Āļ„āļģāļ–āļēāļĄāļŠāļģāļŦāļĢāļąāļš SCTCP 2017

1. What is the different between version 2013 and 2008 of Declaration of Helsinki according to informed consent process?
A. Sponsors and researchers should make provisions for post-trial access to appropriate care for participants
B. Access to interventions identified as beneficial in the study should be in formed at the conclusion of the study
C. re-consent should be done when serious adverse event had happen
D. re-consent should be done if there is any change in research procedures
2. In what condition waiver of parental permission to join a research can be permitted?
A. Studies the use of recreational drugs.
B. Research address domestic violence
C. Studies involve “emancipated” or “mature” minors
D. Studies involve sexual transmitted diseases
E. All of the above
3. In what condition waiver of IRB review can be granted in a research using specimen from Biobank?
A. The research would not be feasible or practicable to carry out without the waiver
B. The research has important social value
C. The research poses no more than minimal risks to participants
D. Not at all
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