UK Biobank
I have just received an invitation to take part in the UK Biobank study. For those of you who are not familiar with it, it is an ambitious project to set up a prospective cohort that can be used for a wide range of epidemiological studies, and in the words of the UK Biobank website, "with the aim of improving the prevention, diagnosis and treatment of a wide range of serious and life-threatening illnesses – including cancer, heart diseases, diabetes, arthritis and forms of dementia". It aims to recruit 500,000 participants, and will collect data on a wide range biological variables (including taking samples for genetic analysis) and lifestyle factors.
Sounds like a worthy project.
However, I have some serious concerns, and I won't be participating. My first thought when I received the letter was "how the hell did they get my name and address?" Apparently they got it from the NHS, who obligingly sent them my date of birth as well. This is, so they claim, all done in accordance with the Data Protection Act.
I have my doubts about that, but if there is really a loophole in the Data Protection Act that somehow allows the NHS to pass on my personal details to third parties, then shame on the UK Biobank team for exploiting it. I allow the NHS access to some of my personal data in the expectation that they will treat it in the strictest confidence, and I am deeply shocked that they have not done so. I don't care how worthy a research project this is, I am now going to find it hard to trust them.
And if I were going to participate in the research, I would certainly need to trust them. They would hold a great deal of extremely sensitive data about me. As others have pointed out, there are some serious risks involved in that, both arising from the risk of a breach of internal data security in what is a very large project (ie with more opportunities for leaky data) and from the possibility that the government (which, as we all know, has a rather unhealthy desire to know about its citizens' DNA) will be able to access the data if it decides that it wants to.
The tone of the invitation letter was, IMHO, also very inappropriate. They have already made an appointment for me. Although they make it clear that I don't have to go to the appointment, the fact they made it in the first place is extremely presumptuous. If this had come before the research ethics committee of which I am a member, I expect we would have deemed that to be inappropriately coercive and would not have allowed it.
I also find it rather shocking that the ethics committee that approved the project thought it OK for the NHS to release personal data to a third party.
What was the ethics committee thinking?
Update 11:19 am:
And as if all that weren't bad enough, I've noticed something else deeply worrying on the UK Biobank website. They say on their "Confidentiality" page that data will be stored anonymously.
That is not true.
In my ethics committee, we are always extremely strict about ensuring that researchers distinguish between anonymised data (in which it is impossible to link data to an identifiable individual) and pseudonymised data (in which the data are stored separately from identifiable information, but the link is still maintained and so the data can be attributed to an identifiable invididual by anyone who has access to the linking codes). The UK Biobank data will be pseudonymised, not anonymised, and for such as well-resourced study to misuse such ethically important terms, and be allowed to get away with it by their ethics committee, is staggering.
Update 20 July 2010:
For the latest instalments on this story, see my subsequent blog posts here, here, and here.
I'm beginning to despair at the standard of ethical review since the government took charge. I suppose this project did go before an ethics committee. I guess they were either useless or overwhelmed by the scale of the project and didn't want to be obstructive - in other words, useless. Can we ask what committe approved it?
Indeed you can, Geoff. According to the page on the UK Biobank website rather optimistically titled "Our high ethical standards", it was approved by the North West Multi Centre Research Ethics Committee.
I've just submitted an FOI request to try to get the minutes of the meeting at which it was approved. Could be interesting.
This laxity is worrying. Government, NHS and other publicly funded projects should have the same rigor in their ethical standards as would be required of a pharmaceutical company conducting a trial.
It seems to be part of a wider picture of lax standards. I consulted the NHS Choices website recently to research a health topic, and one of the useful links provided was to a website that did not meet basic standards of transparency - the site carried no information on who produced it or where the information came from, so I was forced to dismiss it as unreliable. How can official NHS sites link to a site like that - it's such a basic mistake.
Hi, Very worrying.
Apparently they obtained NHS details under Section 60 Care and services act????
Am submitting FOI to Dpt of health to understand how this occurred.
Am outraged at this, for all our sakes. keep digging!
The Biobank letter states participants will receive "key results from your examination".
Does anyone know what exactly this means?
Tim, that's a good question. If you're thinking of taking part, then you should ask them in detail what it means before you agree. I expect what it means is that if they find that there is something wrong with you (for example, perhaps you have high blood pressure and didn't know about it) then they will let you know, and ideally (and with your permission) write to your GP so that you can have appropriate follow-up.
But do ask them, because it may well be more complicated than this. And feel free to come back here and let us know what they say.
I've just received one of those 'invitations'. I called up to ask where they got my details from, a question was sent back to me stating that I'm registered with a GP. I am a female and the letter was addressed to me as a Ms, yet I'm registered with my GP as a Mrs. I reckon that the details came from the DWP.
My advice is do not attend, where will the information end up? I cancelled my Appointment, but if you read on, it states that we might be invited again.
Hi Concerned
If they said they got the details from your GP, that's worrying. That's not where the come from, and they really ought to know that. They come from records held elsewhere in the NHS (I'm still trying to figure out exactly where).
Have you read my more recent update on this story? See the "Recent posts" box, top left.
What a cheek to make me an appointment with detais of my name address and date of birth I haven't given permission to be used. Then they're going to whip my DNA out of me and store in some huge shed so that when the Regime comes along they can see if I'm any use or not! George Orwell didn't even think of that one.
All of this is a bit over the top isn't it? It's a few drops of blood in a glass phail, participants can refuse to answer questions they don't like and of course nobody has to do it but perhaps there is just some chance that it may, one day, do somebody else some good. Amy
Interestingly, today I had a patient attend for routine bp check as she was informed by "bio bank" that hers was raised. She listed all investigations, thought it absolutely wonderful and it was" NHS "... She was perplexed that I new nothing about it. Now I too have read around and am horrified at the prospects, the deception involved and also possibly infringing DPA.
Incidentally, she did not know which blood samples had been taken and informed that all results would not be routinely sent to her Gp.
Clearly ,this needs urgent investigation.
Ethics....not here.....!
[...] circumstances tend to become rather non-exceptional. In fact you may remember my talking about the UK Biobank project in Pod Delusion episode 130, where confidential NHS data were shared without consent [...]