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）：决策障碍成年人在临床研究中受到机构审查委员会 (IRB) 和患者授权代表或代理人的保护。然而，尚不清楚IRB和代孕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，当代孕妈妈本身可能被认为是脆弱的时，或者在涉及基因测试的研究中，代孕妈妈可能有潜在的利益冲突。该提案的总体目标是从 IRB 以及患者及其代理人的角度来审查向因病重而无法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 在保护研究中决策障碍成年人方面的做法的可变性；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、联邦资金数额以及涉及精神疾病或痴呆症患者的研究经验建立的保障措施数量和类型的变化。聚类分析将用于确定变异性和多变量分析，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或没有基因检测的不同风险/收益比的假设研究中。患者及其代理人之间关于患者是否参加这些研究的协议将使用加权和未加权的 Kappa 分数来确定。使用因子分析和重复测量方差分析，患者与代理人的一致性程度将与研究的相对风险和潜在益处以及是否提出基因检测相关。该提案具有重要的健康相关性。研究中对无行为能力成年人的保护直接涉及 PA：人类研究中的伦理问题研究，并且是紧急和重症监护领域研究中日益重要的问题。该研究提案与公共卫生相关，因为它适用于几乎所有有关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损害我们当中最脆弱的群体为代价。