Determination of the method for Inormed Consent Form preparation based on understanding and mental status of patients in Translational Research
| 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
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| Project Status |
Completed (Fiscal Year 2013)
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| 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 |
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| 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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Report
(4 results)
Research Products
(55 results)
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[Journal Article] Unrelated cord blood transplantation after myeloablative conditioning regimen in adolescent patients with hematologic malignancies: a single institute analysis2012
Author(s)
Ebihara Y, Takahashi S, Mochizuki S, Kato S, Kawakita T, Ooi J, Yokoyama K, Nagamura F, Tojo A, Asano S, Tsuji K
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Journal Title
Leukemia Res
Volume: 36(2)
Pages: 128-131
Related Report
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[Journal Article] Unrelated cord blood transplantation after myeloablative conditioning regimen in adolescent patients with hematologic malignancies: a single institute analysis.2012
Author(s)
 Ebihara Y, Takahashi S, Mochizuki S, Kato S, Kawakita T, Ooi J, Yokoyama K, Nagamura F, Tojo A, Asano S, Tsuji K
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Journal Title
Leukemia Res
Volume: 36
Pages: 128-31
Related Report
Peer Reviewed
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[Journal Article] Unrelated cord blood transplantation after myeloablative conditioning regimen in adolescent patients with hematologic malignancies: a single institute analysis2012
Author(s)
Ebihara Y, Takahashi S, Mochizuki S, Kato S, Kawakita T, Ooi J, Yokoyama K, Nagamura F, Tojo A, Asano S, Tsuji K.
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Journal Title
Leukemia Res
Volume: 36
Pages: 128-131
Related Report
Peer Reviewed
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[Journal Article] Unrelated cord blood transplantation after myeloablative conditioning in adults with advanced myelodysplastic syndromes2011
Author(s)
Sato A, Ooi J, Takahashi S, Tsukada N, Kato S, Kawakita T, Yagyu T, Nagamura F, Iseki T, Tojo A, Asano S
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Journal Title
Bone Marrow Transplant
Volume: 46(2)
Pages: 257-261
Related Report
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[Journal Article] Unrelated cord blood transplantation after myeloablative conditioning in adults with advanced myelodysplastic syndromes.2011
Author(s)
Sato A, Ooi J, Takahashi S, Tsukada N, Kato S, Kawakita T, Yagyu T, Nagamura F, Iseki T, Tojo A, Asano S.
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Journal Title
Bone Marrow Transplant
Volume: 46
Pages: 257-61
Related Report
Peer Reviewed
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[Presentation] 多発性骨髄腫におけるLINE-1 異常低メチル化と臨床遺伝学的特徴の相関2013
Author(s)
Nojima M, Aoki Y, Yasui H, Maruyama R, Yamamoto E, Asaoku H, Tokino T, Nagamura F, Ishida T, Imai K, Shinomura Y, Suzuki H
Organizer
日本癌学会学術総会
Place of Presentation
横浜
Related Report
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[Presentation] 多発性骨髄腫におけるＬＩＮＥ-1異常低メチル化と臨床遺伝子学的特徴の相関2013
Author(s)
M Nojima, Y Aoki, H Yasui, R Maruyama, E Yamamoto, H Asaoku, T Tokino, F Nagamura, T Ishida, K Imai, Y Shinomura, H Suzuki
Organizer
第72回 日本癌学会学術総会
Place of Presentation
横浜
Related Report
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