An exploratory study of therapeutic misconception among incarcerated clinical trial participants

AJOB Empir Bioeth. 2016;7(1):24-30. doi: 10.1080/23294515.2015.1058303. Epub 2015 Jun 24.


Background: Therapeutic misconception, the misunderstanding of differences between research and clinical care, is widely prevalent among non-incarcerated trial participants. Yet little attention has been paid to its presence among individuals who participate in research while incarcerated.

Methods: This study examined the extent to which seventy-two incarcerated individuals may experience therapeutic misconception about their participation in one of six clinical trials, and its correlation with participant characteristics and potential influences on research participation.

Results: On average, participants endorsed 70% of items suggestive of therapeutic misconception. The tendency toward therapeutic misconception was significantly higher among: African Americans and Latinos compared to Whites; older and less educated participants; enrollment in a substance abuse-related trial; and correlated with a belief that the trial was the only way to obtain needed treatment.

Conclusions: Therapeutic misconception may be particularly high among select incarcerated individuals and is associated with a perceived lack of treatment options. Further examination of therapeutic misconception among incarcerated research participants is needed.

Keywords: incarceration; informed consent; prisoners; therapeutic misconception; vulnerable populations.