IRB Member Assessment of Decisional Capacity in Psychiatric and Medical Research

描述（由申请人提供）：除其他职责外，IRB负责保护弱势受试者。一项初步研究显示，IRB成员对与试验主要目的（神经精神与医学）相关的决策能力和自主性的判断存在差异。假设的神经精神试验的参与者被认为比医学试验的参与者提供知情同意的能力更低，即使医学受试者的诊断经常与神经精神共病相关。研究结果表明，有两个过程可能影响IRB对人类受试者的保护：1）倾向于低估医疗患者的决策脆弱性，2）神经精神病患者对此类脆弱性的潜在超敏感性。拟议的研究将澄清初步调查结果背后的机制。使用OHRP注册的IRB的系统性随机样本，将随机选择正式成员，并要求其评估符合临床试验条件的小插曲中描述的受试者的决策能力和自主权。两项试验涉及健康状况（III期结肠癌，神经性疼痛）。对于每种健康状况，有关抑郁症的信息将有所不同，以创建三个级别的抑郁症显着性：1）抑郁症信息缺失，2）描述性抑郁症信息存在，以及3）描述性信息存在抑郁症作为研究参数。一项针对重度抑郁症患者的精神病学试验也将被描述。我们将评估1）抑郁症信息及其显著性的纳入是否会影响对有医学诊断的研究对象的决策能力的判断，以及2）精神病学试验中的参与者的判断是否与以抑郁症为研究参数的医学试验中的参与者的判断不同。每个实验条件下的一个参与者子集将完成一项态度测量，以评估精神病污名是否与决策能力评估相关。另一部分参与者将不会接受污名化措施。接受该措施的参与者的判断将与未接受该措施的参与者进行比较，以确定该措施是否使受试者对精神问题敏感。

DESCRIPTION (provided by applicant): Among other duties, IRBs are charged with protection of vulnerable subjects. A preliminary study showed differences in IRB member judgments of decisional capacity and autonomy related to the primary purpose of the trial (neuropsychiatric versus medical). Participants in hypothetical neuropsychiatric trials were viewed as less capable of providing informed consent than participants in medical trials, even though medical subjects had diagnoses that are frequently associated with neuropsychiatric co-morbidities. The results suggests two processes that could impact IRB protection of human subjects: 1) a tendency to discount decisional vulnerabilities in medical patients, and 2) a potential hyper-sensitivity to such vulnerabilities among neuropsychiatric patients. The proposed study will clarify mechanisms underlying the preliminary findings. Using a systematic, random sample of OHRP-registered IRBs, full members will be randomly selected and asked to evaluate decisional capacity and autonomy for subjects described in a vignettes that are eligible for a clinical trial. Two trials involve health conditions (stage III colon cancer, neuropathic pain). For each health condition, information on depression will be varied to create three levels of depression salience: 1) depression information absent, 2) descriptive depression information present, and 3) descriptive information present with depression as a research parameter. A psychiatric trial for patients with major depression also will be described. We will evaluate 1) whether the inclusion of depression information and its salience affects judgments of decisional capacity for research subjects with medical diagnoses, and 2) whether judgments of participants in psychiatric trials differ from those in the medical trials with depression as a study parameter. A subset of participants in each experimental condition will complete an attitude measure to assess whether psychiatric stigma is associated with evaluations of decisional capacity. Another subset of participants will not receive the stigmatization measure. Judgments of participants who received the measure will be compared to those who did not to determine whether the measure sensitized subjects to psychiatric issues.