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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. |