2015 Fiscal Year Final Research Report
A Comprehensive Research aiming at an Integration of Various Ethical Guidelines involving Medical Research -Protection of Study Participants and Public Welfare-
| Project/Area Number |
25500003
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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 | Kanazawa University (2014-2015)
Kyoto University (2013) |
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Principal Investigator |
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| Co-Investigator(Kenkyū-buntansha) |
IHARA TOSHIKO (伊藤 登志子) 京都大学, 医学(系)研究科(研究院), 助教 (90425447)
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| Co-Investigator(Renkei-kenkyūsha) |
NISHIMURA HIROMI 公益財団法人先端医療振興財団, その他部局等, 客員研究員 (10359440)
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| Project Period (FY) |
2013-04-01 – 2016-03-31
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| Keywords | 研究者主導臨床研究 |
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| Outline of Final Research Achievements |
Having been reviewed since December 2012, ‘Ethical Guidelines for Medical and Health Research Involving Human Subjects’ were at long last enacted in April 2015, partially reflected with our policy recommendation. On the other hand, we released ‘Points to Consider on Investigator-initiated Clinical Trials financially supported by Industry, Ver.1” by the Secondary Clinical Study Advancement Working Group in the Japan Society of Clinical Trials and Research in February 2015, and issued a booklet, ‘Project Management in the Notified Clinical Trials (Chiken) by Academia’, by the PM Liaison Committee of ARO Consortium in September 2015, as well. Furthermore, we launched to prepare ‘The Guidelines for Compensation of Bodily Health Damages in the Academia-initiated Clinical Trial Participants” in the Clinical Study Risk Management Forum, and have opened a public lecture enlightening clinical trials annually.
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| Free Research Field |
臨床開発システム構築学
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