Clinical trials & medical research (young people)

Making the decision to take part and giving assent and consent

A doctor, nurse, or other researcher should always give you information about what is involved to help you decide whether to take part in a clinical trial. If you are aged 16 years and older you cannot take part in a trial unless you have given your consent and signed a form to say you agree to take part.

Giving consent to take part in a trial made Hannah feel she was being responsible for her own health, but it is important to understand what you are signing for.

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Age at interview: 17

Sex: Female

Age at diagnosis: 4

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I decided then because I was above 16. So they said that was fine for me to decide if I wanted to do it or not. But then it was my parents’ decision if they wanted to fill it out or not. So it wasn’t necessary that they had to fill it out.

So you did sign your own consent?

Yes

Did your parents didn’t have to sign to say you could take part?

No, they just had to sign one for them, like just to say that they were happy for them to fill it out.

That’s good, because you’re over 16?

Yes.

…so that makes a difference?

Yes.

Does that, is that good do you think?

Yes, it was, it…

Do you think that was…?

Yes.It was, yes, it was good. Like feel like you’re responsible for doing something. Don’t have to ask your parents all the time. Because I d-, I go to clinic without my parents now, so I feel like a bit more independent. Like get the bus there and sort yourself out. Because when I went with my parents they tended to speak for me a little bit. So they’d kind of answer my questions. Whereas if I go on my own I can say exactly what I feel and what I want out of everything.

That’s good, isn’t it? That’s important?

Yes, a lot better. The doctors said that that would be better because they noticed that my dad kind of butts in when I’m trying to say something [laugh]. But that’s just the way my dad is.

Do you think taking part as well is because you know them there?

I think they feel that they were more able to come up to me because they can, I’m more approachable. Because they know me very well and I’ve been there a long time and they know that I’ll help anything that they need to do. But I think they, I think they still would ask anyone, even if they were just new diabetics. I don’t think that really had much of an impact. But they were just able to talk to me more about it.

So you were approachable?

Yes.

But did you; did sort of knowing them and being in a familiar hospital and knowing them make it easier for to say [yes]?

Yes, I felt more comfortable saying like, I could say what I think in front of them and they won’t take anything the wrong way. Or if I need to ask questions, e-, no matter how stupid it is, they’ll just answer it.

And do you think you know, in terms of asking questions, that’s an important part before signing anything, isn’t it?

Yes, you need to be able to understand what you’re signing for. Because a lot of people might not read it properly or they might look at it and said they’ve read, read it and they haven’t.

If you are under 16 years of age, you cannot give formal legal consent - this has to be given by a parent or guardian - but you should be involved in the decision as far as possible. In this case, you may be given an ‘assent’ form to sign.

Assent means children give their permission or agreement to take part in trials. To give assent children need to understand the research process and be informed about what they are expected to do. All children have the right to receive information given to them in a way that they can understand, and to consider assenting, or not (to say they agree to take part, or not). In deciding whether to give assent, children can express their views and any worries about taking part. Doctors need to listen to the opinions and wishes of children who are unable to give full consent, and do their best to help them. Consent from parents and assent from children are both needed for children under the age of 16 to take part in trials.

It's important young people of all ages are given the opportunity to give their consent to take part, or not, in a clinical trial, says Mohini.

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Age at interview: 12

Sex: Female

Age at diagnosis: 9

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My consultant discussed it with me, so he gave me like quite a while before my block and then like every time, we’d sort of discuss it every time I went to see him and then I think we just sort of came to the conclusion. And I think it was really good my parents, because my parents let me decide, they didn’t see it as it was their decision not mine. They realised that I was mature enough and it was my life I was playing with and that I should be able to make that decision.

Do you think that’s important as well?

Yes I mean parents as well as doctors have to understand that when a child gets a serious illness they’re not children anymore. They’re almost adults in the way they think and the way they do things. And they have to understand that it’s their lives that they’re playing with not their parents, not theirs but the child’s life and they have to be able to make the final call no matter what age. It should be their decision, if they’re old enough to understand then why should they not be allowed to make the decision. I agree with things like consent, a parent to consent but I think that children should also have to give consent as well.

Yes. I think in some study’s they do give assent.

I mean yes I think in most studies now they do assent, I think in mine I had to do assent as well but I think that should be in all trials because it’s not the parents life it’s the child’s at the end of the day.

It is important families understand how clinical care and research fit together. The process of consent and assent is an ongoing process and not just a one-off 'yes' at the start of the trial says Dr William van't Hoff.

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In clinical trials for adults, the adult gives consent to take part. But for children taking part in studies the situation is very different, because the consent is given by an adult parent or carer who is not themselves the person who is going to undergo the trial and the benefits and the risks. So the situation is different. And researchers need to explain that carefully to families to under- to ensure that they understand that. Of course parents and carers consent for their child’s care in general, and this process of consent is similar for research. But it’s important that they receive and understand carefully the written or other information that’s provided to them, so they’re clear which parts of the care are research and which parts are part of routine care. Older children who understand what is being suggested can also take part in the process of agreeing for research. We call this assent, and it’s a process whereby a child gives a positive response about taking part in research. And this concept of assent varies actually from different countries. Some countries don’t even recognise it. And the age at which assent is appropriate varies from country to country. But in general terms, assent is something, is a process that should be sought by a researcher in a child who has a, an understanding of the research process. It’s also important to recognise that this process of consent and assent is an ongoing process. It’s not just a one-off ‘yes’ at the time of signing a piece of paper. It’s ongoing through the study and can be withdrawn at any stage, and researchers will respect that.

Helena explains the age at which children can give assent and consent and what may happen when there is a difference of opinion between young people and their parents.

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Sex: Female

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At what age can, what age do children assent to take part?

For some studies information sheets produced from children from three which are three to five which are basically pictures. And if you’ve given information sheet there’s a lot of the sponsors who are running the studies like the children to give their assent. So they like them to say yes okay I’ll do this. It’s debatable at what age is appropriate and that’s something that varies from people to people and from researchers to researchers. But obviously fifteen year old knows their mind and as long as they’re given the right information you will always get assent from them but because it’s a clinical trial you wouldn’t be able to give consent you would still need to speak to the parents. And then if there’s a difference of opinion that’s something that needs to be discussed locally and decided on whether you’re going to put that patient in the study or not.

So sort of aged sixteen and over, under sixteen they still have to have, even if they agree, they’ve still got to have parental consent?

Yes, until the child's sixteenth birthday, if it’s a clinical trial of a drug, the clinical trials regulations state that parents give consent and if the child is aware enough about the study and are able to we would take assent from them, once they’ve been given all the information as well.

It is important that you have enough information to give informed consent, or assent, and an opportunity to ask as many questions as you like. You should also be given time to make a decision. (See ‘Being invited to take part in a clinical trial' information and questions’).The UK Clinical Research Collaboration booklet on ‘Understanding Clinical Trials’ has a checklist of questions you might like to ask. You can print off the pages which include space to jot down your own notes.

People have different preferences for how much information they want. To help you decide whether to agree to take part, the researcher should explain'

• The aim of the study – what it is trying to find out

• How you will be treated and what you will need to do

• What the possible risks and benefits are

Before making the decision to take part, most of the young people we talked to discussed the trial with their parents. Sometimes it was a joint decision. Sometimes young people discussed it with other family members and close friends too.

Discussing it with family and friends helped Lois make a decision to take part in a trial. She was particularly pleased that it was her decision to take part, or not, and she was given an assent form to sign.

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Age at interview: 14

Sex: Female

Age at diagnosis: 13

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Did you have to make the decision there and then or did you go away?

No we had like as long as you like and stuff and like it was my decision it wasn’t like my mum’s or dad’s it was like my own decision.

Right, was that, did you like that?

I liked that idea.

Did you, did that make, did you think that was important that you have a say?

Yes you have got to say because it’s you that it’s happening to really.

Yes that’s right. And did you discuss it with your mum?

Yes we discussed it and she was like are you sure you want to take part and I was like yes.

Okay and was that when you came home and looked at all the information yes?

Yes we read it through and stuff and everything.

Yes, and did you discuss it with any of your friends?

Yes and like family members too and stuff and they said yes it sounds good to do.

And did that help you make the decision?

Yes because it made it like it made me like want to do it like a little bit more really because it would help people as well like I know it would do.

Some young people we interviewed were in hospital when they were invited and were unsure about taking part because they had just been diagnosed or were feeling poorly.

Joanna was undecided about taking part in a trial so she discussed it with her mum and asked the doctors to explain it again.

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Age at interview: 17

Sex: Female

Age at diagnosis: 16

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Did you make the decision quite quickly?

No, they gave us time to think about it. Because there was this, I think they came to see me when I, my mum wasn’t there. Because she owns a café, so she was, was quite busy. But when she got there, talk about it, and as soon as my mum got there she said, “Do it.” Because I was a bit unsure about doing it. But then she was like, “Do it, because they will keep closer an eye on you.” And it is so rare, what I’ve got, that they won’t be able to find that many people to do it.

Why were you unsure at the time?

Just, it was, I don’t know. I didn’t, I didn’t really understand at first about it all because they just came in and started to talk to me about the trial and I was like, “Oh.” And then they explained it more. But once my mum got back, well, they explained it again and then I think I took it in a bit more and I understood then and thought it would be quite a good idea.

Knowing that other young people had taken part in the trial and being able to have the treatment at home rather than stay in hospital also influenced Stephanie's decision to take part in a trial.

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Age at interview: 18

Sex: Female

Age at diagnosis: 15

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So what was different about the trial?

Just that instead of going, you know, every couple of days like or staying at hospital even longer than I had been or going back every few days to have intravenous treatment, that I could take two pills twice a day at home. You know I could stay at home and have to be at hospital less. Which is, when you’ve been there for a couple of months is quite, quite tempting.

So that’s quite a big difference really, isn’t it? From having chemo and going in…

I think especially when you have chemo it’s really, you have to be a lot more careful. I mean even though it still has the same concept of kind of breaking down your immune system and building it back up from scratch, it’s, I think chemo, you’re much more susceptible to illnesses and viruses. And for a while you have to be in like a little containment, one of the rooms, those have got, they’ve got rooms at [hospital] which are for patients with like leukemia and HIV and things like that have, that are all very very clean and very well contained. And I had to stay in them one night. And I thought if I had to stay there for a bit longer I would be, go a bit crazy. It felt a bit like a prison cell.

So had the drug been trialed on, on other people before, or in your condition before?

They had a girl a few weeks before me who was, I think, a year younger than me, in my ward, who had been diagnosed with Wegener’s. And she went on the trial as well and she was having in a couple of weeks quite good success. Because, they, and they told me about it because it’s such an uncommon disease and the fact that two girls around the same age within a couple of weeks were both diagnosed was quite uncommon for them. So she went on the trial and she was she was doing quite well. So that kind of swayed me.

Once Stephanie had made the decision to take part she just wanted to get on with the treatment and didn't want to discuss it anymore.

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Age at interview: 18

Sex: Female

Age at diagnosis: 15

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Did you say you discussed it with your mum at the hospital? Could you come home and discuss it?

I wasn’t allowed home at that point. I was there for a month and a half in [hospital] and I’d been at the hospital near me for like three weeks. So I’d been home only like three, two times. So I wasn’t, I wasn’t allowed to come home and like kind of fully discuss it. But we talked a lot in the hospital. And my mum was allowed to like take me out and we’d go kind of like to eat and talk it over. But I think once I’d kind of, I kind of agreed to it quite quickly, I was swayed very quickly, and then I was just like, “Yes” and I didn’t want to talk about it anymore. I tend to not talk about any of it at all. I kind of just get on with it and its part of my, my life and my day-to-day routine. And I think that’s how it is for most people with a long-term diseases is that, you know, if you relapse you relapse and it happens and there’s nothing you can do about it. So I mean if you dwell over it too much it does get quite tedious.

In all cases, and however little time is available to make a decision, there should never be any pressure on you to take part in a trial. Most young people we talked to recalled being told it was their decision, and most remembered being given plenty of information and explanation about the trial without probing them for a decision. Sometimes young people had a feeling that health professionals were really hoping they would say yes, even if they did not say so.

Alexander feels it really matters how health professionals communicate to young people at a time when they are feeling vulnerable.

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Age at interview: 18

Sex: Male

Age at diagnosis: 16

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And, so what, your motivation for, or the reasons for taking part, what were they?

Just to get some more like normal stabilising ability or anything, just to be a bit more normal, a bit more active. You know, what, as I said earlier, I needed help to do everything from cutting food to going to the loo. I didn’t have a life. It was just being here. So I didn’t, I was getting quite depressed not doing anything. So it was just kind of, “Yes, okay, we’ll do this and hope for the best.” So, yes, that was kind of my main point. Even if it made me 10 per cent better, I would be happier, I could be a bit more normal. Even if it made me better one day out of a month to a year, I don’t care, as long as it was something I can be looking forward to.

So it was kind of quite a low really?

Yes, it was probably one of the lowest points I’ve ever been, to decide, “Okay, what do I want to do here? Drug, no drug? What’s going to happen?” really.

So that was a key decision then really? It’s quite a big decision, isn’t it?

Yes, it was quite a long thought, well, it wasn’t really long because there was a few hours to really think about this, “Am I going to do it? Am I not?” So it was that kind of week where you thought, “Okay, if I do get all these, am I going to do it? Am I not? What’s the plan?”

And did you feel that you had to make a decision there and then?

They didn’t really leave me much option really. I’m not sure if they just wanted me, to get me better or they wanted to get me on this trial as quickly as possible. So it was, felt like a very pushed-in thing at the time. But it may have been for the better, it may have been for the worse. It’s still not known.

And did you have to sign anything to say…?

I signed hundreds of bits of paper just to say I’m quite happy to take this drug. So it’s, I still do this to this day. It’s still lots of paperwork. I have to say, “Yes, I’m happy to do this. I’m not happy to do this.” However because I was, did this when I was [under] age, my mum still has a lot more paperwork than I actually have to do still. So it’s constantly ongoing. If they find something new about the drug I have to sign a new consent form. When I first went on to the drug I had to sign a consent form. Each part of the trial, trial I have to go on to a, I have to sign something else and I have to learn more information.

Taking part in a trial can help you to feel better about your condition, as well as helping others. Lauren was pleased to have time to make a decision and not feel rushed.

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Age at interview: 16

Sex: Female

Age at diagnosis: 13

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So you kind of made the decision. Did you make it quite quickly?

I had, I thought about it, but I thought about it for a couple of days and then I decided that I wanted to do it. And I wanted to do this trial because it was the first trial that I’d ever done including, for diabetes. And to me, I felt like because I didn’t have a good time to begin with doing it, I wanted to help other people. And if this was one way that I could help them in the future, I wanted to do that.

Do you think that was your key motivation for taking part?

Yes.

Helping others? Was there some personal benefit as well, do you think?

I wouldn’t, I don’t know at the moment. I’m halfway through the trial, but the only thing it seems to be doing is hurting more. So not really.

But at the time when you were making the decision, did you think, “It might help me”?

Yes, yes, I thought that would help me. And I also thought that if I did the trial I might feel better about myself and better about having this illness, kind of disease kind of thing. I didn’t like it.

And did, you know, those things were going through your mind and you made your mind up. But did you ask questions at the time, after reading, and before making that decision?

I didn’t actually. I just thought, “I want to do it. I’m just going to do it blindfolded.” So I went in. Plus I couldn’t actually think of any questions. So it was just a, more of a case of, “Yes. Give me the information. If I have any questions, I’ll ask.” But I didn’t, I didn’t really because they more or less covered everything. And I just thought, “Do you know? I really want to do this. And I’ll do it no matter what” to be honest. When I get stuck in to something, I’ll do it.

You just, but did you like having that time to make that decision?

Yes, I did like not being rushed. And then obviously all the way through they’ve always said, “If you want to take, like go out of the trial, you can.” But I like the idea of staying in it for the; for the year, just to see what happens at the end really.

Clinical trials are done because there is a possibility that a new treatment will be better than an existing treatment. It may have already been shown to work for other conditions or other groups of patients. However, trials are just as likely to find that new treatments are worse than existing treatments. Patients who desperately want to get better may interpret doctors’ words in a way doctors do not mean, or, ‘read between the lines’. This underlines the importance of staff being very careful about what they say, and how they say it.

Young people may feel that there are benefits from participating, such as extra monitoring and appointments, or a feeling of helping others. However, it is important to make your decision based on unbiased information about the trial.

Taking part in the trial meant Kay would be closely monitored and any health problems could be picked up and dealt with quickly, but it may mean extra hospital appointments.

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Age at interview: 23

Sex: Female

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I suppose they can be quite time consuming, if you don’t fit it in with your normal routine. I managed to fit mine in with my routine quite well and it was actually saved me time rather than anything else. But I suppose it depends what you sign up for, it depends what kind of medication you’re going on, or what kind of research you’re taking part in. And I actually quite liked being part of the study because it meant that I was kept, my lung function was kept an eye on quite closely and the bugs I was culturing were kept an eye on quite closely. And it means that if anything was picked up I could start on a new medication that would treat it so it was actually quite nice. So I was getting kind of really really, well I don’t know everything was kept an eye on quite closely and it meant that I could either change my physiotherapy regime like to increase it so that my chest would be better, or I could do more exercise, or the doctor could prescribe an antibiotic if I was culturing a certain bug. So I thought it was quite, I found it quite nice. But some people I don’t know, I’m quite conscientious with my CF and I like to do as much as I can, whereas other people might not.

Yeah.

So they might find it a bit annoying having appointments because of the trial and things but I quite liked it because it meant that I could.

So in a way you were getting closer treatment, closer, they were keeping a closer eye on you.

Yeah, yeah.

That kind of gave you a nice feeling?

Well it just meant that if my lung function was dropping it could be the problem could be looked at straight away rather than maybe leaving it a month and then think, feeling really really ill. So if I felt ill they could treat me straight away rather than maybe leaving it a month or so, and obviously prophylactic treatments are the way forwards so.

Trusting health professionals was also something young people talked about.

Trust in the health professionals was important to Kay when making the decision to take part (or not) in a clinical trial.

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Age at interview: 23

Sex: Female

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CF care is quite a different to kind of other care and you; you do go for quite a lot of appointments in comparison to other conditions. You do have in-patient stays for a few weeks. You do, it kind of, you do trust them because there are so many different things that you go through with like I’ve been attending a CF clinic since, well since I was born. One was when I was in Paediatrics and I moved over to Adult Care at nineteen and I’ve been in that clinic for four years now. And I could go once a month, so you know and it’s quite, it’s quite a regular kind of contact with them. So I suppose you do, you have to trust them because they are making medical decisions on behalf of you sometimes. Obviously you have a say but I suppose you do put your trust in someone medical sometimes because you, well you have to.

In Robert's view when you are approached to take part in a trial by a doctor or nurse that you know, it can make the decision to take part (or not) easier.

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Sex: Male

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Yes well with, so with the trials where it’s been with doctors I already know then obviously that’s been much easier because I know that they’ve looked after me before and that everything’s been fine. So I know I can trust them. But yes I guess with the other ones you just have to, I think it depends on how involved the trial is. So like this one that took my breath was a man I’d never met before and was, you know, all I know is my breath has been taken away and frozen somewhere [laughter] so, but then I have to think well it’s just a sample of my breath. Whereas, you know, if that man had wanted to approach me for the gene therapy one I might had, because that’s had much greater involvement I might have thought more about it whereas when you’re approached for an involved trial by someone you know and that yes I think that makes it easier.

Last reviewed March 2017.