Capacity to Consent to Research on Bipolar Disorder

描述（由申请人提供）：显然需要对双相情感障碍进行持续的临床研究，以确定更有效的治疗方法。然而，通常与这种情况相关的主要情感症状以及洞察力和认知功能的缺陷可能对一些患者同意参加此类研究的能力产生不利影响。除了我们从中老年双相患者的小样本中获得的初步数据外，还没有发表过关于双相患者同意研究能力的研究。提出的纵向研究的目标是在172例双相I或II型障碍患者的临床和人口统计学异质性样本中，以及118例健康对照受试者（hc）中，确定与同意研究能力水平和稳定性相关的因素。我们还将评估通过交互式披露过程提高对披露信息理解的程度。采用标准的测量方法，决策能力、精神病理严重程度、洞察力缺陷和神经心理功能将在基线、6周、12周和26周就诊时进行系统评估。我们假设双相患者在决策能力方面相对于hc患者会有明显的缺陷，但组内存在相当大的异质性；人与人之间的决策能力差异与认知缺陷水平的关系比与精神病理或洞察力缺陷的严重程度的关系更强。然而，随着时间的推移，个人内部的可变性将是精神病理学和洞察力变化的一个功能。我们还假设，先前情感事件的数量将与较差的决策能力有关，但这种关系将被多重情感事件对认知功能的有害影响所调节，并且所有参与者之间的理解水平将通过反复的披露过程得到改善。这项研究将具有很高的公共卫生和生物伦理意义，因为仍然需要对双相情感障碍进行临床研究，但缺乏经验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进行道德登记。公共卫生相关性：双相情感障碍的特点是精神状态的波动，这可能与患者对研究参与给予有意义的同意的能力有关，但双相情感障碍患者的研究决策能力几乎没有得到实证关注。因此，患者、研究者、伦理委员会、利益相关者倡导团体和监管机构缺乏必要的经验信息，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是必要的，并且可以有效地确保在双相情感障碍临床研究中伦理地招募患者。在拟议的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.