Wednesday, June 27, 2007

Are human tissues owned?

There's not a whole lot of legal precedent in the biorepository field, and when a case lands in an appeals court, it's very important.

The bare bones of the case are as follows: Dr. Catalano, a prostate cancer researcher at Washington University, saved tissues in a biorepository over several decades. When he took a job at another institution, he sent out a letter to many of the people whose tissues were stored in the biorepository. The letter asked for permission to transfer their tissues to his new employer. He received a number of letters granting the permission. Washington University stepped in and informed Dr. Catalano that the tissues would need to remain in the Washington University biorepository.

Wash. U. asked the court for a declaratory ruling that the tissues were owned by Washington University and could not be taken by Dr. Catalano. The appellate court upheld that the tissues were owned by Washington University.

The text of the ruling is publicly available.

I read over the entire ruling and found myself in total agreement with the court. It was very interesting to read the evidence that the court considered important for their decision.

There was one point in their ruling that I found troubling. The court noted that the tissues were donated to Washington University by patients (which assumes that patients were the original owners of the tissues). Once donated (according to the court), the tissues were owned by Wash U (not Dr. Catalona). The problem here is that there's been a long tradition of not assigning ownership for human tissues. I'm no lawyer, but it's been my impression that removed human tissues carry a variety responsibilities (e.g. render a diagnosis, store in a paraffin archive, provide copies of diagnostic reports as needed) and rights (use tissues for biomedical research). Traditionally, All this is done through an exercise of rights and responsibilities, without an assignment of ownership.

Ownership is a mercantile concept and implies that the owner can sell the property. If you own a cow, that means you can sell the cow. If you own a house, you can sell the house. If you own a tissue sample, that would seem to mean that you can sell the tissue sample. But that is exactly why the tradition has been that tissue samples are never owned. Ethicists have commented that we shouldn't be selling tissues, and that implies that we shouldn't be owning tissues. We can use tissues for different purposes without assigning ownership. An analogy is that we breathe air from the atmosphere, but nobody owns the atmosphere. We also can be required not to pollute the air, even though we don't own the air. Basically, we can have a system of rights and obligations without assigning ownership.

Well, this court decision seems to break a long-held tradition. The court clearly thought it needed to determine who owns the tissues (Wash U or Dr. Catalona), and they ruled that the tissues were property owned by Wash U. So what happens next? Have archived tissues become property [that can be bought and sold]?

-Jules Berman
Science is not a collection of facts. Science is what facts teach us; what we can learn about our universe, and ourselves, by deductive thinking. From observations of the night sky, made without the aid of telescopes, we can deduce that the universe is expanding, that the universe is not infinitely old, and why black holes exist. Without resorting to experimentation or mathematical analysis, we can deduce that gravity is a curvature in space-time, that the particles that compose light have no mass, that there is a theoretical limit to the number of different elements in the universe, and that the earth is billions of years old. Likewise, simple observations on animals tell us much about the migration of continents, the evolutionary relationships among classes of animals, why the nuclei of cells contain our genetic material, why certain animals are long-lived, why the gestation period of humans is 9 months, and why some diseases are rare and other diseases are common. In “Armchair Science”, the reader is confronted with 129 scientific mysteries, in cosmology, particle physics, chemistry, biology, and medicine. Beginning with simple observations, step-by-step analyses guide the reader toward solutions that are sometimes startling, and always entertaining. “Armchair Science” is written for general readers who are curious about science, and who want to sharpen their deductive skills.