Norwegian researchers found guilty of gross negligence

[anyolddinosaur]

https://tinyurl.com/2euxyhde from the National Treatment Service for Gender Incongruence apparently and seems mainly for using data without proper consent

This is Google Translation of headlines:
Researchers found guilty of gross negligence: – Heavy and unfair
Kristoffer Salvesen's health data was used in research without consent. Now five researchers have been found guilty of gross negligence.

– I feel relieved. Finally someone is taking this seriously.

This is according to Kristoffer Salvesen, who has experienced that his private data has been used in research at Oslo University Hospital (OUS) without his consent.

On Tuesday, it was announced that five researchers at the hospital have been dismissed for using health information in their research without permission from the patients.

– It has been difficult and feels unfair. But some people have to have the strength to stand in that fight, and I understand that not everyone does, says Salvesen.

The joint integrity committee at the University of Oslo has concluded, under doubt, that the researchers have acted with gross negligence – and not intentionally.
......
last para:
– I am furious. Extremely serious research ethics violations have been committed against an already highly vulnerable patient group. This is a shame and a scandal, says SV's health policy spokesperson Kathy Lie.

– Now Health Minister Jan Christian Vestre (Ap) must intervene immediately, and at the very least initiate a full investigation.

Seher Aydar from Rødt also reacts strongly.

– The Integrity Committee's conclusion must have real consequences. The Minister of Health should initiate a clean-up to ensure that transgender people receive a proper public health service that is built on competence, help and consent.

I use google - so it gives me an option to translate webpages. Sorry if that is not available in other browsers.

It also says

"Several "serious violations"
The committee has examined four published articles:
Two research articles are recommended for withdrawal for violations of scientific integrity.
Two others share a common ground of reprehensible violations of recognized research ethics norms. These may also risk prosecution for scientific misconduct and retraction in the future"

Ends justified the means, did they?

As far as I can understand, I suspect this arose because the named patient felt they were identifiable and (from there) that the researchers should have sought permission for using data about the patient.

It’s not explained what the papers were about, or what aspect the patient objected to.

Therefore, it’s difficult to conclude what the objections were.

It's much more serious than that (and very easy to find further information if you google). This wasn't just an administrative mistake or poor anonymisation, the researchers were explicitly denied permission by the regional ethics committee to conduct this research because of the lack of proper patient consent and they went ahead anyway under the loophole that it was for internal "quality control" not research, and then subsequently published research papers anyway.

If someone wants a digestible account, look here:

https://x.com/benryanwriter/status/2069460678407069970

https://nitter.net/benryanwriter/status/2069460678407069970

Briefly, a win for people wanting to restrict research into health outcomes for "transgender youth".

The lead author of the two papers which will be withdrawn for gross misconduct was Anne Wæhre. Wæhre's work has been presented at SEGM, praised by Genspect and was cited in the Cass report.

If they broke the rules, they broke the rules. It's not at all clear, though, why this should be of more concern for gender incongruence patients than for gall bladder or glaucoma patients.

Is it because of the risk of 'outing'?

Or is there a suggestion that the researchers deliberately broke the rules as part of a scheme to influence medical opinion about the appropriateness or effectiveness of such treatments (positively or negatively)?

Researchers who go rogue usually have an objective in view: in the absence of that, it's hard to understand why the story ('researchers break ethics rules, for some reason') is newsworthy.

I'm remembering the way Dr Cass's team were prevented from accessing very relevant data of existing previous patients. TransActual crowed about how this was a Good Thing, because patient confidentiality....

ETA I see PPs posted answers while I was typing....

So those opposed to having any accurate information succeed in having papers withdrawn. If any patient was identifiable then that should happen, if not then do Norway have employment tribunals?

It's not at all clear, though, why this should be of more concern for gender incongruence patients than for gall bladder or glaucoma patients.

No one has said it is "more of a concern"; if gall bladder or glaucoma researchers had been found to have done likewise they presumably would have faced the same consequences.

I'm remembering the way Dr Cass's team were prevented from accessing very relevant data of existing previous patients. TransActual crowed about how this was a Good Thing, because patient confidentiality....

Well yes. Do you not think people should have the right to consent to participate in research?

This isn't an employment issue. And it's unclear why you're blaming the patients who objected to their data being used without their consent instead of the researchers who chose to use that data without consent against the warnings of the ethics committee.

It is an employment issue as they were dismissed. I'm not "blaming the patients" I'm questioning whether they really were identifiable to anyone except themself. Patients should have a right to object to identifiable data being published, they should not have a right to ban any research.

If you actually read the article you shared, whether or not the patients were potentially identifiable was only one of the cited issues; even if they weren't identifiable they still have the right to consent to how their data is used. No one has "banned any research" - all research involving human patients is subject quite rightly to rigorous ethical standards which in this case were violated by the researchers - apparently deliberately, since the ethics committee informed them in advance of them going ahead that they were in violation. There isn't any justification for that.

That you happen to wish the rules they broke were not the rules is neither here nor there.

No one has said it is "more of a concern"; if gall bladder or glaucoma researchers had been found to have done likewise they presumably would have faced the same consequences.

Yes, but I bet the health minister wouldn't have been bearded with questions about how this happened to this 'vulnerable patient group' who '[deserve] a sound public health service'. How will they get that without good data?

Well yes. Do you not think people should have the right to consent to participate in research?

Agree. I just don't understand why transgender people and their allies are so unconcerned about lack of good quality data about treatment outcomes. To the point of resisting its collection.

The "ethical standards" that were imposed on them are not the ethical standards that generally apply to research on outcomes. They are designed to prevent meaningful research. Therefore they should not exist. If a treatment is experimental a patient has the right to opt out of treatment, that is not the same as opting out of data collection.

Then perhaps the researchers should have sought proper consent in the first place.

The elephant in the room is there is of course already an awful lot of good data out there about treatment outcomes for gender affirming care that doesn't violate research ethics standards, but it just doesn't say what the gender critical movement wants it to say unfortunately.

These are exactly the same ethical standards that apply to anyone conducting research in Norway. Are you suggesting the University of Oslo is deliberately and maliciously imposing impossible ethical standards on researchers to prevent them from conducting meaningful research? For what purpose?

If a treatment is experimental a patient has the right to opt out of treatment, that is not the same as opting out of data collection.

That may be your opinion of what the rules should be, but it is not what the rules are, either in Norway or in the UK for that matter. The right to consent to participation in medical research is considered a fundamental human right.

Well yes. Do you not think people should have the right to consent to participate in research?

Not if they are treated for free by the NHS. It's part of the social contract that you make your anonymised medical data available for research.

I think @anyolddinosaur has already answered this. A waiver could have been granted, but was not. What do you think was the purpose of refusing the waiver? It would have to be a good reason, to outweigh the loss of valuable information about how best to treat this vulnerable patient group. Who deserve better, indeed.

Why on earth would or should they grant them a waiver to violate ethics standards? All they needed to do to get their research approved was seek proper patient consent. They were told this clearly in advance by the ethics committee so there can't even be any reasonable claim they didn't realise they were in violation - they were told and instead of fixing the problems the ethics committee raised, they chose to go ahead anyway. You can twist it how you want but there really isn't any justification for that or for being surprised that they've now faced the consequences for it.

This is untrue. There is no fundamental right or "social contract" for the NHS to use your data. There are some anonymised NHS databases that researchers can use without specific individual consent, but patients still have the right to opt out of having their data included. For any research beyond this general database, the patient needs to give specific permission.

For any research beyond this general database, the patient needs to give specific permission.

Why? They received free state funded medical care. The quid pro quo is to participate in research. In any case what possible reason could anyone object to their data being used?

"Why" is not really relevant to this conversation; people might have all sorts of reasons, but the point is they do have the right to opt-out, so your claim that participation in research is a compulsory consequence of NHS treatment is false. And even if it wasn't false, which is it, it still wouldn't change the facts in this case which involved Norwegian researchers bound by Norwegian ethics standards.

By definition, ethics committees do not issue waivers that violate ethics standards! I was simply curious to know what you think is the objective benefit of refusing the waiver (assuming that anonymity can be maintained).