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.
Michael Farias, MD, MS, MBA and Rahul H. Rathod, MD
A distinguishing feature of a SCAMP is its ability to capture knowledge-based diversions from a recommended pathway and to “learn” from such individualized patient management.
Chromosomal microarray analysis reveals many gene variants of unknown significance. The uncertainty about these variants—might they be deleterious or are they benign?—complicates genetic counseling.
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.
Industrialized nations could benefit from strategies emerging in developing nations such as respectful collaboration between traditional out-of-hospital birthing practices and maternity units in partnering hospitals.
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.