Capacity to Consent to Research on Bipolar Disorder

同意双相情感障碍研究的能力

• 批准号: 7629022
• 负责人: Barton W. Palmer
• 金额: $ 31.59万
• 依托单位: VETERANS MEDICAL RESEARCH FDN/SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-12-01 至 2013-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7629022
• 关键词: Address; Advocacy; Affect; Affective; Affective Symptoms; Alcohols; Attention; Beneficence; Benefits and Risks; Bioethics; Bipolar Disorder; Characteristics; Chronic; Clinical; Clinical Research; Clinical trial protocol document; Cognitive; Cognitive deficits; Comorbidity; Complex; Consent; Data; Decision Making; Disclosure; Disease; Effectiveness; Elements; Enrollment; Ensure; Equilibrium; Ethics; Evaluation; Foundations; Frequencies; Funding; Future; Goals; Heterogeneity; Impairment; Informed Consent; Justice; Knowledge; Length; Longitudinal Studies; Manic; Measures; Mediating; Medical; Mental disorders; Modeling; Moods; Nature; Neurobehavioral Manifestations; Onset of illness; Outpatients; Participant; Patients; Perception; Persons; Pharmaceutical Preparations; Phase III Clinical Trials; Placebo Control; Policies; Process; Protocols documentation; Psychopathology; Psychotic Disorders; Public Health; Publishing; Randomized; Recording of previous events; Recurrence; Relative (related person); Reporting; Research; Research Design; Research Ethics Committees; Research Personnel; Risk; Role; Sampling; Schizophrenia; Severities; Source; Substance Addiction; Substance abuse problem; Symptoms; Time; Variant; Visit; Writing; authority; cognitive function; decision-making capacity; depression; depressive symptoms; disability; effective therapy; experience; follow-up; functional disability; improved; insight; interest; meetings; mental state; middle age; neuropsychiatry; neuropsychological; older patient; public health relevance; remediation; response; risk perception; skills; standard care; standard measure; treatment as usual; willingness

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.

描述（由申请人提供）：显然需要对躁郁症进行持续的临床研究，以识别更有效的治疗方法。但是，通常与这种情况相关的洞察力和认知功能缺陷的主要情感症状，可能会对某些患者同意参加此类研究的能力产生不利影响。除了我们的初步数据来自一小部分的中年和年长的双极患者样本外，还没有公开的对双极患者研究能力进行研究的研究。拟议的纵向研究的目标是确定与临床和人口统计学异质样本中172名双极I或II或II障碍患者以及118名健康比较受试者（HCS）中的172名患者（HCS）中的同意能力的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可以改善对公开信息的理解的程度。使用标准措施，决策能力，心理病理学的严重程度，洞察力缺陷和神经心理学功能将在基线，6-，12-和26周访问时进行系统评估。我们假设双极患者相对于HCS，双极患者的决策能力会出现严重的缺陷，但是组内异质性将有相当大的差。在人之间的差异之间，决策能力的差异将与认知缺陷的水平更密切，而不是与精神病理学或洞察力缺陷的严重程度。但是，随着时间的流逝，人体内变异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，但是这种关系将由多个情感发作对认知功能的有害影响介导，并且所有参与者之间的理解水平将通过迭代披露过程提高。这项研究将具有很高的公共卫生和生物伦理意义，因为仍然需要对躁郁症进行临床研究，但是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此类参与者的道德入学人数。公共卫生相关性：双相情感障碍的特征是心理状况的波动，这可能与患者给予有意义的研究参与的能力有关，但是双极患者研究的决策能力几乎没有得到经验的关注。因此，患者，研究人员，IRB，利益相关者的倡导群体和监管机构缺乏基本的经验信息，无法为诸如何时，何时以及哪种形式的其他保护措施有效且有效，以确保患者对双相情感障碍的临床研究的道德注入。拟议研究中收集的数据将是填补这一重要信息差距的关键组成部分。