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

Question

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 subject's husband, who has the authority to consent for his wife because he has legal power of attorney for health care, 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? (Select all that apply.)
a. Yes, it does.
b. No, it does not.
c. The subject should have been told the purpose of the study over and over again, and the tests the researcher planned to administer, until the subject 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 subject.
e. The researcher need not obtain assent for research involving persons with decreased ability or total inability to give informed consent. The subject will probably not remember any of this later, anyhow.
f. The subject should have been asked to consent, and the husband to assent. That is the proper procedure.
g. The prospective subject can understand only simple commands but, because of her TBI, she is not competent to consent.
h. The subject 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.

Answer 1

ANS: A, G, H
Some persons have diminished autonomy or are vulnerable and less advantaged because of legal or mental incompetence, terminal illness, or confinement to an institution (Fry et al., 2011). These persons require additional protection of their right to self-determination, because they have a decreased ability, or an inability, to give informed consent. In addition, these persons are vulnerable to coercion and deception. Neonates and children (minors), the mentally impaired, and unconscious patients are legally or mentally incompetent to give informed consent. They should, however, be asked to assent, since their cooperation is essential for high-quality data collection. If an individual is judged incompetent and incapable of consent, the researcher must seek approval from the prospective subject and his or her legally authorized representative.