“以目标为导向教学”以更好地评估被监禁的临床研究参与者对知情同意的理解
"Teach-to-Goal" to Better Assess Informed Consent Comprehension among Incarcerated Clinical Research Participants.
作者信息
Ahalt Cyrus, Sudore Rebecca, Bolano Marielle, Metzger Lia, Darby Anna M, Williams Brie
机构信息
A researcher and policy analyst in the Department of Medicine at the University of California, San Francisco.
A professor of medicine at the University of California, San Francisco, where she serves as a geriatrician, palliative medicine physician, and clinician investigator.
出版信息
AMA J Ethics. 2017 Sep 1;19(9):862-872. doi: 10.1001/journalofethics.2017.19.9.peer3-1709.
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.
惩教健康研究需要重要的保障措施，以确保研究参与在伦理上得以进行。除了教育程度和识字率极低之外，被监禁者还患有可能影响认知的健康相关疾病（例如创伤性脑损伤、物质使用障碍、精神疾病）。然而，相关联邦指南并未要求采用经过修改的知情同意程序来评估参与者对参与研究的风险和益处的理解。鉴于刑事司法改革背景下对惩教健康研究的需求增加，推动对知情同意文件理解情况的评估尤为及时。我们认为，理解情况评估可以识别出应被排除在研究之外的人员，并帮助那些最终将参与研究的人更好地理解参与研究的风险和益处。
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