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.
Laurel J. Lyckholm, MD and Arwa K. Aburizik, MD, MS
Decision-making capacity can be preserved in patients with mental illness and should be formally assessed in the context of their values and past decisions.
AMA J Ethics. 2017;19(5):444-453. doi:
10.1001/journalofethics.2017.19.5.ecas4-1705.
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.
Art therapy helps trafficking survivors deal with trauma, but anti-trafficking advocates who exhibit survivors’ artwork must guard against re-exploitation.
AMA J Ethics. 2017;19(1):98-106. doi:
10.1001/journalofethics.2017.19.1.imhl1-1701.
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.
Mollie Gordon, MD, Rebecca Chen, MD, John Coverdale, MD, MEd, Mike Schiller, CRMP, Hanni Stoklosa, MD, MPH, and Phuong Nguyen, PhD
Little attention has been given to roles played by human trafficking in health care organizations’ supply chains of key equipment, such as hand sanitizers and gloves.
AMA J Ethics. 2024;26(4):E348-356. doi:
10.1001/amajethics.2024.348.
Dr Hanni Stoklosa and Mike Schiller joins Ethics Talk to discuss their article, coauthored with Drs Mollie Gordon, Rebecca Chen, John Coverdale, and Phuong Nguyen: “How Should Health Care Organizations Limit Roles of Human Trafficking in Their Labor and Supply Chains?”