In order to successfully resolve ethical conflicts, bioethics consultants must pay attention to process and heed stakeholders’ perspectives and values.
AMA J Ethics. 2016;18(5):485-492. doi:
10.1001/journalofethics.2016.18.5.ecas2-1605.
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.
Asking for forgiveness may be oppressive to a patient or family still grappling with the fact of the harm, the impact of the harm, and their own emotional response to the harm.
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.