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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: bflee@mail.ncku.edu.tw TEL: 886-6-2353535 ext 2483 FAX: 886-6-2766609

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2 ??WHY??

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3

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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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12

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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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15

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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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18

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19 _

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20

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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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