New Bill Requires Federal Registration and Oversight for Human Body Brokers Starting in 2027

Congress is looking at a new set of rules for handling human bodies and body parts donated for science, education, or research – basically, everything except organ transplants. The "Consensual Donation and Research Integrity Act of 2025" aims to bring federal oversight to a largely unregulated space by requiring entities that acquire and sell these materials across state lines for profit to register with the Department of Health and Human Services (HHS).

Getting on the List: Who Needs to Register?

Starting two years after this bill potentially becomes law, if you're in the business of acquiring donated human bodies or parts and selling them for profit across state lines, you'll likely need to register with HHS. Think companies sometimes referred to as 'body brokers'. The bill carves out exceptions for established players like the official organ transplant network, funeral directors doing their usual work, and non-profit schools or research outfits. Getting registered involves submitting details about your business, what you do, where you operate, and promising to follow the new rules on inspections, record-keeping, and labeling.

The Fine Print: New Operating Standards

This isn't just about signing up; registered organizations face ongoing requirements. Expect regular inspections of facilities. You'll need to keep meticulous records for every body or part handled, tracking everything from the original donor's consent documentation and medical history to who it was transferred to, how it was used, and its final disposition. Think of it as a chain-of-custody log to ensure everything is accounted for and handled ethically. The bill also mandates specific labeling and packaging to clearly identify contents and include necessary warnings, aiming for safety and integrity.

Privacy, Respect, and Penalties

Protecting donor information is a key piece here. The bill limits how individually identifiable information can be used or shared, restricting it to purposes authorized by HHS. There's also a requirement to ensure respectful final disposition of remains, either by returning them to the donor's family or arranging for it through a contracted third party. Dropping the ball on these rules isn't taken lightly; violations can lead to hefty fines (as defined under federal law) and potentially losing your registration. Falsifying labels is also explicitly called out as a violation.

What This Means on the Ground

This legislation tries to balance bringing much-needed ethical oversight and transparency to the non-transplant donation sector with the practical needs of research and education. On one hand, it offers donors and their families more assurance about respectful handling and aims to prevent exploitation. On the other, the new registration process (which includes fees set by HHS to cover costs), detailed record-keeping, and inspection requirements will undoubtedly add administrative load and costs for the businesses involved. The question is whether these costs might trickle down, potentially making anatomical materials more expensive for the medical schools and research labs that rely on them.