Human subject protection in clinical cancer trials : Action research
| Project/Area Number |
15390676
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| Research Category |
Grant-in-Aid for Scientific Research (B)
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| Allocation Type | Single-year Grants |
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| Section | 一般 |
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| Research Field |
Clinical nursing
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| Research Institution | Kitasato University |
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Principal Investigator |
INAYOSHI Mitsuko Kitasato University, School of Nursing, Professor, 看護学部, 教授 (60203212)
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| Co-Investigator(Kenkyū-buntansha) |
MINEGISHI Hideko Kitasato University, School of Nursing, Associate professor, 看護学部, 准教授 (20258883)
KUBO Satsuki Kitasato University, School of Nursing, Associate professor, 看護学部, 准教授 (60348597)
HIRATA Kaori Kitasato University, School of Nursing, Research Associate, 看護学部, 助手 (30406904)
諸田 直実 (諸田 直美) 北里大学, 看護学部, 講師 (20210205)
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| Project Period (FY) |
2003 – 2006
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| Project Status |
Completed (Fiscal Year 2006)
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| Budget Amount *help |
¥7,300,000 (Direct Cost: ¥7,300,000)
Fiscal Year 2006: ¥1,400,000 (Direct Cost: ¥1,400,000)
Fiscal Year 2005: ¥2,100,000 (Direct Cost: ¥2,100,000)
Fiscal Year 2004: ¥2,200,000 (Direct Cost: ¥2,200,000)
Fiscal Year 2003: ¥1,600,000 (Direct Cost: ¥1,600,000)
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| Keywords | Concept analysis / Clinical cancer trial / Human subject protection / Informed consent / Risk and benefit analysis / Advocacy / Collaboration / Decision making / がん治験 / インフォームドコンセント / リスクベネフィット評価 / アクションリサーチ / 治験参加者保護 / 治験参加者の自己擁護 / 葛藤 / 被験者擁護 / 新聞報道 / リスク情報 / 危険 / 不安・恐怖 / 癌臨床試験 / 危険性-有益性分析 / 人権擁護 / 不安 / 希望 / 癌治験 |
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| Research Abstract |
Outcomes of action research over 4 years are summarized as follows:
A. Networking for research nurses involved in clinical trials of cancer
Oncology research nurses required networking opportunities to discuss and resolve patients' issues. We initially started study meetings and then approached the Japanese Society of Cancer Nursing to organize special interest groups to respond to members' requests. The plenary session approved 14 Special Interest Groups in 2006 and Clinical Trial Nurses comprised one of them. Networking was the most important outcome of this action research.
B. Simultaneous concept analysis of human protection in clinical cancer trials
We conducted simultaneous concept analyses in 3 phases: 1) the current situation in Japan; 2) the current situation in other countries; 3) integrating situations in Japan and other countries. We then formed a consensus group. Concepts for analysis and independent clarification included "informed consent", "risk/benefit assessment", "advoca
… More
cy", and "collaboration". Critical attributes, antecedents, enablers, and outcomes of each concept are described in detail in a figure. Furthermore, extracted common factors associated with each concept and the definition of human subject protection in clinical cancer trials was refined. The common factors, namely antecedents and enablers, "regulation of research on humans", "waivers" and "information" suggested that human subject protection can be controlled in clinical cancer trials.
C. Comparison between qualitative analysis by nursing experts and software for text data analysis
Risk information from clinical cancer trials was analyzed from articles in the Asahi Shinbun and Yomiuri Shinbun because these newspapers have data systems that allow computer-based searching of published articles. The software for text data analysis, WordMiner【○!R】, selected keywords from the meanings of words in headings and articles, whereas nursing experts selected them from interpreting the words in context. These findings suggest that trustworthiness of the collected data requires comparing expert interpretations by mutual consent. Thus WordMiner【○!R】 selects valuable information (words) that experts might overlook while reading because distinctive characters are extracted by probability tests. Less
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Report
(5 results)
Research Products
(21 results)
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[Book] がん看護コアカリキュラム2007
Author(s)
小島操子, 佐藤禮子(監訳)
Total Pages
791
Publisher
医学書院
Description
「研究成果報告書概要(和文)」より
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[Book] がんサバイバーシップ2006
Author(s)
近藤まゆみ, 嶺岸秀子(編著)
Total Pages
212
Publisher
医歯薬出版
Description
「研究成果報告書概要(和文)」より
Related Report
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