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Review Question - QID 8311

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QID 8311 (Type "8311" in App Search)
You have been waiting to enroll a patient into your recent institutional review board (IRB)-approved clinical research protocol. A patient is admitted who, upon initial screening, meets all inclusion criteria. However, he has late-stage dementia, and you are told by your research coordinator that this condition is an exclusionary criterion. This scenario demonstrates the need for which aspect of proper informed consent?