A researcher obtains consent from a person with a recent traumatic brain injury (TBI) to observe the person and test her at intervals, using cognitive survey instruments. The person has not yet regained the ability to speak and can understand and obey only simple commands. She nods yes, and shakes her head for no. The participant's husband is consented for the study, and the patient is asked to assent. Does this fulfill the requirements for consenting someone with diminished capabilities? Why or why not?
A) Yes, it does.
B) No, it does not.
C) The participant should have been told the purpose of the study over and over again, and the tests the researcher planned to administer, until the participant nodded that she understood. Her husband should not make this decision for her.
D) The researcher must obtain consent from both the legal representative and the participant.
E) The researcher need not obtain assent for research involving persons with decreased ability or total inability to give informed consent. The participant will probably not remember any of this later, anyhow.
F) The participant should have been asked to consent, and the husband to assent. That is the proper procedure.
G) The prospective participant can understand simple commands but, because of her TBI, she is not competent to consent.
H) The participant is asked to assent, in case she has an opinion about this and might understand the purpose of the study. Eliciting her cooperation is wise, in either case.
Correct Answer:
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