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

In the United States, the Belmont Report identified three ethical principles that underlie the Common Rule and guide Institutional Review Boards (IRBs) in their efforts to protect human subjects in research: respect for persons, beneficence, and justice (1). Respect for persons requires that informed consent be obtained for research participation and that special protections are given to protect persons with diminished autonomy. It is now recognized that many older adults with acute illnesses may be incapacitated and unable to consent to research. During acute illness, 26% to 67% of elderly patients, 32% of patients with acute myocardial infarction, and 14% of patients with diabetes have impaired cognition (2–7). Delirium and dementia, common contributors to decisional impairment among hospitalized patients, are more common among the elderly (8–11). As the population ages, the number of U.S. adults with dementia is expected to increase to 13.2 million by 2050 (12), and the number of potentially incapacitated adult patients in the hospital will likely increase. In the intensive care unit (ICU), most of the patients are impaired in their decision-making and unable to consent to research. Yet, the issue of how IRBs should best guide research that involves incapacitated adults is unclear. The Common Rule allows for informed consent for research from the subject or the subject’s legally authorized representative, but it leaves the definition of surrogate to applicable state laws (13, 14). Unfortunately, most states have no laws regarding surrogate consent for research, and reliance on health care proxies is problematic because most elderly individuals do not have a legally authorized representative for medical decision-making (15–17). Federal regulations also dictate that in research involving decisionally impaired adults, “additional safeguards” should be included to protect this vulnerable population (18). However, the regulations are silent about the nature of these safeguards. A number of national, state, and international bodies, including the National Institutes of Health (NIH) and the National Bioethics Advisory Commission, have proposed guidelines for research involving incapacitated individuals. These guidelines describe six possible safeguards: assessment for competence to consent, demonstration that research cannot be performed without enrolling incapacitated adults, use of surrogate decision-makers with evidence of the patient’s previous preferences depending on research risk, institutional assessment of the research risk and benefit to ensure that they are appropriate, a requirement for assent or dissent from participants, and a requirement for independent consent and participation monitors to ensure that research participation is consistent with the patient’s preferences (19). However, there is debate about the specifics, necessity, and implementation of these safeguards. The resulting confusion has led to a working group convened by the Office of Human Research Protection to make recommendations with regard to research involving decisionally impaired adults (Subcommittee for the Inclusion of Individuals with Impaired Decision-Making in Research) (20). Consequently, it is not clear how IRBs handle research involving incapacitated adults. In this study, we examined the variability of IRB practices with regard to surrogate consent and other safeguards implemented to protect incapacitated adults, including ICU patients, in research. Understanding the scope of IRB practices with this population is especially timely and important given the increasing age of the population and the current discussions of how best to protect this group of vulnerable individuals.