ARCHIVED CONTENT: Last maintained 9/26/2018
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6. An "autonomous person" is someone who:
A. Has reached the legal age to provide informed consent in the State.
B. Is willing to accept certain risks if the research will benefit others in the future.
C. Understands the risks and benefits of his or her participation and is able to make a voluntary
decision if adequate information is provided.
D. Meets all eligibility criteria for a study and asks the investigator if she or he may participate.
Respect for Persons: Section Quiz
7. 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.
8. 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
9. 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.
10. The three fundamental principles of Informed consent are:
A. Voluntariness, Equipoise, Respect
B. Voluntariness, Comprehension, Disclosure
C. Benefits, Comprehension, Privacy
D. Disclosure, Equipoise, Privacy
11. The regulations strongly suggest but do not require that the informed consent
process be delivered in a language that is understandable to the subject.
A. True
B. False