Consensual Donation and Research Integrity Act of 2023

Consensual Donation and Research Integrity Act of 2023

This bill requires certain entities that acquire human bodies and sell for profit a whole human body or human body part to register with the Department of Health and Human Services.

Registered entities must comply with record-keeping, labeling, packaging, and disposition requirements.

The registration and related requirements do not apply to

• the Organ Transplantation Network (a public-private partnership that links the professionals involved in the U.S. donation and transplantation system) or its members;
• the preparation, transportation, and final disposition of human bodies or body parts by funeral service professionals; and
• schools of medicine, dentistry, and mortuary science and other research and training entities that do not sell whole human bodies or body parts for profit.

Bill 118 hr 4275, also known as the Consensual Donation and Research Integrity Act of 2023, aims to address issues related to the donation of human tissue for research purposes. The bill seeks to establish guidelines and regulations for the donation of human tissue, ensuring that donors provide informed consent and that their rights and privacy are protected.

Under the provisions of the bill, researchers and institutions receiving donated human tissue must obtain consent from the donor or their legal representative. This consent must be voluntary, informed, and documented in writing. The bill also requires researchers to disclose the intended use of the donated tissue and any potential risks or benefits associated with its use.

Additionally, the Consensual Donation and Research Integrity Act of 2023 includes measures to ensure the integrity of research conducted using donated human tissue. Researchers must adhere to ethical standards and best practices in the handling, storage, and use of human tissue. The bill also establishes penalties for violations of these regulations, including fines and potential criminal charges. Overall, the Consensual Donation and Research Integrity Act of 2023 aims to promote transparency, accountability, and ethical conduct in the donation and use of human tissue for research purposes. By establishing clear guidelines and regulations, the bill seeks to protect the rights and privacy of donors while ensuring the integrity of research conducted using donated human tissue.