McDermott Barbara E, Gerbasi Joan B, Quanbeck Cameron, Scott Charles L
Department of Psychiatry, Forensic Division, UC Davis School of Medicine, 2230 Stockton Boulevard, Sacramento, CA 95817, USA.
J Am Acad Psychiatry Law. 2005;33(3):299-307.
The ability of psychiatric patients and prisoners to provide informed consent to participate in clinical research has given rise to much debate. Forensic psychiatric patients present a particular concern regarding their competence to consent to research, as they are both patients and prisoners. The primary goal of this research was to evaluate whether, by employing structured assessments of capacity to consent to research, we could determine if this combined vulnerability leads to differences in competence from the published abilities of nonforensic psychiatric patients. Subjects deemed incapable of providing informed consent scored differently and lower than the other consent groups on three aspects of the decision-making process. Diagnosis evidenced only a slight relationship to decision-making abilities, and this difference was only in the ability to understand the basic procedural elements of the research. Psychiatric symptoms were modestly related to decision-making. Positive symptoms were associated with poorer performance on the Understanding subscale of the MacCAT-CR, and negative symptoms were associated with lowered performance on the Reasoning subscale. These results are in accord with several published studies of nonforensic psychiatric patients and suggest that concerns regarding both forensic and nonforensic psychiatric patients' ability to provide informed consent may be unwarranted, especially in patients with few active symptoms.
精神病患者和囚犯参与临床研究时提供知情同意的能力引发了诸多争议。法医精神病患者在同意参与研究的能力方面存在特殊问题，因为他们既是患者又是囚犯。本研究的主要目的是评估通过采用对研究同意能力的结构化评估，我们是否能够确定这种双重脆弱性是否会导致其同意能力与已发表的非法医精神病患者的能力存在差异。被认为无能力提供知情同意的受试者在决策过程的三个方面得分与其他同意组不同且更低。诊断仅与决策能力有轻微关联，且这种差异仅体现在理解研究基本程序要素的能力上。精神症状与决策有一定关联。阳性症状与MacCAT-CR理解子量表上较差的表现相关，阴性症状与推理子量表上较低的表现相关。这些结果与几项已发表的关于非法医精神病患者的研究一致，表明对法医和非法医精神病患者提供知情同意能力的担忧可能是不必要的，尤其是在症状较少的患者中。
