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.

o 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.

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.

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.

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.

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.

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.

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.

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, Ye
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.

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.

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 m?

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 wha 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.

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.

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.

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.