Social Studies, 15.04.2020 03:25 brinleychristofferse
46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is on going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?
A. Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.
B. A general requirement for the informed consent is that no informed consent may include any exculpatory language.
C. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence
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46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. W...
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