Leader in education affairs,

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• Leader in education affairs,
• Human Experiment and Ethics Committee (HEEC)
• ????
• ???????????

??? (Bi-Fang Lee)
Bi-Fang Lee, MD, PhDClinical Assistant
Professor.Director, Section of
Radioimmunoassay.Email bflee_at_mail.ncku.edu.twTE
L 886-6-2353535 ext 2483 FAX [phone]
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Instruction for authors

• 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.

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???? 2007.08.23_??????? ??????_???/????
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• Tuskegee Trial - 1932-72.
• ?1932 -1972???????????
• ??200-300????????
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• Tuskegee Trial - 1932-72.
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• 1972???????
• 1973????
• 1997 ?5?????Clinton???? .what the United
  States government did was shameful and I am sorry"

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• Tuskegee Trial - 1932-72.
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• ???????????????????(????????????)?
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• ????Belmond Report (1974)

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• ?????(Nuremberg Code for Human Experimentation)
  1948????
• ????Voluntary participation
• ????Consent
• ??????Benefits overweight risks
• ??????(Declaration of Helsinki)
• ??????1964????
• ?????,???2000???
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www.doh.gov.tw
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????????
??(Hospital) ?????(Sponsor) ??????(C.R.O.)
??? (Regulator)
???????(IRB orJ-IRB)
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Organization of Human Experiment and Ethics
Committee (HEEC) at NCKU Hospital
Chairman
Staff
Vice-Chairman /Executive Secretary
Three leaders of member are in charge of
review, audit and education affairs
Review
Audit
Education
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Review Process

• Full-board review
• ????
• Full-board review2-3 members

• Expedited review
• ??????
• Expedited review2 members

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• ????????????????????????????????,????????(minimal
  -risk) ?
• ??????????????????????,??????????????????????????

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