JANUARY 30, 2005

Who owns patient spare parts?

Teasing out the intricacies of informed consent

In September 2000 a worker at a storage facility in Halifax made a gruesome discovery. The lease on a storage space had expired, and on opening one of its boxes he found human organs in a plastic bag. They turned out to be from an eight-year-old girl.

Soon after, an arrest warrant was issued for Dr Dick van Velzen, a Dutch pathologist and former head of pathology at Halifax's IWK Hospital until being fired in 1998. It quickly emerged he was facing charges for removing organs from hundreds of dead children at a UK hospital without the parents' permission. On December 15, British prosecutors announced that, after a lengthy police investigation, they could not charge him because they couldn't prove which organs came from which children.

As for the Nova Scotia case, Dr van Velzen admitted to the charge of improperly storing body parts removed from the girl after having conducted post-mortem tests at her parent's request. He was convicted in July 2001 and given 12 months probation.

In both the Canadian and British cases, Dr van Velzen has always claimed that he only ever removed and stored organs for research and educational purposes. This incident, and similar ones in Ireland and the US, has fuelled debate in hospitals and research institutions about whether the use of removed human tissue for research purposes requires consent from the patient. Is a removed tumour still the property of the patient? What about a spleen or a limb?

"Consent issues are more and more on people's minds," says Dr Gordon DuVal, from the University of Toronto's Joint Centre for Bioethics. "Privacy legislation has made everyone sensitive about these kinds of issues."

Canada's Interagency Advisory Panel on Research Ethics, which sets out the parameters for any human research in the country, holds that "Researchers shall provide, to prospective subjects or authorized third parties, full and frank disclosure of all information relevant to free and informed consent."

This is clear when a physician or researcher knows ahead of time that they wish to use their patient or their removed tissue in a research project, but clarity can be lost when it comes to removed and discarded tissue researchers may wish to use after the fact. Is this material part of the patient's informed consent?

The policies of Canadian hospitals regarding this issue vary, according to experts. And the fact that Canada lacks a clear national policy further complicates the issue. But coming up with one carries its own complications.

After its organ retention scandals, Britain drafted a comprehensive human tissue bill. But many research bodies there are critical of its stringent controls, saying the red tape will set research back in that country. "It's like using a sledgehammer to crack a nut," said Lord May, president of Britain's Royal Society, in an address to the scientific academy. "No distinction is made between tissue samples taken during routine diagnostic tests at one end of the scale and the removal of organs during post-mortem at the other." He went on to say the added bureaucracy involved in getting consent for every tissue sample could hamper advances in several fatal diseases.

Another British body, the Nuffield Council on Bioethics, thinks the matter could be simplified by a view that consent is consent. In its report "Human Tissue: Ethical and Legal Issues," it recommended that, "when a patient consents to medical treatment involving the removal of tissue, the consent should be taken to include consent also to the subsequent disposal or storage of the tissue and to any further acceptable use provided that this is regulated by appropriate ethical, legal and professional standards."

But in the absence of consensus here and abroad, Dr Randi Zlotnik-Shaul, a bioethicist at The Hospital for Sick Children in Toronto, advises doctors and researchers err on the side of caution, but adds that maybe we need to tweak our system for obtaining consent. "In terms of the ethics of it, a lot of people would argue that within a regular consent form for surgery there should be something included saying that waste may be stored or used for research or educational purposes," she says. "Some say there should be an opt-out clause for patients so they will be able to say 'I don't want any discarded tissues used for research'."

Dr DuVal adds that in the case of fetal tissue or stem cells some patients may have strong convictions regarding their use, making detailed, informed consent even more critical. "I wouldn't accept the argument that [this tissue] was discarded or had been intentionally abandoned when the person didn't know that it could be used for research or be valuable in somebody else's hands," he says.



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