[CCTR 692] -0921- Ethical issue(informed consent)

0921

I. NIH/FDA guidance's for inclusion of minority(race, ethnic subgroup)
 In Phase III Clinical Study(several hundred - efficacy test)
 Sex(Woman, minority)
 Ethnicity & Race(Hispanic -> Hawaiian, More than one race)

II. Ethical issue
 Without impairing the warfare of individuals.
 - Minimize ?harm
 - No serious harm(stop)
 - value, scientific validity, fair selection, favorable benefit, risk balance, independent review,
   informed consent, respect participants.
 - Protection from conflict interest(financial, intellectual): minimize bias.

III. Informed consent
 let them know the information clearly.
 - Nurenberg Code 1947(1st)
 - Declaration of Helsinki(1964 ~ 1996); international ethics/rules
 - Belmont Report 1979; respect for person, beneficence, justice

 Part of informed consent; A process + A document(informed sheet, consent form with signature)

IV. Integrity
      Sharing data <-> Confidentiality.
      Data falsification.