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.
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.
Although patients’ medical gender transition can be facilitated by counseling, as a matter of medical ethics, informed consent must be obtained for treatment.
AMA J Ethics. 2016;18(11):1079-1085. doi:
10.1001/journalofethics.2016.18.11.ecas2-1611.
Julie M.G. Rogers, PhD, C. Christopher Hook, MD, and Rachel D. Havyer, MD
The medical profession’s valuing of intellectual ability may inadvertently harm people with intellectual or cognitive disabilities who have a different notion of “the good life.”
AMA J Ethics. 2015;17(8):717-726. doi:
10.1001/journalofethics.2015.17.8.peer1-1508.