Surrogate consent for research involving adults with impaired decision making: Survey of Institutional Review Board practices

Michelle Ng Gong, Gary Winkel, Rosamond Rhodes, Lynne D. Richardson, Jeffrey H. Silverstein

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

Objectives: Most critically ill adults have impaired decision-making capacity and are unable to consent to research. Yet, little is known about how Institutional Review Boards interpret the Common Rule's call for safeguards in research involving incapacitated adults. We aimed to examine Institutional Review Board practices on surrogate consent and other safeguards to protect incapacitated adults in research. Design, SettingS, AND PARTICIPANTS: A cross-sectional survey of 104 Institutional Review Boards from a random sample of U.S. institutions engaged in adult human subject research (response rate, 68%) in 2007 and 2008. InterventionS: None. MEASUREMENTS: Institutional Review Board acceptance of surrogate consent, research risks, and other safeguards in research involving incapacitated adults. MAIN Results: Institutional Review Boards reported that, in the previous year, they sometimes (49%), frequently (33%), or very frequently (2%) reviewed studies involving patients in the intensive care unit. Six Institutional Review Boards (6%) do not accept surrogate consent for research from any persons, and 22% of Institutional Review Boards accept only an authorized proxy, spouse, or parent as surrogates, excluding adult children and other family. Institutional Review Boards vary in their limits on research risks in studies involving incapacitated adults: 15% disallow any research regardless of risk in studies without direct benefit, whereas 39% allow only minimal risks. When there was potential benefit, fewer Institutional Review Boards limit the risk at minimal (11%; p < .001). Even in populations at high risk for impaired decision making, many Institutional Review Boards rarely or never required procedures to determine capacity (13%-21%). Institutional Review Boards also varied in their use of independent monitors, research proxies, and advanced research directives. Conclusions: Much variability exists in Institutional Review Board surrogate consent practices and limits on risks in studies involving incapacitated adults. This variability may have adverse consequences for needed research involving incapacitated adults. Clarification of current regulations is needed to provide guidance.

Original languageEnglish (US)
Pages (from-to)2146-2154
Number of pages9
JournalCritical Care Medicine
Volume38
Issue number11
DOIs
StatePublished - Nov 2010

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Research Ethics Committees
Decision Making
Research
Proxy
Surveys and Questionnaires
Adult Children
Spouses
Critical Illness
Intensive Care Units
Cross-Sectional Studies

Keywords

  • informed consent
  • proxy
  • Research ethics
  • research ethics committee
  • third-party consent

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine

Cite this

Surrogate consent for research involving adults with impaired decision making : Survey of Institutional Review Board practices. / Gong, Michelle Ng; Winkel, Gary; Rhodes, Rosamond; Richardson, Lynne D.; Silverstein, Jeffrey H.

In: Critical Care Medicine, Vol. 38, No. 11, 11.2010, p. 2146-2154.

Research output: Contribution to journalArticle

Gong, Michelle Ng ; Winkel, Gary ; Rhodes, Rosamond ; Richardson, Lynne D. ; Silverstein, Jeffrey H. / Surrogate consent for research involving adults with impaired decision making : Survey of Institutional Review Board practices. In: Critical Care Medicine. 2010 ; Vol. 38, No. 11. pp. 2146-2154.
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abstract = "Objectives: Most critically ill adults have impaired decision-making capacity and are unable to consent to research. Yet, little is known about how Institutional Review Boards interpret the Common Rule's call for safeguards in research involving incapacitated adults. We aimed to examine Institutional Review Board practices on surrogate consent and other safeguards to protect incapacitated adults in research. Design, SettingS, AND PARTICIPANTS: A cross-sectional survey of 104 Institutional Review Boards from a random sample of U.S. institutions engaged in adult human subject research (response rate, 68{\%}) in 2007 and 2008. InterventionS: None. MEASUREMENTS: Institutional Review Board acceptance of surrogate consent, research risks, and other safeguards in research involving incapacitated adults. MAIN Results: Institutional Review Boards reported that, in the previous year, they sometimes (49{\%}), frequently (33{\%}), or very frequently (2{\%}) reviewed studies involving patients in the intensive care unit. Six Institutional Review Boards (6{\%}) do not accept surrogate consent for research from any persons, and 22{\%} of Institutional Review Boards accept only an authorized proxy, spouse, or parent as surrogates, excluding adult children and other family. Institutional Review Boards vary in their limits on research risks in studies involving incapacitated adults: 15{\%} disallow any research regardless of risk in studies without direct benefit, whereas 39{\%} allow only minimal risks. When there was potential benefit, fewer Institutional Review Boards limit the risk at minimal (11{\%}; p < .001). Even in populations at high risk for impaired decision making, many Institutional Review Boards rarely or never required procedures to determine capacity (13{\%}-21{\%}). Institutional Review Boards also varied in their use of independent monitors, research proxies, and advanced research directives. Conclusions: Much variability exists in Institutional Review Board surrogate consent practices and limits on risks in studies involving incapacitated adults. This variability may have adverse consequences for needed research involving incapacitated adults. Clarification of current regulations is needed to provide guidance.",
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