1 研究的醫學倫理與 人體試驗委員會 leader in education affairs, human experiment and...
Post on 22-Dec-2015
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- 1 Leader in education affairs, Human Experiment and Ethics Committee (HEEC) (Bi-Fang Lee) Bi-Fang Lee, MD, PhD Clinical Assistant Professor. Director, Section of Radioimmunoassay. Email: [email protected] TEL: 886-6-2353535 ext 2483 FAX: 886-6-2766609
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- 2 ??WHY??
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- 4 Materials and Methods For studies using human subjects, the first paragraph should address IRB approval and patient informed consent, as well as HIPAA compliance (U.S. studies). For animal experiments, provide a statement of approval by the institutional animal care committee or appropriate substitute. Instruction for authors
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- 5 2007.08.23_ _ /
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- 6 2007.08.24
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- 7 200 40% 300 30% 25% 731 7
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- 8 Tuskegee Trial - 1932-72. 1932 -1972 200-300 8
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- 9 Tuskegee Trial - 1932-72. 1972 1973 1997 5 Clinton : .what the United States government did was shameful and I am sorry 9
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- 10 Tuskegee Trial - 1932-72. ( ) Belmond Report (1974) 10
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- 11 (Nuremberg Code for Human Experimentation) 1948 Voluntary participation Consent Benefits overweight risks (Declaration of Helsinki) 1964 2000 11
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- 13 Taiwan
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- 14 ( ) 75 11 24 94 02 05 78 78 79 79 80 80 _ 78-80 Taiwan
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- 16 _ 54-57 95 6 20 0950200952
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- 17 _ 2 95 6 20 0950200952
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- 19 _
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- 21 ( 96/7/17 )
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- 22 ( )
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- 23 (93.02.18) (76.02.27; 91.10.21) (92.11.12)
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- 24 (11 ) www.doh.gov.tw
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- 25 (Hospital) (Sponsor) (C.R.O.) (Hospital) (Sponsor) (C.R.O.) (Regulator) ( IRB orJ-IRB)
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- ReviewAuditEducation Staff Chairman Vice-Chairman /Executive Secretary Three leaders of member are in charge of review, audit and education affairs Organization of Human Experiment and Ethics Committee (HEEC) at NCKU Hospital
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- NCKUH IRB-S15-2007/2/11 Review Process Expedited review Expedited review:2 members Full-board review Full-board review:2-3 members
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- 29 (minimal-risk)
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- 30 ?? ??
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