Scientists push for clearer biobank regulations

In the booming, multibillion-dollar biobanking industry, a lack of clarity surrounds the collection and use of patients’ genetic material.

Biobanks are large collections of genetic samples with patients’ corresponding health and personal information. The banks have become important tools in the development of personalized medicines, but the industry hasn’t found a consensus on the best way to balance research goals with the ethical concerns around the use of such personal information.

“These fundamental issues still remain around consent and control of samples,” Timothy Caulfield, a Canada Research Chair in health law and policy at the University of Alberta, said Thursday.

Caulfield is pushing for more coherent laws with regards to what researchers can and can’t do with people’s genetic data and thinks Alberta could be a leader in the field, giving medical researchers here their own “Alberta advantage.”

“The uncertainty makes it more difficult to do research, and then there’s even the possibility ... that a legal issue could jeopardize the biobank,” said Caulfield, pointing to a 2010 settlement that saw five million blood samples of newborns destroyed after just five parents sued the Texas Department of State Health Services over its failure to obtain consent.

Policy and legislation falls on the provinces in Canada and Caulfield wants Alberta to write laws solidifying the industry’s practices here.

The public largely supports biobanks and the research they support, he said, but it also tends to lean in favour of wanting more control over an individual’s genetic data, a disconnect which makes building a legal framework difficult.

Generally, there are two types of consent a biobank can get from patients — specific or broad. Specific consent limits what a bank can use the sample for. Broad consent leaves it more open-ended.

Consent laws in Canada favour specific consent, but with such a large number of samples and the evolving nature of what banks might be useful for in the future, it’s a logistical nightmare to get specific consent from everyone each time a new use for a bank comes up. Researchers have been opting for broad consent amid the lack of legislation.

Generally, Caulfield wants policy which is favourable to researchers without sacrificing the ethical concerns of patients.

“What we need is a legal and ethical framework that is transparent and allows that to happen in a manner that appropriately balances the interests of research participants and the needs of researchers,” he said.