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


METHODS
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.


METHODS
None.


METHODS
Institutional Review Board acceptance of surrogate consent, research risks, and other safeguards in research involving incapacitated adults.


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.
Gong
Michelle Ng
MN
Division of Critical Care Medicine, Montefiore Medical Center, Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, USA. mgong@montefiore.org
Winkel
Gary
G
Rhodes
Rosamond
R
Richardson
Lynne D
LD
Silverstein
Jeffrey H
JH
D035843:Biomedical Research / Q000941:ethics*; D003430:Cross-Sectional Studies; D028744:Ethics Committees, Research / Q000706:statistics & numerical data; D005190:Family; D005260:Female; D019538:Health Care Surveys; D006801:Humans; D007362:Intensive Care Units / Q000941:ethics; D008297:Male; D008875:Middle Aged; D016134:Organizational Policy; D010290:Parents; D018570:Risk Assessment; D018454:Spouses; D020458:Third-Party Consent / Q000941:ethics / Q000706:statistics & numerical data; D014481:United States
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