, True or False: In general, informed consent should be a process rather than a one-time
event.
In order to participate in research, children must ...
A. Provide written informed consent
B. Provide written permission
C. Provide assent, unless the IRB determines that they are too young
D. Sign, or put an "X" on the assent document
For research involving pregnant women, participation requires ...
A. That women have completed the first trimester.
B. That the study be conducted first in men.
C. Permission of the father.
D. Consideration of risks and potential benefits for the fetus and the pregnant
woman.
Why might an individual have diminished autonomy?
A. They are a neonate.
B. They are incarcerated or
involuntarily confined.
C. They are unconscious.
D. All of the above.
True or False: Risks to research participants must be completely eliminated for the study
to be considered ethical.
When are researchers specifically required by NIH policy to describe Data and Safety
Monitoring?
A. For all research involving human subjects
B. For all research involving children as subjects in research
C. For all clinical trials
D. For all research with prisoners
True or False: There must be equipoise in order to justify conducting a clinical trial.
What is an appropriate method for maintaining confidentiality of private information
obtained from human subjects?
A. Keeping data in a password-protected database
B. Storing images in a secured cabinet
C. Coding data or specimens and keeping the key to the code in a separate, locked drawer
D. All of the above are ways to maintain confidentiality
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