The case in summary Eight university hospitals participated in the controversial “Norwait” cancer study, which was stopped in November 2020 after patients relapsed and the cancer spread. Two patients died after the study. Sørvest police district has imposed fines on Helse Bergen and Helse Stavanger for breaches of the Health Research Act. Helse Bergen has received a fine of 1.8 million, and Helse Stavanger a fine of 2.7 million. Managing director of Helse Bergen, Eivind Hansen, says the project has not been carried out as it should have been. The boards of Helse Bergen and Helse Stavanger are now reviewing the basis for the proposal and will respond before the deadline. The summary is made by an AI service from OpenAi. The content is quality assured by news’s journalists before publication. – So gross that it is almost unbelievable, said the Norwegian Health Authority when the news about the Norwait study became known. Altogether, there were eight university hospitals throughout the country that participated in the study, before it was stopped in November 2020. By then, patients had relapsed and the cancer had spread. Two patients died after the study. – This is a very serious matter and a great burden for patients, relatives and survivors, says CEO of Helse Bergen, Eivind Hansen. – We deeply regret this, he adds. On Tuesday, it became known that Sørvest police district has imposed fines on both Helse Bergen and Helse Stavanger in connection with the Norwait study. Hansen tells news that he will encourage the board to adopt the punishment. – Fatal consequences Sørvest police district has fined Helse Bergen a fine of 1.8 million and Helse Stavanger a fine of 2.7 million. State attorney Nina Grande says that the fine to Helse Stavanger is higher, since the company had the coordinating responsibility for the study. – And then they have not followed up the requirements in the Health Research Act regarding, among other things, internal control in relation to the study, she says. Public prosecutor in the Sørvest police district, Nina Grande. Photo: Eirik Gjesdal / news Grande describes the fines as high. – The fines are high in these cases, because it can potentially have fatal consequences, she says. Patients became sicker In the Norwait study, patients with rectal cancer, where the tumor had completely disappeared after radiation, were to skip surgery and rather be closely monitored during a wait-and-see period. In November 2020, the study was stopped, following suspicions that more patients than expected developed spread of the cancer tumor while participating in the study. The proposal is linked to Health Bergen’s role as the institution responsible for research and Health Stavanger’s role as the coordinating institution responsible for research for the multi-centre study. The case has been dealt with by the National Health Inspectorate and the State Administrator in Vestland. Not as it should be The Board of Health Bergen and Health Stavanger are now reviewing the basis for the proposal and will respond before the deadline. SORRY: CEO of Helse Bergen, Eivind Hansen, regrets the burden this case has had on patients and relatives. Photo: Henrik Hauken / news Hansen says the management of the health insurance company has gone through the matter thoroughly. – Now we are going through what is the premise for the police’s work. There is learning value, it is possible to make this better definitely, and avoid this happening again, he says. – Should this project have been started at all? – I do not want to go into the details of that. What we see today is that the project has been carried out as it should have been. One would also have to go all the way back to whether it should have been started, but then I will go into the details. The entire sequence of the project must always be thoroughly assessed from a research ethics perspective. He describes the Norwait case as demanding for the researchers who worked on the study. – Serious case The board of Helse Bergen will consider the case in a board meeting on 21 March. The board of Helse Stavanger – SERIOUS: Managing director of Helse Stavanger, Helle Schøyen, describes the matter as very serious. Photo: Ingvild Taranger / news will consider the case at the board meeting on 18 March. – My recommendation to the board will be to adopt the proposal, says Hansen in Helse Bergen. – This is first and foremost a very serious matter and a great burden for the patients who have been part of this study, and who have not been followed up as they should be, says the CEO of Helse Stavanger, Helle Schøyen on the health company’s website .
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Helse Bergen and Helse Stavanger are fined 4.5 million – news Vestland
