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.

Perspectives of surrogate decision makers for critically ill patients regarding gene variation research

“…Gong et al 10 reported that when presented with a hypothetical genetic epidemiology study involving incapacitated patients, most IRB members reported that such a study would represent greater than minimal risk, and 40% would not allow such a study to proceed in the absence of direct patient benefit. Similarly, in a multicenter genetic epidemiology acute stroke study, Chen et al 11 reported that investigators preferentially enrolled less severely affected, cognitively intact participants because IRBs at 40% of participating institutions would not permit use of SDMs to provide consent in this context.…”

“…6 Investigations involving cognitively impaired individuals are perceived as carrying greater risk and requiring additional safeguards as compared with studies enrolling those who are cognitively intact. 10 When these studies entail collection of genetic material, such concerns appear heightened. 10,11 Although a number of investigations have examined attitudes regarding gene variation research, the manner in which the exigencies of acute illness affect perceptions of genetic data collection is largely unknown.…”

“…10 When these studies entail collection of genetic material, such concerns appear heightened. 10,11 Although a number of investigations have examined attitudes regarding gene variation research, the manner in which the exigencies of acute illness affect perceptions of genetic data collection is largely unknown. [12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30] Conceivably, SDMs do not possess sufficient insight as to the nature of genetic data to permit informed judgment.…”

Public's Approach to Surrogate Consent for Dementia Research: Cautious Pragmatism

“…(3–5) Despite several decades of debate in the U.S., no clear policy exists regarding the involvement of adults with decisional impairments in clinical research. (6) AD research centers(7, 8) research ethics review boards(9, 10), and dementia experts and advocates(11) vary considerably in their viewpoints, policies and practices in dealing with this ethical issue.…”

Research to inform the consent-to-research process

“…To ensure that science and knowledge can continue to advance while respecting the ethical principle of autonomy, we commonly asked substitute decision-makers (SDMs) to provide consent on patients' behalf [1,2]. In situations where a study is deemed to pose only minimal risk, for example, observational studies, some research ethics boards may waive the need for informed consent, although the criteria used to establish minimal risk have varied [3,4]. Studying interventions that must be administered on an emergency basis can further complicate the informed consent process due to the inability to identify SDMs within a suitable time frame [5].…”