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AMA J Ethics. 2017 Sep 1;19(9):862-872. doi: 10.1001/journalofethics.2017.19.9.peer3-1709.

"Teach-to-Goal" to Better Assess Informed Consent Comprehension among Incarcerated Clinical Research Participants.

Author information

1
A researcher and policy analyst in the Department of Medicine at the University of California, San Francisco.
2
A professor of medicine at the University of California, San Francisco, where she serves as a geriatrician, palliative medicine physician, and clinician investigator.
3
A fourth-year medical student at the University of California, Davis School of Medicine, and worked at the University of California, San Francisco Division of Geriatrics as a research assistant.
4
An assistant clinical research coordinator for the Division of Geriatrics at the University of California, San Francisco.
5
A second-year emergency medicine resident at Los Angeles County + USC Medical Center, where she works in the dedicated Jail Emergency Department that serves Los Angeles County, and worked as a litigation assistant at the Prison Law Office advocating for prisoners' health care needs and as a National Institute on Aging Medical Student Training in Aging Research Fellow at the University of California, San Francisco.
6
A professor of medicine in the Division of Geriatrics at the University of California, San Francisco.

Abstract

Correctional health research requires important safeguards to ensure that research participation is ethically conducted. In addition to having disproportionately low educational attainment and low literacy, incarcerated people suffer from health-related conditions that can affect cognition (e.g., traumatic brain injury, substance use disorders, mental illness). Yet modified informed consent processes that assess participants' comprehension of the risks and benefits of participation are not required by relevant federal guidelines. A push to assess comprehension of informed consent documents is particularly timely given an increase in demand for correctional health research in the context of criminal justice reform. We argue that comprehension assessments can identify persons who should be excluded from research and help those who will ultimately participate in studies better understand the risks and benefits of their participation.

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