HR2589-119

What This Bill Does

The Consensual Donation and Research Integrity Act creates a federal registration and compliance system for non-transplant human body and body-part markets. A person that acquires human bodies and sells for profit a whole body or body part in interstate commerce must register with the Secretary of Health and Human Services. The registration requirement excludes the Organ Procurement and Transplantation Network and its members, funeral service professionals handling preparation, transportation, and final disposition, and schools of medicine, dentistry, mortuary science, research or training organizations, and entities that do not sell whole bodies or body parts for profit. Registrants must apply with business names, addresses, premises, equipment, services, responsible representatives, inspection assurances, recordkeeping assurances, labeling and packaging assurances, and privacy assurances; pay annual fees tied to inspection and enforcement costs; renew registrations; report changes within 30 days; undergo regular inspections; keep records documenting consent, donor information, custody, use, disposition, and transfer recipients; label and package bodies and parts with chain-of-custody and safety information; limit use and disclosure of donor identifiable information; ensure proper disposition or contractual transfer of disposition obligations; and face fines, suspension, revocation, or violation findings for noncompliance. The rule applies to acquisitions or transfers after a two-year delayed effective date.

Who Benefits and How

Body donors and families benefit from documented consent, chain-of-custody records, privacy limits, packaging rules, and disposition obligations. Medical schools and research organizations benefit from clearer rules separating nonprofit education and research use from for-profit body-part sales. Patients and the public benefit from safety labeling, contamination controls, infection information, and enforcement over non-transplant body-part commerce. Ethical research advocates benefit from federal oversight of a market that had relied heavily on state law and private practices.

Who Bears the Burden and How

For-profit body brokers must register with HHS, pay fees, submit business information, maintain records, package and label remains, and accept inspections. Health and Human Services regulators must issue regulations, set fees, inspect premises, review records, enforce privacy limits, and suspend or revoke registrations. Human body part sellers face fines under title 18 and registration loss if they violate consent, labeling, packaging, recordkeeping, disposition, or privacy rules. Transferees receiving bodies or parts must assume disposition duties by contract when registrants transfer remains to them.

Key Provisions

• Creates HHS registration for for-profit sellers of whole human bodies or body parts used outside transplantation.
• Requires consent, donor, custody, use, disposition, transfer, labeling, packaging, privacy, and inspection records.
• Authorizes registration and renewal fees based on projected inspection and enforcement costs.
• Provides fines, registration suspension, registration revocation, and label-falsification violations for noncompliance.