Some commentators say comparative trials of FDA-approved drugs are overburdened by current Common Rule regulations and that researchers should not be required to obtain explicit consent for participation in the most innocuous of these trials.
Withholding information from patients during an informed consent process is ethically unacceptable. Patients may restrict the amount of information they wish to receive or designate someone else to receive the information for them.
AMA J Ethics. 2015;17(3):209-214. doi:
10.1001/journalofethics.2015.17.3.ecas2-1503.