TY - JOUR
T1 - Surrogate consent for research involving adults with impaired decision making
T2 - Survey of Institutional Review Board practices
AU - Gong, Michelle Ng
AU - Winkel, Gary
AU - Rhodes, Rosamond
AU - Richardson, Lynne D.
AU - Silverstein, Jeffrey H.
N1 - Funding Information:
We acknowledge the hard work and dedication of our research staff, Jaime Glick, Nadine Spring, Jeidy Carrasco, Adam Wright, Daniel Ceusters, John Frederick, MD, and the support of David Adams, MD, Corey Scurlock, MD, the cardiothoracic surgeons, critical care physicians, and nurses at Mount Sinai School of Medicine.
PY - 2010/11
Y1 - 2010/11
N2 - 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.
AB - 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.
KW - Research ethics
KW - informed consent
KW - proxy
KW - research ethics committee
KW - third-party consent
UR - http://www.scopus.com/inward/record.url?scp=78049419110&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=78049419110&partnerID=8YFLogxK
U2 - 10.1097/CCM.0b013e3181f26fe6
DO - 10.1097/CCM.0b013e3181f26fe6
M3 - Article
C2 - 20802325
AN - SCOPUS:78049419110
SN - 0090-3493
VL - 38
SP - 2146
EP - 2154
JO - Critical care medicine
JF - Critical care medicine
IS - 11
ER -