Capacity to Consent to Research on Bipolar Disorder

描述(由申请人提供)：显然有必要对双相情感障碍进行临床研究，以确定更有效的治疗方法。然而，主要的情感症状，以及通常与这种情况相关的自知力和认知功能缺陷，可能会对一些患者同意参与此类研究的能力产生不利影响。除了我们从中老年双相情感障碍患者的小范围样本中获得的初步数据外，还没有发表过关于双相情感障碍患者同意研究的能力的研究。拟议的纵向研究的目标是在临床和人口统计学上不同的172名双相I或II障碍患者以及118名健康对照受试者(HCS)中确定与同意研究能力水平和稳定性相关的因素。我们还将评估通过互动披露过程可以在多大程度上提高对披露信息的理解。使用标准测量方法，将在基线、6周、12周和26周的访问中系统地评估决策能力、精神病理学的严重性、自知力缺陷和神经心理功能。我们假设双相情感障碍患者在决策能力方面将表现出与HCS相关的显著缺陷，但组内将存在相当大的异质性；人与人之间在决策能力上的差异与认知缺陷水平的相关性更强，而不是与精神病或自知力缺陷的严重程度有关。然而，随着时间的推移，人内的变异性将是精神病理学和洞察力变化的函数。我们还假设，先前情感发作的数量将与较差的决策能力有关，但这种关系将被多个情感发作对认知功能的有害影响所中介，并且所有参与者之间的理解水平将通过迭代披露过程而提高。这项研究将具有很高的公共卫生和生物伦理学意义，因为双相情感障碍的临床研究仍然存在明显的需求，但缺乏实证数据来指导政策和研究人员在确保有效的初始和持续知情同意方面对这类参与者的伦理登记。公共卫生相关性：双相情感障碍的特征是精神状态的波动，这可能与患者对参与研究给予有意义的同意的能力有关，但双相患者的研究决策能力几乎没有得到经验上的关注。因此，患者、研究人员、IRBs、利益相关者倡导团体和监管当局缺乏基本的经验信息，无法为决策提供信息，例如是否、何时以及何种形式的额外保护可能是必要的和有效的，以确保患者在双相情感障碍的临床研究中进行伦理登记。拟议研究中收集的数据将是填补这一重要信息空白的关键组成部分。

DESCRIPTION (provided by applicant): There is a clear need for ongoing clinical research on bipolar disorder to identify more effective treatments. However, the primary affective symptoms, and deficits in insight and cognitive functioning that are often associated with this condition, may adversely affect the capacity of some patients to consent to participate in such research. With the exception of our preliminary data from a small circumscribed sample of middle-aged and older bipolar patients, there have been no published studies of capacity to consent to research among bipolar patients. The goals of the proposed longitudinal study are to identify the factors associated with the level and stability of capacity to consent to research among a clinically and demographically heterogeneous sample of 172 people with bipolar I or II disorder, as well as among 118 healthy comparison subjects (HCs). We will also evaluate the degree to which understanding of disclosed information can be improved through an interactive disclosure process. Using standard measures, decisional capacity, severity of psychopathology, insight deficits, and neuropsychological functioning will be systematically evaluated at baseline, 6-, 12-, and 26- week visits. We hypothesize that bipolar patients will show significant deficits in decisional capacity relative to HCs, but there will be considerable within-group heterogeneity; between person differences in decisional capacity will be more strongly related to level of cognitive deficits than to severity of psychopathology or insight deficits. However, within-person variability over time will be a function of changes in psychopathology and insight. We also hypothesize that the number of prior affective episodes will be related to worse decisional capacity, but that this relationship will be mediated by the deleterious effects of multiple affective episodes on cognitive functioning and that levels of understanding among all participants will improve through an iterative disclosure process. This study will have high public health and bioethical significance, as there remains a clear need for clinical research in bipolar disorder, but there is a lack of empirical data to guide policy and researchers regarding the ethical enrollment of such participants in terms of ensuring valid initial and continuing informed consent. PUBLIC HEALTH RELEVANCE: Bipolar disorder is characterized by fluctuations in mental status which may be relevant to patients' capacity to give meaningful consent to research participation, but decision-making capacity for research among bipolar patients has received almost no empirical attention. Thus, patients, investigators, IRBs, stakeholder advocacy groups, and regulatory authorities lack essential empirical information to inform decisions such as if, when, and what form of additional protections may be warranted and effective to ensure ethical enrollment of patients in clinical research on bipolar disorder. The data collected in the proposed study will be a key component in filling this vital informational gap.