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.
Anne Drapkin Lyerly, MD, MA and Ruth R. Faden, PhD, MPH
Participation in a research study—in which there are rigorous standards and close monitoring—may be a safer context for the use of medications in pregnancy than the clinical setting, where the evidence base is lacking.
Patients with dementia need social supports and opportunities and acceptance of their disability in order to feel hopeful despite their functional decline.
AMA J Ethics. 2017;19(7):649-655. doi:
10.1001/journalofethics.2017.19.7.ecas2-1707.
Amy Barnhorst, MD, Garen Wintemute, MD, MPH, and Marian E. Betz, MD, MPH
When mandatory reporting of risk of violence is not required, physicians should balance patient autonomy and beneficence with patient and public safety.
AMA J Ethics. 2018;20(1):29-35. doi:
10.1001/journalofethics.2018.20.1.ecas1-1801.
The FDA’s expanded access pathway allows patients with no other therapeutic options to request access to investigational agents, but manufacturers do not often grant it.
AMA J Ethics. 2015;17(12):1142-1146. doi:
10.1001/journalofethics.2015.17.12.stas1-1512.