When a research assistant approached an older patient about enrolling in a clinical trial in the ED, the man cheerfully agreed to participate. At that point, Lauren Southerland, MD, who was training the research assistant, asked the man why he wanted to participate. He replied, “Oh, I help with all the research studies. I think it is nice.”
“I asked him what the study was about, and he didn’t know. He didn’t remember anything we had told him,” Southerland says.
Southerland recognized this man was cognitively impaired — and was about to sign a consent form without understanding the risks and benefits. The researchers thanked him and explained they would meet again when his wife (and legal next of kin) was visiting to discuss it. “This incident made me wonder about the best way to screen for capacity to consent in research studies,” Southerland says.
Southerland and a colleague with similar concerns, both researchers in the department of emergency medicine, decided to study consent in older patients in the ED.1 They conducted a scoping review of randomized, controlled trials from 2014-2019 that included participants in the ED and patients older than age 65 years.
Thirteen studies waived or allowed for exception from informed consent; 256 studies required consent. Of those studies, one-fourth reported excluding patients because of impaired capacity to consent. Only 4% of studies documented the use of a capacity screening tool. Most studies did not report how or if they assessed capacity to consent. “Likely, most studies use the gestalt of the researcher who is recruiting,” Southerland offers.
The findings do not prove anyone enrolled participants lacking decision-making capacity or did anything unethical. Since capacity to consent is not a mandated area to report for most journals publishing research, it may be left out for space or other reasons. “We just want to start a conversation about this,” Southerland says.
During an ED visit, clinicians have to assess capacity “in many small ways,” notes Southerland. Emergency providers have to consider these questions: Is this patient capable of understanding their illness and their medication regimen? Does the patient understand he or she must return to the ED if their condition worsens (and can they return)? Who is their caregiver and legal next of kin? Should that individual be informed regarding the patient’s illness or medical needs? “Capacity to consent to research is slightly different than these clinical considerations,” Southerland explains.
When consenting to participate in research, people are taking on additional risk, often for no personal gain. Ethicists can help with the process by becoming familiar with different “capacity to consent” tools, and which ones are appropriate for high-risk vs. low-risk studies or for various settings.
Ethicists also can educate clinicians about the need to formally assess decision-making capacity. This is preferable to allowing a research assistant (who could be an undergraduate student or new researcher) to assess capacity informally. “Ensuring appropriate capacity to understand the risks and benefits is imperative. Using a quick cognitive test or capacity evaluation can help in these situations,” Southerland says.
Determining decision-making capacity for older adults’ consent for research can be difficult under the best of circumstances.
“It can become even more challenging when approaching a patient in acute distress in the emergency department,” says Meghan K. Mattos, PhD, RN, CNL, assistant professor at the University of Virginia School of Nursing.
Distress can manifest in many forms — physical, emotional, or psychological. Any of these can affect decision-making ability. There also is the possibility ED patients think they have to agree to research participation to receive care, even if the consent process states participation is optional.
“The adult may not recognize that they have the right to say no when presented in an unfamiliar environment for time-sensitive, health-related needs,” Mattos notes.
Older adults also are more likely to experience cognitive and age-related changes that limit their understanding of what it means to participate in the research study. “This does not mean that they should not be approached for research participation based on age,” Mattos stresses. “But additional care should be given to assess their decision-making capacity.”
To ensure research staff are able to assess capacity to consent, Mattos conducts mock informed consent sessions. Experienced study staff role-play as patients, allowing researchers to practice. Mattos requires research staff to complete at least three successful practice sessions. Documentation of the informed consent and capacity assessment process allows investigators to determine if staff adhered to the protocol. “This includes asking specific study-related questions to ensure comprehension and understanding,” Mattos says.
Research staff ask open-ended questions that require more than just a “yes” or “no” response. For example, patients explain what the study is about, describe some risks and benefits, or tell why they chose to participate. “The study investigator must be confident in each study staff member’s ability to assess capacity to consent,” Mattos says.
REFERENCE
1. Southerland LT, Benson KK, Schoeffler AJ, et al. Inclusion of older adults and reporting of consent processes in randomized controlled trials in the emergency department: A scoping review. J Am Coll Emerg Physicians Open 2022;3:e12774.
It likely is an accident if investigators enroll participants lacking decision-making capacity in trials. Since capacity to consent is not a mandated area to report for most journals publishing research, it may be left out for space or other reasons. Nevertheless, some researchers are seeking to start a conversation about this.
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