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Surrogate Consent in Research

研究中的替代同意书

基本信息

批准号：
7868027
负责人：
MICHELLE Ng GONG
金额：
$ 40.3万
依托单位：
ALBERT EINSTEIN COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-08-04 至 2012-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7868027
关键词：
Acute Address Adult Agreement Analysis of Variance Benefits and Risks Child Clinical Research Cluster Analysis Conflict of Interest Consent Critical Care Cross-Sectional Studies Decision Making Dementia Dependence Emergency Situation Enrollment Ensure Ethical Issues Ethics Factor Analysis Family member Funding Future Genetic Genetic screening method Health Human Impaired cognition Impairment Individual Informed Consent Institution Intensive Care Units Laws Left Measures Medical Medicine Mental disorders Multivariate Analysis New York Patient Participation Patient Preferences Patients Police Process Public Health Regulation Relative Risks Research Research Ethics Committees Research Proposals Research Subjects Risk Surveys Vacuum Vulnerable Populations Weight common rule cost experience research study response risk benefit ratio

项目摘要

DESCRIPTION (provided by applicant): Decisionally impaired adults are protected in clinical research at the level of the institutional review boards (IRBs) and the authorized representative or surrogate of the patient. However, it is not clear how IRBs and the practice of surrogate consent protect these individuals in research especially in the critical care setting when surrogates may be considered vulnerable themselves or in studies involving genetic testing where the surrogates may have a potential conflict of interest. The broad objective of this proposal is to examine the protections afforded to adults who are too sick to consent from the perspective of the IRBs and the patients and their surrogates. Specifically we aim to 1) determine the variability in IRBs' practices in protecting decisionally impaired adults in research and 2) to assess the views of patient and their surrogates' towards research with differing risk/benefit ratios in the critical care setting. In SA #1, a cross-sectional survey of IRB chairs will be conducted to determine the variability in the number and types of safeguards established by the IRBs according to state, amount of federal funding and experience with research involving patients with mental illness or dementia. Cluster analyses will be used to determine variability and multivariate analyses and MANACOVA will be used to determine correlation with funding and experience. In SA #2, patients and surrogates in intensive care units will be surveyed about their views of surrogate decision making and asked if they would enroll the patient into hypothetical studies with differing risk/benefit ratios with and without genetic testing. Agreement between patients and their surrogates on whether the patient would participate in these studies will be determined using weighted and unweighted Kappa scores. Using factor analyses and Repeated Measures Analysis of Variance, the extent of patient-surrogate agreement will be correlated with the relative risks and potential benefit of the studies and with whether or not genetic testing was proposed. This proposal has important health relatedness. The protection of incapable adults in research directly addresses the PA: Research on Ethical Issues in Human Studies and is an increasingly important issue in research in the emergency and critical care setting. This research proposal is relevant to public health as it applies to almost any research on acute or serious medical conditions. Results from this study will inform the current debate and guide future polices so as to ensure that important advances in medicine does not come at the cost of compromising the most vulnerable among us.

描述（由申请人提供）：在机构审查委员会（irb）和患者的授权代表或代理人的层面上，决定性受损的成年人在临床研究中受到保护。然而，目前尚不清楚irb和代理人同意的做法如何在研究中保护这些个体，特别是在重症监护环境中，当代理人本身可能被认为是脆弱的，或者在涉及基因检测的研究中，代理人可能有潜在的利益冲突。这项提案的主要目的是从伦理委员会和病人及其代理人的角度，审查对那些病得太严重而不能同意的成年人提供的保护。具体来说，我们的目标是1)确定irb在研究中保护决策障碍成人的做法的可变性；2)评估患者及其代理人对重症监护环境中不同风险/收益比的研究的看法。在SA #1中，将对IRB主席进行横断面调查，以确定IRB根据州、联邦资金的数量和涉及精神疾病或痴呆症患者的研究经验建立的保障措施的数量和类型的变化。聚类分析将用于确定可变性和多变量分析，MANACOVA将用于确定与资金和经验的相关性。在SA #2中，重症监护病房的患者和代理人将接受调查，了解他们对代理人决策的看法，并询问他们是否会将患者纳入有基因检测和没有基因检测的不同风险/收益比的假设研究中。患者及其代理人对患者是否参加这些研究的同意将使用加权和未加权Kappa评分来确定。使用因子分析和重复测量方差分析，患者-代孕者的一致程度将与研究的相对风险和潜在获益以及是否提出基因检测相关。这一建议与健康有重要关系。在研究中对无行为能力成年人的保护直接解决了人类研究中的伦理问题，并且在紧急和重症监护环境的研究中日益重要。这项研究计划与公共卫生有关，因为它适用于几乎所有关于急性或严重医疗状况的研究。这项研究的结果将为当前的辩论提供信息，并指导未来的政策，以确保医学的重要进步不会以牺牲我们中最脆弱的群体为代价。