Swedish biobank research suffered serious defeat last week. The Swedish Data Inspection Board decided that the ongoing collection of biological samples and health data to the large biobank LifeGene is against the law.
Karolinska Institutet (that runs LifeGene) must now stop collecting further data and is not allowed use already collected data. The reason for the decision is said to be the loosely formulated purpose of LifeGene: “future research.” Participants cannot give consent to anything that vague, the Data Inspection Board argues.
Well, that openness happens to be the point of this new type of biobank!
LifeGene is not a research project, nor is it part of a research project. LifeGene is intended as infrastructure of future biobank projects. Researchers are invited to apply for access to the biobank within specific studies of, for example, genetic and environmental risk factors for widespread diseases.
The more specifically formulated research purposes enter later in the process!
Collecting hundreds of thousands of biological samples and health data anew, each time researchers want to ambitiously study widespread diseases, is unfeasible. Therefore, LifeGene was developed as standing infrastructure of such biobank research in the future.
… And now it has been decided that developing such infrastructure is illegal. Because the purpose cannot be specified as in the research projects that later use the biobank!
This is a category mistake, as philosophers say when what is fundamentally distinct is conflated. In this case, research infrastructure is conflated with research projects.
Other posts about biobanks on this blog are directly related to the risk of the decision that the Swedish Data Inspection Board made:
- Debate on changes to the European Data Protection Directive.
- Taiwanese researchers forced to destroy biobank samples?
- Does my blood sample make me a research subject?
My views can be summarized in two simple points:
- Infrastructure for biobank research must not be treated as if it were one of the projects meant to use it.
- My given blood sample does not make me a research participant (who must give consent each time the sample is used).
LifeGene represents a new reality in the making. It remains for the authorities, for legislators, and for all of us to better understand it!
Hej Per,
Jag blev intresserad av vad du exakt menar med “LifeGene represents a new reality in the making”?
Dear Åke,
I found your question above about what I mean by LifeGene as a “new realtity” very stimulating. I therefore decided to anwer it in a separate post: http://ethicsblog.crb.uu.se/2012/01/02/can-infrastructure-for-biobank-research-make-ethical-notions-obsolete/ I hope you don’t mind! Best wishes, Pär
Thank you for your blog.Thanks Again. Cool.