Cyrus Ahalt, MPP, Rebecca Sudore, MD, Marielle Bolano, Lia Metzger, Anna M. Darby, MD, MPH, and Brie Williams, MD, MS
The teach-to-goal method should be used to assess comprehension of incarcerated patients and other vulnerable groups during the informed consent process.
AMA J Ethics. 2017;19(9):862-872. doi:
10.1001/journalofethics.2017.19.9.peer3-1709.
Research is often conducted without the knowledge or consent of those whose tissues are banked and poses possible harms to social groups if information about a few members is unscientifically applied to all.
Federal regulations governing egg donation fall into two categories: safety testing and truth in advertising. Neither deals directly with informed consent by, for example, specifying what information donors must be given.
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.
Erin P. Williams, MBE and Jennifer K. Walter, MD, PhD, MS
Undue influence, which occurs when prospective research participants who otherwise would not enroll are induced to enter studies that might pose significant risks, may also involve social injustices such as unequal payment and participant selection methods that unequally distribute the potential harms and benefits of research.
AMA J Ethics. 2015;17(12):1116-1121. doi:
10.1001/journalofethics.2015.17.12.ecas2-1512.
The continuance of public and institutional support for medical research after the publicized deaths of human research participants in the 1950s contrasts sharply with the disciplining of institutions responsible for two such deaths in recent decades, which suggests that medical research participants are no longer receiving public recognition for their contributions to science.
AMA J Ethics. 2015;17(12):1166-1171. doi:
10.1001/journalofethics.2015.17.12.mhst1-1512.
The AMA Code of Medical Ethics’ opinions on clinical investigation, subject selection for clinical trials, including members from vulnerable groups, and managing conflicts of interest in the conduct of clinical trials.
AMA J Ethics. 2015;17(12):1136-1141. doi:
10.1001/journalofethics.2015.17.12.coet1-1512.