Does that now make you kind of reflect on how secure and confidential things are being kept?

Well, I think that for me that was the biggest thing I had to really think about with the Biobank, because my concern isn’t so much about what I’m giving, but being sure that it’s being treated with respect. And that means, you know, confidentiality and ensuring that it’s safe and secure. And, you know, you do hear of data being lost, and hackers hacking into databases, and all these sorts of things. So it is something that I considered. But at some point, and I know things like the research regulations, research governance is sort of tightening things up, and we’ve got the Human Tissue Act which, you know, I know that there are licenses for storage and inspections and new regulations. So that does give me a little reassurance there. And at some point you have to decide on the balance, don’t you, the good against potential for problems. I mean there’s always something that can go wrong. But at the end of the day it’s a leap of faith. And the balance for me was that this was a really important thing to be involved in, and I was happy to go through it and give, well, tissue samples and also huge amounts of personal information [laughs]. Which was interesting as well.

Before they induced me they, I did sign a form. I remember signing a consent form to say that they, they could take my stem cells and also if I needed any other further intervention due to the pregnancy and possible caesarean, I signed those then. And I think they took, they took a blood test after, I think – yes, after I’d had my caesarean, but I really wasn’t very compos mentis at that stage [laughs] because I’d had an epidural and rather a lot of gas and air. So little bit hazy on those details [laughs].

So they took consent quite a long time after you’d first read the information?

Yes. Yeah. I’m not sure, I mean, from what I remember – I didn’t keep the information leaflet unfortunately – but I don’t think it was the national database that I signed up for. I think it was a local bio-banking for local research, rather than a national one, because I don’t think they do the national one in our centre – yet. I mean, they may well do soon but yeah.

I mean, I suppose, I’m just interested in this gap
Mm.

between when they gave you the leaflet, which was sort of 18 weeks in
Yes.

.. and then you don’t sign consent till some time later?

I signed consent just before I gave birth.

Basically. Well, when George was delivered, yeah. It was a long gap in between. But I had brought it up a couple of times with my midwife and you know, when I saw her at my antenatal appointment I mentioned the fact that I’d read this leaflet and I really wanted to do it, and she put it in my notes. And so anybody seeing the notes was aware that I wanted to do this.

And they just said it was very simple, if you didn’t want to consent, if you wanted to un-consent, all you had to do was just let them know, or decide not to sign the form just before you gave birth.

I mean, it, there was a long, there was quite a gap before – I mean, it sounds as if I was signing just as they were wheeling me into the operating theatre – but it was, it was about eight hours before, so I was fully compos mentis. And I actually, I remember coming out, when I came out of the anaesthetic, talking to my husband. I said, They did do the stem cell thing, didn’t they And he said, Yes, they did

Did you feel you could still remember enough about what was in the leaflet and what you’d consented to?

Yes. Yes. I mean, it, because you weren’t really consenting to very much. All you were, I mean, it literally was they were going to take it off after you gave birth, and you gave a blood test at, you know, at the same time, and then that was, that was it. So there really wasn’t very much that you had to do, and so it wasn’t something that I felt I needed to revisit at any time. I felt I’d given, been given plenty of information on the sheet, and I thought, you know, I give blood, I’ve donated blood and various things to other research projects at various points. I’ve got no problem with, you know, furthering research. And I just thought, you know, it would only end up in the bin if I didn’t, so why not?

And so I really had no problem with the consent issue. It, even though it was a long time since I had the leaflet. There was a telephone number that you could ring up and ask for further information if you wanted any more details. But I didn’t feel I needed them. So

Do you think the people running the research project would be worried to think that you hadn’t read all the way through the leaflet?

No, because I know what it is. At the end of the day when I get there they have someone there to talk you through it, you have to sign something, you have to sign to say you know all about it, you have to sign, go on the screen and it won’t let you progress until you’ve said that you’ve signed it, you accept it and you sign it. So no, I don’t think they – I mean, they give you that information to get you there, and half the people are going to get there just because they know a bit about it like me and don’t mind or are happy to. And, presumably, the paperwork is to convince another proportion. And some proportion are going to throw it away whatever it says.

Do you think, when you talked about it not being on the front page, would there be any benefit in having like a sort of a one-page summary as well as more detailed information?

Yes, you see I just think anything that comes through the post, if it isn’t on the first page it ain’t going to get read. So to enclose a leaflet, which I think it did, is great, so yes, I think – I mean how you achieve this is very difficult.

No, I felt the information was fine, but I’m not a person that reads instructions. I didn’t want information, I didn’t want instructions, I just wanted to get on with it. The other thing that I found quite hard throughout, and this wasn’t just at the cancer centre but other places, is when you’re asked to make your own decisions. I do my job, I consider myself the expert at my job, and the doctors are doing their jobs, and they should be the experts at their jobs. And if they want to come to me for my professional advice, I’ll give them my professional advice, and I’d like it to work the other way on, but I feel that they just give you the information and tell you what, what your choices are and you really have to make a decision from there. And I think I found that really hard, knowing that you’ve made the right decision.

No, if they want to take some blood or want to take some tissue sample, or anything, fine. Get on with it; I’m happy to do that, if it means that I get what I want.

Do you remember signing consent forms?

Yes I do, yes, yes. I’ve always signed the consent forms. And I’ve always felt that the hospital has been very anxious to make sure that I had all the information and that I signed all the forms and I did everything properly. I wasn’t bothered about that, but that’s the way I work anyway in the rest of my life, so I don’t suppose that’s any different.

Do you sometimes feel that actually with things like tissue samples and blood samples that we go through too many consent procedures, or do you think it’s about right?

I think it’s difficult, because I think so many people are so different. And I do think I’m probably right at one end of the scale, and I think it’s hard to consider the other people at the other end of the scale when you don’t know how that feels. So its fine for me, I don’t mind. But then there are other people that would mind dreadfully.

you said you don’t sort of like reading too much about the rules and stuff, and when you get information leaflets about different research projects do you sit and read them fully?

No [laughs]. No, never.

Do you think the doctors would be shocked by that?

I think those that have sweated blood in order to write them in the middle of the night might be a bit upset with me, but they have to do it, and I think it’s the same as things in my job – you have to do them. Whether they’re needed or not is irrelevant. You know you have to do it. So they might be upset, I don’t know. I think they probably know me well enough by now to know how I’d react anyway.

Well, of course it all sort of harks back to Alder Hey* and the awful – I mean it must have been pretty awful for those families to know that bits of their children – and, you know, the consent procedures were not in place, were they, for storing tissue. I think it has been very highly magnified in the, in the press. But that has led to better regulation. I mean the Tissue Act, the Human Tissue Act, and better regulation and increasingly the sort of focus on consent, which I think is at the very heart of this. And I’m very pleased that it is. But I think now we need to move on from that and, you know, lessons have been learned and things have changed and
Because the flipside is that you end up making it harder to do research?

Of course, and more expensive to do research. And it has to be a balance, doesn’t it? But at the end of the day I think it is the right thing to do, to involve and include the people who are your research subjects, if you like. Because I think people genuinely, most people, want to help and want to be part of this and want to know that they’re doing that. And therefore I don’t think that it should be not done because the researchers don’t think it matters, or the researchers think, Oh, well, they wouldn’t give consent, so I won’t do it I think it has to be a partnership, and I think the appropriate level of consent is a really important principle in all these things.

* FOOTNOTE’ This refers to the discovery that a pathologist at Alder Hey children’s hospital had been retaining organs without consent after post mortems in the 1980s and 1990s. The investigation into this case was one of the factors which led to the setting up of the Human Tissue Authority.

So do you have any sense of how they’ve used the samples that they’ve taken, what they’ve done with them?

No not really. The trial that I was on for chemotherapy I was kept fairly well informed about that, and for pure nosiness I read up about it on the internet when the trial results came out. But I found them quite shocking, and in a way quite upsetting at the number of people who hadn’t survived the trial, so I think going back to my plan A of not really knowing or wanting to know about it is probably the best one. I think some people would lap it up, but I’m not really interested. But it is good to know – it’s sad to know that so many people didn’t survive the trial regime, but it’s great to know I’m one of the survivors. And if I hadn’t done it would I still be one of the survivors? So… enough knowledge, but not too much.

Do you ever worry about if samples – I don’t know, I mean are the samples that you’ve given, do you know if they’re being kept long term for other research projects?

don’t know, don’t care.

Well, you do have to give your GP details, I think. Yes, I’m sure you do. And they will be following up, yes, and linking, which certainly was one thing that, you know, it’s a bit, there’s a bit more to it than just donating something, as you say. So there is a long-term sort of link-up. And I gather you may be invited back for further assessments or something like that. I’m not sure what.

With the blood sample ones, do you know if they’re going to link it back to your medical records in future?

Do you know, I can’t remember. I wouldn’t be surprised. I mean I wouldn’t have thought any of this would be of any use without being able to link it back to the type of cancer that you suffered from, so there must be an element of that. I can’t see how it would work otherwise.

Yeah, okay.

Although this is for metastasis, the blood one, as far as I know, so yeah, it must be linked to the medical record, yeah. Because they need to know the timing, they need to know the, you know, the fact that you’re suffering from cancer and – yes, so there must be an element of that, even if it’s anonymous.
And that doesn’t worry you?

No, not at all.

My, probably I felt some misgiving about the nature of it, inasmuch as it’s a long-term study, without specific aims that I could identify. So it was to collect a lot of data and personal data, it would have access to my GP record, and collect a massive database on everything for whatever purpose was deemed necessary in the future. And that type of research would concern me.

Why?

I have an innate suspicion of, of the government – not that this is the government – but of databases, of CCTV. Most recently, to give an example, although this is since the research request, a database covering all children throughout the country to try and aid child protection, when most people who know anything about it would say it doesn’t and can’t. And in that instance they collect data from schools. They give parents no right to opt out of that particular database. And there seems to me to be an element of Big Brother collecting data. At the moment it is probably fair to say that the government can’t get its act together to use all the data it’s got as it may wish to, but that in the future may change. If they linked, for instance, a database developed by Biobank with my shopping in Tesco’s with whatever else is on a database, increasingly it all joins up and they can know everything about you.

And what would be your fears about what they might ultimately do with that?

That’s interesting. Because there is an argument to say, If you haven’t committed a crime, you have nothing to worry about I don’t subscribe to that view. I think probably the biggest worry for the individual is a misuse of data – perhaps a misunderstanding, perhaps a mistake. Perhaps you get locked up because they have linked the wrong shop with the wrong Biobank information or whatever. Mistakes happen, data goes missing. It, you know, it may sound paranoid, but it can be misused.

Is one of the elements of the project that they’ll link to your future medical records to sort of compare your health now with what happens in the future?

Well, it is, I suppose. It must be, you know – 53 now and I suppose, you know, there’s less life in front of me than there is behind and you get slightly more concerned about health issues. And I have to say I consciously thought it would be good to get a sort of benchmark now to measure things against in the future. I don’t – you know, yeah.

I guess I, you know, it’s my assumption they’re going to do that. It sort of doesn’t seem sensible just to do a, get a benchmark and not to track at least some of those people through, over a long period of time. And, you know, certainly that makes sense, and I would continue with it, you know, if they contact again.

So you wouldn’t be worried about the…

The implications of it? No, because it’s, it’s useful to me, I suppose, as well. And again I’ve tapped into that usefulness and it’s seems daft to volunteer for one part of it and then refuse to act on, you know, carry out the full commitment, so to speak.

What if they weren’t going to tell you? I mean if they were just sort of doing it independently, monitoring your sample and then your future medical records, but it wasn’t ever fed back to you?

That would, there’s certain aspects of that could, you know, could well concern me. It depends whether they’re doing it anonymously, and if that information is going, you know, my identity’s being connected, in a way which is then accessible to other, you know, third parties, insurance companies and so on, then that is a concern [laughs]. That’s not what I signed myself up for. I don’t want insurance companies poking around without my say so.

With giving research samples, as you have done, and we’ll talk a bit more about that one, I know some people worry that that may somehow get out into the public domain and their medical records may be linked to the samples and so on. Has that ever been a worry for you, about the way that the data are handled?

No, I’ve not worried about it because I do know the governance process that they go by.

Again I have advantage of access to the governance processes. That doesn’t mean they’re in any way infallible. I think it would be a – it would be very unlucky if there was an association made with me. Because I’m not – shall we, let’s take the example you took, which is quite a good one – I’m not a media person or somebody who’s well known, where it does become crucial and there is a, more of a reason for people to want access. In my case I’m relatively Joe Public, and if it got out, it got out. There wouldn’t be – as of yet there is no impetus for people to take the effort to do the data mining required to join it all together. That doesn’t mean I can’t see that – I think I’ll be all right in my lifetime. I can see it coming of where the insurance – I think that’s where it will be driven from – the insurance companies and similar will have a real appetite for medical history, especially as they unravel more of the DNA structure.

I think my personal data and medical information getting into the wrong hands is a general worry, mainly because of confidentiality issues. I’m not entirely sure if anybody would be able to use that data to harm me, other than to invade my privacy. But yes, I do think the security of the data, privacy, anonymity – where that’s appropriate in a study – I think they’re very important.

But you obviously felt confident that it would be handled well or you wouldn’t have taken part, I guess?

Yes, yes, these people are professionals. Yes, mistakes are made. Had the nature of the data – for example looking at mental health – had the disclosure of the findings been able to have had a negative impact on me, I might have asked for more information on that area, on the security of the data, at the start of a project. But giving blood and urine samples when you’re pregnant, that really doesn’t worry me at all.

And they ask you all sorts of questions about yourself, and there are some where you think, Oh, God. This is very personal And then you have to remind yourself that this is about research, that you have to have confidence in the confidentiality and that actually, if enough people answer these questions we are going to get a picture about our population, and that if we can do that, we can understand what the different factors that influence their health and their lifestyle are doing. And it will better enable us to improve the health of the population, which of course is what research is all about. So it is an honour to be involved in doing something like this.

I bet some people would think, This is big government being snoopy In fact, when I’ve talked to people about it they’ve said, Why would anyone want to have all that level of information? Doesn’t it concern you It doesn’t bother me a jot. But then I’m not one that doesn’t like – I wouldn’t give my e-mail address to people when I’m buying something – but I don’t really mind about, you know, cards and – not, I mean I don’t mind about having population-based cards. I think things that help with our security and identity can be a very positive situation, although I know that isn’t a wide, you know, it isn’t – it’s probably as widely held view as the other way, which is that this is infringement on your civil rights and liberty. So I go with if I’m asked to help, if I can I will. And if there’s something that can be in it for me as well then that’s great.

And if the sharing were with private organisations like, say, pharmaceutical companies, would you be equally happy for that kind of use?

As long as it’s not being abused, absolutely, absolutely. And I know abuse is something that we have to put up with in this day and age, but for something as complicated as this I, I would back it all the way. And, again, trust in the group that you’re working with and knowing who, that they’re going to give it to the right people, that would give me absolute confidence that if pharmaceutical companies were being involved they were doing it for the right reason.

And we all know cancer can hit people, and huge funding goes into cancer, etcetera etcetera. But no, I’m, I’ve got a disease which is not so common. I’m more than happy for anyone who’s interested in finding a cure for it getting involved with me. And, you know, my data is not for sale. it’s there to help create some sort of miracle in the future. And it could be that just round the corner there it’s going to be something simple. We just don’t know, do we?

So are you worried about the long-term Biobank and where things may end up and how your data may be used?

I think yes, only in the sense that I just don’t want it to end up sort of just being used for, I don’t know, commercial exploitation. I want it to be used specifically for MND research. it’s not that I wouldn’t necessarily give samples for another form of research if it was necessary, but I, you know, I’ve given it on the understanding that it is to the benefit of people with Motor Neurone Disease in the long term, and so I would want some sort of safeguards that they’re used appropriately. And from the information that I’ve been given for both studies I don’t have any qualms about that.

Is there anything in the information that suggests they may be used by private companies, sort of pharmaceutical companies?

I don’t think so. I, of course I haven’t, I haven’t read – I mean, it’s quite a while since I gave to the MND DNA Bank. I’m fairly certain that that wasn’t there, but having said that, if it’s done in collaboration with the academic team, that it’s working together, I don’t care who uses it if they actually get a result. So I’m not in the least worried, if it is collaboration between a pharmaceutical company and an academic department, the MND Association, whoever it might be. That’s absolutely fine by me. And, but I, it’s a while since I read the small print, and in all honesty I don’t feel so possessive about a blood sample that I worry about it. And, you know, I feel that so long as the bank is regulated sort of in a reasonable way, that the samples are controlled, what they choose to do with them, I think, is up to them.

Does it depend also on whether it’s the NHS or a university or a commercial organisation?

I think personally I’d probably be more willing to give for educational purposes and for NHS research rather than private companies. But it does, again it does depend on, you know, if it’s a big deal, if it takes a lot of time, if you have to do anything on top or you have, there’s some follow up or anything like that. And again, if it was a private company, because it’s a private company the profits stay within a private company therefore you’d probably expect to be paid to be frank, if you were going to do that. Right, whereas if it’s the NHS it’s sort of that greater good experience.

I mean, what are your thoughts about getting feedback from research studies that you’ve taking part in?

I think it’s quite difficult, I would assume, because of the time span. It must take a long time for actually any results to come out of anything. I think it’s quite important to know maybe two years’ down the line that what you did was beneficial, but I don’t know how easy, because you’ve got to draw a fine line between people doing the studying and then spending money on all the admin. I mean, you know, I like giving to charities but it irritates me no end when they keep sending me stuff through the post saying, Thank you for your Give As You Earn [laughter]. Keep your money. I don’t want you to spend that on that, I don’t want you to spend it on that, you know, so again, it’s getting a fine line, isn’t it, between, you know, giving feedback but don’t waste the money on it. I’m sort of sitting on the fence on that one [laughter].

I think researchers are quite often rather bad at feedback I’ve taken part in sort of small survey sort of studies before which are going for a sort of PhD thesis or whatever, and you’d be just interested to know, having given your time, what the results were. And even when they say, Oh yes, we’ll let you kno, the chances are they don’t. I actually know that, you know, with the [study name] study for example, I’m pretty certain that we will get the feedback, and I don’t care really how long it takes, because I’m fully aware having sort of done research myself, of the processes involved and that, you know, just because you’ve had your last appointment for the research that a fortnight later you’ll get the results, I mean it isn’t like that at all. But I would want to know what the upshot was of the collective experience of everybody who took part, what they gleaned from that, and whether it has moved things forward or kept things as they are or, you know, it’s been – whether it’s negative or positive, it is very good to know, and it just makes you feel that your part has been of value. And I think there’s a tendency that if you have taken the time and trouble to participate in something, then it’s just a common courtesy to sort – a short little brief summary that can be sent out to the participants is enough. I do also know that because the MND Association is very good at putting out information with a big study like [study name], it would come out on their website anyway. So I’m fairly certain I will get feedback. And I also think the researchers are geared up to doing that. But I think in all studies it would be a lesson to everybody that if you are taking up people’s time, a little bit of feedback doesn’t go amiss, and then people are much more likely then to volunteer in the future. I think if you don’t do that, then there could be a thing next time, Well, I gave up all that time and effort, you know, to take part in it and you couldn’t be bothered to tell me, why should I participate again And I have met people who’ve – in various walks of life – who that has happened to, and they just refused to take part in any more research. So I think from the researchers’ point of view it’s a two-way benefit.

As a participant – I think the biggest way that my trust could be abused would be by misrepresenting the results, being dishonest with the data. I think that’s what would bother me most. You asked me before if, how I would feel if samples I’d already given for one project where then used in another project. Well, of course that very often happens with data, that the data of an earlier study contributes to a later study. I actually feel very positive about that as long as it’s an honest study. I actually have a very deep interest in alternative medicine and I use things like homeopathy myself, and I understand enough about it to know that scientifically it doesn’t make sense, but personally, anecdotally, I’ve used it a lot. And so I see it as a balancing act, that by taking part in hard-core evidence-based research we can get better information which does make gentler approaches more effective.