Summary of HR 4184: Exclusion of Clinical Trial Compensation from Gross Income

Bill Number: HR 4184

Introduced: June 26, 2025

Status: Introduced in House

Primary Sponsor: Mike Kelly

Cosponsor: Chrissy Houlahan

Purpose and Intent

HR 4184 aims to amend the Internal Revenue Code of 1986 to exclude certain compensation received by individuals participating in approved clinical trials from their gross income. The intent of this legislation is to encourage participation in clinical trials by alleviating the tax burden associated with compensation and reimbursement for expenses incurred during participation.

Key Provisions

The bill introduces a new section, 139J, to the Internal Revenue Code, which includes the following key provisions:

1. Exclusion from Gross Income:

   • Gross income will not include any amount received as a qualified clinical trial payment.

2. Definition of Qualified Clinical Trial Payment:

   • A qualified clinical trial payment includes:
     • Compensation for participation in an approved clinical trial.
     • Reimbursement for reasonable and necessary expenses incurred during participation in an approved clinical trial.

3. Definitions:

   • Approved Clinical Trial: Defined as per section 2709(d)(1) of the Public Health Service Act, specifically relating to trials for life-threatening diseases or conditions.
   • Dependent: Defined according to section 152 of the Internal Revenue Code.

Impact

Who Would Be Affected?

• Participants in Clinical Trials: Individuals participating in approved clinical trials, as well as their dependents, would benefit from this exclusion, making it financially easier to participate in potentially life-saving research.
• Clinical Research Organizations: Organizations conducting clinical trials may see an increase in participant enrollment due to reduced financial barriers.

Potential Benefits

• Increased Participation: By removing the tax implications of compensation, the bill could lead to higher enrollment rates in clinical trials, which are essential for advancing medical research and treatment options.
• Support for Patients: Participants may find it easier to manage the costs associated with their involvement in trials, particularly those related to life-threatening conditions.

Legislative Process

• Referred to Committee: Upon introduction, the bill was referred to the House Committee on Ways and Means for further consideration.
• Next Steps: The bill will undergo discussions and potential amendments within the committee before it can be brought to the House floor for a vote.

Conclusion

HR 4184 represents a significant step towards promoting clinical research participation by addressing the financial concerns of participants. By excluding certain compensations from gross income, the bill aims to foster a more conducive environment for clinical trials, ultimately benefiting medical research and patient care.