Capacity to Consent to Research on Bipolar Disorder

同意双相情感障碍研究的能力

• 批准号: 8204571
• 负责人: Barton W. Palmer
• 金额: $ 30.92万
• 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/8204571
• 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; Health; Heterogeneity; Impairment; Informed Consent; Institutional Review Boards; Justice; Knowledge; Length; Longitudinal Studies; Manic; Measures; Mediating; Medical; Mental Depression; 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 Personnel; Risk; Role; Sampling; Schizophrenia; Severities; Source; Substance Addiction; Substance abuse problem; Symptoms; Time; Variant; Visit; Writing; authority; cognitive function; comparison group; decision-making capacity; depressive symptoms; effective therapy; experience; follow-up; improved; insight; interest; meetings; mental state; middle age; neuropsychiatry; neuropsychological; older patient; 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缺陷可能会对某些患者同意参与此类研究的能力产生不利影响。除了我们从中年和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，还没有关于双相情感障碍患者同意研究的能力的已发表研究。拟议的纵向研究的目标是确定与 172 名 I 型或 II 型双相情感障碍患者以及 118 名健康对照受试者的临床和人口统计学异质样本中同意研究的能力水平和稳定性相关的因素（ HC）。我们还将评估通过交互式披露流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，决策能力、精神病理学严重程度、洞察力缺陷和神经心理学功能将在基线、6、12 和 26 周就诊时进行系统评估。我们假设双相情感障碍患者相对于正常人来说在决策能力上会表现出显着的缺陷，但组内也会存在相当大的异质性；人与人之间决策能力的差异与认知缺陷的程度的关系比与精神病理学或洞察力缺陷的严重程度的关系更密切。然而，随着时间的推移，人体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，先前的情感发作次数将与较差的决策能力相关，但这种关系将通过多次情感发作对认知功能的有害影响来调节，并且所有参与者的理解水平将通过迭代披露而提高过程。这项研究将具有很高的公共卫生和生物伦理意义，因为双相情感障碍的临床研究仍然存在明显的需求，但缺乏经验数据来指导政策和研究人员在确保有效的初始试验方面对此类参与者进行伦理登记。并持续知情同意。公共卫生相关性：双相情感障碍的特点是精神状态波动，这可能与患者对参与研究给予有意义同意的能力有关，但双相情感障碍患者的研究决策能力几乎没有受到实证关注。因此，患者、研究者、IRB、利益相关者倡导团体和监管机构缺乏必要的经验信息来指导决策，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，以确保双相情感障碍临床研究中患者的道德入组紊乱。拟议研究中收集的数据将成为填补这一重要信息空白的关键组成部分。