A “teach-to-goal” process to assess comprehension of research participation will ensure that participation among incarcerated individuals is both voluntary and informed, according to a recent article published in the AMA Journal of Ethics.
Populations in correctional facilities suffer from high rates of mental illness, substance use disorders, and chronic illnesses such as diabetes and hepatitis C. The National Institutes of Health has called for more research performed with and on behalf of these populations.
Cyrus Ahalt, MPP, from the Department of Medicine at the University of Southern California, San Francisco, and colleagues note that conducting clinical and behavioral health research among incarcerated populations comes with significant ethical challenges.
Correctional settings are by nature coercive and controlled environments that may impede informed decision-making on the part of prisoners. In some cases, health-related disorders, such as traumatic brain injury, mental illness, or substance abuse, can impair cognition. Furthermore, individuals who are incarcerated are more likely to have attained lower levels of education and have a lower literacy rate than the general population.
Despite the vulnerability of the incarcerated population, federal guidelines do not yet require modified informed consent processes to assess subjects’ comprehension of the risks and benefits of participating in a particular study. But additional safeguards should be required. Prior studies have shown that the addition to the informed consent process of test/feedback interventions such as teach-to-goal or of extended discussion is beneficial in vulnerable populations.
In the teach-to-goal process, potential participants are read a consent form and then asked to describe the research procedures or to answer questions about the study. In doing so, researchers can correct misconceptions and then reassess a participant’s comprehension. Those who do not show comprehension after several tries are excluded from the study.
The authors call for additional safeguards to ensure comprehension among vulnerable populations, including incarcerated participants. In addition, future research should investigate factors that affect poor comprehension in potential research participants.
Ahalt C, Sudore R, Bolano M, Metzger L, Darby AM, Williams B. “Teach-to-Goal” to better assess informed consent comprehension among incarcerated clinical research participants. AMA J Ethics. 2017;19(9):862-872.