By Stacey Kusterbeck
Clinical research is necessary to improve the management of potentially suicidal individuals. However, there are multiple ethical concerns about how to protect the rights and well-being of study participants. “Enrolling people in suicide prevention research is important, yet complicated,” says Camille Nebeker, EdD, MS, a professor in the UC San Diego Herbert Wertheim School of Public Health and Human Longevity Science and director of the UC San Diego Research Ethics Program.
Nebeker and colleagues collaborated with the UMass Chan Medical School Center for Accelerating Practices to End Suicide (CAPES) research team to analyze ethical issues that came up when the institution’s Institutional Review Board (IRB) was evaluating a suicide prevention research protocol.1 The study was evaluating an experimental suicide risk management app targeting individuals presenting to emergency departments (EDs).
“It is particularly important to evaluate the ethical challenges in ED recruitment of patients,” according to Barton Palmer, PhD, the paper’s lead author and a professor of psychiatry at UC San Diego. The ED is the care setting that people in acute suicidal crises are most likely to present to. Additionally, people who die by suicide commonly have had a recent ED encounter.
However, there are multiple ethical concerns when it comes to recruiting suicidal individuals in the ED setting. “The IRB will want to know how researchers will respectfully engage an ED patient in a conversation about study participation,” says Nebeker.
Suicidal patients are in a vulnerable state with acute treatment needs and did not come to the ED with the intention of volunteering for research. “That doesn’t mean the research should not move forward. There are steps that the researchers can take to alleviate these barriers, and those should be explained in the research protocol,” says Nebeker.
The researchers faced an additional ethical hurdle in getting the study protocol approved. The ED routinely placed suicidal patients in hallway beds in close proximity to other patients, visitors, and staff. According to the study protocol, research staff would approach potentially eligible patients and obtain verbal consent for screening. Once enrolled, patients would answer several verbally administered questionnaires. The IRB denied the initial study recruitment proposal, raising concerns about patient privacy.
“Often, investigators view the IRB as a regulatory gatekeeper rather than as a collaborator invested in advancing important health research,” observes Nebeker. In this case, the study investigators, experts in research ethics, the ED director, and IRB leadership collaborated. Together, the group came up with an ethical, viable approach for recruitment so the study could go forward.
“The key is communication between clinicians, researchers, and the IRB, to find ways to recruit without compromising patient or staff welfare,” says Palmer.
Initially, the IRB suggested that research staff recruit, enroll, and collect data from patients in a private space. The principal investigator explained why this was not a realistic option. The ED did not have enough private rooms to use for study recruitment. Even if rooms happened to be available, moving a suicidal patient to a private room could result in adverse clinical outcomes. Suicidal patients typically do not need the medical equipment in private rooms that may be needed by other ED patients. Also, the hallway setting allows staff to monitor multiple patients simultaneously. The ED director and principal investigator provided the IRB leadership with a tour of the ED to see the hallway bed setups in person.
The researchers also conducted a small pilot study to learn more about how hallway beds actually affected patient privacy and what patients themselves thought about it. “Gathering data on the actual likelihood of being overheard, as well as consideration of the nature of the questions and sensitive content being discussed, was important,” says Palmer.
Three hallway bed setups were evaluated — touching beds, beds at a corner, and separated beds — to see how much of the patient interview could be overheard. For the touching beds, which were closest in proximity, a white noise machine was positioned between the two beds. Research staff conducted a role-playing exercise to see if bystanders could hear the conversation with the patient. It turned out that bystanders actually heard very little of what was said, regardless of where the beds were positioned.
The researchers surveyed 21 participants right after they were enrolled and assessed in a hallway bed. Most (71.4%) patients felt that privacy was sufficient. Most (85%) patients stated that they would not have preferred a telehealth option. Fewer patients (61.9%) stated that they found it easy to hear the survey questions.
The participants who did express privacy concerns tended also to feel uncomfortable with study enrollment in the ED overall and to have difficulty hearing the survey questions in the ED hallway.
The research staff presented the findings to the IRB. Ultimately, the IRB allowed the hallway bed recruitment with these requirements:
- that research staff would use low, hushed tones when speaking with patients;
- that a white noise machine would be used when another hallway bed patient was in close proximity;
- that research staff would clearly explain to patients, before consent screening, that they will be asking personal questions in the hallway bed setting, and then would ask for patients’ permission to proceed;
- that research staff would survey patients after the assessment, about patients’ perspectives on the questions they had been asked.
Palmer says that researchers should consider these ethical questions when recruiting patients for ED suicide research:
- Does recruitment adversely affect clinical activities, quality of care, the clinical staff, or the overall functioning of the unit?
- Does recruitment adversely affect the clinical care for which the patients have presented to the ED?
“All involved in the study design need to consider how the ethical principles of respect for persons, beneficence, and justice are demonstrated in practice,” underscores Nebeker.
Reference
1. Palmer BW, Arias SA, Dunlap DR, et al. The ethics of proximity: Enrolling patients in emergency department hallway beds for suicide research. Acad Emerg Med. 2025; Jan 23. doi: 10.1111/acem.15107. [Online ahead of print].
Clinical research is necessary to improve the management of potentially suicidal individuals. However, there are multiple ethical concerns about how to protect the rights and well-being of study participants.
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