Description for 118th Congress:
The Harley Jacobsen Clinical Trial Participant Income Exemption Act aims to:
- Increase diversity of the enrolled-patient populations across all trials, aligning with the strategic goals of the NIH and FDA, thereby improving the effectiveness of drug development for the benefit of the general American public.
- Provide greater access to experimental therapies to the least-empowered Americans (those with disabilities, minority populations, chronic physical illness, low-income populations, low-education level, etc.).
- Eliminate the reporting requirements for both the patient/caregiver (the payment recipient) and the 1099 reporting requirement of the payor. This will also protect participants who rely on social welfare programs such as SNAP, WIC, and others from exceeding income requirements.
Clinical trial participants (the payment recipient) are required to report all clinical-trial-payments received in a calendar year as gross income. The sponsor of the clinical trial (the payor) is required to report payments in equal to or in excess of $600 in a calendar year.
