Extensive regulations make research difficult

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.

A project like Undlien's must be approved by many entities, including The Regional Committee for Medical Research Ethics, the Norwegian Data Inspectorate and the Ministry of Health and Care Services. In all cases, documentation must show that the research is in accordance with all applicable laws, from the biotechnology regulations to laws governing privacy and health care providers. -It's not uncommon to experience an instance where one group recommends changes that another group has previously rejected," says Dag Undlien. The University Hospital has reacted to the government's bureaucracy by developing its own bureaucracy to help researchers.

These laws and bureaucracy have been developed to protect patients, but Dag Undlien wonders if this is really what patients want. -I don't believe that this is in line with patients' wishes. In my meetings with patients, I've experienced a great and pronounced desire that their illness be researched so that it can be cured, says Undlien.

Jostein Halgunset also doubts that this is in the patients' best interest. He strongly describes what he calls the perverted ethic debate about the biobank laws that regulate using biological material from the healthy population as well as hospital patients. -Consent from patients must not be the only criterion that makes it possible to focus on different diseases. An ethical standard is the result of ethical reflection that involves weighing different factors, and is not based on approval alone," says Halgunset. The platform he is building will co-ordinate research on material from patients with different illnesses, and he would like to see that collected material can be used in various unique research projects.