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.
Patients with dementia need social supports and opportunities and acceptance of their disability in order to feel hopeful despite their functional decline.
AMA J Ethics. 2017;19(7):649-655. doi:
10.1001/journalofethics.2017.19.7.ecas2-1707.
Acknowledging the roles and views of the caregiver may be the first step to resolving disagreements between caregivers and clinicians over artificial nutrition at the end of life.
AMA J Ethics. 2017;19(7):656-662. doi:
10.1001/journalofethics.2017.19.7.ecas3-1707.
Viewing dementia as a distinct disease promotes funding for research but may stigmatize those who have dementia and lead to disinvestment in caregiving.
AMA J Ethics. 2017;19(7):713-719. doi:
10.1001/journalofethics.2017.19.7.mhst1-1707.
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.
One major difficulty in collecting data on which to base injury prevention strategies is the lack of large epidemiologic studies and comprehensive injury surveillance.