Lifting the Barriers Excluding People Living with Disabilities from the Benefits of Inclusion in Research Studies
6 U. Pa. J. L. & Pub. Affairs 489 (2021)
71 Pages Posted: 18 Aug 2020 Last revised: 5 Apr 2021
Date Written: August 17, 2020
As the COVID-19 virus continues to rage out of control in the United States, there are thousands of ongoing clinical trials seeking to develop even a single effective treatment or vaccine. But the only access to the products being tested is by enrolling in a Food and Drug Administration (FDA) supervised clinical trial. And inclusion in a clinical trial has always been by invitation only. This paper addresses a long ignored injustice: on the thirtieth anniversary of the Americans with Disabilities Act (“ADA”) people living with disabilities have found that they are rarely on the list.
This paper will be the first law review article to focus on the widespread exclusion of people living with disabilities from research studies. Although the situation has attracted some notice in bioethics, public health, and disability advocacy communities, there has never been an effort to identify the entities that fund and conduct research as covered entities subject to the ADA. This paper will make the case for immediate action by the Justice Department to ensure that all covered entities are aware of their obligations under the ADA to both remove the barriers that are either directly or by effect excluding people living with disabilities and take proactive steps to promote their inclusion.
It will do so by first marshalling the evidence of exclusion and its resulting harm and then analyzing the characteristics of entities conducting research studies that make them covered entities under the ADA. Moreover, the Article addresses directly the most likely justifications for excluding people living with disabilities which, are of the same type routinely rejected by courts. Adoption of universal design principles in research studies, such as adding captions to materials necessary for communicating with potential participants is only one of many steps that could be implemented immediately.
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