Researchers Often Exclude Adults Living with Intellectual Disabilities
Ethical concerns about including adults living with intellectual disabilities in research usually focus on the ability to make informed, voluntary decisions.
“Such decisions are widely perceived as a hallmark of ethical research, and a major way to uphold individual rights and well-being,” notes Katherine McDonald, PhD, associate dean of research, chair of the IRB, and professor of public health at Syracuse University.
The intellectual disability can contribute to difficulties understanding information. Consent documents used in clinical trials cover complex concepts, such as randomization and placebos. “Adults with intellectual disability aren’t the only group to struggle to comprehend complex, nuanced information about health research. It’s important to keep this in mind,” McDonald cautions.
McDonald led a study analyzing the extent to which adults living with intellectual disabilities are excluded from National Institutes of Health-funded clinical trials.1 Nearly three-quarters of studies included eligibility criteria that either directly or indirectly excluded adults living with intellectual disabilities. About one-third included direct exclusion criteria based on diagnosis of intellectual disability or cognitive impairment. Two-thirds of studies indirectly excluded adults living with intellectual disabilities based on factors such as inability to read or write.
“We often see researchers either restricting eligibility to those with consent capacity or using researcher discretion, an approach easily subject to biases,” McDonald reports.
Investigators often fail to offer accommodations, such as reading consent materials aloud. Also, researchers do not actively recruit in places inclusive of adults living with intellectual disabilities. “These approaches and assumptions readily fuel exclusion from health research,” McDonald says.
Historically, adults living with intellectual disabilities have not been considered among potential participants in the recruitment phase of studies, or have been presumed to lack capacity for first-person consent and excluded on that basis.
“While there is a contemporary trend toward greater inclusion, these barriers to research participation remain important concerns,” says Robert S. Olick, JD, PhD, associate professor emeritus of bioethics and humanities at Upstate (NY) Medical University.
Many adults living with intellectual disabilities face challenges in understanding the purpose of a study, along with the risks and benefits, and might face related challenges regarding reading, writing, and using technology. “But there should be no categorical, status-based exclusions from research participation based on disability,” Olick says.
In fact, adults living with intellectual disabilities possess a range of functional abilities. Clinical trials, as well, vary in terms of complexity. “Adults with intellectual disability should be considered for clinical trials in the same manner as other patients who may benefit from the trial,” Olick asserts.
Scientists should include adults living with intellectual disabilities as potential participants at the recruitment phase of the trial, based on the overall inclusion and exclusion criteria of a study. There should be careful attention to the individual’s ability to consent.
“Researchers should not presume that this population is incapable of first-person consent,” Olick underscores.
Federal rules for human research allow for consent from a “legally authorized representative” (LAR). The federal rules defer to state law as to who may serve as an authorized representative to give consent on behalf of a research participant. This means adults living with intellectual disabilities might be able to participate in research with consent of a guardian or family member, depending on state law.
“In some states, consent from a healthcare proxy may be an option,” Olick adds.
Involving a LAR does not mean the values and preferences of the adult living with an intellectual disability are simply ignored. “Respect for autonomy and dignity means that for adults with intellectual disability, their voices still count, even when they lack sufficient capacity to give first-person consent,” Olick explains.
One ethical approach to inclusion is to obtain consent from a LAR — and also obtain assent from the person living with an intellectual disability. “Researchers should also design trials to offer accommodations,” Olick suggests.
That might consist of reading materials aloud, using easy-to-understand language, or using multimedia to present consent materials. “Researchers may design protocols with specific accommodations in mind, but should also be prepared to offer accommodations tailored to the needs of trial participants to engage in all aspects of the study,” Olick says.
Clinical trials can be designed to allow for involvement in the ongoing consent dialogue of someone trusted by the adult living with an intellectual disability. “This is sometimes referred to as supported decision-making,” Olick notes. “This may be the LAR, but could also be another trusted person.”
Researchers should begin by understanding they are ethically obligated to find ways to include adults living with intellectual disabilities, says McDonald, “so science can learn from them, and scientific advances can inform their healthcare.”
This means investigators are ethically obligated to alter the way information is presented to adults living with intellectual disabilities, as needed.
“We now understand that exclusion from health research, an approach once seen as a protection, is dangerous,” McDonald warns.
Exclusion means healthcare professionals treating adults living with intellectual disabilities are doing so absent information about treatment effectiveness and potential risks.
“We can no longer accept widespread exclusion fueled by approaches that presume incapacity, discriminate on the basis of disability, assume a need for proxy report, refuse to include those with legal guardians, or fail to nourish meaningful assent,” McDonald concludes.
1. McDonald KE, Schwartz AE, Sabatello M. Eligibility criteria in NIH-funded clinical trials: Can adults with intellectual disability get in? Disabil Health J 2022; Aug 20:101368. doi: 10.1016/j.dhjo.2022.101368. [Online ahead of print].
Historically, adults living with intellectual disabilities have not been considered among potential participants in the recruitment phase of studies, or have been presumed to lack capacity for first-person consent and excluded on that basis. While there is a contemporary trend toward greater inclusion, these barriers to research participation remain important concerns.
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