Volk v DeMeerleer may conflict with professional guidelines regarding physicians’ obligations to breach patient confidentiality to protect third parties.
AMA J Ethics. 2018;20(1):10-18. doi:
10.1001/journalofethics.2018.20.1.peer2-1801.
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.
Surgery’s unique characteristics, including difficulties in standardizing, blinding, and recruiting participants for clinical trials, render problematic the application of evidence-based standards to surgery.