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.
Students more familiar with the quantifiable knowledge taught in medical and premedical curricula become aware that this perspective is not the only or even the most comprehensive way to see health, illness, and healing.
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.
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.