Canada’s research chairman in health law and policy says provincial governments should look into creating laws to clarify who owns excised human tissue once it’s been removed from the body.
Timothy Caulfield, who is also research director at the University of Alberta’s Health Law Institute, says there’s currently no consensus on who owns tissue that has been surgically removed from patients. Some say hospitals have ownership of the tissue and can conduct research on it; others say the specimens belong to patients.
“If you think of the amount of research that has gone on in the world around human tissue and you think of the billions and billions of research dollars that have been invested and things that have emerged from research with human tissue, you would think we would have this property issue resolved,” says Caulfield.
Caulfield and his team asked patients, researchers, and privacy commissioners about who owns the tissue. “There’s just a variety of opinions,” he says. “There’s no clarity at all.”
The question is even more important to answer now as both the value of genetics information and privacy concerns intensify, Caulfield adds.
A research ethics group in the U.S. is currently reviewing its own policy on this issue. Alan Belaiche, a health lawyer and former in-house counsel at St. Michael’s Hospital, agrees it’s time Canada follows suit.
“If they’re looking at it in the U.S., Canada should be looking at it as well,” Belaiche says.
But Caulfield says what’s needed is beyond policy or guidance from Canada’s Panel on Research Ethics.
“We need to go beyond ethics policy and actually create legal clarity,” he says.
In July 2014, an Ontario Superior Court addressed the question of tissue ownership for the first time in a Canadian court. In that case, Master Ronald Dash decided hospitals, not patients, own excised tissue in a ruling that ignited some controversy. That decision, which took place in the context of a medical malpractice matter, was never appealed and remains the law. Experts, however, disagree on how much weight that decision has, given it was decided by a master in an interlocutory matter.
“The decision that was released wasn’t really something anybody would appeal from because there was no public interest, there was no public interlocutor per se; it was kind of like a decision made on the fly,” Belaiche says. “It doesn’t strike me as being particularly compelling or persuasive.”
According to Belaiche, the general public would support a review of the rules. The public perception is that companies should not profit from other people’s tissue and that patients should know how their tissue is being used, he says.
“The overly broad assertion of right [by hospitals] is being used now and I don’t think people are really aware of it and they should be aware of it,” Belaiche adds.
He says Dash’s 2014 decision in Piljak Estate v. Abraham was too simplistic. It was “an overly broad derogation of the individual patient’s rights to their tissue,” he says. He adds his view is that a patient’s excised tissue should not be used for purposes other than what the patient has consented to and reasonably expects, which is typically for the treatment and care of patients themselves.
In the U.S., a consultation is underway as to the consent requirements for conducting research on excised human tissue. Last year, the U.S. Department of Health and Human Services, along with 15 other federal departments and agencies, announced proposed revisions to the Federal Policy for the Protection of Human Subjects.
The proposal seeks to bolster consent requirements for secondary research conducted using samples of human tissue.
“. . . Informed consent would generally be required for secondary research with a biospecimen (for example, part of a blood sample that is left over after being drawn for clinical purposes), even if the investigator is not being given information that would enable him or her to identify whose biospecimen it is,” the proposal says. “Such consent would not need to be obtained for each specific research use of the biospecimen, but rather could be obtained using a ‘broad’ consent form in which a person would give consent to future unspecified research uses.”
The proposal, released in September 2015, acknowledges the societal value of research. It says maximizing such research would mean reducing barriers to the secondary use of biological specimens to a wide extent.
“However, there is a growing recognition that many people want to have some degree of control over the circumstances in which an investigator can derive information about them, above and apart from their interest in whether or not that information might be inappropriately disclosed,” the proposal says. “More specifically, a growing body of literature shows that in general people prefer to have the opportunity to consent (or refuse to consent) to research involving their own biological materials.”