Biobanking
Information and questions
Before taking part in any research, people must be given an information sheet telling them what the study is about and exactly what they will be required to do. This should also describe any benefits or disadvantages there might be. People need information to be able to decide whether or not to take part.
There was a mixed reaction among the people we spoke to about the information sheets they had received. Some thought the information was “clear”, “about right” and that there was enough information for them to decide whether to participate or not. However, others felt that the leaflets were quite lengthy, repetitive and that the language used was too technical for ordinary people to understand. A few sought extra help from a family member or friend to understand the information. The information sheet is important as it can encourage or discourage people from taking part.
Julie felt that the information sheet contained everything she needed to know.
Julie felt that the information sheet contained everything she needed to know.
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The information was just long enough to give me everything I needed to know, and just set out very clearly that this was looking at...So the information was full enough to tell me everything I needed to know about participating in the project, and didn’t take particularly long to read. And it explained that it was looking at better information on the causes of pre-eclampsia and identifying pre-eclampsia. And at the beginning of my pregnancy I only vaguely knew what pre-eclampsia was, and so I got a slightly better understanding of the condition through reading the information I was given.
The information Gareth received for several studies gave a detailed explanation of what would be involved, but he was glad he had someone medically qualified in the family to discuss it with.
The information Gareth received for several studies gave a detailed explanation of what would be involved, but he was glad he had someone medically qualified in the family to discuss it with.
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I mean, I felt the information they gave me was really quite detailed. It was - and certainly for the insulin one which I declined it was detailed enough for me to think, “I don’t really want to do that.” For the adrenaline one there was enough, there was lots of information. And some elements of it I thought, “Well, that’s interesting, I...” And some elements I thought, “Well, I’m not entirely certain on that.” There was plenty of information but I’m, I didn’t feel qualified enough to understand it. It talked about medical, you know, they were all medical procedures. And I can’t remember whether they actually gave a percentage risk for any of them. But the implication was that, you know, it’s invasive and there are risks associated with all of these. So I read through it and thought, read through it a couple of times and thought, “Well, I’m interested enough to do it. And it sounds - it doesn’t sound dangerous otherwise they wouldn’t be putting it out.”
So I, the information they gave me was sufficient to, for somebody to make a decision. I didn’t feel it was enough for me to make the decision on my own. So I’m not sure what my GP would have thought if I’d gone to them and asked them to read through it. But I, you know, I was fortunate in having somebody in the family who I felt I could ask and would give me a reasonably honest opinion.
Chris thought the information was a bit 'technical'. She doesn't always want so much information and sometimes it can be off-putting when it doesn't need to be.
Chris thought the information was a bit 'technical'. She doesn't always want so much information and sometimes it can be off-putting when it doesn't need to be.
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Again, the leaflets they send you, sometimes, as I say, a bit technical because I’m a layman, so - and with the best will in the world, I think even if they try to explain it in layman’s terms, I don’t think Joe Public always understands anyway, because you don’t really understand what - you know, telling me about looking for metabolism, the liver function, that was easy to understand, but I’m sure some of the ones I’ve done before I’m not really sure what they were looking for, [laughter] because it’s, it’s not part of my body that I actually understand how it works in the first place, if that makes sense.
So, you know, you’ve got all these different organs and what have you, you know. We all know what our liver does and what our heart does, but some of the other bits I think have been a bit technical. But again, they do go out of their way to try and explain, and the only other thing they do go into great detail, sort of to, when you go there, to like - you’ve got it written down what they’re going to do, but then they will go into great detail about saying how many needles they’re going to use and how many samples they’ll take. And sometimes they’ll sort of say, “Well, you know, we need to do this”, and they’ll go into great detail, and I think sometimes I don’t think I really want to know. Because if I think about it, sometimes it’s a bit, “Oh, no.” You might sort of think, “Oh, no, I don’t really want that done.” Whereas as at the end of the day it’s, to the layman it’s just an injection, you know, because whatever they’re taking out of my body it doesn’t really matter - to me it doesn’t seem to matter, maybe - I don’t know if that’s right or wrong.
Some of the people said that they had not read the information sheets they had received, and a few thought the pendulum has swung a bit too far these days towards giving everyone lots of information about everything. Given that biobanking generally involves very little risk or inconvenience, some felt they did not need such lengthy, detailed leaflets, and did not really care how their samples were used. More summarised information might help, but at the same time people recognised that it is difficult to know what each individual will prefer.
Claire thought that the important facts people need to know should be summarised on the first page of the leaflet. She said, 'if it isn't on the first page, it ain't going to get read'.
Claire thought that the important facts people need to know should be summarised on the first page of the leaflet. She said, 'if it isn't on the first page, it ain't going to get read'.
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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.
Sometimes it feels as though we get too much information ' but each individual will feel differently about how much they need.
Sometimes it feels as though we get too much information ' but each individual will feel differently about how much they need.
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You don’t need to have all this bumf through the door. You know, you have an appointment now - they send you a letter. You know, I don’t need all this because I know I’m going to do it anyway, but then it’s like every charity, isn’t it? It’s sort of, you know, getting a happy medium.
So there’s a bit too much information sometimes?
Sometimes. But I think, again, it’s hard to gauge between people. You know, for everyone that says there’s too much there’ll be somebody that says there’s not enough.
Karen never reads the information leaflets, and would like more guidance from doctors as to what she should do. But she knows other people would not feel the same way.
Karen never reads the information leaflets, and would like more guidance from doctors as to what she should do. But she knows other people would not feel the same way.
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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.
Jean argued that everyone should get the same information, but that it should be clear and understandable.
Jean (a former doctor) thinks that staff should make no assumptions about people's knowledge, and ensure they explain everything clearly to everyone.
Jean (a former doctor) thinks that staff should make no assumptions about people's knowledge, and ensure they explain everything clearly to everyone.
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Anything about the information that you were given that you feel could have been improved, or that you thought was particularly good or? Was it easy to understand?
Well, I thought so. I’m probably not the best person to say that, though, because, you know, I have got an advantage in having a medical background. But I think in all honesty that they explained things very well, and I would imagine that for everybody who takes part they feel they’ve got a very good understanding, either from the documentation that they received, or alternatively just talking to the researchers, because they do go through it, you know, very carefully, and I think in fairly easy language. But that’s the one thing that I’m probably not the best placed person to be absolutely certain about, because I’ve got that sort of medical knowledge, that you sort of take a bit of jargon for granted because you know it, and maybe things may, if they slip through the net it may slip past me too. But I would doubt it. I think that the information I got would have been self-explanatory to everybody and was very clear and precise.
And actually you’d mentioned before that sometimes you feel disadvantaged as a doctor dealing with other health professionals. And actually this sounds like an instance where that wasn’t the case, that they didn’t assume knowledge that you didn’t have.
No, I don’t think it did, basically because I think in a research project that it’s of paramount importance, that you’re dealing with volunteers, basically, and I think it’s very important that you must be sure that whoever it is happy that they’ve got all the information that they need. And I think the way to treat anybody, from whatever background they are, is to treat everybody the same. And I think that’s true in clinical medicine as well. Don’t make assumptions. And I think it’s, you know, of paramount importance if you’re dealing with a volunteer in research. And therefore it’s much easier for the researchers to go through the same talk initially with first-time study participants, irrespective of their background, and I think that’s what they tend to do.
Whilst most people felt they had enough or even too much information, some felt there were things missing or things they did not understand.
Before taking part in any research, people must be given an information sheet telling them what the study is about and exactly what they will be required to do. This should also describe any benefits or disadvantages there might be. People need information to be able to decide whether or not to take part.
There was a mixed reaction among the people we spoke to about the information sheets they had received. Some thought the information was “clear”, “about right” and that there was enough information for them to decide whether to participate or not. However, others felt that the leaflets were quite lengthy, repetitive and that the language used was too technical for ordinary people to understand. A few sought extra help from a family member or friend to understand the information. The information sheet is important as it can encourage or discourage people from taking part.
Richard did not want to take part in the UK Biobank because it was not clear how the data would be used. He worried it could be misused and was also concerned about privacy.
Richard did not want to take part in the UK Biobank because it was not clear how the data would be used. He worried it could be misused and was also concerned about privacy.
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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.
The written information David got was very like a contract. When he spoke to the staff, they made it more personal for him and gave him interesting explanations.
The written information David got was very like a contract. When he spoke to the staff, they made it more personal for him and gave him interesting explanations.
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Would you have liked better written information? I mean, was it just that it was so dry and difficult to read that probably the information was there but it wasn’t understandable, or was it not even there until you asked questions?
No, it was there. It was there, but it was just in clinical terms, really. Yeah, I mean it was, and it was more like a contract than - it was saying what would happen, for example, if the trial went wrong and I needed treatment outside of it, you know, who would be responsible and what, if you like, laying out what their responsibilities would be, and would not be, you know? In other words I suppose it was a bit of a liability, a waiver to some extent on their liabilities. So it was, it’s a little bit daunting when you see it, because it was all steeped in technical jargon, trying to explain from a medical viewpoint what they were trying to do, but on the other hand not giving much away because they don’t want it to get in the public domain, and at the same time a contract with me so that I understood that I could say no at any time, but that I would be expected to do certain things if I stayed on the trial, and at the same time telling me what the different liabilities would be from their viewpoint.
Whereas when you talked to them, what happened when you talked to them?
Oh, much less of that. I mean, it was more personal when I spoke to them, but I had to ask the questions. You know, I had to say, “Well what are they doing with this? What is it they’re really interested in?” you know. “Well it’s the proteins” “Oh the proteins, oh interesting”, you know, “Oh yes, they’re on the surface of the tumour, and that’s what we need to know, because what we need to know is that the treatment is actually going to stop those proteins from working. It gets in, and it affects this gene, and it stops it dead.” And I found out all things like that, the real detail, the stuff which I found fascinating, yeah? Maybe other people wouldn’t be interested.
A few people felt they had unanswered questions about the secure storage of data, and personal privacy. For example, one man who was a healthy volunteer worried that that donating samples for biobanking might have negative implications for his insurance policies. It was also apparent that some people had misunderstood what they had consented to, for example not realising that their sample might be shared with other research groups or that researchers might have access to their medical records in future (see ‘Ethical issues and future use of samples’).
As David suggests, being able to ask further questions face to face was important, and most people we talked to felt they had been able to ask for further explanation from the staff. Those who asked questions generally found staff to be informative and good at explaining things, but some were better than others. (See also ‘Communication and relationship with staff’).
Gill contrasts her experiences of two research projects. One member of staff could not answer her questions, but the other was much more knowledgeable.
Gill contrasts her experiences of two research projects. One member of staff could not answer her questions, but the other was much more knowledgeable.
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I’d forgotten about this one, but I was asked to provide an extra blood sample. This was during the same period of time, so during the course of my breast cancer surgery. And it was providing a sample for what I presume was a local study for blood marker assays. I don’t know what they are [laughs]. And I just got a leaflet and was asked if I would give a little extra blood, during a normal blood test a little extra blood which would then be used for doing research around cancer. And as I say I can’t remember what assays mean, because I’ve only just found this leaflet again. I’d forgotten all about the fact that I had done that.
And in fact the nurse who took the blood didn’t know anything about it. So I did ask her at the time and she didn’t really know any more about it than that, than the information I’d got. So, yes, it - yes, it’s not, it’s not hugely helpful, this leaflet. [laughs] Well, it’s two sides of A4, which really doesn’t say a great deal. I mean the purpose of the study is that small two paragraphs there, very, very small.
I think it would have been helpful for her to have known something about it. She, she just sort of, “Oh, yes, I think I know what you’re talking about” sort of thing. But, yes, I think so. And had it been at a different time I would probably have asked for more information on this one.
Because I think you talked last time about problems with recruitment often stemming from a lack of involvement of –
Yes, yes.
-- those staff at the front line.
I think that’s true. I mean, it doesn’t inspire confidence if the staff involved don’t know what it is they’re taking the sample for, and can’t tell you a little bit more about it. I mean it doesn’t, it isn’t a lot of information that they would have to carry, I think, but at least to know what the basics are about this. And then, you know, if there are more detailed things you want to know, to be able to point you in the right direction for somebody to help I think is really important. Because it, you know, gives you confidence that somebody knows what they’re doing and it’s going to the right place.
And with the tissue bank, was the person taking consent informed about the study?
Yes, yes, she was much more involved. I think she probably did this as her full-time career, [laughs] full-time job. She was actually sitting and talking to patients. As part of your clinical appointment there was a sort of ten minutes with her to, if you wanted to do that, to talk through the donation of surplus tissue. So that seemed much more structured, and well set up, and I assume that’s been going for some years.
People also had discussions about taking part with their GPs and relatives who were knowledgeable about medicine.
Not everyone felt that they needed to ask many questions. For example, one woman said she was so heavily monitored during her pregnancy that she never felt the need to ask anything. Ruth did not feel she needed to ask anything but knew where she could turn to if she had questions later.
Ruth explained that there was a telephone number to contact the researcher on the information sheet.
Ruth explained that there was a telephone number to contact the researcher on the information sheet.
Sex: Female
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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 …
So they took consent quite a long time after you’d first read the information?
Yes. Yeah. I’m not sure, I mean, from, 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.
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.
Gill also found the internet a useful additional source of information and commented on how interesting she found the UK Biobank website. Gareth, on the other hand, cautioned that it can be difficult to find trustworthy information through general searching. He said, ‘If I can get the same information from two or three sources then I start to believe it…Websites are full of information but it’s also full of noise.’
Occasionally people did not feel able to ask questions of the staff when they attended for their appointment.
However, Elaine encouraged people not to be afraid to ask and has always found staff willing to respond.
The staff have always been willing to discuss the research with Elaine and answer her questions.
The staff have always been willing to discuss the research with Elaine and answer her questions.
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And the kind of information that you’ve been given about these different research projects, what are your feelings about the way that the information is presented?
It’s fine. I mean, some of it is obviously, it does go into quite a lot of detail and it’s beyond, you know, I think most people’s sort of knowledge. You know, it’s quite hard to take in. But I mean the nurses and doctors that I’ve encountered are always more than willing to go through and talk through it with you. And they also do say in the letter that if you want to discuss it with them you can phone them at any time or you can discuss it with your own GP. So you’ve got plenty of opportunities to sort of find out more about it if you want to.
Is there anything you think they could do to improve the information?
I suppose it’s difficult, because I mean I - obviously you like to know what’s happening to you, and there have been times where I can remember one time reading something and I’m thinking, “Oh God, I don’t really understand that. That sounds quite invasive.” But I talked it through with a nurse that I know, and when she explained it to me I thought, “Actually, it’s not that bad.” So I suppose that it could be off-putting to people when you get, you know, a big wad of paper and it’s all medical terms. But the fact that if you do, if you are unsure, do talk it through with somebody because you’ll get a better idea.
Last reviewed February 2016.
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