| Project/Area Number |
21590592
|
|---|
| Research Category |
Grant-in-Aid for Scientific Research (C)
|
| Allocation Type | Single-year Grants |
|---|
| Section | 一般 |
|---|
| Research Field |
Applied pharmacology
|
|---|
| Research Institution | Kyoto University |
|---|
Principal Investigator |
|
|---|
| Co-Investigator(Kenkyū-buntansha) |
YOKODE Masayuki 京都大学, 医学研究科, 教授 (20252447)
MINAMI Manabu 京都大学, 医学研究科, 助教 (90511907)
|
|---|
| Co-Investigator(Renkei-kenkyūsha) |
NISHIMURA Hiromi 先端医療センター研究所, 血管再生研究グループ, 客員研究員 (10359440)
|
|---|
| Project Period (FY) |
2009 – 2011
|
| Project Status |
Completed (Fiscal Year 2011)
|
| Budget Amount *help |
¥4,680,000 (Direct Cost: ¥3,600,000、Indirect Cost: ¥1,080,000)
Fiscal Year 2011: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2010: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2009: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
|
|---|
| Keywords | 臨床試験・倫理 / 無過失補償 |
|---|
| Research Abstract |
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.
|
