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.
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