Surrogate Consent in Research

Summary

Principal Investigator: MICHELLE GONG
Affiliation: Montefiore Medical Center
Country: USA
Abstract: 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.
Funding Period: 2006-08-04 - 2011-06-30
more information: NIH RePORT

Top Publications

  1. ncbi Genetic epidemiology of acute respiratory distress syndrome: implications for future prevention and treatment
    Michelle Ng Gong
    Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Mount Sinai School of Medicine, New York, NY 10029, USA
    Clin Chest Med 27:705-24; abstract x. 2006
  2. ncbi Polymorphisms in the mannose binding lectin-2 gene and acute respiratory distress syndrome
    Michelle N Gong
    Pulmonary and Critical Care Unit, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02115, USA
    Crit Care Med 35:48-56. 2007
  3. ncbi Early versus late intravenous insulin administration in critically ill patients
    Shyoko Honiden
    Section of Pulmonary and Critical Care Medicine, Department of Medicine, Yale University School of Medicine, New Haven, CT, USA
    Intensive Care Med 34:881-7. 2008
  4. ncbi Diabetes, insulin, and development of acute lung injury
    Shyoko Honiden
    Department of Medicine, Section of Pulmonary and Critical Care Medicine, Yale University School of Medicine, New Haven, Connecticut, USA
    Crit Care Med 37:2455-64. 2009

Detail Information

Publications5

  1. ncbi Genetic epidemiology of acute respiratory distress syndrome: implications for future prevention and treatment
    Michelle Ng Gong
    Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Mount Sinai School of Medicine, New York, NY 10029, USA
    Clin Chest Med 27:705-24; abstract x. 2006
    ..The challenges and potential contributions of genetic epidemiology to the future prevention and treatment in ALI are discussed...
  2. ncbi Polymorphisms in the mannose binding lectin-2 gene and acute respiratory distress syndrome
    Michelle N Gong
    Pulmonary and Critical Care Unit, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02115, USA
    Crit Care Med 35:48-56. 2007
    ..We postulate that the variant MBL-2 genotypes are associated with increased susceptibility to and mortality in acute respiratory distress syndrome (ARDS)...
  3. ncbi Early versus late intravenous insulin administration in critically ill patients
    Shyoko Honiden
    Section of Pulmonary and Critical Care Medicine, Department of Medicine, Yale University School of Medicine, New Haven, CT, USA
    Intensive Care Med 34:881-7. 2008
    ..To investigate whether timing of intensive insulin therapy (IIT) after intensive care unit (ICU) admission influences outcome...
  4. ncbi Diabetes, insulin, and development of acute lung injury
    Shyoko Honiden
    Department of Medicine, Section of Pulmonary and Critical Care Medicine, Yale University School of Medicine, New Haven, Connecticut, USA
    Crit Care Med 37:2455-64. 2009
    ....