2006 Fiscal Year Final Research Report Summary
Developing the guidebook for the ethically sound clinical research
| Project/Area Number |
17590456
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Single-year Grants |
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| Section | 一般 |
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| Research Field |
Medical sociology
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| Research Institution | Kyoto University |
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Principal Investigator |
SATO Keiko Kyoto University, School of Public Health, Asscciate Prossol-(JST), 医学研究科, 助教授 (10398456)
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| Project Period (FY) |
2005 – 2006
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| Keywords | Clinical research / Research protocol / Consent forms / Institutional Review Board / manual |
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| Research Abstract |
[Background]
A number of studies have reported that. investigators have no methodological skills to develop research protocol and institutional review boards (IRBs) do not function appropriately in Japan. We developed a practical guidebook for investigators, IRB members and research professionals to support writing and reviewing the protocol.
[Results]
1)We developed concept and contents of the guidebook as follows : (1)How should research be done? (2)Conceptual analysis is necessary (3)Developing protocol and informed consent documents (4)Role of IRBs and the points to consider when reviewing protocols (5)Role of institution that conducts research. This guidebook will be published by a medical publisher.
2)We developed manuals, templates and sample documents to help investigators write protocols and consent forms. These will be released on internet homepages.
3)We developed check lists for IRB members to review protocols and informed consent documents.
[Future research]
The purpose of the guidebook and materials is to provide a basic background information on research design, some of the methodological skills and purpose of the IRB review system. These will be support investigators and IRB members, however, many unsolved problems remain to conduct scientifically and ethically sound research. Education and certification systems, rules and policies to promote local responsibilities should be established to protect research participants.
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