Assessing Federal Policies to Reduce Economic Barriers to Clinical Trial Enrollment

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.

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Publication Details

Journal
The Journal of Law Medicine & Ethics
Published
2025-01-01
DOI
https://doi.org/10.1017/jme.2025.61
Primary Topic
Ethics in Clinical Research
Type
article
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article

Assessing Federal Policies to Reduce Economic Barriers to Clinical Trial Enrollment

Joseph Liss, David Peloquin, Barbara E. Bierer, Erika Hanson et al.
The Journal of Law Medicine & Ethics
Ethics in Clinical Research
article

Assessing Federal Policies to Reduce Economic Barriers to Clinical Trial Enrollment

Joseph Liss, David Peloquin, Barbara E. Bierer, Erika Hanson, Daniel Albert-Rozenberg
article en

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.

The Journal of Law Medicine & EthicsVol. 53(2)
Brigham and Women's Hospital (US), Harvard University (US), Hogan Lovells (United States) (US), Sullivan University (US), Jonathan A Law & Associates (GB)
Reduced inequalities
Openalex Percentile: Top 84%
Ethics in Clinical Research
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Assessing Federal Policies to Reduce Economic Barriers to Clinical Trial Enrollment — Joseph Liss, David Peloquin, et al. · The Journal of Law Medicine & Ethics (2025) | TGRS Research Map | TGRS