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

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.

Figure 1

Flow diagram of Institutional Review Boards (IRBs) selected and enrolled for survey. OHRP, Office of Human Research Protection.

Figure 2

Frequency with which Institutional Review Boards (IRBs) reviewed studies involving the patient populations at risk for impaired decision making. ICU, intensive care unit.

Figure 3

Institutional Review Board (IRB) responses on whether studies with different risk-benefit ratio would be allowed by the IRB if the study involves incapacitated adults.

Figure 4

Respondents’ categorization of risk for study procedures and their responses as to whether this risk level is permitted in studies involving subjects who are incapacitated in studies without potential direct benefit (A) and with direct benefit (B). Institutional Review Board representatives were asked to categorize the risk of the following procedures: 10 mL blood for protein analysis study, 10 mL blood for genetic epidemiology study, one chest computed tomography (CT) scan, and administration of a drug with a 3% risk of severe bleeding. Each bar represents the number of respondents who categorize each study procedure as minimal risk, minor increase over minimal risk, or more than minor increase over minimal risk. Within each bar are their responses on whether their Institutional Review Board (IRB) would (white) or would not (gray) permit that risk level in studies involving incapacitated adults when there is no potential benefit (A) and when there is potential direct benefit (B). Cross-hatching indicates those who replied “unsure.” Two respondents were unable to categorize study risks for the gene study, CT scan, and drug study, resulting in two missing values.