We asked people who had been invited to or taken part in cohort studies whether they had any concerns about doing so. They talked about whether they trusted the researchers and what types of risks they thought might be involved in taking part in a study. Some people said they did not have any concerns or see any risks in being involved. Others talked about possible issues and sometimes hypothetical situations that they were uncertain or uneasy about. The main worries people talked about were:
• Data protection and the risk of ‘data leaks’;
• Concerns about study activities (e.g. discomfort, getting ‘bad news’ about health from test results); and
•
Data sharing with other researchers and potentially commercial interests (e.g. pharmaceutical companies)
Brian feels confident that the researchers protect his personal information. He is reassured by studies being run by well-known organisations.
Brian feels confident that the researchers protect his personal information. He is reassured by studies being run by well-known organisations.
Age at interview: 73
Sex: Male
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I honestly, I mean it’s meant to be safe and secure but I really don’t know that. I’ve trusted them; they are one of the, you know, foremost medical research centres in the world. If they can’t get it right, who can, so I think if it was probably somebody less known I’d be a little bit worried about it but I’m not worried about them. I, you know, I’m sure I can trust them to do the right thing.
Whilst this section covers issues that some people felt worried or unsure about, there were also lots of things that people found interesting, important and enjoyable about taking part in cohort studies. You can read more about these in the section about
reasons for wanting to take part in cohort studies.
Trust and risks around data storage and confidentiality
Lots of people talked about trusting the researchers to keep their data secure and to use it appropriately. Teresa felt confident the researchers did this and she didn’t feel a need to know any more details. Some people, like Jess and Luke, said they knew medical research was carefully regulated. Roland said, “I don’t believe in mad scientists, Frankenstein… doctors going around doing their own thing and not being ethical”.
A few people, like Douglas and Nadera, felt that the regulations around research actually meant things were sometimes “overdone”. For Teresa, being asked to confirm her consent again and again was off-putting. Douglas remembers a time when the researchers were very concerned because someone “forgot to get me to tick off some boxes”, but he himself didn’t feel worried about this. Nadera was involved in a cohort study as a patient representative and she felt that restrictions around data protection were part of an imbalance: she (and other participants) ‘give’ data but aren’t allowed to see (anonymised) data that they might find helpful.
Teresa says that processes, like giving consent, can be “overdone” in some studies and that repeatedly asking isn’t “respecting people’s time”.
Teresa says that processes, like giving consent, can be “overdone” in some studies and that repeatedly asking isn’t “respecting people’s time”.
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I think it can be overdone, I really do, I think look at a way of streamlining it because it’s, it can be really irritating. I just think it ought to be, you know, a process where the question is asked once and not the dozen or so times it feels like and I suppose that’s partly to do with respecting people’s time.
And, you know, it clearly needs to be made in such a way that it’s understood. But it’s a little bit along the lines of every single thing you do now like you’re asked to give a feedback and it becomes a sort of manacle in the end [laughter].
Jade feels confident that the researchers in a twins study she was part of “take good care of your data”.
Jade feels confident that the researchers in a twins study she was part of “take good care of your data”.
Age at interview: 25
Sex: Female
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I guess that what they’ve done is they’ve anonymised it, or de-identified it and then inputted it. I think this is a hot topic, isn’t it, how our data’s stored and used and. They always say that researchers are more worried about it than participants, but I’m not really worried about that because it’s a big study. It’s- who is it done by, is it [university]?
I think so, yeah.
You have an element of trust that they would take good care of your data and kind of manage it appropriately and to the standard you’d expect and ensure that it is, you know, de-identified and kept in a-, kept as it should be.
There wasn’t a specific type of misuse that Keith thought could happen with cohort study data, but it was “an uneasy fear at the back of my mind”.
There wasn’t a specific type of misuse that Keith thought could happen with cohort study data, but it was “an uneasy fear at the back of my mind”.
Age at interview: 68
Sex: Male
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I suppose the only thing, the only thing that could possibly occur is that the data could be misused, it could be tapped into somehow and misused and I think we’re all a bit wary now about the use of data and especially with problems with Facebook and different…
Okay.
…different data breaches that have happened. But I’m not quite sure what to be perfectly honest, it’s just an uneasy thought of lack of, an uneasy fear at the back of my mind really.
A number of people felt that the type of data participants gave to researchers in cohort studies was not particularly worrying. Alan Y said, “They don’t have my bank account details or anything like that”. Anthony explained that “the risk’s minimal. I can’t see any risk to me personally, but who knows, I don’t dwell on it”. Others mentioned some situations where they thought it could be a problem. Brian and Douglas thought there could be impacts if a study participant hadn’t disclosed an illness to an insurance company and there was a data breach from the research. Malcolm didn’t mind his own physical information being “broadcast worldwide, if necessary,” but wouldn’t want to share any personal data related to his family life.
Some people found it reassuring to know that their data would be anonymised or de-identified and given a code or number instead of the researchers using their real names. Linda explained, “I don’t think they can identify [me] because you’re just a number anyway”. Barbara says that ‘being a statistic’ is “good in this context”.
Malcolm thinks plenty of health professionals have encountered information about him. He isn’t worried about this being the case in research too.
Malcolm thinks plenty of health professionals have encountered information about him. He isn’t worried about this being the case in research too.
Age at interview: 75
Sex: Male
Age at diagnosis: 48
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Well the only risk would be data, the escape of data but I don’t see any problem becauseI’m not really too worried about people knowing what my medical condition is. Everybody who treats me and I’ve had sort of 25/30 years of hospital treatment and hospital visits and surgery and all the time people have data on me and they have sort of take, take biopsies and they have, still have bits of my bits of my body and so I find it all, I’m quite unexercised about it so I don’t mind. So it wouldn’t worry me too much about the risk of any of the information being broadcast because it’s, although it’s private, I don’t have anything to hide. I don’t have any worries about people knowing my detail of my physical state and the state of my heart or the state of my lungs, so.
Concerns and discomfort relating to research activities
• Feeling unhappy with activities involved in the study
We spoke to some people who talked about study activities that could be risky, physically painful or could make them feel uncomfortable and awkward in some way. Gareth, a healthy volunteer in a biobanking study, declined a sub-study which would have involved having lots of blood tests and insulin injections which he thought was “fairly invasive”. He was invited to another study which, “despite it being equally invasive, it appealed to me”. He sent the information leaflet to some relatives with medical backgrounds to get their input, before deciding to take part because he thought it was an interesting topic and he could “see the benefits”. Roland and Ian declined sub-projects within their cohort studies that would have involved lumbar punctures.
Some people, like Jade and Lucy, found taking part in the research was a burden or made them feel uncomfortable in some way. Jade and her twin stopped taking part in a study because the “endless questionnaires” were “an intrusion”. Mr S felt that there is sometimes pressure on participants to answer questions they might feel uncomfortable about: “it contradicts itself in a sense, where you’re saying, ‘Look, okay, don’t answer it but then if you don’t answer it, if you prefer not to say… then the results are not going to be [as complete]’”.
Teresa, who takes part in a birth cohort, remembers thinking that keeping a very detailed log of her diet for the study was “a bit invasive”.
Teresa, who takes part in a birth cohort, remembers thinking that keeping a very detailed log of her diet for the study was “a bit invasive”.
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And I don’t remember much though in my teens to be quite honest. Whether there’s just so much else going on, I don’t know, but I imagine I must have made some input and carried on. I remember it more later when I’d become a mother and there seemed to be a lot then, a lot about diet. Sometimes the questions were quite invasive because you had to acquire a lot of material, you had to keep a record of your diet for two weeks you had to write down the recipes if you’d made something, you had to include absolutely everything, it was really detailed.
Teresa had been part of a group of volunteers to try out a planned subproject within her birth cohort study. She found it tiring and unpleasant in some ways, but also thinks the research would be interesting.
Teresa had been part of a group of volunteers to try out a planned subproject within her birth cohort study. She found it tiring and unpleasant in some ways, but also thinks the research would be interesting.
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And they took us round because where, where this, where we had the meeting in the university building they’ve got other resources nearby, very, very well equipped and they took us all through them and showed us, and they showed us the tests and they did some of the tests. You would think, you know, you would have hoped to be alert to do them, they’re going to be interesting to do but I think it will be also quite tiring, three days.
Yeah, absolutely.
And also a bit stressful because frankly it’s not great fun being mauled around really and they will be taking lots of blood tests. I mean they made it very clear that, you know, you’ll start off by not having breakfast and then when you did eat then they would actually take a blood test before, they would take a blood test in the middle and I mean that’s not great when you’ve got some vampire sort of hanging around you while you eat [laughter]. but it’s, I think it’s a small price to pay really because it really is important that information is passed on and it’s also really fascinating.
Lucy takes part in a study in which researchers count her moles and freckles. This made her uncomfortable when she was a teenager with acne, though she never said this to the researchers.
Lucy takes part in a study in which researchers count her moles and freckles. This made her uncomfortable when she was a teenager with acne, though she never said this to the researchers.
Age at interview: 30
Sex: Female
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And feeling really self-conscious, sucking my gut in as I’m standing there in my bra and pants, with having two people taking photos and sort of documenting any marks on my body really. And I suppose because I also had acne as a sort of teenager and young adult, I remember feeling quite self-conscious generally about my skin in particular as well as all the flabby bits and saggy bits and so on [laughs]. So yeah, it was actually quite an uncomfortable experience.
Yeah. And do you remember ever communicating that to the staff or to your family or-?
No, I don’t think I did. I mean body language wise, I probably- you know, I was sucking in my gut and I probably was quite uncomfortable and there were probably sort of signs that they maybe could have picked up on. But I don’t remember ever having a conversation about it. And I don’t remember ever saying, “No”. And I don’t know if that’s because I just hadn’t- I hadn’t almost thought that I could decline, or if I just thought ‘arr no, it’s not that big a deal and it’ll be over in a few minutes’.
But most people felt that being asked occasionally to do activities for the study (like complete a questionnaire) was not a problem. Margaret, Louise and Anthony said that taking part had never been intrusive for them.
• The risk of receiving bad news about personal health
In
studies which offered participants feedback about their personal health [link to TS10] from tests, some people were worried that they might get some ‘bad news’. Nadera thought that research might tell some people information about their health that they might not want to know. Margaret understood why some people might not want to find out if, for example, early signs of dementia were picked up in a brain scan for a study. Louise felt it was usually better to know though: “if it unearths something that I don’t want to hear, it’s still valuable”. Emily also felt this way and had genetic counselling in one study looking into Alzheimer’s.
In some studies, the researchers contacted the participant’s GP with test results. Alan Y said one risk of taking part in some cohort studies is that someone might become overly reliant on the check-ups. Luke also felt that these studies shouldn’t be relied on for “health monitoring”. Sometimes people were told that results would only be sent if there was something concerning. Most people were happy with this, but others worried that there might be a miscommunication or that their GP wouldn’t spot a problem in the test results.
• Not getting answers to medical questions or concerns
There were a few examples of things that researchers had said to people that they were disappointed with. James, who had experienced a transient ischaemic attack (TIA – a ‘mini stroke’), raised concerns to researchers about treatment side-effects but felt the response had been dismissive. Lucy felt disappointed by a lack of advice from the researchers in the study she was part of.
Lucy asked the researchers in her study for some advice about a large mole which had been damaged but didn’t feel she got a helpful answer.
Lucy asked the researchers in her study for some advice about a large mole which had been damaged but didn’t feel she got a helpful answer.
Age at interview: 30
Sex: Female
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I had a really big mole on my back that was right by a bra strap and I kept catching it. And this had been going on for probably a few years at that point and I’d basically accidentally ripped it off actually at one point and it was quite disgusting and sort of dangling off [laugh] and I’d stuck it back down and hoped it healed. But I became quite anxious about that being something dangerous and that I could’ve started a mutation off with the cells, and I was asking the researchers, you know, “What do you think I should do? Should I get it cut off, should I get it removed?” and I remember them being quite- well I suppose I thought it was unhelpful at the time, but they didn’t really say either way. And just kind of left it up to me about what I did with it. And yeah, I suppose that was them being neutral in their research but I remember sort of thinking-, feeling like I just wanted a bit more direction about whether it was okay or whether I should be concerned about it, and if it kept happening would something serious happen with it, mutating and sort of developing into a, into a cancerous mole.
Data sharing with other researchers
Some people we talked to remembered agreeing to their data being used by other researchers. Ian had been asked if he would be happy with his data being shared with international researchers, which he agreed to. But often people weren’t sure who these researchers or organisations were, or where in the world they might be based. Keith thought this was fine providing the data was being used by “reputable organisations”. Mr S agreed that “big organisations” could be trusted to keep the information private and confidential. Malcolm was comfortable with other researchers accessing his data providing it was anonymised.
Rafi remembered signing forms and consenting to data sharing, but he doesn’t have copies of the paperwork.
Rafi remembered signing forms and consenting to data sharing, but he doesn’t have copies of the paperwork.
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There was a consent form I think that we filled that in and we gave them consent that you can use this information for research and, you know, for these purposes, so they can share the limited information, you know, to third parties which is related to the healthcare.
No, they didn’t even give us them, the copies.
You know, what are we going to do with the information? But it obviously when it’s come back after a few years then you’re thinking, ‘Oh I should have the copy,’ but, you know.
A few people expressed concerns about not really knowing where their data might be shared. Gareth had read an information leaflet but thinks he overlooked a bit about being added to a database for future research. He felt the leaflet was written in a lot of medical language and he “didn’t feel qualified enough to understand it”. Lucy remembers photographs being taken of moles on her skin but doesn’t know whether these might have been shared at conferences or in papers, which makes her feel uneasy.
The researchers in Ian’s study were “very open” about the fact they did not precisely know how they would use or share blood samples, and he was happy with this. Not everyone felt this way though. Richard decided not to take part in a biobanking study because he felt it was unclear what the aims were and how the data might be used or shared in the future. He was concerned about “Big Brother collecting data” and linking up information from various sources, including his medical records, which he thought “may sound paranoid but it [data] can be misused”.
Gareth hadn’t realised his DNA screening data would be held in a database. Finding this out at a later date was “slightly surprising”.
Gareth hadn’t realised his DNA screening data would be held in a database. Finding this out at a later date was “slightly surprising”.
Age at interview: 49
Sex: Male
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And it was at that point, I hadn’t realised until up to that point when they talked about what I’d got myself into, that all my samples had gone off and they’d put me on to this national - they’d done a full DNA screening on my blood - and there was now this, it was now part of this growing DNA database that the group is maintaining. So that was interesting, and sort of it was slightly surprising. You think, “Oh, there’s this computer somewhere that knows more about me than I do”. But, yeah, that wasn’t off-putting towards the study.
Yes, I suspect it was in the information. Because the reason I took part in that one was really to get a free blood test and a bit of a, you know, check-up on the body and things like that. So I suspect I wasn’t rigorous enough in reading that one, because it was - and I haven’t been able to track the paperwork down since. It’s not surprising, I mean it was a couple of years ago and it’s around in the house somewhere. And then, yes, and when I went back for this trial, and they said one of the ways they select potential candidates for trials is to go, to use the DNA database because they can pick up specific genetic abnormalities or genetic traits that research groups want. So I did question them on that a bit because it, I wasn’t quite sure how they were sharing the data. But, you know, they were quite reassuring in that they don’t sell the data, and they don’t just free-issue the data. I think they mainly act as a service to find potential lists of candidates. And I think they would then, they would, if candidates, I’d be approached by the group that hold the DNA database rather than them just passing my details on. I don’t think I’ve given them consent to pass my details on to anybody else. I hope I haven’t [laughs]. But, you know, my expectations are, or my understanding is that they own the database and then they restrict, they’re, in fact they were quite clear they’re very restrictive on who can access the database. And although they’d use the database to generate potential genetic traits, they wouldn’t pass that information on. They’d approach the DNA owner, I think.
Luke thinks the idea of “informed consent” is questionable when it’s uncertain how your data may be used or shared in the future.
Luke thinks the idea of “informed consent” is questionable when it’s uncertain how your data may be used or shared in the future.
Age at interview: 35
Sex: Male
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Yes they did although I don’t think I truly understand and I don’t think I still really understand the consequences of long term or open ended consent, and I don’t think many people do. Because, and even I don’t think they do because they don’t know what their research group are going to do in the next ten years with the data that I’ve provided or anybody else has provided. And so it’s odd isn’t it that we talk about informed consent because we assume that, those can, you know, being consented are being told what they’re being consented to do because the person doing the work knows, whereas in this case I’m not sure that’s the case. I don’t think they do always know what the future holds for them in terms of research because part of it is to do with what they get funded to do. And also because it’s a bio resource, they are mandated to share that data with researchers around the world who have, you know, declared a legitimate need or desire that data for their work and they have no, they can’t tell what that research is going to be.
Well they can guarantee, you know, they do guarantee many things, they guarantee that they’re not going to be used for commercial purposes. They’re not gonna be used for, oh gosh I can’t quite remember what the limitations are, some of them I supposed would be quite standard. Anyhow I was quite satisfied that they weren’t going to abuse my data but they couldn’t specify what it is that they were going to use my data for so you get a sort of very broad parameter, or you agree to very broad parameters.
The involvement of commercial organisations using medical data was a tricky issue. Ian said his “data is not for sale” and Ronald didn’t like the thought of someone “making money off my data”, but both wanted their data to be used to ‘help’ others – which might include use by pharmaceutical companies. Ronald recognised that this might mean some companies are profiting, but felt this was okay providing it also helped patients. Linda was involved in both commercial and non-commercial medical studies and said “I don’t mind either way”.
In a study he is part of, Brian says the other researchers using the data must report their findings back to the original study team.
In a study he is part of, Brian says the other researchers using the data must report their findings back to the original study team.
Age at interview: 73
Sex: Male
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Yeah I think whatever information they’ve sent out on, you know, about research, what the info, the data the raw data...
Yeah.
…then the condition is that they get the information back that the research that they’ve found so it goes back to the [biobanking study] and again they share, it’s all sharing.
Sharing, right.
So you can’t take the information away and use it and hide it and keep the research, you have to bring it back to the [biobanking study]. So it’s a massive sharing, a bit like presumably what you’re doing here really...
Right.
…where it’s shared around the world.
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