Biobanks are an invaluable resource for modern medical research, collecting together genetic, tissue or health data on an unprecedented scale.
Their potential for scientific advances is huge, particularly around medical treatments, and as a result billions have been invested by governments, industry and research institutions to establish vast, complex biobanks.
However, in their eagerness to establish such valuable resources, researchers have not established a standard method to acquire informed consent, meaning a host of legal and ethical principles remain that have the potential to completely derail the entire process, according to University of Alberta health law researchers Timothy Caulfield and Blake Murdoch.
Writing in a freely available article in the journal PLOS Biology, Caulfield and Murdoch argue that urgent policy action is required if biobanks are not to be completely undermined, and thus the associated research be significantly impeded.
“The international research community has built a massive and diverse research infrastructure on a foundation that has the potential to collapse, in bits or altogether,” said Caulfield.
“This issue would benefit from more explicit recognition of the vast disconnect between the current practices and the realities of the law, research ethics and public perceptions.”
While many biobanks have a robust consent process, there are some where although consent is sought, it is not adequate to be completely free of legal risk.
And while in principle it may seem like no one would object to their tissue, genes or health data being used to aid medical breakthroughs, in reality it is entirely possible that negative public perceptions could result in significant legal challenges to the operation of biobanks.
The rise in the idea of biorights, as well as growing distrust of scientists from some quarters, could pose a problem. The involvement of industry partners could also be an issue, with many likely to be concerned about the idea of companies profiting from research that has been aided by their own health data or cells.
While many biobanks are likely to remain successful resources for robust research, there is already some precedent for the destruction of a biobank due to legal issues.
In 2010, for example, the settlement of a legal case forced the Texas Department of State Health Services to destroy over 5 million blood samples from newborn babies, as a result of just 5 parents suing over a lack of proper consent.
In this case, a valuable resource for future research was lost due to a poor consent handling with a tiny number of people.