6 FEBRUARY 2023 – The ‘Research Ethics’ magazine (Magasinet Forskningetikk), an independent magazine on research ethics by the National Research Ethics Committees (FEK), has published an update on the Norwait study [Link] [1].

Contrary to our own impact criteria for regulatory updates, this will not (immediately) impact the regulatory requirements for conducting real world research in Norway.  However, given the significance of the scientific, regulatory, and ethical breaches we have included this as a significant update.  Researchers conducting observational studies in Norway should be aware of the Norwait study.

“We must not forget that the Norwait case is about people”

The Norwait Study – Overview and Background

According to the National Research Ethics Committees (FEK), the aim of the Norwait research project was to examine a wait-and-see scheme for patients who had become completely free of rectal cancer after radiotherapy, a so-called complete response [1].

Surgeons at the Haukeland University Hospital (HUS) included patients even if their cancer was not completely gone. These patients should have had surgery immediately instead of being included in a wait-and-see scheme. Decisive treatment was thus delayed, according to Norwegian Patient Injury Compensation (NPE) [1].

In 2021, Norwait’s steering group itself carried out an investigation (monitoring) of the inclusion at the various hospitals. This was done by surgeons associated with the project.

The monitoring revealed that at least 16 out of 31 patients had residual cancer when they were included in the study. They should therefore not have been included. Only two HUS patients were documented and included [1].

The monitors went through the inclusion at all seven hospitals that participated in Norwait, and concluded that all the hospitals except HUS had “complied with the protocol to a large extent” [1].

The Norwegian Health Authority’s Conclusion

The Norwegian Health Authority concluded in November 2022 that a number of offences had occurred in Norwait, and has also reported to the police [1]:

• • • Helse Bergen HF and Helse Stavanger HF have breached the requirements for soundness and internal control.
    • The project manager has breached requirements for professional integrity.
    • The project manager has breached the reporting obligation.
    • Many of the offences and deviations are serious.
    • Data about the patients included at Haukeland must come out of the scientific study.

The Sør-West police district is now investigating the case in collaboration with the West police district. This is the first time the police are investigating whether there have been criminal breaches of the Health Research Act [1].

Norwegian Patient Compensation (NPE) Conclusions

“We must not forget that the Norwait case is about people”…emphasizes Anne-Mette Gulaker, director of Norwegian Patient Injury Compensation (NPE)

Norwegian Patient Compensation (NPE) has concluded in several cases that HUS patients had a worse prognosis and were harmed by being part of Norwait [1].

“Several had the cancer spread, and the prognosis worsened due to delayed treatment”, says NPE director Anne-Mette Gulaker, to Magasinet Forskningetikk [1].

Nine individual cases have so far been received, and only from patients who were included via the Haukeland University Hospital (HUS). NPE has so far provided compensation to seven patients who suffered injuries as a result of the study. Five of these received a worse prognosis for their cancer. Two cases are still being processed [1].

“Our case management shows that the consequences for some have been catastrophic”, according to NPE director Anne-Mette Gulaker, to Magasinet Forskningetikk [1].

In one patient, during the wait-and-see period, the cancer spread from the rectum to the lungs and lymph, and the cancer became incurable. In another case, the patient died, from the same cause [1].

Common to those who have been approved by the NPE is insufficient examination and documentation before they were included in the study. In some cases, the patients were included in the wait-and-see scheme even though physical examination showed residual wounds and tumor tissue [1].

Research Transparency is Important

In the wake of the conclusions from the Norwegian Health Authority and Norwegian Patient Compensation (NPE), several actors in the professional community have become involved in the debate about Norwait. None of them provide information on how the affected patient group is faring [1].

From NPE’s point of view, however, it is important to say whether the failure in Norwait has had consequences for the patients [1].

“Transparency is always important, especially when something goes wrong. In NPE, we have detailed knowledge of how things have gone wrong for certain patients. We want to ensure that the knowledge from the specific cases does not disappear in the debate. We must not forget that this case is about people. People who have been hit hard by the failure of the project” says NPE director Anne-Mette Gulaker [1].

NPE director Anne-Mette Gulaker describes the case as unique [1]…

”There is no doubt that this is a research scandal”

What Next?

The police investigation is ongoing and the state administrator is in the process of investigating whether the Norwait patients at HUS received proper health care.  We’ll provide updates when they become available.

References

1. National Research Ethics Committees (FEK) – Research Ethics Magazine – Deterioration for Several Participants in a Controversial Observational Cancer Study (February 2023)

Link: https://www.forskningsetikk.no/ressurser/magasinet/2023-1/forverring-for-flere-deltagere-i-omstridt-kreftstudie/