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

I don't really understand the question. As you say, ethics committees don't issue waivers that violate ethics standards. So the benefit here is that they didn't issue a waiver that violated ethics standards.

I doubt the majority of the country have ever heard of HES or CPRD though. And anonymised is generous - they are pseudo-anonymised. If you know enough about someone already you could cross reference and have a good chance of finding them.

If you want to get fired, you could have a go, I suppose.

They've only recently started using secure remote workspaces for the health databases. There's probably thousands of people who have various copies of them on their own machines acquired over decades that they can access and query as they want. There have been a couple of cases recently of them being sold online - one was Biobank iirc.

That's very concerning. But not really relevant to the topic of the thread.

It is because what we define as giving consent for our health data to be used for research is constantly changing and, while improvements are being made, most patients or lay people are wildly under informed about how their medical data can be used.

Over COVID there was a relaxation in the level of ethics approval needed for COVID related studies and so loads of research was conducted and published using this loophole.

The fact that these Norwegian researchers have been found negligent is a very unusual exception.

It's not because this case doesn't concern the NHS. I was drawn into a diversion by someone making a false claim about NHS data and patient consent, but it's not relevant to this case because NHS rules are irrelevant to Norway.

The fact that these Norwegian researchers have been found negligent is a very unusual exception.

Well yes, because most researchers having had their research disapproved by the ethics committee would not have gone ahead with it anyway so would not have found themselves in this position.

Interesting, because the apparently data-violated patients are quite happy to give their names to and clearly reveal their trans identities all over Norwegian media.
Patients happy to reveal data and identities to Norwgian media

The obvious difference being that was his choice to do. You'd think a feminist forum would have a better grasp of the concept of consent.

This kind of thing happens because, over the last three decades, clinicians have been carrying out treatments on minors (including wildly off-label drug treatments), which, because of their serious and irreversible effects, should only ever have been countenanced as properly conducted clinical trials, with everything that implies including patient consent to participate and have their data collected and used.

As a result, we now have a massive cohort of already-treated patients, but are still scrambling to work out whether the treatments are actually safe and effective.

It's ironic because such clinical trials might have struggled to get ethics approval, but we can't get at any information about the outcomes of the treatments because they weren't clinical trials. This is financially rewarding unethical operators, and stopping us from finding out what harm they've done.

I do not understand why transgender people themselves do not want this information to be made available if at all possible, as they are the most likely to be harmed by its lack.

Sure, she and the other woman in the article chose to reveal themselves in the media and didn't choose to allow some aspects of their data to be used in research. Absolutely their right, although it does make one question how much they wished to remain anonymous and whether anonymity was really their motive in their complaint.

I absolutely get the concept of consent (does Mumsnet define itself as a feminist forum?) and their wish for anonymity should be respected. Even though, from what I understand they actually were anonymous in the published research.

It does raise the question why they request anonymity in one context and not another. The impression one gets is that they would be happy for some of their data to be used in research if the research stated the kinds of things they believe in but not if the research comes to conclusions they disagree with.

I guess one "good" thing about the controversial Pathways puberty blocker trial is that all the child participants have given their assent/consent to the data collected by the trial being made public and transparent. So it will be publicly known whether they are starting to get indications of osteoporosis or, specifically for the boys, that they have had to freeze their sperm as the puberty blockers are likely to make them infertile.

Clearly the patients in the Norwegian case didn't want any data being revealed specifically for research purposes - even though they were absolutely anonymous and no one would have known who they were. But, they may have had issues with research that showed, for example, that trans-identified people have a range of mental health issues. Their objection certainly wasn't because they wanted to remain anonymous to society.

He makes it quite clear in the article that his objection was to researchers accessing and publishing some very personal details contained on his medical record. "These medical records contain extremely personal and private information. Not knowing where my information had gone, or who knew what about me, was very disturbing....These medical records contain detailed information about people’s mental health, identity and sexuality. For those who have undergone treatment, they also include data from surgery and images of genitalia."

Obviously no such deeply personal information or images were contained in the article. There's very obviously a world of difference between being happy to have a voluntary and non-explicit chat with a journalist and having pictures of your genitals accessed and used in research without your consent or even knowledge. And even if you refuse to see that difference, that doesn't change the fact it's up to these individuals what they choose to consent to and what they don't, regardless if anyone else approves of their reasoning or their other choices.

The impression one gets is that they would be happy for some of their data to be used in research if the research stated the kinds of things they believe in but not if the research comes to conclusions they disagree with.

Or maybe they would be happy if they'd just been asked in the first place?

There are multiple existing trials and studies into the effect of gender affirming treatment on minors which have managed to collect data with ethics committee approval and without violating patient's rights. Nor is it actually difficult to obtain proper consent - you just have to ask patients on admission if they consent to their data to being used in research, they say yes or no, if they say no you don't use their data. It's unclear in this case whether the researchers were using data from people who'd explicitly refused or if they'd just never bothered asking, but in either case the fault is with the researchers and one they could have easily rectified but instead chose to go ahead anyway. This is entirely the fault of the researchers no matter how much you try and handwave it away.

The Cass Review found there was insufficient existing good quality data to demonstrate safety and efficacy. The Norwegians' only option was a discretionary waiver, so not a situation they could 'easily rectify'. Obviously they were wrong to go ahead without a waiver. But that still leaves a massive information gap.

If these treatments can't be proved to be safe and effective then the only ethical thing to do is to ban them.

Exactly. The existing so-called studies are mostly of poor quality and almost invariably have a strong ideological motive, especially the ones done in the US.

The UK puberty blockers trial seeks to fill in the information gap on some issues relating to children. My main problem with it, however, is that one of its main goals is to learn the risks of puberty blockers and even admits that there are plenty of risks with putting kids on puberty blockers!

A discretionary waiver was their only option because they went ahead and did the study without consent or approval and had to try and get retrospective approval when it was already too late to fix the problems they'd created. This wouldn't have been the case if they'd done what most researchers would have done as a basic first step and ensured their research was consensual and ethically approved from the get-go. Again, this is their own fault, a problem they created for themselves. Tell me, do you think this kind of egregious fuck-up is going to make this patient group more or less likely to trust researchers with their data in the future?

As for the Cass Review, Cass looked at a total of 50 studies into the efficacy of puberty blockers, of which she deemed one "good quality", 24 "moderate quality" and 25 "low quality". It is important to understand that these quality designations are technical terms based on the methodology used and don't necessarily mean the papers themselves were bad - Cass designated anything that didn't involve a double-blind random clinical trial to be less than high quality, but puzzlingly Cass's own approved trial the Pathways trial is also not a double-blind RCT, the reason being it's virtually impossible to do a double-blind trial with puberty blockers because patients and clinicians will quickly know who is taking PBs and who is taking a placebo because of the physical effects. So it's questionable - and indeed has been questioned by many reputable sources - as to whether this is a reasonable standard by which to judge the quality of the evidence. But regardless of the quality of the evidence, the fact remains there are at least 50 existing studies out there wherein researchers have managed to get ethics approval and have managed not to have their papers withdrawn due to gross misconduct, so clearly it is possible to do that, these researchers were just too incompetent to manage it.

I'd also ask anyone reading to consider, honestly, how much of a meal would be made by the regulars on this board if the author of a trans-supportive paper had been found guilty of so much as a minor mistake, let alone multiple counts of gross misconduct and the forced withdrawal of their papers, and consider from there if your instinct to handwave and excuse this level of poor practice is genuinely an objective response.

"These medical records contain extremely personal and private information. Not knowing where my information had gone, or who knew what about me, was very disturbing....These medical records contain detailed information about people’s mental health, identity and sexuality. For those who have undergone treatment, they also include data from surgery and images of genitalia."

So charming of this woman to reveal to the Norwegian media just what kind of personal and private information was cited not just about herself but all the other people whose data was used in the published research! Did she check with those people whether they consented to her revealing this information about themselves to the Norwegian media?

Pretty much no one in Norway - or even those of us in other countries who are discussing it - would have had a clue what this private data was if it had just remained in an academic publication, but she's splattering it all over the Norwegian tabloids for the whole to read about! They even published an English translation of the interview with her to make sure as many people as possible could learn about this data!

Oh give over with your desperate grasping at straws, saying "these records contain personal information about people's physical and mental health" is obviously not the same as revealing that information, and it's certainly not the same as accessing the full details of that information without the patient's knowledge or consent.

It's also hardly a bombshell that someone's medical records is going to contain information about their health, so no that's not going to be shocking news to the whole of Norway and the English speaking world. If you were genuinely unaware that medical records contain information about health, then welcome to the world since you were clearly only born yesterday.

Your choice of wording may create in 'anyone reading' the entirely false impression that the researchers carried out an unethical clinical study, when in fact they were analysing already-collected data. In that situation, retrospective approval is the only option: they were wrong to publish without it, and no-one is excusing that.

And what on earth is a 'trans-supportive' paper? Shouldn't the conclusions of research be based on the data, not the political beliefs of the researchers?

For retrospective research like this, consent doesn’t work because it is almost impossible to get consent from everyone in the cohort. People move or lose touch or die. But a data analysis on a partial cohort is not informative. That is why the ethics committee can grant waivers for this type of research to allow the study without consent.

The question is, why didn’t they grant the waiver? It seems like these researchers thought the ethics committee was being biased and unreasonable in refusing the waiver, and went ahead with the study anyway. That was wrong and they should receive some sanction.

However, there is still the question of why the waiver was not granted, when many might argue it should have been. This is where ethics committees can have too much power and not much accountability.

Pointing out this woman's hypocrisy and suspecting that the only reason she objcted to the research was because she is ideologically opposed to it is hardly "grasping at straws".

I thought medical records were meant to be private. Since when is it ok for someone like this woman to reveal that they contain information on people’s mental health, identity and sexuality, data from surgery and images of genitalia to the world? And not just hers but other people's? Nobody beyond a few in the academic world would have heard about any of this if she hadn't told the world.

Norwegian research should be held to very similar standards to the UK though whereas that doesn't necessarily hold true for research conducted in a lot of countries.

My point was that the same kind of thing and worse is happening all the time when it comes to health research and all over the globe. I just know more about UK research being based here so useful to compare.

It's really not uncommon that researchers get around a lack of ethics approvals by exploiting a loop hole.

They call the research a service evaluation or an audit (like these researchers) and then claim not to need ethics approval.

Or they don't get approval from one ethics committee so they go to a second one.

Research fraud is a massive issue.

"Mol, like Roberts, has conducted systematic reviews only to realise that most of the trials included either were zombie trials that were fatally flawed or were untrustworthy. What, he asked, is the scale of the problem? Although retractions are increasing, only about 0.04% of biomedical studies have been retracted, suggesting the problem is small. But the anaesthetist John Carlisle analysed 526 trials submitted to Anaesthesia and found that 73 (14%) had false data, and 43 (8%) he categorised as zombie. When he was able to examine individual patient data in 153 studies, 67 (44%) had untrustworthy data and 40 (26%) were zombie trials. Many of the trials came from the same countries (Egypt, China, India, Iran, Japan, South Korea, and Turkey), and when John Ioannidis, a professor at Stanford University, examined individual patient data from trials submitted from those countries to Anaesthesia during a year he found that many were false: 100% (7/7) in Egypt; 75% (3/ 4) in Iran; 54% (7/13) in India; 46% (22/48) in China; 40% (2/5) in Turkey; 25% (5/20) in South Korea; and 18% (2/11) in Japan. Most of the trials were zombies. Ioannidis concluded that there are hundreds of thousands of zombie trials published from those countries alone."

https://blogs.bmj.com/bmj/2021/07/05/time-to-assume-that-health-research-is-fraudulent-until-proved-otherwise/

Why? I'll hazard a guess it's because forums like this don't have countless hostile posts demonising all people who have glaucoma or gallbladder issues.

No. It's because people with glaucoma or gallbladder issues are more invested in finding out the truth, even if the truth is that the treatment they received is unlikely to have helped them in terms of objective outcomes.

Whereas a lot of people undergoing treatment for gender dysphoria only want data that promotes the idea they should get what they want. And unfortunately far too many researchers involved in gender dysphoria research are also activists before they are scientists, as we have seen again and again.