Collaborating with Commercial Tissue Repositories: An ethics guide for IRBs, researchers and policymakers
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Home Legal Issues Excised Tissue

Who owns excised tissue?

This question is currently difficult to answer. There is no federal law on the ownership of excised tissue. There is federal law prohibiting the sale of human tissue but allowing for reasonable reimbursement for tissue collection, storage and distribution. (e.g. the National Organ Transplant Act). Tissue clearly belongs to the patient before surgery but once the tissue is removed from the patient's body, does it become the property of the medical center that stores or discards it or the patient? Conventional wisdom is that excised tissue belongs to the medical center (e.g., patients cannot take it with them). However, personal information associated with the tissue belongs to the patient. Identifiable tissue contains private information about the patient that the patient has a right to control. Hence, informed consent is required for educational or research uses of identifiable tissue. Property rights in tissue/information are subject to state laws.

The question when phrased as one of ownership suggests that our bodies are property. Yet, if it is property, then it is the patient's property and should be in the patient's control. But if a property model is applied to the body, then since patients are not allowed to sell bodily organs and tissue, the body is a special kind of property. People are allowed to make decisions about medical procedures and transfer the control of excised tissue and organs, but, with the exception of sperm, eggs, and platelets, (where donors are compensated for time and inconvenience), donors are not allowed to be compensated for giving their organs and other bodily materials to others for therapeutic use. In the U.S. and elsewhere, there is great resistance to commercializing the human body. Still, much of the basis of property law is used in arguing about bodily rights. In this regard, the body both is and is not property from a legal perspective.

A second issue arises from any claim that the patient's tissue belongs to the patient. We can ask if excised tissue is no longer recognizable as belonging to a particular patient, does it still belong to the patient? For instance, when excised tissue is anonymized, (stripped of all personal information) is it still considered the "property" of the patient? The most far reaching bill for genetic privacy, The Model Genetic Privacy Act (which was passed in one state, Oregon), claims that de-identified excised samples are no longer the property of the patient. A 1997 revision on this point states "An individual's genetic information and DNA sample are the property of the individual except when the information or sample is used in anonymous research."

Key Point: There is no federal regulation on the ownership of excised patient tissue.

Key Point: State laws on individual property rights regarding human tissue vary widely.

Key Point: Some believe that an ownership view of excised tissue inappropriately commercializes the body.

Key Point: State laws regulate genetic privacy issues and vary widely.

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