Experiences of participating in the 100,000 Genomes Project
Data protection and sharing in the 100,000 Genomes Project
The 100,000 Genomes Project has data protection systems in place to protect the information of people who take part. The personal details of people are removed and replaced with a unique code. This de-identified data is kept in a secure data centre (see also Sample Storage) and researchers who want to access it need to apply and have their application approved before they can have access to the data. There is more information on the Genomics England website – see Resources page.
Data is de-identified, rather than anonymised, in a way that allows Genomics England to send findings back to the participant’s clinical team. If data is fully-anonymised, this type of feedback would not be possible. Knowing that their identity would be de-identified was important to people who took part in the project. Nicola said, “I trusted them in terms of confidentiality, because I know I haven't got a name, I've got a number.”
Mark and Julie feel happy that their data will be sufficiently de-identified before it is shared with other researchers.
Mark and Julie feel happy that their data will be sufficiently de-identified before it is shared with other researchers.
Mark: Yeah I mean the first thing they said to us was that I know our information wouldn’t be directly identifiable to us.
Julie: No I mean it has a number but it remains
Mark: So somebody somewhere has the secret list with names next to numbers but that, that is held securely and not shared with any research establishment or third party. And indeed the data is then, you know within a pool of data of course and but we are not separately identifiable to you know, anybody who is using the data. That’s the way it’s been explained to us.Aileen knows that a research project has to go through a strict research ethics approval procedure so she isn’t worried about her personal data being kept on a database.
Aileen knows that a research project has to go through a strict research ethics approval procedure so she isn’t worried about her personal data being kept on a database.
Yes I did. I think there was. I mean obviously the university will be using the data but there is also other people. And I am very aware that medical companies need that information if they are producing medication and treatments they will need that information as well. I believe that I am a number. My name isn’t given on anything. So that makes me anonymous.
Ok.
To that type of company. So I will be a number rather than a name. They won’t know where I live or who I am. It’s anonymous (de-identified).
So you understand about that fully. And how did you feel about it? I mean did you have any kind of queries or kind of concerns or.
Well I mean databases are database aren’t they and IT is IT? And you hear about people, you know, being able to access information. I honestly think there is nothing in my information that, you know, that is particularly worrying to me. I wouldn’t want anybody, everybody to have my information but actually, you know, I do have breast cancer. I’ve [laugh]. You know there’s an awful lot of people who know an awful lot about me anyway. You could always live on the what ifs, what ifs and that percentage is very small and the risk is very minimal. And I think the fact that it is research that’s you know, ethically people who do research have to jump through so many hoops to get approval that actually probably it’s one of the safest methods of having your information out there anyway. So it, it doesn’t worry me particularly. I think we’re at risk anyway and it doesn’t put me at any more risk. I don’t think.
Having their data protected also meant knowing the data would be used primarily to advance medical science to improve diagnosis and treatment in the future.
Betty trusts that the NHS will keep the data within the remit of the Genomes project and not give it to the wrong people.
Betty trusts that the NHS will keep the data within the remit of the Genomes project and not give it to the wrong people.
I hope not. I mean I’m giving it because I trust the people who are going to look at this and say, you know, make up their mind about me and what’s happening to me. I trust them not to give this information to the wrong people whoever they may be. You know like we have now been made aware of all sorts of. When we sign up to things that it can go worldwide almost. And I trust the NHS to keep, to keep things within the remit of the project.
Ok so the wrong people would be people who have other interests?
Yes, of say pharmaceuticals, somebody who might want to persuade me to spend my good money on medication that really is not possibly required. I guess I don’t trust the pharmaceutical industry. I think they obviously need to make a profit because of their research but at the same time I think that charges to the health service for. I mean I don’t know what everything costs really except someone said, “I had an MRI scan and someone said, “It costs about £600 you know.” And I thought, wow. You know it’s all huge money. So I don’t want the wrong people to get back to me and say, “Well this would benefit you.” When it’s possibly not necessary.Lucy Y explains why she trusts that her sample will be protected and used only for medical benefit.
Lucy Y explains why she trusts that her sample will be protected and used only for medical benefit.
Most people felt happy about sharing their data with commercial companies if their data was going to be used for further research to advance medical knowledge and to develop new treatments. Although some did not like the idea of pharmaceutical companies making money from their sample they thought it was beneficial if it led to new medicines being developed and it provided financial support for the project. The project is funded by the Department of Health and Social Care, but Betty thought perhaps it was necessary to involve commercial companies to provide enough money to do the project.
Aileen thinks that it’s important for her de-identified information to be shared with commercial companies so that they can develop treatments.
Aileen thinks that it’s important for her de-identified information to be shared with commercial companies so that they can develop treatments.
Yes.
And…
Yes so that again is included in the consent form. It does, it does state that results of the research will be used commercially. But again that’s what this is all about. And there is no use doing some research in genetics if then the companies that can do something about the treatments don’t get that information. So for me that was part of the process and part of the, part of being involved and the purpose of the study. So I think if you consent to being part of the Genome Project you have to realise that it will be used commercially. Your information will be used but as part of the group and anonymised (de-identified) and one of the 100,000 people rather than who I am, where I am and.
Ok, ok. So did you have any worries about it?
No I didn’t have any worries about how my information would be used.
Or do you have any worries now.
No, no.Pam doesn’t mind her data being shared with commercial companies if it is going to be used to develop medicines linked to the findings of the project.
Pam doesn’t mind her data being shared with commercial companies if it is going to be used to develop medicines linked to the findings of the project.
There was, there was. And I did actually think about that. Because it said for non-commercial purposes, and sometimes for commercial purposes. And I thought about it, and I thought - if they are commercial purposes, I would like to imagine that they are for good commercial purposes. Not just someone trying to make money from them. But doing good things from them.
So, did you agree to that, then? Was that something you agreed to do?
No. I had no idea that this would be used commercially until I read all the details on the paper.
Ah, so it was only afterwards that you realised this?
Yes, yes.
Yes. And when you just said about good purposes, can you explain that a little bit more? What, what sort of would constitute a good purpose for you?
Well if they were tied up with the results from the tests. So that, say they went to a pharmacological firm, they would be able to make pills or medicines or something that would help whatever they discovered.
Mmm. Yeah. And so you’re happy for pharmaceutical companies to have access to your data, and things like that?
I am, because I can only think that it’s for a good purpose.
Yeah. So creating - so good purpose would be something like creating drugs?
Yes, yes.Since Linda’s identity will not be revealed she is not worried about sharing her data. She ticked all the boxes on the consent form.
Since Linda’s identity will not be revealed she is not worried about sharing her data. She ticked all the boxes on the consent form.
Again you’re a name, you’re just a number or a letter and a number. So that’s ok. I’ve not a problem with that.
Ok.
If it’s going to be, do good then let’s do it.
Ok because I mean. Was anything said about possibly commercial uses of the samples, the use by private companies, drug companies?
I think it was mentioned, yes. And was I happy with that. I think that was one of the tick boxes, yes and I agree. Yeah, yeah I agreed to that.
Why did you?
Because again it’s got to, you know, we’ve got to move forward and learn and I think the process is. If you are going to take on this trial you embrace it totally. You don’t do a little bit of it and not the other bit of it. So if you are going to do it you do it as a whole issue.
Ok. But you have no concerns with sharing the?
No, no ,no. You again, you know, it’s not going to be broadcast that it’s me is it [laugh]. So as far as I am concerned it’s fine.
Ok. So there are no worries at all?
No, none.Grandma Football dislikes that pharmaceutical companies will make money from developing new drugs but accepts the need to share her data with them.
Grandma Football dislikes that pharmaceutical companies will make money from developing new drugs but accepts the need to share her data with them.
Ok so you have a more pragmatic view, practical view?
Yeah. We need to know if, if a drug can be found don’t you? You know and if a private company is going to do the research then I totally agree with them being paid for that research. I don’t agree with them making money out of the treatment that they are going to offer other people afterwards. It stinks but there you go.Mark and Julie were concerned that they may be contacted by commercial companies selling products but were reassured by the research team that this would not happen.
Mark and Julie were concerned that they may be contacted by commercial companies selling products but were reassured by the research team that this would not happen.
Mark: Well I mean we all leave a, leave a footprint in everything that we do these days in life whether you’re searching on the internet, buying something online and what have you. And you know, there’s unfortunately there’s companies out there that, that do profiling and all the rest of it. Apart from the annoyance factor you’ve then got insurance companies who, if they could get hold of that data relating to you would then go, “Right [Name] I know, I know that you’re diabetic. I’m going to whack it, a premium of 25% more because of that knowledge which isn’t the…
Julie: Similarly you wouldn’t like it to be, you know, so that people selling things will say, “Ok we know he has got that condition so they are going to, you know, bombard you with phone calls and letters and emails trying to sell you products.” And do you know what I mean? It’s sort of, you know, that you don’t want that to become the case do you. So
Mark: No you don’t. You don’t want it to cost you more [laugh].
Ok. Were these important issues to you that they assured security?
Julie: Yeah I think the knowledge that they, they did, you know make sure that we knew that that wasn’t going to be the case that was important, yeah.
Ok. Do you have belief that they will be secure?
Julie: Yeah I, yeah I trust, yeah
Mark: Well I think we can only trust that. I mean I’ve not inspected their systems and their processes and procedures so all there is left is trust actually. And that’s the balance that you have when you enter, you know do a project of this nature is that there is a line where you can only get so far and then it is, it does become a trust barrier that you go through. But I think
Julie: I think the desire to want to do good with it for something good to come out of it is going to be far outweighs the negative thoughts which I have had so far.
Mark: Yeah exactly.Through his own work experience Nick believes that commercial companies will use the data to look at trends and they will not be interested in individual cases.
Through his own work experience Nick believes that commercial companies will use the data to look at trends and they will not be interested in individual cases.
Yeah.
And that’s just, that was my understanding. I’m probably reading too much into it, but yeah.
And how do you feel about that, sort of the potential for commercial companies knowing that? You said about the data would be anonymised (de-identified). How do you feel about commercial companies?
[Laughing] no issue whatsoever [laughing].
And why is that?
Probably from my commercial background. In that I know that the information is there, used. It tends to be, it is used just purely for the data purposes. Looking at it from a similar perspective of how I’ve done it previously in work, is that all you’re interested in is the results that you get from it. You don’t care if it’s Joe Bloggs, or whoever. You’re looking for the trends to find out why. Yeah.Emma and her husband want to know that companies couldn’t trace their results back to them and that they didn’t have to disclose results to insurance companies. They felt reassured by the staff who were very knowledgeable about the study.
Emma and her husband want to know that companies couldn’t trace their results back to them and that they didn’t have to disclose results to insurance companies. They felt reassured by the staff who were very knowledgeable about the study.
But I think we were, we were really - we don’t mind companies having access to the data if it will help at all. But we just wanted to be sure that it was very, very secure, that nobody could trace back who we were. And also that it wouldn’t be used - I think certainly my big concern was that it wouldn’t be used to ostracise or, you know - insurance datas and making - if you’d ever tested for this that or the other. That was our big concern. Actually are we going to have to say we’ve been involved in the study? And is that going to impact on insurance in the future? That that was one of our big questions. Because it’s a concern. We’ve all watched the sci-fi movies and Gattaca and the like, and you think actually are we going to start making decisions based on people's DNA code? So that was one of our big concerns, I think.
Yes and how do you feel they addressed those concerns? What did they sort of say about that?
They, they tried to reassure us I think. And tell us that you know - there certainly is nothing like that in the pipeline, there’s - they’re not allowed to use that insurance. We don’t have to say that we’ve been involved in the study at all. Sheila and Edward aren’t worried about how their data might be used in future. As long as there is good communication and transparency about how it is used.
Sheila and Edward aren’t worried about how their data might be used in future. As long as there is good communication and transparency about how it is used.
Sheila: Mmm.
And what about commercial uses? Would you be content for it to be used commercially?
Edward: Well I mean obviously it'd be nice to see some of the royalties first [laughing].
Sheila: I take the opinion if they can find anything useful in my blood, they're welcome. [laughing] People might find a cure for the common cold in there somewhere. It, it doesn't particularly bother us.
Edward: No.
Sheila: I think if you're sensible and you think about it, we're not really into the Frankenstein side of things here, are we? You know, that this is more common sense.
Edward: Yeah.
Sheila: Let's just look at what you have got, kind of approach.
Edward: I mean, from my point of view, I don't really - I don't really mind in a way, if people make commercial use of genetic material, so long as it's clear what's being done with it and it's transparent. And so long as , you know, if somebody's genetic material is being used, then they are compensated, or they are informed accordingly. It makes sense, really.
Sheila: Communication, really.
Edward: Yeah. But we've not been - we've not been kept in the dark at any stage, have we.
Sheila: No. No concerns.
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