Misra Sahana, Socherman Robert, Hauser Peter, Ganzini Linda
Portland Veterans Affairs Medical Center, Portland, OR, USA.
Bipolar Disord. 2008 Jul;10(5):635-46. doi: 10.1111/j.1399-5618.2008.00609.x.
Ethicists have debated whether patients with serious mental illness can appreciate the risks of research participation and make autonomous decisions. We compared the abilities of euthymic and manic bipolar patients to appreciate and make voluntary decisions regarding research participation.
Twenty-six subjects with mania and 25 euthymic subjects reviewed hypothetical consent forms for three research studies of varying risk. We assessed subjects' appreciation of: their diagnosis and need for treatment; the researcher's role; the risks of participation; and the degree of influence of family, the treating clinician, and payment on decisions to participate.
Most subjects (92%) agreed they had bipolar disorder requiring medication treatment. Subjects were less likely to participate in riskier studies. About half of subjects erroneously believed that researchers would make decisions based solely on what would be the best care for them (therapeutic misconception); and in randomized medication trials, they mistakenly believed they had improved chances of receiving one treatment over another. There were no differences between mood groups on these measures. Over half of subjects (59%) indicated that their mental health provider might influence them to participate in a study even when they did not want to, but most rejected a role for family in decision making. Payment was rated as having little impact on decisions to participate in research.
Mania does not substantially influence appreciation of research participation. Subjects with bipolar disorder, regardless of mood state, are at risk for therapeutic misconception and optimistic bias. Special protections may be needed when mental health professionals approach their own patients to participate in research.
伦理学家一直在争论患有严重精神疾病的患者是否能够理解参与研究的风险并做出自主决定。我们比较了心境正常的双相情感障碍患者和躁狂发作的双相情感障碍患者对参与研究的理解能力以及做出自愿决定的能力。
26名躁狂发作的受试者和25名心境正常的受试者审阅了针对三项风险各异的研究的假设性同意书。我们评估了受试者对以下方面的理解：他们的诊断和治疗需求；研究人员的角色；参与研究的风险；以及家庭、主治医生和报酬对参与研究决定的影响程度。
大多数受试者（92%）同意他们患有需要药物治疗的双相情感障碍。受试者参与风险更高研究的可能性较小。约一半的受试者错误地认为研究人员会仅基于对他们而言什么是最佳治疗来做出决定（治疗性误解）；并且在随机药物试验中，他们错误地认为自己接受一种治疗比另一种治疗的机会更大。在这些指标上，不同情绪组之间没有差异。超过一半的受试者（59%）表示他们的心理健康提供者可能会影响他们参与一项研究，即使他们不想参与，但大多数人拒绝让家人在决策中发挥作用。报酬被认为对参与研究的决定影响不大。
躁狂发作并不会实质性地影响对参与研究的理解。双相情感障碍患者，无论情绪状态如何，都有治疗性误解和乐观偏差的风险。当心理健康专业人员让自己的患者参与研究时，可能需要特别的保护措施。
