Surrogate Consent in Research

Summary

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

Top Publications

  1. pmc Healthcare disparities in critical illness
    Graciela J Soto
    1Division of Critical Care Medicine, Department of Medicine, Jay B Langner Critical Care Service, Montefiore Medical Center, Bronx, NY 2Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Emory University, Grady Memorial Hospital, Atlanta, GA 3Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY
    Crit Care Med 41:2784-93. 2013
  2. pmc Prognostic and diagnostic value of plasma soluble suppression of tumorigenicity-2 concentrations in acute respiratory distress syndrome
    Ednan K Bajwa
    1Pulmonary and Critical Care Unit, Department of Medicine, Massachusetts General Hospital, Boston, MA 2Department of Medicine, Massachusetts General Hospital, Boston, MA 3Department of Environmental Health, Harvard School of Public Health, Boston, MA 4Department of Anesthesia, University of California San Francisco, San Francisco, CA 5Cardiology Division, Department of Medicine, Massachusetts General Hospital, Boston, MA
    Crit Care Med 41:2521-31. 2013
  3. pmc Sex, race, and the development of acute lung injury
    Luciano B Lemos-Filho
    Montefi ore Medical Center Albert Einstein College of Medicine, Bronx, NY, USA
    Chest 143:901-9. 2013
  4. pmc Contemporary ventilator management in patients with and at risk of ALI/ARDS
    Steven Y Chang
    Division of Pulmonary and Critical Care Medicine, University of Medicine and Dentistry of New Jersey, New Jersey Medical School, Newark, New Jersey 07103, USA
    Respir Care 58:578-88. 2013
  5. pmc Body mass index and acute kidney injury in the acute respiratory distress syndrome
    Graciela J Soto
    Division of Critical Care Medicine, Jay B Langner Critical Care Service, Department of Medicine, Montefiore Medical Center, Bronx, NY 10467, USA
    Crit Care Med 40:2601-8. 2012
  6. pmc Body mass index is associated with the development of acute respiratory distress syndrome
    M N Gong
    Division of Critical Care Medicine, Department of Medicine, Montefiore Medical Center, Bronx, New York, USA
    Thorax 65:44-50. 2010
  7. pmc Statins and outcomes in patients with bloodstream infection: a propensity-matched analysis
    Sharon Leung
    Division of Critical Care Medicine, Department of Medicine, Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA
    Crit Care Med 40:1064-71. 2012
  8. pmc Statin therapy as prevention against development of acute respiratory distress syndrome: an observational study
    Ednan K Bajwa
    Pulmonary and Critical Care Unit, Department of Medicine, Massachusetts General Hospital, and Department of Environmental and Occupational Health, Harvard School of Public Health, Boston, MA, USA
    Crit Care Med 40:1470-7. 2012
  9. pmc Pre-B-cell colony-enhancing factor and its clinical correlates with acute lung injury and sepsis
    Kathleen A Lee
    Department of Medicine, Rhode Island Hospital, Alpert Medical School of Brown University, Providence, RI, USA
    Chest 140:382-90. 2011
  10. pmc Surrogate consent for research involving adults with impaired decision making: survey of Institutional Review Board practices
    Michelle Ng Gong
    Division of Critical Care Medicine, Montefiore Medical Center, Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, USA
    Crit Care Med 38:2146-54. 2010

Scientific Experts

  • Ednan K Bajwa
  • MICHELLE GONG
  • Sharon Leung
  • Graciela J Soto
  • Shyoko Honiden
  • Greg S Martin
  • Ousama Dabbagh
  • Adebola Adesanya
  • Luciano B Lemos-Filho
  • Steven Y Chang
  • Kathleen A Lee
  • Pauline K Park
  • Harry L Anderson
  • Atul Malhotra
  • Marie Carmelle Elie
  • NINA GENTILE
  • Amee Patrawalla
  • Annette Esper
  • Ognen Gajic
  • Mark E Mikkelsen
  • Daniel S Talmor
  • Ognjen Gajic
  • James M Blum
  • David C Christiani
  • Angela J Frank
  • David M Nierman
  • Atara Schultz
  • Shelly A Im

Detail Information

Publications15

  1. pmc Healthcare disparities in critical illness
    Graciela J Soto
    1Division of Critical Care Medicine, Department of Medicine, Jay B Langner Critical Care Service, Montefiore Medical Center, Bronx, NY 2Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Emory University, Grady Memorial Hospital, Atlanta, GA 3Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY
    Crit Care Med 41:2784-93. 2013
    ..To summarize the current literature on racial and gender disparities in critical care and the mechanisms underlying these disparities in the course of acute critical illness...
  2. pmc Prognostic and diagnostic value of plasma soluble suppression of tumorigenicity-2 concentrations in acute respiratory distress syndrome
    Ednan K Bajwa
    1Pulmonary and Critical Care Unit, Department of Medicine, Massachusetts General Hospital, Boston, MA 2Department of Medicine, Massachusetts General Hospital, Boston, MA 3Department of Environmental Health, Harvard School of Public Health, Boston, MA 4Department of Anesthesia, University of California San Francisco, San Francisco, CA 5Cardiology Division, Department of Medicine, Massachusetts General Hospital, Boston, MA
    Crit Care Med 41:2521-31. 2013
    ....
  3. pmc Sex, race, and the development of acute lung injury
    Luciano B Lemos-Filho
    Montefi ore Medical Center Albert Einstein College of Medicine, Bronx, NY, USA
    Chest 143:901-9. 2013
    ..We sought to determine whether sexual and racial differences exist in the rate of ALI development and ALI-related mortality after accounting for differences in clinical presentations...
  4. pmc Contemporary ventilator management in patients with and at risk of ALI/ARDS
    Steven Y Chang
    Division of Pulmonary and Critical Care Medicine, University of Medicine and Dentistry of New Jersey, New Jersey Medical School, Newark, New Jersey 07103, USA
    Respir Care 58:578-88. 2013
    ..We examined factors associated with choice of set tidal volumes (VT), and whether VT < 8 mL/kg predicted body weight (PBW) relates to the development of ALI/ARDS...
  5. pmc Body mass index and acute kidney injury in the acute respiratory distress syndrome
    Graciela J Soto
    Division of Critical Care Medicine, Jay B Langner Critical Care Service, Department of Medicine, Montefiore Medical Center, Bronx, NY 10467, USA
    Crit Care Med 40:2601-8. 2012
    ....
  6. pmc Body mass index is associated with the development of acute respiratory distress syndrome
    M N Gong
    Division of Critical Care Medicine, Department of Medicine, Montefiore Medical Center, Bronx, New York, USA
    Thorax 65:44-50. 2010
    ..The relationship between body mass index (BMI) and development of acute respiratory distress syndrome (ARDS) is unknown...
  7. pmc Statins and outcomes in patients with bloodstream infection: a propensity-matched analysis
    Sharon Leung
    Division of Critical Care Medicine, Department of Medicine, Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA
    Crit Care Med 40:1064-71. 2012
    ..It was postulated that statins may be a good candidate as novel therapeutic agents for the treatment of sepsis. We investigated whether ongoing statin therapy is associated with mortality in patients with bloodstream infection...
  8. pmc Statin therapy as prevention against development of acute respiratory distress syndrome: an observational study
    Ednan K Bajwa
    Pulmonary and Critical Care Unit, Department of Medicine, Massachusetts General Hospital, and Department of Environmental and Occupational Health, Harvard School of Public Health, Boston, MA, USA
    Crit Care Med 40:1470-7. 2012
    ..We investigated whether previous statin therapy affects outcomes in patients at risk for acute respiratory distress syndrome...
  9. pmc Pre-B-cell colony-enhancing factor and its clinical correlates with acute lung injury and sepsis
    Kathleen A Lee
    Department of Medicine, Rhode Island Hospital, Alpert Medical School of Brown University, Providence, RI, USA
    Chest 140:382-90. 2011
    ..We aimed to determine the clinical correlates for elevated plasma PBEF upon ICU admission for severe sepsis and the usefulness of PBEF to predict ALI development and sepsis mortality...
  10. pmc Surrogate consent for research involving adults with impaired decision making: survey of Institutional Review Board practices
    Michelle Ng Gong
    Division of Critical Care Medicine, Montefiore Medical Center, Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, USA
    Crit Care Med 38:2146-54. 2010
    ..We aimed to examine Institutional Review Board practices on surrogate consent and other safeguards to protect incapacitated adults in research...
  11. pmc 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
    ....
  12. pmc 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...
  13. pmc 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)...
  14. pmc 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...