This bill, known as the "Consensual Donation and Research Integrity Act of 2025," aims to amend the Public Health Service Act to create a federal regulatory framework for the donation and transfer of human bodies and body parts. Its core purpose is to ensure consensual donation and respectful disposition of these materials when used for education, research, or the advancement of medical, dental, or mortuary science, specifically excluding their use in human transplantation. The legislation mandates that any person or entity acquiring and selling for profit whole human bodies or body parts in interstate commerce must register with the Secretary . Exemptions are provided for the Organ Procurement and Transplantation Network, funeral service professionals, and non-profit schools or research organizations. Registrants are required to submit detailed applications, agree to inspections, maintain comprehensive records, and adhere to strict labeling and packaging standards, while also limiting the use and disclosure of donor information. Key provisions include the requirement for registrants to document the donor's knowing consent for the specific non-transplantation use and their awareness of the registrant's disposition obligations. Records must also detail the chain of custody, donor medical history, and the ultimate use and disposition of each body or part. All human bodies and parts must be labeled and packaged to prevent contamination and ensure integrity, with labels including donor information, contents, and a clear "not for transplantation" statement. Registrants are responsible for the proper disposition of human remains, either by returning them to a relative or personal representative, or by contracting with another person to assume this obligation if transferred. Violations of these requirements can lead to fines and the revocation of registration . These amendments will become applicable to any acquisition or transfer of human bodies or body parts two years after the Act's enactment.
Consensual Donation and Research Integrity Act of 2025
USA119th CongressS-1270| Senate
| Updated: 4/3/2025
This bill, known as the "Consensual Donation and Research Integrity Act of 2025," aims to amend the Public Health Service Act to create a federal regulatory framework for the donation and transfer of human bodies and body parts. Its core purpose is to ensure consensual donation and respectful disposition of these materials when used for education, research, or the advancement of medical, dental, or mortuary science, specifically excluding their use in human transplantation. The legislation mandates that any person or entity acquiring and selling for profit whole human bodies or body parts in interstate commerce must register with the Secretary . Exemptions are provided for the Organ Procurement and Transplantation Network, funeral service professionals, and non-profit schools or research organizations. Registrants are required to submit detailed applications, agree to inspections, maintain comprehensive records, and adhere to strict labeling and packaging standards, while also limiting the use and disclosure of donor information. Key provisions include the requirement for registrants to document the donor's knowing consent for the specific non-transplantation use and their awareness of the registrant's disposition obligations. Records must also detail the chain of custody, donor medical history, and the ultimate use and disposition of each body or part. All human bodies and parts must be labeled and packaged to prevent contamination and ensure integrity, with labels including donor information, contents, and a clear "not for transplantation" statement. Registrants are responsible for the proper disposition of human remains, either by returning them to a relative or personal representative, or by contracting with another person to assume this obligation if transferred. Violations of these requirements can lead to fines and the revocation of registration . These amendments will become applicable to any acquisition or transfer of human bodies or body parts two years after the Act's enactment.