IRB Member Assessment of Decisional Capacity in Psychiatric and Medical Research

描述（由申请人提供）：在其他职责中，irb负责保护弱势主体。初步研究显示，IRB成员对决策能力和自主性的判断差异与试验的主要目的（神经精神病学与医学）有关。假设的神经精神病学试验的参与者被认为比医学试验的参与者更没有能力提供知情同意，即使医学受试者的诊断经常与神经精神合并症有关。结果表明，有两个过程可能影响人类受试者的IRB保护：1)内科患者倾向于忽视决策脆弱性；2)神经精神患者对此类脆弱性的潜在超敏感性。拟议的研究将阐明初步研究结果背后的机制。使用ohrp注册的irb的系统随机样本，将随机选择正式成员，并要求评估在小插曲中描述的有资格参加临床试验的受试者的决策能力和自主性。两项试验涉及健康状况（III期结肠癌、神经性疼痛）。对于每一种健康状况，关于抑郁的信息会有所不同，从而产生三种程度的抑郁显著性：1)不存在抑郁信息，2)存在描述性抑郁信息，以及3)以抑郁为研究参数的描述性信息。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)抑郁信息的纳入及其显著性是否影响医学诊断研究对象的决策能力判断，以及2)精神病学试验参与者的判断是否与以抑郁为研究参数的医学试验参与者的判断不同。每个实验条件的一部分参与者将完成一项态度测量，以评估精神病耻感是否与决策能力评估有关。另一部分参与者将不会接受污名化措施。接受测试的参与者的判断将与未接受测试的参与者的判断进行比较，以确定该测试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.