A sponsor-employed nurse conducts the informed consent discussion for a trial at an investigative site. What is the key concern with this arrangement?
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A
Nurses are not qualified to explain clinical trial procedures
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B
The participant may feel undue pressure to enroll because the nurse represents the entity funding the trial
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C
It violates GCP because only physicians may obtain consent
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D
The sponsor nurse cannot be listed on the consent form as the person who explained the study