Biobanking

 

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].

 

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.

 

 

Mm.

Yes.

 

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.”

 

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…

 

 

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.

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.

 

Don’t know, don’t care.

 

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.

 

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.

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.

 

 

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.

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 know”, 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.