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.
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.