Cohort Studies
Being asked or volunteering to take part in cohort studies
Apart from those who had started the study when they were babies or young children, most of the people we interviewed could remember being invited or volunteering to join their cohort studies but they could not always remember the details about the information given or the consent process. For some, this was because they enrolled in a study a long time ago. Sometimes the experience of being invited and agreeing to take part was not very memorable. As Anthony said, “They may have explained but a lot of these things don’t stick in your mind, you know, I can remember the more important things in life, but… [laughs]”.
Those who started a study when they were babies or young children hadn’t been involved in making the decision to enrol. Instead, this decision was made by their parents. Some thought that the researchers had probably asked their permission again at a later date and as they got older, but often they couldn’t remember this happening for certain. A number of people we talked to only became aware that there were/are part of a birth cohort study when they were contacted by researchers many decades later. As Derek explained, “Prior to that, I wasn’t aware I was part of any study at all”.
Keith received a letter about a renal (kidney) study via his GP. He met with the researcher to discuss it and to sign some forms.
Keith received a letter about a renal (kidney) study via his GP. He met with the researcher to discuss it and to sign some forms.
I did via the GP asking if I wanted to volunteer. I did volunteer and that’s a smaller-scale operation than the [biobanking study] and initially I went for a meeting with a researcher who was doing the research on [renal cohort study], lasted about an hour, again lots of information and lots of forms to sign giving my permission for the use of the data and then I suppose the interview took an hour and had a series of tests, blood tests, urine tests heart, heartbeat pulse rate and a series of questions, quite a lot of questions about how I was affected by only having one working kidney.
Anne can’t remember joining a birth cohort study, and it was many years later that she received some information in the post from the researchers.
Anne can’t remember joining a birth cohort study, and it was many years later that she received some information in the post from the researchers.
I’m sorry, but I don’t, I don’t really remember the initial kind of joining or, or being part of it until I was a young adult when I started to have my own address and they kept, I somehow got information from them through the post to say I was part of the cohort. So really it’s been purely something that I’ve just re-registered over the years to let them keep up to date with where I am and agree to continue, you know, agreeing to their requests to continue to use any of my medical data and so on.
Being invited or volunteering to join a study
Of the people we interviewed who could remember being asked to join a cohort study, there were different ways that they were first approached. Sometimes people were invited through their GP medical practice, either by letter or in person or they had seen an advert in the practice and had volunteered. Other times, people were asked in hospital when they were attending an appointment or as an inpatient after being diagnosed with a medical condition. John was invited to join a research study about transient ischaemic attack (TIA – ‘mini stroke’) and stroke whilst he was in hospital, and he “was delighted to do so”. Sometimes people had seen an advert, poster or leaflet looking for volunteers, which they had responded to. Luke saw a television programme which mentioned a twins study and he contacted the researchers to ask about joining.
James was invited to a study through his GP after having a transient ischaemic attack (TIA). He agreed because it helped give him quicker access to a specialist clinic and team of professionals.
James was invited to a study through his GP after having a transient ischaemic attack (TIA). He agreed because it helped give him quicker access to a specialist clinic and team of professionals.
Anyway, she sits down, sits me down and asks me what my symptoms are. I said, “I just felt dizzy and I felt that someone had knocked me over. If I had been in a crowd, I would have thought someone had done that, knocked me over.” I’d only got halfway through the symptoms and she’s reaching for the phone and I thought, ‘This isn’t good.’ So, she got onto the [cohort study name], you know, at the hospital and discussed something with them and she said “Would I like to take part in the study because what I’d had was a TIA?” you know, what one of these are?
Yes, yep.
I said, I don’t know anything about it but what are the options I said if I have to wait for NHS, how long before I get an appointment?” She said, “Oh, four to six weeks?” I said, “What happens if I volunteer for the study?” She said, “Ten o’clock tomorrow morning.” Enough said.
Elaine received a letter in the post to invite her to join a cohort study. She was already involved in medical research and the timings didn’t work out.
Elaine received a letter in the post to invite her to join a cohort study. She was already involved in medical research and the timings didn’t work out.
Well, I just, again, a letter came through but it had a fixed appointment on it and I think I was, I already had an appointment to go up and do the diabetic studies and it didn’t fit in with what was going on at the time, and so I didn’t take part. But I know that was more of a national thing.
I think you said earlier that you thought you were already doing enough, in a way.
Yeah, well, that’s- I think that’s sort of the wrong, the wrong word, because I would never say, you can never do enough, can you, really? But I think at the time there was enough going on, you know. Maybe if it had come at a different time and it was a day that I, you know, I didn’t have to change the times or- I think the times that they had written down just didn’t fit in with what was going on at that time and therefore I decided just to leave it.
Others did not know or could not remember how they were invited to join their study. Emily has taken part in a few medical studies and couldn’t recall how she was first invited or volunteered for each. Some people, like Gill, were already involved in another medical research study or had indicated they would be interested in future research, and they thought this might be why they were invited to join a cohort study. There are strict rules about how personal data can be shared, meaning it was unlikely, but Gareth wondered if the research team contacted him because he was a regular blood donor and “I don’t know whether they share lists”.
Salma enrolled herself and her unborn child into a cohort study after she was approached by a member of the research team whilst waiting in hospital for a test.
Salma enrolled herself and her unborn child into a cohort study after she was approached by a member of the research team whilst waiting in hospital for a test.
When I was expecting with my first, when I had the glucose intolerance test it’s a long window that you have to wait for. First they check your sugar levels then you wait, they have, you have a drink and then you wait for two hours or so. So I was approached at that time when I was waiting and it was something that caught my eye. It was interesting, that’s good it’s not gonna just help me but it will help the wider community and others, so I said I’m interested and since then I was recruited as a parent in 2008/9.
Alan Y was approached about taking part in a cohort study whilst recovering from a transient ischaemic attack (TIA) in hospital.
Alan Y was approached about taking part in a cohort study whilst recovering from a transient ischaemic attack (TIA) in hospital.
The long term study, okay, so I ended up in hospital in [hospital], after something happened, an event happened and I ended up, I was in a bed hooked up to lots of tubes and wires and monitor things and doctor came around, the doctor who was looking after me and asked me, “If I would be interested in being part of the long term study?” and I said, ‘Long term?” and I asked the question, “A long term study of what? And she said, at that time, “We think it’s a TIA.” “What’s a TIA?” So I asked, asked all the questions and I said, “Yes,” to being part of the study because I thought if I can help other people and find out why I had the TIA because I was fit, I’d, I don’t really drink a lot. I don’t smoke. I’m very active and why was I, all of a sudden, on this bed hooked up to all the wires? So, she asked me, it was probably the first day I was in, towards the end of that first day in hospital after the event.
Getting information and asking questions about the study
Although the details were hazy, most people we talked with were sure they had received adequate information about the study before or at the time that they were asked to join. There was usually some written information, such as a leaflet that arrived in the post or was handed out by a healthcare professional. Some people, like Mr S and Alan Y, had met a member of the research team or spoken to them on the phone to find out more about the research and what would be involved in taking part.
Most people were happy with the information they had received about the study early on. Nadera felt the written information was “very simple which is a good thing”. Some found the language was too medical, but this varied between studies and for different individuals. Sometimes study leaflets were available in languages other than English, or there were research staff and translators who could speak other languages. This wasn’t always the case though, and Iram would have preferred information about the study to be available in Pashto. A few people felt the information they were given was too vague – either it hadn’t been explained clearly and in way they could understand, or because they felt the researchers were unsure at that stage how the data would be used. Malcolm recognised that not everyone wants lots of detail and “it all very much depends on the individual”.
Compared to the “awful” paperwork for brain donation, Roland found the information leaflet about a biomarker study “easy to understand”.
Compared to the “awful” paperwork for brain donation, Roland found the information leaflet about a biomarker study “easy to understand”.
I have donated my brain to a brain bank in [county]. That’s- was surprisingly quite difficult to manage. Apparently, it is useful, or will be useful, for my brain to be donated, but the - just to be a bit negative - the paperwork involved was awful. And it was written in, well, by - let’s be rude – by, if you like, a PhD student who put everything in medical terms, and I didn’t have a clue as to what many of the questions meant. And I took it along to my consultant neurologist, and he took one look and he couldn’t understand it either. Anyway we got a simplified form out of that and…
And that contrasts with your experience of the [biomarker study] study?
Oh indeed, yes, and any other study I’ve taken part in. They’ve always been straightforward and easy to understand, and I mean this isn’t a research project and it’s just a matter of me donating my brain, but it’s speaking the obvious to say that if you can’t fill the form in, then what use is donating your brain? Well, you’ve got to make life easy for people.
For Emily, the interesting part of the information leaflet is about the purpose of the study. The other paperwork is “all the standard stuff”.
For Emily, the interesting part of the information leaflet is about the purpose of the study. The other paperwork is “all the standard stuff”.
Yeah the information about the study’s interesting, the rest of the bumf you have to fill in is all the standard stuff that says usually that we will anonymise and then I’m usually skipping to see what feedback they’ll give me and how long the study will go on and whether there’s any drugs involved or anything like that.
Speaking to a member of the research team was often welcomed as an opportunity to ask questions. Gareth felt the written information was quite medical and “I didn’t feel it was enough for me to make the decision on my own”. He was “fortunate” to have some relatives who had worked in medical research and asked them for their advice when deciding whether to take part. He took these questions to his first meeting with the researchers. For Alan Y, “The most important thing was this part of the question-and-answer and being able to actually talk to someone, rather than read it”. However, Linda cautioned that not everyone would feel confident asking questions. She said some people “might feel intimidated and don’t want to ask because… of embarrassment or feeling inadequate or silly”.
Alan Y doesn’t remember a lot about the information he initially received but recalls that it was helpful to discuss with a member of the research team in person soon afterwards.
Alan Y doesn’t remember a lot about the information he initially received but recalls that it was helpful to discuss with a member of the research team in person soon afterwards.
It must have been understandable in some way and I think because there was a, the follow-up was quite soon and I was able to talk to that same doctor again and ask the questions and it was almost as we’re doing here. The interviewer asking, “Do you understand this?” “Well, I don’t. Tell me more.” So that was really important, the follow up with, it wasn’t a long time, so the first follow up might have been two weeks after I’d had the event.
Malcolm received a letter about a study and then went to talk to a researcher with a medical background.
Malcolm received a letter about a study and then went to talk to a researcher with a medical background.
Yes, it was a lot of detail so I haven’t retained, I haven’t retained all of it or very much of it in fact, a lot of detail about how the links work and how the heart works and how the links between heart valves and, and what happens in the body with- with the heart to cause maybe dementia or to maybe bring on dementia. So yes it was very thoroughly explained to me and I understood it at the time.
Was it explained on, on a leaflet or by, by research nurse or doctor?
By the consultant who was doing it, I presume he was a consultant he didn’t actually tell me what his job was but I think he’d been involved in, in, in the hospital cardio, cardiac department of the hospital. He was part of, I don’t know if he was a surgeon or if he was a consultant or if he’s a GP but he’s certainly a, I think he was a doctor.
Salma was given a leaflet and spoke with a research nurse about a study. She felt comfortable asking questions and the researchers are “a very friendly team”.
Salma was given a leaflet and spoke with a research nurse about a study. She felt comfortable asking questions and the researchers are “a very friendly team”.
Yes. Yes, they explained it to you and basically this is what we’re trying to do, they verbally explain it and then they give you the form so you can read the forms, if you have questions you can ask them.
Okay.
And then once you’re satisfied then like filling this form out I asked, you know, this is what I need to do, why they’re asking these questions so if I have concern about something I’ll ask them and they’re, you know, willing to answer it as opposed to saying, you know, why are you questioning this.
Okay.
They’re a very friendly team.
They explain to you what they, what their goal is, what they’re trying to achieve. So if you’re alright with it, you know, you can sign up if you’re not alright with it you can have the right to say I refuse to participate in this study, so it’s your choice nothing is done by force or without your consent.
Completing paperwork and giving consent
Some people could remember completing some paperwork when they joined a cohort study. Keith said, “The decision was made instantly,” to take part and he signed some forms to enrol in the study when he met with a researcher. Mr S and his wife were approached by research staff whilst waiting for an appointment and so “we had the time” to complete the paperwork. Malcolm couldn’t remember exactly what had been on the form when he agreed to take part in a study but thought there would have been topics like data sharing as “one of the questions in the tick boxes”.
A few people who had been in a birth cohort study for many decades, like Teresa and Linda, thought that the process of giving consent was different when their parents were asked to enrol them. As Linda said, “I dare say my parents got a consent form”. Isobel thought that many decades ago, “there never would have been a discussion with the children, the discussion would have been with the teachers and your parents”. She wasn’t sure if her parents were even asked their permission and thought maybe it had been a school decision. Teresa agreed that the approach now was different and felt that it could be excessive: “That’s of the time really isn’t it, I mean it’s only now when it’s become a little bit ponderous where it’s checked and checked and checked”.
Barbara’s parents agreed for her to take part in a birth cohort study. She thinks their willingness to enrol her was reflective of the attitude towards research at that time.
Barbara’s parents agreed for her to take part in a birth cohort study. She thinks their willingness to enrol her was reflective of the attitude towards research at that time.
I think really it was always very much, you know, this is something that you’re doing and it’s not a moral duty but I think I always understood that it was something that was important. You know, it was all stressed the importance of participating in these studies and of course in those days if you got, if our parents, you know, got a request or something, you know, you did it, you did it. There was no question about, you know, ‘I’m not going to do it, what’s in it for me?’ It started at a time when I think people felt an obligation really if the government or anybody had asked them to participate in a survey.
That’s a really interesting point actually.
Yeah because I’m sure these days, I mean certainly from my own work in research a different sort of research it’s quite difficult to get people to participate in anything, what with data protection and certainly I’m sure that parents, you know, with young children would probably find some excuse for not doing it.
For some of the people we interviewed who were babies or children when they first took part in a cohort study, there was a point later on when they were asked by the researchers whether they still wanted to take part and to ‘re-consent’. A few people felt their continued participation in the research was an unspoken way of them re-consenting – they felt that if someone didn’t want to continue anymore, they could simply stop responding to the researchers.
Luke felt that giving “long-term or opened ended consent” in a study like his was quite complicated. He pointed out that the researchers themselves don’t know how they might use his data in future years, and so he questioned how it was possible to give ‘informed consent’. He also highlighted that although his twin brother agreed to enrol, it was as “a favour” to Luke and there can be “asymmetries between the pairs” in terms of keenness to take part and complete the research activities in twins studies.
As an adult, Barbara thinks that each time she chooses to return a questionnaire or arrange a visit is a kind of ‘re-consenting’ to the research.
As an adult, Barbara thinks that each time she chooses to return a questionnaire or arrange a visit is a kind of ‘re-consenting’ to the research.
But there was a point in my life for all the participants where, you know, when you became your own person, no longer a child you did have the option of saying no I’m not interested I mean, I think that’s, I think, you know, that’s the point where you, I suppose quite a lot of people may have dropped out because they said, “I don’t want to do this anymore, why am I doing this?” So I suppose effectively after the age of 18 was when I sort of started to participate in my own right.
And what do you remember about that? Was it a particular form that came where you were asked to re-consent or?
No I think, I suspect that there’s probably at every stage they probably have a bit of a drop out. Obviously the number of participants isn’t going to increase but people I suspect do drop out because they move, you know, if you move to Australia it’s a bit more difficult to sort of, you know, to participate, or of course some people die. I mean it’s as simple as that. So I think, you know, it’s a conscious effort, effort’s the wrong word, it’s a conscious decision to continue.
Each time?
Each time, yes.
Brian can’t remember a re-consenting process in his birth cohort study and doesn’t think it was particularly necessary because he “was involved already” and “never thought of not doing it”.
Brian can’t remember a re-consenting process in his birth cohort study and doesn’t think it was particularly necessary because he “was involved already” and “never thought of not doing it”.
And, right just thinking about the consenting process which we’re so focussed on nowadays. Obviously you didn’t get to consent?
No [laughter] not at all I just found, I arrived [laughter] obviously my parents did as far as I remember they were very happy to help out so I think it was totally random, you know, they just, there were six babies in the bed and in the ward and they just choose three of them, you know, I think it was half, that’s how they did it, it was pretty simple. I suppose if you didn’t want to do it then you, you know, they found somebody else to do it but that’s what they were looking for about half of the people, those children born at that time.
Yeah. And when you became an adult yourself…
Yeah.
…was there a sort of re-consenting process?
I can’t remember one, I can’t remember one but there probably was but I probably didn’t realise, you know, they were just probably on the form that, you know, that you are happy to give this information, you know, and I always was. I never, I never thought of not doing it to be honest.
Yes.
It seems a good, good thing to do, so yeah, so I didn’t have to worry about consenting, I was involved already.
Sometimes people had kept paperwork about the studies they were part of, but often this paperwork had been thrown out or lost. Sometimes this was a major concern, as for Lucy who felt frustrated by her lack of knowledge about the study she had been in. Iram and Rafi weren’t given copies of their paperwork; at the time, they didn’t mind but “after a few years, you’re thinking ‘Oh I should have the copy’”. Others were not concerned. Some people, like Jade, had looked online and found information about the study and study team, including contact details if they wanted more information.
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