One of the issues preceding the Swedish Data Inspection Board’s decision to stop the population-based biobank LifeGene concerned participation of minors.
LifeGene had planned to collect samples from half a million Swedes, including children. A regional ethical review board, however, decided against collecting data from children. Only data collection from adults was approved of.
LifeGene saw participation of minors as essential to their purposes and therefore appealed against the decision.
Unfortunately for LifeGene, the central ethical review board took the fateful decision that LifeGene couldn’t even undergo ethical review. LifeGene’s broad purpose – “future research” – indicated that LifeGene was infrastructure for research and not a specific research project. (According to the law, only research projects are ethically reviewed.)
The broad future-oriented nature of LifeGene’s purpose later became the main reason for the Data Inspection Board to stop LifeGene.
The fact that the stopping of LifeGene was preceded by the issue of children’s participation in biobank research makes a recent publication on this problematic all the more relevant for biobankers to read.
The article by Kristien Hens, Kris Dierickx and colleagues, published in the European Journal of Human Genetics, aims towards an ethical policy for minors’ participation in biobank research.
The authors emphasize that relevant ethical concerns differ from those of adult participation in biobank studies as well as from those of children’s participation in clinical trials. There is therefore a need for principles that apply uniquely to minors’ participation in biobank research.
I will not summarize the authors’ conclusions since they are so neatly summarized at the end of the article in the form of eight principles about, for example, subsidiarity and consent.
The eighth and final principle, however, deserves special mentioning, since it introduces a new policy concerning return of individual results. If I understand it right, the principle states that parents have a limited right to decide not to receive genetic information about their children. If an incidental finding concerns a preventable or treatable early-onset disease and it has clinical validity and utility, then parents should be informed about the finding regardless of their wishes.
The right not to know is overruled in this particular case.
The article is well worth reading as a constructive discussion of concerns that need to be addressed when children are included in biobank research.