Introduction
Clinical trials generate medical knowledge that benefits trial participants, their communities, and society at large. Trials should, therefore, reflect the demographic distribution of the population for whom the trial intervention is intended. Currently, US clinical trials reflect neither the populations affected by conditions under study nor US demographics.Reference Clark1 The FDA and NIH have issued guidance to correct such underrepresentation,2 and Congress passed legislation in 2022 that required clinical trial sponsors to create “diversity action plans” for certain late-stage drug trials, as well as for most device studies.3 Eliminating economic and other barriers to clinical trial participation will further address the underrepresentation of diverse populations in clinical research.4
Clinical trial sponsors often offer modest compensation, independent of financial need, to clinical trial participants to offset the additional time, burden, and inconvenience of participation, and to help ensure that clinical trial participants are not worse off for having volunteered for the benefit of science and society.Reference Bierer5 State and federal governments generally treat such monetary compensation as income, for purposes both of income taxation and of determining eligibility for most means-tested programs.Reference Rand and Kesselheim6 A “means-tested program” is a benefit program that limits eligibility based on an individual or family’s income and/or assets. Many means-tested programs decrease benefit amounts progressively based upon enrollees’ income and discontinue benefits entirely above certain income thresholds. Beneficiaries of means-tested programs therefore may risk losing part or all of the benefits they would otherwise receive if they were to accept compensation for participating in clinical studies. Alternatively, uncertainty regarding the effect of clinical trial participation on benefits or services is a practical and significant disincentive for means-tested beneficiaries to enroll.
Historically underrepresented populations in research — including racial and ethnic minorities, older individuals, people with disabilities, and rural populations — are often overrepresented in low-income groups.Reference Bierer and Schwartz7 For example, in 2021, 58.7% of Black Americans and 53.7% of Hispanic Americans relied on some form of publicly provided health insurance, compared with only 28.1% of White Americans.8 Similarly, older individuals are more likely to rely on cash benefits. Social Security and Supplemental Security Income (SSI) accounted for nearly 90% of the total cash income received by those aged 65 and over in 2021.Reference Li and Dalaker9 Census data from 2021 also shows that people with disabilities are more likely to have incomes below the federal poverty line (20.1%) than people living without disabilities (11.6%).10 Finally, despite declines in rural poverty over the past decade, a distinct gap remains between the US nonmetro and metro poverty rates (the ratio of the number of people whose income falls below the poverty line): the nonmetro poverty rate was 15.4% in 2019, compared with 11.9% for metro areas.11 Thus, diverse representation in clinical trials suffers, despite the public interest in ensuring that medicines are safe and effective for all Americans.
Limited movement has been made on this front. In 2010, Congress passed the Improving Access to Clinical Trials Act,12 which excluded $2,000 per year of clinical trial compensation from being counted toward Medicaid or SSI eligibility,13 but only for clinical trials relating to a “rare disease or condition,” defined as those involving (1) a drug for a condition which “affects less than 200,000 persons in the United States” or for which recovering the cost of drug development is not a “reasonable expectation” or (2) a device or “medical food” for an “infrequently” occurring condition.14 This exclusion was made permanent in the Ensuring Access to Clinical Trials Act of 2015.15 But the $2,000 exclusion established in 2010 neither was indexed to inflation nor addressed barriers to clinical trial participation for those with more prevalent conditions or those who rely on other means-tested programs.
A 2014 Government Accountability Office (GAO) report examining the effects of the exclusion on SSI beneficiaries notes that, between April 2011 and September 2014, 36 SSI beneficiaries were recorded as having some amount of clinical trial income excluded from eligibility calculations.Reference Bertoni and Kohn16 Of those, 6 recipients received more than $2,000 in trial compensation in a year, ranging from $2,850 to $8,300, causing 5 recipients to become SSI ineligible for at least one month.17 These data reveal that the law has a de minimis effect in protecting SSI recipients’ continued access to benefits and that the exclusion affects a small amount of money compared with the costs of clinical and pharmaceutical research (and the volume of US tax revenues). More importantly, the threat of losing these benefits provides a strong disincentive to trial participation. Since the 2014 GAO report, no organized data of which we are aware has been published examining the effects of the Ensuring Access to Clinical Trials Act on Medicaid and SSI beneficiary participation in clinical trials. We acknowledge that research regarding Phase I, or healthy volunteer, clinical trials has found overrepresentation of minority and low-income individuals, despite the limited treatment benefits and continued risk of such studies.Reference Fisher and Calbaugh18 While addressing these ethical questions is beyond the scope of our research, we start from the premise that no clinical trial participant should receive compensation without considered review by and approval from an independent IRB.
In early 2024, two identical resolutions with overlapping, bipartisan cosponsors were introduced in the US House of Representatives that seek to amend the Internal Revenue Code to exclude certain compensation to clinical trial participants from gross income.19 As many means-tested programs determine benefits and eligibility based in part on gross income, this exclusion could facilitate participation by low-income individuals in trials for life-threatening conditions20 without risk of losing access to those programs. Both bills were referred to committee but without a companion Senate resolution or hearing scheduled, are far from enactment.
In this article, we examine the shortcomings of the current legislative landscape in creating equitable access to clinical trials and analyze the effect of compensation for participation in clinical trials on eligibility for twelve different means-tested programs. While income thresholds for the different means-tested programs vary, they are universally low. Our research shows that estimating the potential effects is a state-by-state, program-by-program endeavor that would be impracticable and burdensome for potential clinical trial participants. The impact of compensation is typically unpredictable, and the burden falls only on low-income individuals, rarely with assistance from investigators or disclosure in informed consent documents. We recommend specific legislative reforms to facilitate participation in clinical trials by beneficiaries of means-tested programs. Ultimately, elimination of these economic barriers can help to address underrepresentation in clinical research to the benefit of participants, medicine, and society.
Methods
We analyzed the effects of clinical trial compensation on twelve federally funded means-tested programs that provide individuals and families with access to free or lower-cost services (such as housing and health insurance), cash assistance, and other social safety-net benefits (program descriptions provided in Table 1):
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1. Advance Premium Tax Credit (APTC)
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2. Children’s Health Insurance Program (CHIP)
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3. Cost Sharing Reduction (CSR)
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4. Earned Income Tax Credit (EITC)
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5. Federal Low-Income Housing
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6. Modified Adjusted Gross Income (MAGI) Medicaid
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7. Supplemental Nutrition Assistance Program (SNAP)
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8. Supplemental Security Income (SSI)
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9. Temporary Assistance for Needy Families (TANF)
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10. Head Start
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11. Social Security Disability Insurance (SSDI)
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12. Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)
Table 1: Effect of Clinical Trial Compensation on Eligibility for Means-Tested Program as of February 1, 20241
1 The contents of this table do not constitute legal advice. Clinical trial sponsors, investigators, sites and enrollees should seek legal advice from their own counsel as to specific programs and circumstances.
2 Asset or resource limits are the maximum countable resources a beneficiary or household may have while still being eligible for the means-tested program. Asset limits typically count money available to the beneficiary (in cash, checks, bank accounts, etc.) as well as the value of certain other non-essential possessions.
3 The Federal Poverty Level (FPL) is a measure of income set by the federal government every year that is used to determine eligibility for certain benefit programs. Federal poverty level (FPL), Healthcare.gov (Accessed Feb. 8, 2024), https://www.healthcare.gov/glossary/federal-poverty-level-fpl/.
4 26 U.S.C. § 36B; 26 C.F.R. § 1.36B-4.
5 42 U.S.C. 1397bb; “Medicaid, Children’s Health Insurance Program, & Basic Health Program Eligibility Levels,” Centers for Medicare & Medicaid Services, December 1, 2023, https://www.medicaid.gov/medicaid/national-medicaid-chip-program-information/medicaid-childrens-health-insurance-program-basic-health-program-eligibility-levels/index.html (last visited February 7, 2025); “CHIP Eligibility,” Centers for Medicare & Medicaid Services https://www.medicaid.gov/chip/eligibility/index.html (last visited February 7, 2025); “CHIP Cost Sharing,” Centers for Medicare & Medicaid Services https://www.medicaid.gov/chip/chip-cost-sharing/index.html, (last visited February 7, 2025).
6 42 U.S.C. § 18071(c)(2); 45 C.F.R. § 155.305(g)(1)(i)(C); “Cost Sharing Reductions,” Center on Budget Policy and Priorities, updated October 2024 https://www.healthreformbeyondthebasics.org/cost-sharing-charges-in-marketplace-health-insurance-plans-part-2/ (last visited February 7, 2025).
7 26 U.S.C. § 32; M.L. Crandall-Hollick, G. Falk, and C.F. Boyle, EITC: How It Works and Who Receives It (Congressional Research Service, updated November 14, 2023) https://sgp.fas.org/crs/misc/R43805.pdf.
8 24 C.F.R. §§ 5.603, 5.609(b)(24), 960.201(a)(2), 960.202(b)(1)(i), 960.206(a)(1); Housing Opportunity Through Modernization Act of 2016: Implementation of Sections 102, 103, and 104, 88 F.R. 9600, 9636-9637 (Feb. 14, 2023).
9 24 C.F.R. §§ 960.603(a); Housing & Urban Development Department, Operations Notice for the Expansion of the Moving to Work Demonstration Program, 85 F.R. 53444 (August 28, 2020).
10 Housing Opportunity Through Modernization Act, supra note 8; 24 C.F.R. §§ 5.628(a), 960.253.
11 Not all individuals who are Medicaid-eligible are eligible based on the MAGI methodology. This analysis only evaluated the effect of clinical trial compensation on MAGI-Medicaid beneficiaries.
12 Supra note 3.
13 The Patient Protection and Affordable Care Act (PPACA), Pub. L. No. 111-148, 124 Stat. 119; “Eligibility,” Centers for Medicare & Medicaid Services https://www.medicaid.gov/medicaid/eligibility/index.html (last visited February 7, 2025); 42 C.F.R. § 447.52.
14 The Ensuring Access to Clinical Trials Act. Pub. L. No. 114-63, 129 Stat. 549 (2015); 42 U.S.C. § 1396a(e)(15).
15 Supra note 3.
16 51 U.S.C. § 2014; Food & Nutrition Service, “SNAP Eligibility,” U.S. Department of Agriculture, updated January 22, 2025, https://www.fns.usda.gov/snap/recipient/eligibility (last visited February 7, 2025); Food & Nutrition Service, “Broad-Based Categorical Eligibility (BBCE),” U.S. Department of Agriculture, updated October 1, 2024, https://www.fns.usda.gov/snap/broad-based-categorical-eligibility (last visited February 7, 2025).
17 See Broad-Based Categorical Eligibility, supra note 16.
18 7 U.S.C. § 2015(d); Food & Nutrition Service, “SNAP Work Requirements,” U.S. Department of Agriculture, updated December 9, 2024 https://www.fns.usda.gov/snap/work-requirements (last visited February 7, 2025); 7 C.F.R. §§ 273.7(a)(3), 273.24(a)(1).
19 20 C.F.R. § 416.1112; “How much you could get from SSI,” U.S. Social Security Administration, https://www.ssa.gov/ssi/amount (last visited February 7, 2025); “Understanding SSI - SSI Income,” U.S. Social Security Administration, https://www.ssa.gov/ssi/text-income-ussi.htm (last visited February 7, 2025); “SSI Federal Payment Amounts for 2025,” U.S. Social Security Administration, https://www.ssa.gov/oact/cola/SSI.html (last visited February 7, 2025).
20 20 C.F.R. §§ 416.1201, 1205.
21 Ensuring Access to Clinical Trials Act, supra note 14; 42 U.S.C. § 1382a(b)(26); D. Bertoni, and L.T. Kohn, Clinical Trials: Little is Known about Participation by Supplemental Security Income Recipients (Government Accountability Office, September 9, 2014), https://www.gao.gov/assets/gao-14-734r.pdf.
22 S. Knowles, et al., Welfare Rules Databook: State TANF Policies as of July 2021 (Urban Institute, June 2023) https://www.acf.hhs.gov/sites/default/files/documents/opre/2021%20Welfare%20Rules%20Databook%20Text%20%286%2029%202023%29.pdf; Welfare Rules Database, TANF Policy Tables: Table II.A.1. Benefit Determination Policies (Urban Institute, July 2021), https://wrd.urban.org/wrd/tables.cfm.
23 Supra note 3.
24 Food & Nutrition Service, “Broad-Based Categorical Eligibility (BBCE),” U.S. Department of Agriculture, updated October 1, 2024, https://www.fns.usda.gov/snap/broad-based-categorical-eligibility (last visited February 7, 2025).
25 45 C.F.R., Part 261, Subpart A.
26 Supra note 2.
27 42 U.S.C. § 9840; 45 C.F.R. § 1302.12(c); B. Futrell, “Head Start Categorical Eligibility for Families Eligible for the Supplemental Nutrition Assistance Program ACF-IM-HS-22-03,” U.S. Department of Health & Human Services, April 21, 2022, https://eclkc.ohs.acf.hhs.gov/policy/im/acf-im-hs-22-03.
28 20 C.F.R. §§ 404.1571–3; “Working While Disabled: How We Can Help,” U.S. Social Security Administration, January 2024, https://www.ssa.gov/pubs/EN-05-10095.pdf.
29 42 U.S.C. §§ 1758(b), 1786(d)(2)(A); Food & Nutrition Service, “WIC Eligibility Requirements,” U.S. Department of Agriculture, updated December 19, 2024, https://www.fns.usda.gov/wic/wic-eligibility-requirements (last visited February 7, 2025); Food & Nutrition Service, “WIC FAQs,” U.S. Department of Agriculture, updated September 26, 2024, https://www.fns.usda.gov/wic/frequently-asked-questions (last visited February 7, 2025).
Eligibility for and the amount of the benefit received in each of these programs is based on varying methods of calculating income and assets, unique definitions of income and differing exclusions, and myriad state policies. Likewise, the effect of monetary compensation for clinical trial participation on these calculations varies with whether the compensation counts as income at all, whether the compensation is considered “earned income” or “unearned income”, and how much income the individual is already earning.
Findings
Although the programs each have different requirements and target populations, clinical trial compensation may affect eligibility in 3 primary ways: (1) causing the individual to exceed benefit income thresholds and therefore lose a benefit entirely, (2) changing the benefit amount an individual receives (by either decreasing or increasing the benefit amount), and/or (3) counting toward an individual’s work requirement, if applicable (i.e., requirements to demonstrate employment or similar activity for a specified number of hours during a given time period to remain eligible for benefits) (Table 1):
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• Clinical trial compensation can result in the total loss of the benefit in 9 of the programs analyzed: CHIP, EITC, MAGI Medicaid, SNAP, SSI, TANF, Head Start, WIC, and SSDI.
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• Clinical trial compensation can result in a change to the benefit amount in 8 of the programs analyzed: APTC, CHIP, CSR, EITC, Federal Low-Income Housing, SNAP, SSI, and TANF.
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• Participation in a clinical trial may fulfill work or similar requirements in 4 of the programs analyzed: Federal Low-Income Housing, SNAP, TANF, and SSDI.
Of the 12 benefit programs analyzed, only Medicaid and SSI have provisions directly excluding some clinical trial compensation from eligibility calculations, but only for some clinical trials under certain conditions. WIC treats certain Medicaid beneficiaries as categorically (i.e., automatically) eligible, incorporating the Medicaid exclusion by proxy, but individuals whose WIC eligibility is determined based on income do not enjoy the same exclusion. Furthermore, SSDI regulations are unclear regarding whether participation in a clinical trial would constitute “substantial gainful activity” that could make a participant ineligible to continue receiving SSDI. We are not aware of any states with current legislation or policy proposals to exclude clinical trial compensation from eligibility calculations for state- or federally-funded means-tested programs.
Discussion
Clinical Trial Compensation Can Disqualify Individuals From Means-Tested Programs
The income and resource limits for means-tested programs tend to be very low, and it may be hard for a beneficiary enrolled in several programs with differing income eligibility rules to determine the benefits effects of receiving compensation for clinical trial participation.Reference Ballentine, Goodkind and Shook21 Accepting even a small amount of compensation could cause an individual or family to fall off the “benefits cliff,” whereby a small increase in earnings triggers a sudden and often unexpected decrease or loss in public benefits.22 For example, compensation for participation in a non-rare disease clinical trial may tip a Medicaid recipient’s income over their state’s eligibility threshold and cause them to lose Medicaid coverage. Since clinical trials often do not pay for associated routine medical care that Medicaid may cover instead,23 this compensation could also cause the beneficiary to become unable to continue participating in the clinical trial itself. 24
Interactions with clinical trial protocols and state laws add further complications. First, the unpredictability of the amount and timing of clinical trial compensation exacerbates the uncertainty of eligibility effects since research protocols may tie compensation to meeting participation milestones and to continued trial eligibility. Second, program eligibility limits vary by state and by means-tested program. For example, in 2021, the TANF income eligibility limits for a family of three ranged from $268 a month in Alabama to $2,413 a month in Minnesota.25 In 2023, the income limits for Medicaid eligibility for a single parent in a family of three ranged from 16% of the Federal Poverty Level (FPL) in Texas to 221% FPL in the District of Columbia.26
Loss of TANF and SNAP eligibility is particularly troubling, as several other means-tested programs treat TANF or SNAP beneficiaries as categorically eligible. In most states, for example, enrollment in either program makes a person automatically income-eligible for WIC,27 Head Start,28 the Low Income Home Energy Assistance Program,29 and free or reduced-price meals in the National School Lunch Program.30 Additionally, as of July 2023, 41 states, as well as D.C., Guam, and the US Virgin Islands, used TANF eligibility as a categorical basis for SNAP eligibility.31 Disqualification from either TANF or SNAP could thus lead to a clinical trial participant being disqualified from these other programs and incurring sudden and unexpected expenses.
SSDI, by comparison, is generally only available to those who cannot engage in “substantial gainful activity.”32 If clinical trial participation were deemed to be “substantial gainful activity” (a question considered in more detail below), then compensation that raises monthly income over $1,110 (for 2024) could start the clock on SSDI’s nine-month “trial work period,” after which any monthly income over $1,550 (or $2,590 for a blind person) would disqualify them from receiving SSDI.33
Clinical Trial Compensation Can Change the Amount an Individual Receives in Benefits
In SSI, TANF, the APTC, CSRs, SNAP, and for federal low-income housing, compensation for participating in a clinical trial may reduce the amount a beneficiary receives by some fraction of total income, counting the clinical trial compensation (see Table 1). SSI compensation that is not excludable under the Ensuring Access to Clinical Trials Act will reduce an individual’s SSI benefits by 50% of the compensation amount. States reduce TANF recipient benefits by variable percentages of earned income. The APTC is calculated at the beginning of the year based on anticipated income. If clinical trial compensation is unaccounted for (for instance, because an individual did not know that they will participate), the beneficiary may have to repay some portion of the APTC during their annual tax filings. Although CSRs do not need to be repaid if a beneficiary’s income increases during the year, the amount of the cost sharing reduction may decrease prospectively. An individual who remains SNAP-eligible even after accounting for the compensation will see their SNAP benefit reduced by 30% of the clinical trial compensation.34 Total tenant rent payments for low-income public housing may be based on family income,35 and thus, tenant rent may increase due to receiving clinical trial compensation.
In the case of the EITC, which provides supplemental monies to low-income individuals who work, clinical trial compensation could increase or decrease the credit to which an individual is entitled.36 Take the example of a single parent with two children in 2023: Until the single parent’s income reaches $16,510, the parent would receive $0.40 for every $1 earned, up to a maximum credit of $6,604. The credit would stay at $6,604 up to an income of $21,560. Finally, each dollar earned above $21,560 would shrink the credit by $0.21 until the recipient’s income reached $52,918, at which point the credit would disappear completely.Reference Crandall-Hollick, Falk and Boyle37 For a low-income individual with inconsistent, part-time work, the exact effect of clinical trial compensation is difficult to predict a priori.
Reductions in means-tested benefits decrease the effective financial compensation a clinical trial participant receives for their participation. Investigators, study sponsors, and institutional review boards (IRBs) cannot easily account for this deficit, since the effects of clinical trial compensation on an individual’s benefits will vary based on timing, as well as a range of person- and state-specific factors.38 Further, since the impact on the individual is uncertain, the investigator cannot appropriately advise the potential participant of these possible financial risks of participation without considerable resources.
Clinical Trial Participation Could Count Toward Work Requirements
For the three programs reviewed that impose a work requirement on certain participants — SNAP, TANF, and federal low-income housing — the treatment of clinical trial participation as employment could help an individual meet their hours requirements (see Table 1). The treatment of clinical trial participation as employment, however, may pose a problem for SSDI recipients: SSDI requires that beneficiaries be unable to engage in “substantial gainful activity.”39 The Social Security Administration “generally use[s] earnings guidelines to evaluate whether … work activity is [substantial gainful activity.]”40 However, certain kinds of work (including work done “as a patient in a hospital”) may not meet this definition based on, for example, the need for special assistance to participate, whether participation is at “irregular hours” or with “frequent rest periods,” and the need for assistance from others to “prepare for or get to and from” the work site.41 Although we found no case law directly on point, courts have held that the ability to work a few hours a week,42 or even on a part-time basis,43 does not necessarily disqualify an individual from SSDI eligibility. Thus, the sporadic nature of clinical trial participation might prevent it from being deemed “substantial gainful activity,” but it remains an untested fact pattern.
Policy Proposals
Congress can further demonstrate its commitment to clinical trial diversity by taking steps to open participation to populations that receive means-tested program benefits — a disproportionately large percentage of whom are from populations underrepresented in research.44 Congress should amend the Internal Revenue Code to exclude clinical trial compensation from income for the purpose of determining eligibility for federally-funded means-tested programs, either by excluding it from gross income altogether, or by expanding the carve-out in the Ensuring Access to Clinical Trials Act. Using the Act as its template, Congress has multiple, nonexclusive options, including expansion of eligible clinical trials, exclusion of clinical trial income in eligibility calculations for a wider range of means-tested programs, and increasing the amount of excluded clinical trial compensation.
Changing the Tax Treatment of Clinical Trial Compensation
House Resolutions 709045 and 741846 provide that “[g]ross income shall not include any amount received by an individual as payment or reimbursement for participation in an approved clinical trial (including amounts paid or reimbursed for meals, lodging, or other travel expenses incurred in connection with such participation).” Since means-tested programs often tie eligibility to gross income (or another metric derived therefrom), this, or similar legislation, would prevent clinical trial compensation from disqualifying participants from means-tested programs. However, it may affect an individual’s ability to claim the Earned Income Tax Credit (EITC), depending on whether or not clinical trial compensation is considered “earned income.”47 Overall, these resolutions are targeted only at clinical trials related to “cancer or other life-threatening disease[s],” possibly because prior legislation similarly focused on this subsection of clinical trials; a broader definition would better support the sponsors’ goals of increasing diversity of and access to “all trials.”48
Expanding the Clinical Trials Eligible for Exclusion
Under the Ensuring Access to Clinical Trials Act, Congress has already endorsed excluding clinical trial income from some clinical trials. However, the income exclusion applies only to clinical trials that both “involv[e] research and testing of treatments for a rare disease or condition,” and “meet[] the standards for protection of human subjects as provided under [the ‘Common Rule.’]”49 Limiting the exclusion to this narrow group of disorders does not address the lack of diverse representation in trials that seek to address other, more common diseases and conditions.
The Common Rule requires that for all federally funded human subjects research, safeguards be included to protect the welfare of economically disadvantaged research participants. Limiting the exclusion to a subsection of government-supported trials runs afoul of this directive, as well as the requirement that selection of subjects be equitable.50 Similarly, the Belmont Report cautions researchers to consider “whether some classes … are being systematically selected” for clinical trials.51 The current model creates a disincentive to participate for low-income individuals, who may be substituting clinical trial income for means-tested program income. By comparison, higher-income trial participants are able to enjoy compensation for clinical trial participation as added income.
Congress should extend the exclusion to apply to all clinical drug, device, or biologic trials that comply either with FDA regulations on human subjects research52 or the Common Rule or both sets of regulations. Expanding the exclusion to clinical trials subject to the FDA regulations, in addition to the Common Rule, would encourage participation in clinical trials funded by life sciences companies that do not receive federal funding and, thus, are not subject to the Common Rule.
Expanding the Clinical Trial Compensation Exclusion to More Means-Tested Programs
All twelve means-tested programs evaluated in this study likely treat clinical trial compensation as income, aside from the narrow SSI and Medicaid exclusions discussed above. With the exception of the EITC, Congress should exclude clinical trial compensation from income eligibility thresholds and benefit calculations in each of the programs we discuss. Continuing to treat clinical trial compensation as income for the EITC may help the lowest-income recipients maximize their benefit, though we acknowledge that it may harm higher-income recipients for whom the clinical trial compensation would cause the EITC to decrease or phase out entirely.
A broader exclusion would be particularly impactful for SNAP and TANF beneficiaries, as both programs convey categorical eligibility for a number of other social safety-net programs.
Removing or Raising the Maximum Amount of Excludable Clinical Trial Compensation
The exclusion of up to $2,000 a year in clinical trial compensation, which was established in 2009 in the Improving Access to Clinical Trials Act, was not tied to inflation and does not correspond to the amount that participants are presently paid on average for participating in clinical research. A 2021 study of compensation of healthy volunteers participating in Phase I clinical trials, which tend to be among the highest-compensated trials, reported a median clinical trial compensation of $3,070 (range $150–$13,000).Reference Fisher53 Thus a Phase I clinical trial participant in 2024 receiving a median payment would have $1,070 above the $2,000 maximum yearly exclusion potentially count toward income calculations for any means-tested programs in which they were enrolled. Driven by guidance issued by FDA and the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP),54 IRB review already ensures that clinical trial compensation is fair and appropriate.55
However, while the cap creates potential confusion for trial participants, it may help Congress respond to complaints that this tax break is subject to overuse and abuse. Thus, Congress should at least raise the yearly cap for clinical trial compensation exclusions to an amount that will not significantly impede individuals enrolled in means-tested benefits from participating in clinical research. One way to set a reasonable limit that is regularly adjusted for inflation would be to set the cap at some multiplier of the Federal Poverty Line (FPL). For 2024, for example, setting the cap at 50% of FPL would allow exclusions of up to $7,530 for an individual, or $15,600 for a family of four, from being counted toward means-tested program eligibility.56 This would enable potential clinical trial participants to participate in a wide range of trials without having to worry that participation might disqualify them from any means-tested benefits on which they rely.
Conclusion
Paying individuals to participate in clinical research cannot fully compensate them for the risks they undertake for the benefit of society. At the bare minimum, participation in clinical research should not leave participants financially worse off than they started. Our proposed changes would facilitate clinical trial participation by individuals at the lowest end of the income scale. Congressional inaction, by contrast, would leave in place a significant disincentive for low-income individuals to participate in, and benefit from, clinical research. By implementing the legislative reforms proposed above, Congress can facilitate participation by a more diverse and representative pool of clinical trial participants.
Acknowledgements
The authors acknowledge Carmel Shachar of Harvard Law School for her thoughtful advice, Jack Ferdman of the MRCT Center for his research and other assistance, and the entire MRCT Center team for supporting this project.
Open access
