The Data Inspection Board has audited the processing of data in the LifeGene project, which has been gathering information voluntarily provided by participants about their health and lifestyles. The project will help to improve diagnostics, treatments and preventative recommendations.
However, the Data Inspection Board has ruled that the gathering of personal information for future research is in breach of the Personal Data Act and that LifeGene is to cease the collection and processing of such data.
"Putting a stop to this kind of project is a devastating blow for medical research," says Professor Harriet Wallberg-Henriksson, president of Karolinska Institutet. "Without the collection and analysis of large volumes of data by projects like LifeGene, it might be impossible for science to improve healthcare."
The collection of large amounts of data has been the strength of Swedish medical research. One example of this is how Swedish scientists have been able to produce a major life-saving vaccine for cervical cancer on the basis of biobank samples, which have been stored in national registers since the 1960s; if these registers had been closed, neither the research nor the vaccine would have been possible.
The objective of LifeGene, which is operated by all medical faculties in Sweden and hosted by Karolinska Institutet, is to collect data from 500,000 individuals who give written consent for the project to gather information about their health and lifestyle and store blood and urine samples in a biobank for the purposes of future research. So far, 20,000 people have signed up. All data is anonymised to protect personal integrity and is available to researchers at universities around the world.
"LifeGene gives us unique opportunities for understanding the complex interplay between environment, lifestyle and heredity and how it affects disease," says Professor Wallberg-Henriksson. In its decision, the Data Inspection Board writes that the database management of personal data for future research is such as important issue that the parliament and government should review current legislation. Karolinska Institutet agrees.
"This shows that there are flaws in the law," says Professor Wallberg-Henriksson. "When it comes to research registers, the legislators cannot have meant for the Data Protection Act to be applied in the way that the Data Inspection Board is now doing. It not only affects LifeGene but also a whole host of other research projects vital to the future of healthcare."
Karolinska Institutet will be appealing the Data Inspection Board's ruling.