In a Norwegian ME study, the researchers failed to inform that one of the researchers had a strong financial conflict of interest. The study participants were not informed that they were being treated by students. Research ethics instances are aware of the matter but see no reason to take action. Are they more concerned with protecting their own than with research ethical principles?
A Norwegian study with 236 ME patients was published in April 2021. Two years later, the journal which published the article, Frontiers Psychiatry, has published a correction in which it is informed that one of the researchers in the project, professor of psychology Tore C. Stiles, had a financial conflict of interest.
Takes no action
In March 2023, the Regional Ethics Committee (REC) and the National Commission for the Investigation of Research Misconduct (NCIRM) were informed of this and that the project’s application for ethical approval in 2008 also failed to inform about this conflict of interest.
In the application, it is informed that «there will only be clinical psychologists in the treatment section». Now it turns out that a second-year psychology student treated the patients who took part in the study. The patients were not informed about this.
When asked how REC and NCIRM assess the matter and what measures may be taken, REC replies that they «pre-evaluate projects».
NCIRM replies that the case must first be dealt with by the Research Ethics Committee at the Norwegian University of Science and Technology, NTNU, which must then report cases of possible serious breaches of recognized research ethics norms to NCIRM.
The Research Ethics Committees secretariat at NTNU has assessed the case and replies that the journal (Frontiers) has provided the article with a correction and considers this to be normal procedure and characteristic of how quality assurance occurs in connection with scientific publishing. «As the matter has been investigated and the error corrected, we see no reason to bring this up in the Research Ethics Committee.»
The research ethics committee seems to take for granted that the journal’s investigation is sufficient and that it is true that the research conclusions have not been influenced in any way. This despite the fact that Frontiers is considered a predatory journal.
Weakens the trust in research
Since the Coperio center was established by Stiles in 2002 and until it was sold in 2022, Stiles has co-authored at least 79 published research articles, of which 21 were clinical studies. Most of the articles are concerning topics and treatment related to Coperio’s services. Frontiers has published 10 of these articles. It is only this one which now discloses the financial conflict of interest. Coperio has an agreement with public health service Helse Midt HF and the Norwegian Labour and Welfare Administration (NAV).
Stiles has therefore had a financial vested interest in the results of the research.
ME patients are a vulnerable group dependent on NAV. Researchers Anne Kielland and Line Melby write that their research project has found that ME patients feel they have been «forced» to participate in research by NAV. In their opionion, recruiting vulnerable research participants through NAV is an ethical problem: “Recruiting vulnerable research participants via NAV is an ethical problem” (Norwegian text).
Norway is committed to the Declaration of Helsinki, which states that research must follow accepted scientific principles and be carried out by scientifically qualified persons.
The fact that the researchers failed to disclose the financial conflict of interest and failed to inform the study participants that they were to be treated by non-authorized personnel is a serious breach of international research rules. The fact that the research ethics bodies see no reason to take action weakens the confidence in Norwegian research.
Read the Norwegian research article here
Nina E. Steinkopf
Formerly HSE and Quality Chief Executive
Now; ME patient and writer
The ME Global Chronicle 