Informed consent requires that a study subject has free power of choice regarding participation and:
a. general knowledge and comprehension of the study.
b. information on the study design.
c. psychological support from the researcher and staff.
d. the right to direct his or her role in the study.
ANS: A
Informed consent includes disclosure to the subject of essential study information, comprehension of this information by the subject, competence of the subject to give consent, and voluntary consent of the subject to participate in the study.
Information on the study design is given only as it applies to what will happen to the subject. The correct answer is "general knowledge and comprehension of the study." Informed consent includes disclosure to the subject of essential study information, comprehension of this information by the subject, competence of the subject to give consent, and voluntary consent of the subject to participate in the study.
Psychological support should come as needed and as part of any debriefing process. The correct answer is "general knowledge and comprehension of the study." Informed consent includes disclosure to the subject of essential study information, comprehension of this information by the subject, competence of the subject to give consent, and voluntary consent of the subject to participate in the study.
Self-determination refers to individuals' rights to knowingly become a subject in the study or not and to do so of their own free will.
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