Consensual Donation and Research Integrity Act of 2025
Sponsored By: Representative Bilirakis
Introduced
Summary
Regulating commercial trade in donated human bodies and parts. The bill would create a federal registration, inspection, labeling, and recordkeeping system for the donation and interstate sale of deceased human bodies and body parts used for education and research, explicitly excluding transplantation.
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- Families and relatives: Requires documented donor consent and limits use of identifiable donor information. Remains must be returned to a relative or personal representative or the transferee must agree to carry out disposition consistent with written instructions.
- Researchers and nonprofits: Exempts certain Organ Procurement and Transplantation Network affiliated entities and some nonprofit and educational activities that do not sell bodies or parts for profit. Other entities that sell for profit would need to register, pay annual renewal fees set by the Secretary of Health and Human Services, and comply with labeling, packaging, and chain of custody rules.
- Commercial sellers and brokers: Would require registration, regular inspections, and detailed case records including donor consent, medical history, prior possessors, and transferee information. Violations could lead to federal fines and suspension or revocation of registration. Registrants must notify the Secretary within 30 days of covered changes and the rules would apply to acquisitions and transfers occurring two years after enactment.
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Bill Overview
Analyzed Economic Effects
7 provisions identified: 2 benefits, 3 costs, 2 mixed.
Must return or properly dispose of remains
If enacted, registrants would have to ensure remains are returned to a relative or personal representative, or disposed of per written instructions. If they transfer a body or part, they would need a contract making the transferee take on that duty.
Tighter privacy rules for donor information
If enacted, donor‑identifying information collected under these rules could only be used for purposes HHS allows by regulation. Returning remains for burial would be allowed. Other uses would need clear approval in HHS rules.
New registration and fees for body donation businesses
If enacted, for‑profit businesses that acquire and sell whole bodies or parts across state lines would have to register with HHS. They would need to keep detailed case records, report changes within 30 days, and allow regular inspections. They would also pay annual registration and renewal fees set by the Secretary based on enforcement costs.
Stricter labeling and packaging of human remains
If enacted, registrants would have to label and package bodies and parts under new HHS rules. Labels would go under the outer packaging and include details like donor name, contents, test results, implants, and “not for transplantation,” unless privacy rules limit this. Packaging would need to prevent leaks and contamination and protect handlers.
Fines and registration loss for violations
If enacted, violations could bring fines under federal criminal law. HHS could suspend or revoke a registration. Changing or falsifying label information would be forbidden and could be penalized.
Two-year delay before rules take effect
If enacted, the new rules would apply only to acquisitions or transfers that happen two years after enactment. Deals before that date would not be covered. The timing would be set by the date of each acquisition or transfer.
Who is covered and who is exempt
If enacted, the bill would define who counts as a donor and what counts as a human body part. It would exclude blood drawn for medical care and growing cell lines, and say criminal-investigation autopsies are not “research.” It would exempt funeral professionals doing preparation, transport, and final disposition, and exempt schools and research groups that do not sell for profit.
Sponsors & CoSponsors
Sponsor
Bilirakis
FL • R
Cosponsors
Fletcher
TX • D
Sponsored 4/2/2025
Barr
KY • R
Sponsored 4/15/2026
Rep. Van Orden, Derrick [R-WI-3]
WI • R
Sponsored 4/29/2026
Rep. Shreve, Jefferson [R-IN-6]
IN • R
Sponsored 5/12/2026
Roll Call Votes
No roll call votes available for this bill.
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