I agree
The main issue with the study is that the "method" explicitly involves asking the participants to ignore symptoms, and pretend they are healthy. OBVIOUSLY THAT WILL RENDER THE QUESTIONNAIRE SCORES MEANINGLESS. Im writing this in caps cause I am simply shocked REK did not comment on this, I even mentioned it to them in detail.
A lawyer I know will submit a complaint in accordance with the public administration act here in Norway. He will bring up points related to paragraphs in in the Norwegian health research act. That will maybe lead to something. If you want me to forward some points related to the methodology or likewise, u can. Just need to be before friday
I would also ask him to look at "The act on ethics and integrity in research". (My bolding)
Research ethics committee said:
Misconduct involving fabrication, falsification and plagiarism (FFP) is considered serious. The preparatory work of the Act also lists additional actions which can be considered serious in particular cases. The list includes p. a.:
- to withhold-, mislead about-, or selectively/secretly dispose of undesired results;
- to mislead or conceal one's own or others scientific efforts and / or scientific achievements. Improper allocation of authorship etc.
- to destruct research data / material to prevent investigations of misconduct.
The list of such actions specified in the Act is not exhaustive.
The act also states that no action will be regarded as misconduct unless it was committed intentionally or with gross negligence.
(
https://www.forskningsetikk.no/en/r.../the-act-on-ethics-and-integrity-in-research/)
I think this only stands in the preparatory works (høring) and the law itself states something along the lines of "other serious misconduct".
Calling it a "three day intervention" instead of stating it's LP from the start is misleading, using highly contested references and not mentioning that they are highly contested is withholding information. Since they are interested in work and disability payments, that the active arms of PACE had more disability payouts would be a nice mention I think (and something they should know about, seeing how large PACE is and how much knowledge they claim to have on the subject. So either they are misleading/withholding information or grossly negligent).
Also that long term follow up results in other studies show that participants don't answer as positively at LTFU (the reanalyses done might also come in hand, but I'm not sure it's needed). These points could play into the health research act as well since it's stated there that patients should not be harmed.
They were going to have some data from NAV to look at disability and stuff so I guess they can show to some objective markers as well and thus complaining about the subjective questionnaires might lead us nowhere. I would really try to get in something about their conduct, as that is very important for the ethics side of things. I think it will give more strength to the arguments than just focusing on the methodology (can we use the NICE's tables to show previous studies like these produce low quality research, and there has been a lot of it in this field? Seeing how
research should be of "hiqh academic quality").
The way some of the people involved characterized patients in the "ME-war" story in Dagbladet is not exactly ethically sound conduct. I don't think NEM has any guidelines for public speaking, but the other two ethics committees do and NEM look to their guidelines, might be worth looking into as well if mentioning Dagbladet.
Everything Steinkopf has written about the study and how different bodies have said they knew nothing about the study and had nothing to do with it might also go under "misleading"? If nothing else it looks very messy from the outside.
At least in its suggested form.
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