Surrogate Consent in Research

描述(由申请人提供)：在机构审查委员会(IRBs)和患者的授权代表或代理人一级的临床研究中，决定受损的成年人受到保护。然而，在研究中，特别是在代孕者本身可能被认为是脆弱的危重护理环境中，或者在涉及代孕者可能存在潜在利益冲突的基因检测的研究中，IRBs和代孕同意的做法如何保护这些个人尚不清楚。这项提案的广泛目标是从IRBs和患者及其代理人的角度审查为病情严重而不能同意的成年人提供的保护。具体地说，我们的目标是1)确定IRBs在研究中保护决定性受损成年人的做法的变异性，以及2)评估患者及其代理人对危重护理环境中风险/收益比率不同的研究的看法。在SA#1中，将对IRB主席进行横断面调查，以确定IRB根据州、联邦资助额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异性。将使用集群分析来确定可变性和多变量分析，并将使用MANACOVA来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孕者将被调查他们对代孕决策的看法，并被问及他们是否会将患者纳入具有不同风险/收益比率的假设性研究，包括基因测试和不进行基因测试。患者和他们的代理人之间是否同意患者是否会参与这些研究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的方差分析，患者-代孕协议的程度将与研究的相对风险和潜在利益以及是否提出基因检测相关。这项建议具有重要的健康相关性。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，并成为紧急和危重护理环境下研究中日益重要的问题。这项研究建议与公共卫生有关，因为它适用于几乎任何关于急性或严重疾病的研究。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，以确保医学方面的重要进展不会以损害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.