Shenango Valley News

WASHINGTON, D.C. - U.S. Representatives Mike Kelly (R-PA) and Chrissy Houlahan (D-PA) have introduced the Harley Jacobsen Clinical Trial Participant Income Exemption Act. The legislation aims to exempt all payments received by participants in clinical trials from being counted towards their gross income.

Currently, payments that are not categorized as reimbursements are considered taxable income. This can create a financial burden for participants, especially those in lower income brackets. By exempting these payments from gross income, the burden can be alleviated, making participation in clinical trials more accessible and accommodating to individuals' lives.

Rep. Kelly emphasizes that the legislation puts patients first and aims to improve patient care and outcomes. He states, "By exempting these payments from gross income, we can alleviate this burden and make participation in clinical trials more accessible and accommodating to individuals' lives."

Rep. Houlahan highlights the importance of clinical trials in cutting-edge research and development. However, she acknowledges that these trials often take a toll on participants' time and finances, resulting in less economic diversity and fewer people able to take part. She expresses pride in introducing the Harley Jacobsen Clinical Trial Participant Income Exemption Act, which will allow payments received by participants in clinical trials to be tax-exempt. This change would increase access to trials, diversify the participants, and contribute to better advancements in medical research through a more comprehensive patient population.

The Harley Jacobsen Clinical Trial Participant Income Exemption Act has several objectives. It aims to increase the diversity of enrolled patient populations in all trials, aligning with the strategic goals of the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). This alignment will improve the effectiveness of drug development for the benefit of the general American public.

Additionally, the act seeks to provide greater access to experimental therapies for marginalized populations, including those with disabilities, minority populations, chronic physical illness, low-income populations, and low-education levels. By eliminating reporting requirements for both the patient/caregiver and the payor, the act also protects participants who rely on social welfare programs from exceeding income requirements.

The bill addresses the current requirement for clinical trial participants to report all payments received as gross income. It also eliminates the 1099 reporting requirement for the payor when payments equal or exceed $600 in a calendar year.

The introduction of the Harley Jacobsen Clinical Trial Participant Income Exemption Act signifies a step towards increasing access and diversity in clinical trials. By exempting payments from gross income, the financial burden on participants will be reduced, allowing for a more inclusive and comprehensive patient population in medical research.

To read the full bill, please click here.