| Project/Area Number |
23613002
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Bioethics
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| Research Institution | The University of Tokyo |
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Principal Investigator |
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| Project Period (FY) |
2011 – 2013
|
| Project Status |
Completed (Fiscal Year 2013)
|
| Budget Amount *help |
¥2,860,000 (Direct Cost: ¥2,200,000、Indirect Cost: ¥660,000)
Fiscal Year 2013: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2012: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2011: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
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| Keywords | 橋渡し研究 / 被験者 / 説明同意文書 / 心理状況 / 理解度 / トランスレーショナルリサーチ / 心理状態 |
|---|
| Research Abstract |
The required content of Infrmed Consent Form (ICF) on clinical trial has been increased, such as information on Conflict of Interest, source of research money, and anticipated belongingness of Intellectual Property. Patients on Translational Research, which applies the results of basic research foe medical applications, are with life-threatening diseases and under status of non-existing standard therapy, and their anticipated life is limited and Quality of Life is deteriorated. Under such circumastances, to provide the ICF considered patients' understandings and mental status is important. We analysed the reports from clinical psychologist on participants' mental status and understandings. From the result, we made the sample ICF including the points of making ICF and considering points of explanations to patients. This sample will enable investigators to obtain appropriate IC from patients.
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