Excluding People with Serious Mental Illness from Research Is Ethical Problem
In caring for patients with serious mental illness, J. Irene Harris, PhD, is struck by the difficulty many face when trying to access healthcare. “In addition to their symptoms, they have realistic fears that healthcare providers will not take their concerns seriously,” says Harris, a clinician-investigator at VA Bedford (MA) Healthcare System.
Some years ago, in a different setting, Harris referred a patient with schizophrenia to a chronic pain rehabilitation program, where someone said, “We can’t take this client in our program. There is no research on the safety or effectiveness of our interventions for people with schizophrenia.”
The remaining alternatives were riskier. Harris pushed back. Eventually, the patient was accepted to the program and derived significant benefit. However, without aggressive advocacy, the patient likely would have been limited to medication options.
“When lack of research is used as a justification for exclusion from treatment, but the population is excluded from research, we have a spiral that systematically denies interventions to people with serious mental illness,” Harris says.
As a career researcher, grant proposal reviewer, and IRB member, Harris was well aware it was almost standard practice to exclude individuals with serious mental illness from research.1,2 “Now that I was seeing the impact of that research exclusion from care, I wanted to look more closely into that practice,” Harris says.
Harris and colleagues examined patterns of research exclusion for people with serious mental illness.3 “The practice of routinely excluding all of those people is weakening, but still persists, and needs further careful consideration,” Harris says.
Nine percent of studies of substance use disorders, 16% of studies of chronic pain, and 1% of ischemic heart disease studies explicitly excluded serious mental illness. A total of 83% of substance use disorder studies, 55% of chronic pain studies, and 20% of ischemic heart disease studies could exclude people with serious mental illness based on broader criteria.
Excluding everyone with serious mental illness might have been ethically justifiable at one time, when outcomes were poor. “With current treatment methods, many individuals managing serious mental illness function well, maintain employment, hold valued roles in their communities, and are clearly able to consent and participate in research,” Harris notes.
When people managing serious mental illness are excluded from a study, it is important IRBs learn more. “It should be routine procedure to request a rationale for that exclusion,” Harris offers.
In some study protocols, the rationale is individuals managing serious mental illness may not be competent to consent, or may not understand and follow study instructions. “That’s not a sufficient rationale,” Harris says. “Most people who manage serious mental illness can do both of those things most of the time.”
Instead of automatic exclusion based on diagnosis, researchers could base exclusion on someone’s ability to consent and follow study directions. If the only rationale is concern about capacity to consent and follow directions, that should be assessed, rather than presumed on the basis of a serious mental illness diagnosis. “Routinely excluding potential participants based on a serious mental illness diagnosis violates the principle of justice,” Harris emphasizes. “In effect, it winds up limiting access to care for this population.”
- Humphreys K, Blodgett JC, Roberts LW. The exclusion of people with psychiatric disorders from medical research. J Psychiatr Res 2015;70:28-32.
- Lembke A, Humphreys K. A call to include people with mental illness and substance use disorders alongside ‘regular’ smokers in smoking cessation research. Tob Control 2016;25:261-262.
- Harris JI, Hanson D, Leskela J, et al. Reconsidering research exclusion for serious mental illness: Ethical principles, current status, and recommendations. J Psychiatr Res 2021;143:138-143.
With current treatment methods, many individuals with serious mental illness function well, maintain employment, hold valued roles in their communities, and can consent to and participate in research.
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