Abstract

The risk of losing access to crucial means-tested programs — like Medicaid, Supplemental Security Income (SSI), the Supplemental Nutrition Assistance Program (SNAP), and Temporary Assistance for Needy Families (TANF) — poses a barrier to the enrollment of low-income Americans in clinical trials. This burden likely disproportionately affects members of racial and ethnic minority groups, people with disabilities, elderly individuals, and rural populations, and may frustrate efforts to reflect the US population in clinical trial enrollment. To help achieve representative clinical trials for myriad conditions, Congress should pass legislation excluding payments to clinical trial participants from gross income and expand the clinical trial compensation exclusions for means-tested programs established in the Ensuring Access to Clinical Trials Act of 2015.