以及研究者发起的未通知临床试验的补偿学术指南。

项目成果

期刊论文数量（0）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

C-C chemokine receptor 2 inhibitor improves diet-induced development of insulin resistance and hepatic steatosis in mice.

DOI：
10.5551/jat.3368
发表时间：
2010-03
期刊：
Journal of atherosclerosis and thrombosis
影响因子：
4.4
作者：
Yukinori Tamura;M. Sugimoto;T. Murayama;M. Minami;Yuki Nishikaze;H. Ariyasu;T. Akamizu;T. Kita;M. Yokode;H. Arai
通讯作者：
Yukinori Tamura;M. Sugimoto;T. Murayama;M. Minami;Yuki Nishikaze;H. Ariyasu;T. Akamizu;T. Kita;M. Yokode;H. Arai

N-Acetylcysteine Reduces the Severity of Atherosclerosis in Apolipoprotein E-Deficient Mice by Reducing Superoxide Production