Consensual Donation and Research Integrity Act of 2025
- Bill Number
- H.R. 2589
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-04-02: Referred to the House Committee on Energy and Commerce.
- Last Updated
- 2026-05-13T08:06:21Z
AI-Generated Summary
Purpose
The Consensual Donation and Research Integrity Act of 2025 aims to regulate the acquisition, sale, transfer, and disposition of human bodies and body parts donated for education, research, or advancing medical, dental, or mortuary science—specifically excluding uses in human transplantation. It seeks to ensure all such donations are consensual, properly documented, and handled respectfully, while preventing misuse or unethical practices in the non-transplant body donation sector.
Key Provisions
- Registration Requirements: Individuals or entities that acquire human bodies or parts and sell them for profit in interstate commerce must register with the Secretary of Health and Human Services (HHS). Exceptions include the Organ Procurement and Transplantation Network, its members, funeral professionals handling preparation/transportation/disposition, and non-profit educational or research institutions like medical schools that do not sell for profit. Applications must include business details, premises descriptions, compliance assurances, and other specified information. Registrations require renewal at intervals set by HHS, with fees based on enforcement costs (collected via appropriations). Changes in information must be reported within 30 days.
- Inspections: HHS must conduct regular inspections of registered entities' premises to ensure compliance.
- Record Keeping: Registrants must maintain detailed records for each acquisition or transfer, including:
- Proof of the donor's informed, knowing consent under applicable laws.
- Notification to the donor about disposition obligations.
- Dates, donor details, medical history (including autopsy reports if applicable), chain of custody, and documentation of use, transfer, and final disposition.
Records must cover prior custodians (e.g., funeral homes, hospitals).
- Labeling and Packaging: All bodies or parts must be labeled (affixed under outer packaging) with donor name, contents description, transferor details, tissue types, cause of death (if known), test results, hazards (e.g., infectious agents, radioactive materials), safety precautions, and a clear "not for transplantation" statement. Packaging must prevent contamination, leakage, and hazards while preserving integrity. A chain of custody must be maintained.
- Limitations on Information Use: Donor-identifiable information can only be used or disclosed for purposes authorized by HHS regulations, such as returning remains for burial.
- Disposition Rules: Registrants must ensure respectful final disposition under federal and state laws, either by returning remains to relatives or representatives per donor instructions, or by contracting with transferees to handle it. This applies to deceased donors only.
- Enforcement and Violations: Violations (e.g., non-compliance, falsifying labels) result in fines under federal criminal law (Title 18, U.S. Code), and HHS may suspend or revoke registrations.
- Definitions: Key terms include "donor" (person who consented to non-transplant transfer), "education" (teaching/training on anatomy, diseases, etc.), "human body" (deceased body), "human body part" (organs, tissues, etc., excluding blood draws or cell lines for medical purposes), and "research" (excluding autopsies in criminal investigations).
The provisions apply to acquisitions or transfers occurring 2 years after enactment.
Significant Changes to Existing Law
This bill inserts a new Section 373A into Title III of the Public Health Service Act (42 U.S.C. 241 et seq.), introducing the first comprehensive federal framework for regulating the non-transplant body donation market. Previously, this area relied primarily on state laws for anatomical gifts and remains disposition, with limited federal oversight outside transplantation (governed by laws like the Uniform Anatomical Gift Act). It adds mandatory federal registration, record-keeping, labeling, privacy protections, and enforcement for interstate profit-driven activities, filling gaps in regulating "body brokers" who buy and sell donated remains.
Potential Impacts
- Government Agencies: HHS gains new responsibilities for registrations, inspections, fee collection, and rulemaking, potentially increasing administrative workload and costs (offset by fees). This could enhance federal coordination with state laws on remains handling.
- Citizens: Donors and families benefit from stronger consent verification, privacy safeguards, and assured respectful disposition, reducing risks of mishandling or unauthorized sales. It may deter unethical practices but could raise costs for research/education if passed to institutions.
- International Relations: No direct impacts, as the bill focuses on U.S. interstate commerce and domestic laws.
Main Stakeholders Affected
- Body Brokers and Commercial Entities: Profit-driven acquirers/sellers face new registration, compliance, and penalty burdens.
- Educational and Research Institutions: Medical, dental, and mortuary schools, plus training organizations, are exempt from registration if non-profit but must adhere to record-keeping and disposition rules when receiving transfers.
- Funeral and Healthcare Professionals: Funeral homes, coroners, hospitals, and tissue banks are involved in chain-of-custody documentation but largely exempt from core requirements.
- Donors and Families: Protected through consent mandates and disposition rights, ensuring ethical use of remains.
- HHS and Federal Regulators: Tasked with implementation and enforcement.
Notable Legal, Constitutional, or Political Implications
- Legal: Establishes federal criminal penalties (fines) for violations, harmonizing with state anatomical gift laws while adding interstate commerce oversight under Congress's commerce clause authority. Enhances privacy via restrictions on donor data, aligning with federal health privacy rules (e.g., HIPAA-like protections).
- Constitutional: Supports due process by requiring informed consent and inspections with notice; no apparent free speech or privacy conflicts, as it regulates commercial activities and protects donor intent without restricting speech.
- Political: Addresses public concerns over body trafficking scandals (e.g., unauthorized sales of donated remains), promoting transparency and ethics in science/medicine. As a bipartisan bill (introduced by Reps. Bilirakis (R) and Fletcher (D)), it signals cross-party support for regulating an under-scrutinized industry without overly burdening non-profits.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Bilirakis, Gus M. [R-FL-12]
Cosponsors (4)
Rep. Fletcher, Lizzie [D-TX-7], Rep. Barr, Andy [R-KY-6], Rep. Van Orden, Derrick [R-WI-3], Rep. Shreve, Jefferson [R-IN-6]
Recent Actions
- 2025-04-02: Referred to the House Committee on Energy and Commerce.
- 2025-04-02: Introduced in House
- 2025-04-02: Introduced in House
Bill Versions
- Consensual Donation and Research Integrity Act of 2025 — issued 2025-04-02 — PDF (12 pages)