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.
Clinical equipoise—the idea that the community of medical experts is uncertain about the relative therapeutic merits of the arms of a clinical trial at its outset—mitigates physicians’ responsibility for patients’ poor outcomes when patients are assigned to the control arm or are harmed by an investigational agent.
AMA J Ethics. 2015;17(12):1108-1115. doi:
10.1001/journalofethics.2015.17.12.ecas1-1512.
The AMA Code of Medical Ethics’ opinions on clinical investigation, subject selection for clinical trials, including members from vulnerable groups, and managing conflicts of interest in the conduct of clinical trials.
AMA J Ethics. 2015;17(12):1136-1141. doi:
10.1001/journalofethics.2015.17.12.coet1-1512.