The arrival of the COVID-19 pandemic has cast a bright light on the stigmatization of people living with disabilities beliefs that permeate not just American society, but also our health care system and scientific research endeavors. As one research team put it, “Children with disabilities are abandoned or left behind before, during, or after a disaster, such as the coronavirus disease 2019 (COVID-19) pandemic.” From the earliest days of the COVID-19 pandemic through the present day, it is evident that people living with disabilities have been experiencing disproportionately high rates of death and disability. A recent article in the Lancet explained that “people with disabilities have been differentially affected by COVID-19 because of three factors: the increased risk of poor outcomes from the disease itself, reduced access to routine health care and rehabilitation, and the adverse social impacts of efforts to mitigate the pandemic.” An article co-authored by the current acting commissioner of the Food and Drug Administration (FDA) in the Journal of the American Medical Association (JAMA) noted, although without reference to disability, that “the COVID-19 pandemic has underscored health inequities and linked the disparate results with the low level of racial and ethnic diversity in “new molecular entities and original therapeutic biologics.” The authors concluded that “physicians’ ability to extrapolate from trial results to their own patients would be dramatically improved if a trial’s participants reflected the product’s intended patient population as accurately as possible.”
This exclusion reflects a more generalized phenomena of correspondingly poor outcomes in almost every measurable criteria for population health, such as vaccination, care during disasters, and communicable diseases.
These health disparities were brought directly to public attention in an 2015 article in the American Public Health Association (APHA) journal and, since then, have generated much discussion. But less frequently highlighted is the association between poor outcomes and the absence of people living with disabilities from the research studies. In 2019, a Lancet article identified a link between the phenomena of premature death among people living with learning disabilities and the trials intending to develop products and protocols to prevent premature death. “This finding,” they wrote, “mirrors the poor access of this population to the clinical research that should lead to better health outcomes.” Another glaring example is the exclusion of people living with mental disabilities from smoking cessation research even though they are, as a population, more likely to be smokers. Or the failure to include people with pre-existing disabling conditions, about a third of the population who experience disabling strokes, in research related to after-care.
More so than any time since the arrival of HIV/AIDS in the late 1980s, the last widespread deadly new virus, COVID-19, has left the Earth’s population facing a threat for which there were, initially, no known effective tests, treatments, or methods of prevention. Again, as in that time, the threat generated intense scientific research but created a situation in which the only access to treatment involved enrollment in a research study. It was frustration at the restriction of enrollment that led to the most effective major patient rights movement — Act-up — which demanded and achieved the removal of barriers to inclusion.
While no two crises are exactly alike, the situation people living with disabilities face in the time of COVID is quite similar. They both lack access to treatments only available to research subjects and are not part of the data evaluating safety and efficacy.
As I wrote in an article this summer, the exclusion of people living with disabilities is not only wrong, but it is also actually illegal under U.S. law, because it violates both the spirit and the letter of the Americans with Disabilities Act. But because recruitment into research studies is an activity under the direct control of those conducting research, excluded participants will never be aware that they have not been invited.
Although the laws against disability-based discrimination are as robust as those prohibiting race- or gender-based discrimination, they are implicitly seen as different because of concerns over exploitation of people with mental disabilities which might affect their ability to make an informed decision. This belief is allowed to go unchallenged, because researchers are free to create protocols that either explicitly or through design implicitly exclude populations who they believe will make the research more expensive or difficult. These exclusions persist despite direct advocacy by researchers across different disciplines who have tirelessly advocated for universal design to promote inclusion and rebutted both implicit and explicit objections — including those claiming that including diverse populations would skew the results and, therefore, reduce the benefit to everyone.
These exclusions either take the form of direct statements that people with preexisting “serious” mental illness are not eligible or catch-all provisions allowing the principal investigator to exclude anyone who may hinder the research process.
While not mentioning the word “disability,” 45 CFR 46 creates a framework for assessing acceptable risk among populations vulnerable to exploitation. Based on the principles of the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report, the result has been a considerable wariness among those who serve as gatekeepers to research studies and clinical trials against enrolling individuals who lack capacity for consent. That the goals of respect and inclusion can coexist is evidenced by the reality that both the United Kingdom and the European Union require that all government research include participants from populations who are likely to use or benefit from its products. While implementing these goals is not the same as having them, the result has been to focus attention on reasons for exclusion, as well as the development of an extensive literature addressing the practicalities of inclusion, including obtaining consent from individuals who are under the protection of a guardian.
There is reason to be optimistic that the tide is shifting. For one thing, as more people living with disabilities become doctors and researchers, more research is being done both on potentially disabling conditions and incorporating people living with disabilities. The Food and Drug Administration is currently required by chapter 610 of its latest reauthorization act to evaluate inclusion criteria for the purpose of promoting expanded access to clinical trials and has initiated a series of hearings to gather information. But without enforcement of existing anti-discrimination protections or adoption of specific mandates for inclusion in research, it is unlikely that change will proceed at anything other than a glacial pace.
At a time when there is still no safe and effective treatment for a raging pandemic that is killing thousands of people every day and disproportionately affecting those living with disabilities, there has never been a more important time for inclusion.
