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Query into the Absence of People with Disabilities in Clinical Trials Background People with disabilities are at a higher risk for numerous health conditions compared to the general population. For example, clinical trials for Alzheimer’s exclude people with Down syndrome, even though approximately 90% of people with Down syndrome will develop Alzheimer’s disease or dementia by age 55.[1] Not only are people with disabilities (PWDs) at higher risk for many conditions and diseases compared to the general population, disability itself can change the presentation and/or management of a disease, and clinicians need to be aware of these differences.[2] The exclusion of PWDs in research has been well-documented.[3] The exclusion of people with psychiatric, substance use, and intellectual disabilities is especially prevalent. Eligibility criteria affecting people with disabilities included exclusions for psychiatric (68 percent), substance use (62 percent), HIV or hepatitis (53 percent), cognitive or intellectual (42 percent), visual (34 percent), hearing (10 percent), mobility (9 percent), long-term care (6 percent), and speech and communication (3 percent) disability-related domains. Documented justification was provided for only 24 percent of these exclusions.[4] The discriminatory practices continue partly due to stigma and bias of PWDs and vague, generalized, and subjective exclusion criteria that is often copied and pasted from one study to another. Phrases such as: · “In the investigator’s opinion, [participants] are well-motivated, and capable.”; · “Subject is generally frail, or has any (medical) condition that, in view of the investigator or the sponsor’s responsible medical officer, is likely to prohibit or limit further participation in the study…; · “Subject has any condition that confounds the ability to interpret data from the study.”; · “Is judged by the Investigator to be inappropriate for the study.”; · “Any other reason the Investigator deems exclusionary.” Given the pervasive stigma and bias of PWDs combined with a clinical trial investigators ability to exclude anyone from a research study, it should be no surprise that PWDs are not well represented in clinical trials. Some investigators have explicitly excluded people with intellectual disabilities by requiring subjects pass cognitive assessments or requiring that subjects know how to read and write.[5] Few studies offered a reasonable accommodation so that PWDs could participate. (Plosky at 1426) This, despite the fact that Universal Design[6] recommendations for medical research have been available for over a decade.[7] Researchers who receive federal funding also have a legal obligation not to discriminate against PWDs under Section 504 of the Rehabilitation Act. Whether the exclusion of PWDs in clinical trials is explicit or implicit, such exclusion is a possible violation of Sec. 1557 of the Patient Protection and Affordable Care Act, which states that “an individual shall not be excluded from participation in, be denied the benefits of, or be subjected to discrimination on the grounds prohibited under Title VI of the Civil Rights Act of 1964, 42 U.S.C. 2000d et seq. (race, color, national origin), Title IX of the Education Amendments of 1972, 20 U.S.C. 1681 et seq. (sex), the Age Discrimination Act of 1975, 42 U.S.C. 6101 et seq. (age), or Section 504 of the Rehabilitation Act of 1973, 29 U.S.C. 794 (disability), under any health program or activity, any part of which is receiving federal financial assistance; any program or activity administered by the Department under Title I of the Act; or any program or activity administered by any entity established under such Title.” Report Purpose The purpose of this report is to address the explicit and implicit exclusion of people with disabilities in clinical trials, the repercussions of exclusion on the disability community, the legal requirements of clinical trial investigators to include PWDs in clinical trials and repercussions for not abiding by those requirements. The final report will provide recommendations and promising practices to increase the acceptance and participation rates of people with disabilities in clinical trials. Research Questions · How can clinical trial researchers, administrators and universities ensure meaningful participation of PWDs in clinical trials? · What promising practices exist to combat conscious and unconscious bias which leads to the exclusion of PWDs in clinical trials? · What recommendations need to be made to federal agencies to ensure inclusion of PWDs in clinical trials? · What is the value of having people with disabilities included in clinical trials? · What are the consequences of not having people with disabilities included in clinical trials? Time Period 6 months The deliverable for this project will include: A detailed preliminary framing paper. A revised framing paper incorporating input from NCD Council members and staff. A first draft report incorporating initial findings, conclusions, and recommendations that can be drawn from the examination. A final report of no more than 100 pages (not including endnotes or appendices) incorporating input from NCD Council members and staff. The final report must contain an executive summary with key findings and key recommendations; and specific sections on methodology; all findings; and all recommendations, organized according to the entity to which they are directed. A brief “Report Highlights” document for each report to succinctly and in plain language encapsulates the report’s scope and purpose, major findings, and recommendations, and contains a link to the full report at the bottom. For an example of a Reports Highlights Page, refer to: https://ncd.gov/publications/2013/10242013

Background and Statement of Problem In view of Executive Order 13990, “Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis”; and Executive Order 14030, “Climate-Related Financial Risk” directing federal agencies to take a whole-of-Government approach to increase resilience to the impacts of climate change and protect public health, NCD’s annual, statutorily mandated 2022 progress report will address the impacts of climate change and environmental injustice on the lives of people with disabilities. Environmental injustice occurs when minority groups and/or people living in poverty are excluded from environmental decision-making or are disproportionately exposed to environmental hazards. People with disabilities represent 15% of the world’s population and as the increased frequency of extreme weather events and other environmental issues increase, the disability community disproportionately absorbs the impact. According to a 2020 United Nations report, people with disabilities are at increased risk of the adverse impacts of climate change, including threats to their health, food security, water, sanitation and, livelihoods. Sudden onset of natural disasters and slow onset events can seriously affect a person with a disability’s access to food and nutrition, safe drinking water, sanitation, healthcare services and medicines, education and training, adequate housing, and employment. In NCD’s soon to be released report Disparate Treatment of Puerto Rican Residents with Disabilities in Federal Programs, NCD reported on the mass migration of Puerto Rican residents to the states, with one of the main reasons of the migration being to escape the economic hardship on the island created by the multiple natural disasters over the last several decades. This migration has resulted in a shortage of medical doctors, educators, and professionals and an exacerbation of economic hardship given the resulting diminished tax base. Many people with disabilities, because of their economic status are unable to flee unfavorable conditions caused by such natural disasters. Here in the United States, in February 2021, during winter storm Uri, which caused the blackout for over 9.9 million people in the United States and Mexico, and triggered a power crisis in Texas, 75% of Texans with disabilities were without electricity for at least 24 hours, 22% were without power for more than four days. Residents with disabilities experienced spoilage of life-saving medication and the inability to use breathing devices or mobility equipment that were power dependent. There has been an increase in the frequency and intensity of extreme weather events, people with disabilities have had higher rates of illness, injuries, or death from these types of events than people without disabilities. When an extreme weather event requires evacuation, people with disabilities have a high risk of being impacted both physically and mentally. The increased frequency of hurricanes, fires, and floods has a direct impact on people with disabilities who are power dependent. California, a state known for its rolling brownouts and power outages due to wildfires, continues to search for ways to mitigate the impact of power outages for people with disabilities who are power dependent. Disability status in combination with race, ethnicity, and income is a determinant as to the amount of environmental harm one is exposed to. People with disabilities, especially people of color are more likely to be impoverished, forcing them into low-income housing, which makes their residence more likely to be built near pollution sites. Houston neighborhoods located near pollution sources such as Superfund sites and hazardous waste facilities were home to a significantly higher proportion of people with disabilities compared to the rest of the city. Race, ethnicity, and age amplified these inequalities. Pollution and unsafe jobs and environmentally destructive industries not only affect health, but they also cause permanent disabilities. Environmental injustice is more prevalent in indigenous communities. Environmental injustice against Native Americans occurs, in part, because of social and economic injustice. In a study of the relationship between proximity to hazardous waste sites and occurrence of birth defects among 28,401 individuals born in California from 1983 to 1988, the strongest association between toxic exposure and congenital defects was found among Native American populations. The proximity to soil lead and lead dust pollution from mining waste poses a more significant health concern for American Indians than any other population. Environmental injustice also occurs in the planning stages of hazardous waste sites, which targeted Native American lands without any input from the population. According to the U.S. Census Bureau, 24% of American Indian and Alaska Natives have a disability compared to just 19% of the general population. Native coastal communities in Alaska have been impacted by the rise in sea level. They had to abandon their community and relocate on higher ground after experiencing more extreme storm surges, flooding, and sea level rise, which has impacted cultural integrity and access to vital resources. Report Purpose The Purpose of this report is to identify how the increased frequency of extreme weather events and environmental injustice impacts people with disabilities in the United States and in its territories. The report should identify the primary issues people with disabilities encounter because of the increased prevalence of natural disasters and environmental change. This report should also address how environmental injustice has a greater impact on people of color and indigenous tribes leading to an increased prevalence of disability in their community, further complicating these targeted population’s ability to mitigate the impact of increasing and extreme natural disasters. This report will address the impact of the increased frequency of extreme weather events on a person with a disability’s health and access to healthcare, community, housing, employment, and education. The report will also look at the higher prevalence of emergency evacuations, power outages, and their impact on people with disabilities. The report will gather data and evidence to identify the specific issues people with disabilities encounter due to the impact of the increased frequency of extreme weather events and economic injustice. Specifically, the impact, on a person with a disability’s health, access to food, housing, water and sanitation, education, access to the community, and employment. This report will offer recommendations on how to mitigate the impact of the increased frequency of extreme weather events and environmental injustice on persons with disabilities. This report will discuss the intersectionality of disability and how the individual’s specific intersectionality impacts their ability to mitigate and access resources to mitigate the impact of environmental injustice or the increased frequency of extreme weather events. Research Questions Through the lens of disability right laws, the research will seek to answer: 1. How has the increased frequency of extreme weather events and environmental injustice impacted the health and access to health care for people with disabilities? 2. How has the increased frequency of extreme weather events and environmental injustice impacted persons with a disability access to their community? 3. How has the increased frequency of extreme weather events and environmental injustice impacted housing options for people with disabilities? 4. How has the increased frequency of extreme weather events and environmental injustice impacted or exacerbate job opportunities for people with disabilities? 5. How has the increased frequency of extreme weather events and environmental injustice impacted access to food, fresh water, and sanitation for people with disabilities? 6. What actions can be taken to mitigate the findings garnered from the research of this report? Time Period 8 months