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.
Harm occurs when race is used as a proxy for characteristics stereotypically ascribed to members of a group, much as the obligatory mention of age is used to indicate the typical patient’s expected health status and vitality.
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.
Geoff Hollett, PhD and Jennie B. Jarrett, PharmD, PhD, MMedEd
The Strategic National Stockpile is a national system maintained by the US federal government to deliver medical supplies during emergencies, and it needs administrative changes.
AMA J Ethics. 2024;26(4):E315-320. doi:
10.1001/amajethics.2024.315.
Nisha Quasba joins Ethics Talk to discuss her article, coauthored with Elliot Vice: “What Should Prescribers and Policy Makers Know About US Drug Importation?”