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.
Some disability advocates take issue with the “normalization” goals of the medical model of rehabilitation, but expressions of that position can be dismissive of rehabilitationists’ efforts to remediate oppressive functional deficits.
AMA J Ethics. 2015;17(6):562-567. doi:
10.1001/journalofethics.2015.17.6.msoc1-1506.
The Moseley study found no significant difference between those in the arthroscopic lavage and debridement arm of the study and those in the sham surgery arm.
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.
It would be unwise medically, economically, or ethically to ignore medical details and rely instead on crude placeholders such as age in attempting to use resources most efficiently and effectively.