Biobank research: who benefits from individual consent?

Much of the research on which our healthcare knowledge is based has not been carried out under circumstances that would be considered morally acceptable today. Scandals such as the experiments of the Nazi doctors,1 the Tuskegee syphilis study,2 and the retention of organs from children in Alder Hey3 have evoked much anger and contempt. In an attempt to protect people from such offences extensive regulations have been put in place.

In many countries, including the United Kingdom and Sweden, requiring informed consent has become the default position not only for invasive research but also for non-interventional research, such as using leftover material taken within the healthcare system.4 Other countries (including Denmark and Belgium) permit presumed consent for such research. In this article we argue that well intended regulations governing biobank research (defined as research on stored tissue samples and associated data) cause harm by hampering medical advances.