Surrogate Consent in Research

描述（由申请人提供）：决策障碍成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，目前尚不清楚IRB和代理同意的做法如何在研究中保护这些人，特别是在重症监护环境中，代理人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。这项建议的主要目的，是从审查委员会和病人及其代理人的角度，研究向病情严重而无法同意的成年人提供的保护。具体而言，我们的目标是：1）确定IRB在研究中保护决策受损成年人的做法的可变性; 2）评估患者及其代理人对重症监护环境中具有不同风险/受益比的研究的看法。在SA #1中，将对IRB主席进行横断面调查，以确定IRB根据州、联邦资助金额和涉及精神疾病或痴呆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变异性，多变量分析和MANACOVA将用于确定与资金和经验的相关性。在SA #2中，将对重症监护室的患者和代理人进行调查，了解他们对代理人决策的看法，并询问他们是否会将患者入组具有不同风险/获益比的假设研究（有和没有基因检测）。将使用加权和未加权Kappa评分确定患者与其代理人之间关于患者是否参与这些研究的一致性。使用因素分析和重复测量方差分析，患者-代理协议的程度将与研究的相对风险和潜在益处以及是否建议进行基因检测相关。这项建议与健康有着重要的关系。在研究中保护无行为能力的成年人直接涉及PA：人类研究中的伦理问题研究，并且是紧急和重症监护环境中研究中日益重要的问题。这项研究提案与公共卫生有关，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人为代价。

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.