{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T12:03:31Z","timestamp":1765800211184,"version":"3.48.0"},"reference-count":59,"publisher":"Cambridge University Press (CUP)","issue":"2","license":[{"start":{"date-parts":[[2025,5,23]],"date-time":"2025-05-23T00:00:00Z","timestamp":1747958400000},"content-version":"unspecified","delay-in-days":142,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-sa\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Law. Med. Ethics"],"published-print":{"date-parts":[[2025]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The risk of losing access to crucial means-tested programs \u2014 like Medicaid, Supplemental Security Income (SSI), the Supplemental Nutrition Assistance Program (SNAP), and Temporary Assistance for Needy Families (TANF) \u2014 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.<\/jats:p>","DOI":"10.1017\/jme.2025.61","type":"journal-article","created":{"date-parts":[[2025,5,23]],"date-time":"2025-05-23T01:19:02Z","timestamp":1747963142000},"page":"200-209","source":"Crossref","is-referenced-by-count":0,"title":["Assessing Federal Policies to Reduce Economic Barriers to Clinical Trial Enrollment"],"prefix":"10.1017","volume":"53","author":[{"given":"Daniel","family":"Albert-Rozenberg","sequence":"first","affiliation":[{"name":"Emanuel Urquhart and Sullivan LLP"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Peloquin","sequence":"additional","affiliation":[{"name":"Gray LLP"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph","family":"Liss","sequence":"additional","affiliation":[{"name":"Hogan Lovells"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-2127-9014","authenticated-orcid":false,"given":"Erika","family":"Hanson","sequence":"additional","affiliation":[{"name":"Harvard Law School"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6448-8170","authenticated-orcid":false,"given":"Barbara E.","family":"Bierer","sequence":"additional","affiliation":[{"name":"Harvard Medical School"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"56","published-online":{"date-parts":[[2025,5,23]]},"reference":[{"key":"S1073110525000610_r4","unstructured":"4. See US Department of Health and Human Services, Office of Inspector General, Advisory Opinion No. 23-11 (December 22, 2023). The Department of Health and Human Services has recognized that clinical trial costs create barriers to enrollment in ways that harm both potential trial participants and clinical research; Enhancing the Diversity of Clinical Trial Populations \u2014 Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry (US Food & Drug Administration, November 2020)."},{"key":"S1073110525000610_r5","doi-asserted-by":"crossref","first-page":"e159","DOI":"10.1017\/cts.2021.816","article-title":"Fair payment and just benefits to enhance diversity in clinical research","volume":"5","author":"Bierer","year":"2021","journal-title":"Journal of Clinical and Translational Science"},{"key":"S1073110525000610_r31","unstructured":"31. \u201cBroad-Based Categorical Eligibility,\u201d US Department of Agriculture, updated October 1, 2024, https:\/\/www.fns.usda.gov\/snap\/broad-based-categorical-eligibility (last visited February 7, 2025)."},{"key":"S1073110525000610_r47","unstructured":"47. \u201cEarned Income and Earned Income Tax Credit (EITC) Tables,\u201d Internal Revenue Service, updated January 27, 2025, https:\/\/www.irs.gov\/credits-deductions\/individuals\/earned-income-tax-credit\/earned-income-and-earned-income-tax-credit-eitc-tables#Earned%20Income (last visited February 7, 2025)."},{"key":"S1073110525000610_r49","unstructured":"49. 45 C.F.R. \u00a7 46 (2018)."},{"key":"S1073110525000610_r55","unstructured":"55. See FDA, supra note 2."},{"key":"S1073110525000610_r12","unstructured":"12. Improving Access to Clinical Trials Act of 2009, Pub. L. No. 111-255, 124 Stat. 2640, 2641 (2010)."},{"key":"S1073110525000610_r29","unstructured":"29. Low Income Home Energy Assistance Program, \u201cCategorical Eligibility,\u201d Department of Health and Human Services, updated December 10, 2024, https:\/\/liheapch.acf.hhs.gov\/delivery\/income_categorical.htm (last visited February 7, 2025)."},{"key":"S1073110525000610_r18","doi-asserted-by":"publisher","DOI":"10.2105\/AJPH.2011.300279"},{"key":"S1073110525000610_r15","unstructured":"15. Ensuring Access to Clinical Trials Act of 2015, Pub. L. No. 114-63, 129 Stat. 549 (2015); 42 U.S.C. \u00a7 1382a(b)(26) (SSI); 42 U.S.C. \u00a7 1396a(e)(15) (Medicaid)."},{"key":"#cr-split#-S1073110525000610_r19.1","unstructured":"19. H.R.7090, 118th Cong. (2024), https:\/\/www.congress.gov\/bill\/118th-congress\/house-bill\/7090"},{"key":"#cr-split#-S1073110525000610_r19.2","unstructured":"H.R.7418, 118th Cong. (2024), https:\/\/www.congress.gov\/bill\/118th-congress\/house-bill\/7418."},{"key":"S1073110525000610_r21","doi-asserted-by":"crossref","first-page":"1707","DOI":"10.1377\/hlthaff.2022.00742","article-title":"How Low-Paid Parents Navigate The Complex Financial Landscape Of Benefits Cliffs And Disincentive Deserts","volume":"41","author":"Ballentine","year":"2022","journal-title":"Health Affairs"},{"key":"S1073110525000610_r22","unstructured":"22. \u201cIntroduction to Benefits Cliffs and Public Assistance Programs,\u201d National Conference of State Legislatures, December 27, 2024, https:\/\/www.ncsl.org\/human-services\/introduction-to-benefits-cliffs-and-public-assistance-programs (last visited February 7, 2025)."},{"key":"S1073110525000610_r25","unstructured":"25. Table I.E.4. Benefit Determination Policies (Urban Institute, July 2021), https:\/\/wrd.urban.org\/wrd\/tables.cfm."},{"key":"S1073110525000610_r34","unstructured":"34. Food & Nutrition Service, \u201cSNAP Eligibility: How much could I receive in SNAP benefits?\u201d US Department of Agriculture, updated January 22, 2025, https:\/\/www.fns.usda.gov\/snap\/recipient\/eligibility, (last visited February 7, 2025)."},{"key":"S1073110525000610_r35","unstructured":"35. 24 CFR 5.628(a), 960.253(c)(3). But see 24 CFR 960.253(a)(1) (permitting families to choose a flat rent), (a)(2) (setting a minimum rent)."},{"key":"S1073110525000610_r13","unstructured":"13. Reimbursement of costs associated with a person\u2019s participation in a clinical trial, which the statute did not address, is typically not considered income. Such reimbursement typically does not result in a decrease or loss of means-tested benefits, but retention of documentation of expenses is required. For operational simplicity, many clinical trial sites reimburse individuals based on an estimated cost of participation. Any difference between the payment provided and documented expenses may be counted as income."},{"key":"S1073110525000610_r48","unstructured":"48. \u201cKelly, Houlahan introduce \u2018Harley Jacobsen Clinical Trial Participant Income Exemption Act,\u2019\u201d press release, January 29, 2024, https:\/\/kelly.house.gov\/media\/press-releases\/kelly-houlahan-introduce-harley-jacobsen-clinical-trial-participant-income."},{"key":"S1073110525000610_r23","unstructured":"23. See Letter from D. Tsai Center for Medicare and Medicaid Services, RE: UPDATED: Mandatory Medicaid Coverage of Routine Patient Costs Furnished in Connection with Participation in Qualifying Clinical Trials, (April 13, 2022), https:\/\/www.medicaid.gov\/sites\/default\/files\/2022-04\/smd21005.pdf."},{"key":"S1073110525000610_r56","unstructured":"56. See \u201cPoverty Guidelines,\u201d Office of the Assistant Secretary for Planning and Evaluation, January 17, 2024, https:\/\/aspe.hhs.gov\/topics\/poverty-economic-mobility\/poverty-guidelines (last visited February 7, 2025)."},{"key":"S1073110525000610_r26","unstructured":"26. Medicaid Income Eligibility Limits for Adults as a Percent of the Federal Poverty Level, (KFF, 2022), https:\/\/www.kff.org\/health-reform\/state-indicator\/medicaid-income-eligibility-limits-for-adults-as-a-percent-of-the-federal-poverty-level\/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Parents%20(in%20a%20family%20of%20three)%22."},{"key":"S1073110525000610_r10","unstructured":"10. 2021 American Community Survey, 5-year estimates (US Census Bureau, 2021)."},{"volume-title":"Clinical Trials: Little is Known about Participation by Supplemental Security Income Recipients","year":"2014","author":"Bertoni","key":"S1073110525000610_r16"},{"key":"S1073110525000610_r14","unstructured":"14. 21 U.S.C. \u00a7 360ee(b)(2)."},{"volume-title":"The Earned Income Tax Credit (EITC): How It Works and Who Receives It","year":"2023","author":"Crandall-Hollick","key":"S1073110525000610_r37"},{"key":"S1073110525000610_r11","unstructured":"11. T. Farrigan, \u201cRural Poverty & Well-Being,\u201d USDA Economic Research Service, January 14, 2025, https:\/\/www.ers.usda.gov\/topics\/rural-economy-population\/rural-poverty-well-being\/ (last visited February 7, 2025)."},{"key":"S1073110525000610_r42","unstructured":"42. Tucker v. Schweiker, 650 F.2d 62 (5th Cir. 1981)."},{"key":"S1073110525000610_r40","unstructured":"40. Publication No. 64-030, supra note 33."},{"key":"S1073110525000610_r45","unstructured":"45. See H.R.7090, supra note 19."},{"key":"S1073110525000610_r44","unstructured":"44. See US Census Bureau, supra note 8."},{"key":"S1073110525000610_r24","unstructured":"24. See OIG Advisory Opinion No. 23-11, supra note 4."},{"volume-title":"The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research","year":"1979","key":"S1073110525000610_r51"},{"key":"S1073110525000610_r52","doi-asserted-by":"crossref","unstructured":"52. 21 C.F.R. \u00a7 50, 56 (1980).","DOI":"10.7146\/varv.v1980i2.148066"},{"key":"S1073110525000610_r36","unstructured":"36. Because the EITC is a \u201crefundable\u201d tax credit, it can result in a payment from the federal government to an individual even if the individual owes no income tax."},{"key":"S1073110525000610_r32","unstructured":"32. 20 C.F.R. \u00a7 404.1571."},{"key":"S1073110525000610_r46","unstructured":"46. See H.R.7418, supra note 19."},{"key":"S1073110525000610_r53","doi-asserted-by":"crossref","first-page":"477","DOI":"10.1177\/17407745211011069","article-title":"Phase I trial compensation: How much do healthy volunteers actually earn from clinical trial enrollment?","volume":"18","author":"Fisher","year":"2021","journal-title":"Clinical Trials"},{"key":"S1073110525000610_r8","unstructured":"8. 2021 American Community Survey, 1-year estimates (US Census Bureau, 2021)."},{"key":"S1073110525000610_r54","unstructured":"54. See FDA, supra note 2; Hhs.gov, supra note 2."},{"key":"S1073110525000610_r1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cpcardiol.2018.11.002"},{"key":"S1073110525000610_r20","unstructured":"20. As defined in 42 U.S.C. \u00a7\u00a7 300gg\u20138(d)(1), (e)."},{"key":"S1073110525000610_r38","unstructured":"38. The term \u201cbenefit\u201d is used here only as a financial term, and not to refer to the possible clinical, personal, or societal benefit of clinical trial participation."},{"key":"S1073110525000610_r30","unstructured":"30. \u201cSchool Meal Eligibility and Reimbursements,\u201d Food Research & Action Center, https:\/\/frac.org\/school-meal-eligibility-reimbursements (last visited February 7, 2025)."},{"key":"S1073110525000610_r43","unstructured":"43. Martz v. Comm\u2019r, Soc. Sec. Admin., 649 F. App\u2019x 948 (11th Cir. 2016) (holding plaintiff\u2019s two days a week job at a museum to not constitute \u201csubstantial gainful activity\u201d where plaintiff\u2019s employer allowed her to sit as long as she wanted to, and go home early when necessary); Lilian T. v. Kijakazi, No. 3:22-CV-00642 (VAB), 2023 WL 6379439 (D. Conn. Sept. 29, 2023) (noting that plaintiff\u2019s ability to work as a part-time nanny did not rise to the level of \u201csubstantial gainful activity\u201d)."},{"key":"S1073110525000610_r50","unstructured":"50. 45 C.F.R. \u00a7 46.111(a)(3), (b) (2018)."},{"key":"S1073110525000610_r7","doi-asserted-by":"crossref","first-page":"1252","DOI":"10.1056\/NEJMp2215609","article-title":"Why Diverse Clinical Trial Participation Matters","volume":"388","author":"Bierer","year":"2023","journal-title":"New England Journal of Medicine"},{"volume-title":"Poverty among the Population Aged 65 and Older","year":"2022","author":"Li","key":"S1073110525000610_r9"},{"key":"S1073110525000610_r6","doi-asserted-by":"publisher","DOI":"10.1177\/17407745221105896"},{"key":"#cr-split#-S1073110525000610_r33.1","unstructured":"33. Publication No. 64-030 - Red Book (Social Security Admin, 2024), https:\/\/www.ssa.gov\/redbook\/"},{"key":"#cr-split#-S1073110525000610_r33.2","unstructured":"Publication No. 05-10095 - Working While Disabled: How We Can Help (Social Security Administration, 2023), https:\/\/www.ssa.gov\/pubs\/EN-05-10095.pdf."},{"key":"S1073110525000610_r2","unstructured":"2. \u201cPayment and Reimbursement to Research Subjects: Guidance for Institutional Review Boards and Clinical Investigators,\u201d US Food and Drug Administration, January 2018, https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/payment-and-reimbursement-research-subjects; \u201cInformed Consent FAQs: When does compensating subjects undermine informed consent and parental permission?\u201d US Department of Health and Human Services, https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/faq\/informed-consent\/index.html (last visited February 3, 2025)."},{"key":"S1073110525000610_r39","unstructured":"39. Publication No. 05-10095, supra note 33."},{"key":"S1073110525000610_r28","unstructured":"28. Early Childhood Learning & Knowledge Center, \u201cPoverty Guidelines and Determining Eligibility for Participation in Head Start Programs,\u201d US Dept. of Health and Human Services, January 23, 2025, https:\/\/eclkc.ohs.acf.hhs.gov\/ersea\/article\/poverty-guidelines-determining-eligibility-participation-head-start-programs (last visited February 7, 2025)."},{"key":"S1073110525000610_r41","unstructured":"41. 20 C.F.R. \u00a7 404.1573(c)."},{"key":"#cr-split#-S1073110525000610_r3.1","unstructured":"3. Food and Drug Omnibus Reform Act (\"FDORA\") in the Consolidated Appropriations Act or 2023, Pub. L. No. 117-328 (2022)"},{"key":"#cr-split#-S1073110525000610_r3.2","unstructured":"D. Peloquin, M. Barnes, and C. Lam, \"Congress Enacts Legislation Requiring Guidance on Clinical Research Diversity and Modernization,\" Ropes & Gray, January 9, 2023, https:\/\/www.ropesgray.com\/en\/insights\/alerts\/2023\/01\/congress-enacts-legislation-requiring-guidance-on-clinical-research-diversity-and-modernization (last visited February 3, 2025)."},{"key":"S1073110525000610_r27","unstructured":"27. Food and Nutrition Service, \u201cWIC Eligibility Requirements,\u201d US Dept. of Agriculture, December 19, 2024, https:\/\/www.fns.usda.gov\/wic\/wic-eligibility-requirements (last visited February 7, 2025)."},{"key":"S1073110525000610_r17","unstructured":"17. See Bertoni & Kohn, supra note 16."}],"container-title":["Journal of Law, Medicine &amp; Ethics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.cambridge.org\/core\/services\/aop-cambridge-core\/content\/view\/S1073110525000610","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T11:59:18Z","timestamp":1765799958000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cambridge.org\/core\/product\/identifier\/S1073110525000610\/type\/journal_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025]]},"references-count":59,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2025]]}},"alternative-id":["S1073110525000610"],"URL":"https:\/\/doi.org\/10.1017\/jme.2025.61","relation":{},"ISSN":["1073-1105","1748-720X"],"issn-type":[{"type":"print","value":"1073-1105"},{"type":"electronic","value":"1748-720X"}],"subject":[],"published":{"date-parts":[[2025]]}}}