By Stacey Kusterbeck
When ethicists encounter a concern about “moral distress,” it often comes from a nurse who feels aggressive end-of-life care is not in a patient’s best interest. But what about a researcher who feels enrollment in a clinical trial is not in a patient’s best interest?
“Moral distress is a term that’s starting to become more and more common in our ethics vernacular. But its use is often limited to the clinical setting,” says Donna T. Chen, MD, MPH, a professor in the Center for Health Humanities and Ethics at the University of Virginia. Moral distress in healthcare is well-studied, but no researchers had examined the issue from the perspective of clinical research professionals (CRPs). “We often conceptualize clinical care and research as distinct entities, but really there is an entire area of overlap — clinical research,” says Chen. Chen and colleagues interviewed 10 CRPs who self-identified as having experienced moral distress about their experiences of and responses to moral distress.1
“Clinical research professionals face all the difficult ethical scenarios on the clinical side: Caring for patients as individuals, ensuring they understand what is going on, and [managing] all the unique ethical demands of research — adhering to protocol, ensuring the validity of the data you collect, meeting study endpoints, and so on,” says Elena Bosack, the study’s lead author and a medical student at the University of Miami Miller School of Medicine. The authors categorized the root causes of participants’ moral distress into four themes:
Commodification of research. “Even with all of the efforts that go into preventing conflicts of interest, in some ways, the system is just built in a way that allows financial considerations to affect decision-making,” explains Bosack.
Institutional Review Boards (IRBs) generally catch overt conflicts of interest. The interviewees talked about how financial interests influence people in more subtle ways. Research funds tied to enrollment creates pressure to enroll patients and keep them in clinical trials. One interviewee stated, “One part of clinical research is a little bit like sales, which I didn’t know. You do have to sort of convince people to do it, because that’s how I get paid.” Some talked about principal investigators (PIs) “stretching” some of the more subjective inclusion and exclusion criteria to fit participants into studies. One noted, “I didn’t feel like anyone was ever fully coerced into it … it felt like [the PI] kind of stretched things a little bit to kind of meet all those competing demands.”
Concern for research participants. Research staff may feel it is not in a patient’s best interest to enroll in a study. Sometimes, a patient is too sick to undergo additional studies and testing. Interviewees thought it was morally wrong to enroll those patients, but did not feel they could push back against pressure from the PI. One interviewee stated, “Sometimes, our PI sort of wants to push them to try a clinical research trial — I mean, of course they don’t force them to — but they really try to advocate for it. And sometimes, we just don’t agree on that judgment call.”
Informed consent was another factor contributing to interviewees’ moral distress. Some patients enrolled in studies because they felt pressured to do so to please their doctor. This led CRPs to question whether those patients were truly giving informed consent.
Compromised science. Some CRPs observed that PIs’ documentation was after the fact, not contemporaneous. Thus, CRPs worried that the PIs had not actually performed those tasks. One CRP knew that the study protocol required the PI to perform a full physical examination at regular intervals, but observed that the PI rushed through it and performed an incomplete exam. In that case, the CRP chose not to talk to the PI directly about the concern. Instead, the CRP asked the patient some additional medical questions to be sure nothing was missed. “This example demonstrates how many CRPs feel that they must take on additional responsibilities in order to address their moral distress, thus adding to their burden,” says Bosack.
Structures of hierarchy. CRPs did not feel comfortable bringing concerns to the PIs in charge of the studies. One stated, “Our PI, [they] were just not wanting to hear any advice, and I think that was really hard for everybody [who] was working on the big study. It’s just like, ‘Ugh, we can’t voice anything to this person.’ That was really tough.” Some CRPs reported being ignored, or even punished, after raising concerns about the PI cutting corners. Some CRPs feared being held responsible if a monitoring agency investigated the study.
All of the contributing factors of moral distress voiced by the participants reflect the unique ethical challenges faced by CRPs. “They are juggling front-line concerns for their patient-participants with a duty to the study itself. At the same time, CRPs exist in a tight hierarchical structure that often provides little room for feedback from those working on the ground,” says Bosack. “We also had one CRP link moral distress to experiences of racism. This potential for experiences of racism to contribute to moral distress is underexplored and deserves further study.”
The authors also explored CRPs’ responses to moral distress. Self-mitigation, where CRPs assumed additional responsibilities to address perceived gaps in patient care, was common. “While temporarily effective, self-mitigation is ultimately unsustainable, as it places undue burden on individuals,” says Bosack.
Passive responses, including deferring to authority or avoidance, also exacerbated the situation by compromising moral integrity and increasing stress. In contrast, solidarity among coworkers and speaking out offered potential avenues to mitigate moral distress. “These actions were not without risk, as some CRPs faced retribution or were ignored,” acknowledges Bosack.
The findings highlight the need for institutional changes that support CRPs, rather than placing the responsibility solely on them to address systemic issues. “While moral distress used to be viewed more as an individual issue, recent thinking has shifted toward looking at system factors. The presence of moral distress tells us that something needs to change on the systems level to prevent sequelae like burnout and attrition,” says Bosack. For example, if PIs are pressuring some patients to enroll in studies inappropriately because funding is tied to enrollment, that indicates a need to change the way research is funded.
Another concern is that CRPs’ moral distress likely is going unaddressed at hospitals and health systems. “Clinical ethics consultants or research ethics consultants, if the institution has them, should strive to integrate working with CRPs into their services,” recommends Chen.
Some CRPs were aware of resources for moral distress at their institutions but felt that those resources did not necessarily extend to them. “If an institution has a moral distress consultation service, they should also consider what it would take to provide moral distress consultation to the clinical research enterprise,” advises co-author Dawn Bourne, DNP, FNP-C, HEC-C, an assistant professor in the School of Nursing and director of University of Virginia’s Moral Distress Consult Service.
The overarching concern is that concerns about the integrity of clinical research are going unaddressed. “Acknowledging and addressing moral distress in this arena will ultimately benefit the institution as a whole,” says Chen.
Reference
- Bosack E, Bourne D, Epstein E, et al. Investigating moral distress in clinical research professionals — a deep dive into troubled waters. Ethics Hum Res. 2025;47(1):34-45.
When ethicists encounter a concern about “moral distress,” it often comes from a nurse who feels aggressive end-of-life care is not in a patient’s best interest. But what about a researcher who feels enrollment in a clinical trial is not in a patient’s best interest?
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