What the new biobank act means for you as a researcher
A new Swedish biobank act comes into force on July 1. It is expected to make it easier for researchers to use biobanks – i.e. collections of samples of human and fetal tissue – and to collaborate.
“Biobanks are a vital resource in medical research, and this new law is welcome,” says Mark Divers, director of KI Biobank, one of Karolinska Institutet’s core facilities. “It’s a move in the right direction. The new act will make it easier to do research on human tissue while enhancing the privacy of the individual, which makes it possible to respond better to the desire of the sample-providers to contribute to medical research.”
The biobank act regulates how samples of identifiable material from humans can be gathered, stored and used for defined purposes. It replaces the current 2003 act, which had the same intentions but that, amongst other shortcomings, was difficult to administrate and incompatible with other laws.
One important amendment is that the new act places emphasis on the purposes of the sample collection, rather than on where the samples were taken. This means that when samples are collected for research purposes, the research principal – Karolinska Institutet, for example – can be directly legally responsible for the sample collection, even if the samples are collected in a healthcare unit. The current concepts of primary and secondary sample collection will no longer apply.
“The system has been unwieldy and time-consuming,” says Sanela Kjellqvist, head of KI Biobank’s IT and Customer Relations Unit. “It’s now clearer who has legal responsibility and since the same principal is responsible of the entire process, it makes every step simpler: applying to start new sample collections, accessing samples for research and sending samples for analysis. Researchers will notice that the law is more in harmony with the way research works.”
The new act can also aid research collaborations. As biobank principal, Karolinska Institutet can supply sample collections to other universities and partners throughout the country. The act also allows samples sent abroad for analysis, for example, to be put in long-term storage, which is currently not permitted.
“This is essential, not least for medical researchers, who often take part in large international collaborations or use analysis platforms in other parts of the world,” says Mark Divers. “Before, samples had to be destroyed or returned after analysis, which often limited analysis collaborations with other countries.”
Parts of the new law is being reviewed
One cause of concern, however, is a clause in the new act forbidding the use in research of samples taken for the legal purpose of healthcare and treatment of people unable to make their own decisions. When the Act was adopted, the Riksdag therefore urged the government to review the parts of the law that could preclude researchers from using samples from patients with cognitive impairments such as severe dementia or mental illness.
“The review needs to proceed quickly so that research on samples taken in the purpose of care and treatment of patients lacking decision-making capacity can continue,” says Sanela Kjellqvist. “Otherwise, there’s a risk that it’ll impede research on many serious diseases.”