Eligibility criteria in NIH-funded clinical trials: Can adults with intellectual disability get in?

BACKGROUND: Although scientific breakthroughs can promote health equity, there is concern that adults with intellectual disability, a health disparities population, may be excluded from clinical trials. OBJECTIVE: To determine the extent to which adults with intellectual disability are subject to exclusion from National Institutes of Health (NIH)-funded clinical trials. METHODS: We studied recent NIH-funded Phase 2/3, 3, and 4 clinical trials of United States-based working-age adults (>18 < 55 years of age) listed in ClinicalTrials.gov. We coded eligibility criteria for inclusion, direct exclusion, and indirect exclusion of adults with intellectual disability. RESULTS: We rarely identified studies that directly include adults with intellectual disability. Most studies (74.6%) had eligibility criteria that directly and/or indirectly exclude adults with intellectual disability. Approximately one-third of studies had direct exclusion criteria based on cognitive impairment or diagnosis of intellectual disability. Nearly 65% of studies indirectly excluded adults with intellectual disability based on factors likely associated with intellectual disability (e.g., functional capacity, inability to read/write, and/or research staff discretion). CONCLUSIONS: We found less exclusion based on diagnosis of intellectual disability than anticipated. Nonetheless, about three-fourths of studies had eligibility criteria which would likely lead to the direct and/or indirect exclusion of adults with intellectual disability. Our findings suggest substantial cause for concern that adults with intellectual disability experience widespread exclusion from NIH-funded clinical trials-exclusion that may lack appropriate justification and assessment. Consequently, this group is denied equal access to the potential benefits of scientific discovery. We provide recommendations for approaches to include adults with intellectual disability.

Disability, Ethics, and Health Care in the COVID-19 Pandemic.

This article considers key ethical, legal, and medical dilemmas arising for people with disabilities in the COVID-19 pandemic. We highlight the limited application of existing frameworks of emergency planning with and for people with disabilities in the COVID-19 pandemic, explore key concerns and issues affecting the health care of people with disabilities (i.e., access to information and clinician-patient communication, nondiscrimination and reasonable accommodations, and rationing of medical goods), and indicate possible solutions. Finally, we suggest clinical and public health policy measures to ensure that people with disabilities are included in the planning of future pandemic-related efforts.The devastation evoked by the COVID-19 pandemic raises challenging dilemmas in bioethics. It also speaks to social justice issues that have plagued historically marginalized communities in the United States.Responses to the pandemic must be bound by legal standards, principles of distributive justice, and societal norms of protecting vulnerable populations-core commitments of public health-to ensure that inequities are not exacerbated, and should provide a pathway for improvements to ensure equitable access and treatment in the future.

COVID-19 outcomes among people with intellectual and developmental disability living in residential group homes in New York State.

BACKGROUND: People with intellectual and developmental disabilities (IDD) may be at higher risk of severe outcomes from COVID-19. OBJECTIVE: To describe COVID-19 outcomes among people with IDD living in residential groups homes in the state of New York and the general population of New York State. METHODS: Data for people with IDD are from a coalition of organizations providing over half of the residential services for the state of New York, and from the New York State Department of Health. Analysis describes COVID-19 case rates, case-fatality, and mortality among people with IDD living in residential group homes and New York State through May 28, 2020. RESULTS: People with IDD living in residential group homes were at greater risk of severe COVID-19 outcomes: case rates - 7,841 per 100,000 for people with IDD compared to 1,910 for New York State; case-fatality - 15.0% for people with IDD compared to 7.9% for New York State; and mortality rate - 1,175 per 100,000 for people with IDD compared to 151 per 100,000 for New York State. Differences in cases and mortality rate were confirmed across regions of the state, but case-fatality rate was only higher for people with IDD in and around the New York City region. CONCLUSIONS: COVID-19 appears to present a greater risk to people with IDD, especially those living in congregate settings. A full understanding of the severity of this risk will not be possible until US states begin publicly sharing all relevant data they have on COVID-19 outcomes among this population.