According to Norway's functional genomics researchers, it has become more difficult in recent years to begin research projects based on genetic samples from patients from hospitals or participants in health surveys.
Laws and bureaucracy are the reasons for this opinion, and they feel the practice is unethical.
Good medical research is an ethical obligation. It's unethical to not perform research when you have the opportunity to carry out careful study that does not entail any direct stress for patients or participants. This is how the biobank laws function in practice today, making it difficult for research. At the same time this is not quite practical, says Camilla Stoltenberg, a division director at The Norwegian Institute of Public Health and manager of the national Functional genomics programme (FUGE) platform "Biobanks for Health".
Camilla Stoltenberg's opinion is supported by another of FUGE's platform managers, Jostein Halgunset, researcher at The Norwegian University of Science and Technology (NTNU). He has used approximately four years to develop the FUGE platform "Regional Research Biobank in Central Norway". The platform still needs approval from the Norwegian Data Inspectorate before it can begin as planned. Two of the years were used by the authorities needed to make approvals: the first half year was used by the Regional Ethics Committee (REK) and the next year and a half was needed by the Norwegian Ministry of Health and Care Services.
Dag Undlien, professor at the Department of Medical Genetics at Ullevaal University Hospital in Oslo, says that today's laws are so intimidating that a large number of researchers have declined to begin projects because they know about the amount of work needed to secure the necessary permission from the authorities.
Dag Undlien would like to study several hereditary factors that make is easier for some to become obese. The goal is to develop a tailor-made obesity treatment: which patients should receive fat-reducing surgery, which should diet, and which need medications? To determine this, he and his colleagues ask Ullevål Hospital's weight-referrals if they would be interested in participating in a study. Participation means a patient will fill-out a form with personal information and submit a blood sample that will be genetically analysed.
But very complicated regulations apply to this type of research. A great deal of time is needed, not only to understand the regulations, but then to receive necessary approvals, including several discussions with the biobank co-ordinator and privacy ombudsman. A great deal of time was needed to fill out multiple approval applications, rather than a single complete application. Approval proceedings also take a great deal of time, and there is no doubt that the process is more complicated than in previous years.