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119-s-1270119th CongressWALLET

Consensual Donation and Research Integrity Act of 2025

Sponsored By: Senator Tillis, Thomas [R-NC]

Introduced

Summary

Creates a federal registration system for businesses that acquire and sell whole human bodies or body parts for non-transplant research and education. It would require registration with Health and Human Services, regular inspections, strict labeling and per-case records, and would apply to transfers beginning two years after enactment.

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  • Businesses that buy or sell whole bodies or parts for profit would have to register with Health and Human Services, pay fees set to cover inspection costs, renew as required, and face suspension, revocation, or criminal penalties for violations.
  • Registrants must keep a per-case record documenting donor consent, that the material was not for transplantation, chain-of-custody and disposition, medical history and test results, and must notify HHS within 30 days of changes.
  • Donors and families would get privacy and disposition protections: identifiable donor data may be used only as regulations allow, and registrants must return remains to a relative or contract for the final disposition.
  • The Organ Procurement and Transplantation Network, funeral service professionals handling preparation and disposition, and schools of medicine, dentistry, and mortuary science that do not sell for profit are exempt from the registration requirement.

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Bill Overview

Analyzed Economic Effects

4 provisions identified: 1 benefits, 2 costs, 1 mixed.

New rules and fees for body sellers

This bill would require anyone who buys and then sells whole human bodies or parts for profit in interstate commerce to register with HHS. If enacted, registrants would need to provide business details, name an adult responsible person, keep per-case records, allow inspections, and label and package remains to strict rules. The Secretary would set renewal timing and registrants must notify HHS of changes within 30 days. The Secretary would also set annual registration and renewal fees based on projected enforcement and inspection costs.

Two-year delay before rules start

This bill would make the new registration, labeling, recordkeeping, and inspection rules apply only to acquisitions or transfers that occur after the date two years after enactment. Activities before that two-year date would not be covered. The delay would give current businesses time to prepare for compliance and fees.

Criminal penalties for label falsification

This bill would make violations of the new rules subject to criminal penalties under Title 18 and let HHS suspend or revoke registrations for noncompliance. The bill would specifically prohibit altering or falsifying required labels. These enforcement tools would take effect two years after enactment.

Who counts as donors and parts

This bill would define key terms like 'donor', 'human body', and 'human body part' and list exclusions. Blood drawn for medical care and growing cell lines would be excluded. It would also say autopsies done for criminal investigations are not treated as 'research.' These definitions would change who and what the registration rules cover.

Sponsors & CoSponsors

Sponsor

Tillis, Thomas [R-NC]

NC • R

Cosponsors

  • Sen. Murphy, Christopher [D-CT]

    CT • D

    Sponsored 4/3/2025

Roll Call Votes

No roll call votes available for this bill.

View on Congress.gov
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