Controversial ME/CFS study was ethically approved. Then stopped. And now approved once more.
The study aims to test how an intensive psychological course works for ME patients. Approval is contingent on the PhD candidate’s conflict of interest being clearly mentioned. The Norwegian ME Association may appeal the approval.
The study, which is coordinated by the Norwegian University of Science and Technology (NTNU), seeks to investigate whether an intensive 3-day psychological course has any effect in adults with myalgic encephalopathy/chronic fatigue syndrome (ME/CFS).
The course contains components from the controversial Lightning Process method.
The Norwegian research ethics committee for medicine and health sciences – NEM – halted the ethical approval last summer, and the study was put on hold.
On 31 January this year, the researchers again received ethical approval to carry out the study. But REC Mid Norway, one of the regional committees for medical and health research ethics, has set conditions.
REC is requiring all publications concerning the study to state that a PhD candidate in the project has conflicts of interest.
ME Association considers another appeal
Norway’s ME Association (NMEF) is now considering appealing the new decision.
“The ME Association does not see that the applicant has taken NEM’s objections into account in a way that makes any difference to the study,” says NMEF Assistant Secretary General Trude Schei.
NMEF also believes the study design has a high chance of producing unreliable results, which would create further confusion regarding ME treatment and be detrimental to ME patients, Schei notes.
Unjustifiable conflict of interest
REC Mid Norway approved the study for the first time in November 2020. This led to a number of complaints from private individuals, relatives and several associations for ME patients.
The Norwegian ME Association was one of those who appealed the decision to approve the study. NEM processed the complaint.
“The project's greatest weakness is the conflict of interest that arises because the PhD candidate has a strong business interest in the project yielding positive results,” NEM wrote in its decision of 4 June 2021.
Based on this conflict of interest and the PhD candidate's active role in all stages of the project, the project was not considered justifiable, NEM wrote in the decision.
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Will weaken confidence in research results
NEM believed the conflict of interest would weaken confidence in the research results.
The research ethics committee also objected to how the researchers planned to measure the effectiveness of the course and called for objective measures of the results.
PhD candidate Live Landmark intended to include the study in her doctoral dissertation. She has a Lightning Process licence and has previously held courses using the method.
Project manager and Professor Leif E. Ottesen Kennair at NTNU said that the refusal was extremely unreasonable and that stopping the study would negatively impact the patient group.
PhD candidate will not select participants
REC Mid Norway has now processed a new application for approval of the study. How the study will be conducted has changed slightly.
Landmark will no longer be involved in the interviews to select participants. They will now be conducted by a research nurse in Lørenskog municipality.
Landmark will also not take part in processing and analysing the research data.
REC Mid Norway believes that the PhD candidate will still be quite involved in weighing in on interpreting the data. However, the committee found that the project manager adequately addressed NEM's objection.
NEM also objected how the effectiveness of the course would be measured, and that it would have strengthened the project to include more objective measurements in the evaluation.
REC Mid Norway accepted that this point will not be changed.
British health authorities caution against the method
Schei believes that a theoretical basis for the study is lacking.
“British health authorities now clearly warn against the Lightning Process method,” she says.
Schei also points out that large British and American systematic knowledge reviews have not found evidence for the effectiveness of cognitive therapy for ME, where exertion-induced worsening is the main symptom.
REC’s clear demands for transparency of PhD candidate’s role is unusual
The condition that Landmark’s conflict of interest must be communicated openly in all publications based on the study material is unusual for this project.
Hilde Eikemo, head of secretariat for REC Mid Norway confirms this requirement.
“We thought clarifying this conflict of interest was important, and that it was correct to emphasize it to a greater extent than usual, since the PhD candidate’s role was thoroughly problematized in the application phase by both REC and NEM,” says Eikemo.
The same requirement applies to the information sheet that needs to be revised. This is much more common and happens in perhaps 70 per cent of all approval decisions, she says.
The regional committee receives a number of applications where the researchers have conflicts of interest.
“What’s crucial is how researchers handle a conflict of interest. It’s important for them to implement appropriate measures to offset any conflict of interest,” Eikemo says.
And that they play with open cards – with the research participants, the approval authorities and the readers of the publications, she says.
Strong need for knowledge
The researchers point out in their application that effective rehabilitation for ME/CFS patients is lacking, and that there is a strong need for evidence-based knowledge.
If participation in the course shows a promising effect, then it could have positive consequences – not only for people with ME/CFS, their families and health professionals, but also financially for society and the municipalities.
NTNU leads the collaborative project
The project manager for the study is Leif Edward Ottesen Kennair, a professor in NTNU’s Department of Psychology.
Sciencenorway.no has been in contact with Kennair who declined to comment on the case for now.
The study is a collaborative project with researchers from the Department of Public Health and Nursing at NTNU, the Department of Psychology and Institute of Clinical Medicine at the University of Oslo, Lørenskog Municipality and the University of Bristol.
NTNU carries the coordinating responsibility.
The REC Mid Norway decision can be appealed. The appeal deadline for the decision is three weeks.
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Read the Norwegian version of this article at forskning.no
