Consenting the Vulnerable Population
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Assessing potential subjects' capacity to consent and reassessing that capacity should take place when?
Ongoing basis
(wrong answers:
Before potential subject is approached,
During initial consent,
Never,
End of study)
-
If the potential subject has a court-appointed guardian who makes medical decisions for the potential subject, who should consent for the potential subject?
Guardian
(wrong answers:
Legally Authorized Representative,
Subject,
Caregiver,
Power of Attorney)
-
If the potential subject does not have a court-appointed guardian and the potential subject has consent capacity, who should consent for the potential subject?
Subject
(wrong answers:
Legally Authorized Representative,
Guardian,
Caregiver,
Power of Attorney)
-
If the potential subject does not have consent capacity and does not have a court-appointed guardian, who should consent for the potential subject?
Legally Authorized Representative
(wrong answers:
Guardian,
Subject,
Ex-spouse,
Friend)
-
A legally authorized representative must consent for the potential subject due to not having consent capacity? Who should be first considered?
Health Care Representative
(wrong answers:
Spouse,
Adult Child,
Parent,
Adult Sibling)
-
The study team is expected to make and document how many attempts over at least 48 hours to contact the individual with the highest order of priority?
3
(wrong answers:
1,
2,
4,
5)
-
When should procedures stop when a subject's consent capacity changes after the initial consent is obtained?
Immediately
(wrong answers:
After study assessments are collected,
After next visit,
At the end of the study,
Never)