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Clinical trials: Parents’ experiences

Information parents receive when invited to enrol their child

A doctor, nurse, or other researcher should always seek your consent before enrolling your child in a clinical trial. They cannot enter your child in a trial if you do not give your consent. It is important that you have enough information to give informed consent and an opportunity to ask as many questions as you like. You should also be given time to make a decision. 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.
 
Parents may have different preferences for how much information they want. To help you decide whether to enrol your child, the researcher should explain:
  • The aim of the study – what uncertainties it is addressing and 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
You will also be given an information leaflet or ‘participant information sheet’ which you can take away and read. If you decide to enrol your child, you will be asked to sign a consent form to say you agree to your child taking part. (If English is not your first language, the trial should be explained to you in your preferred language and you should be given a consent form in that language.) (See also ‘Involving children in decisions’)
 

Helena, a senior research nurse, explains what information parents might expect to receive and...

Helena, a senior research nurse, explains what information parents might expect to receive and...

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 And what type of information perhaps would parents expect to receive?

 
Parents expect different things for different studies and different types of parents. But obviously there’s legislation guidance out there so there is certain information that we have to give. And we’ve got to give written and verbal information if possible, which can be an issue sometimes for people who can’t read or their first language isn’t English. But we tend to give some verbal information, we produce posters if we can produce posters to tell people about the study and that’s how quite a lot of people do get in contact with us. If they’ve seen posters in the lift or in sports centres, there’s lots of ways of getting, highlighting research to families out there. And then once they make first contact with us we would then send out information sheets, so written information and make contact and discuss with them and invite them to come for a visit and potentially give written consent if that’s what they want to do.
 
And what do you do when maybe as you said it isn’t their first language?
 
It depends really, for some studies the patient information leaflets are translated into different languages. But for example here in [hospital], I can’t remember the number, but I think there’s something like 150 different written and spoken languages. So which language do you choose is always the question? For diseases and studies where it, certain languages are spoken, or for certain ethnic minorities you could sort of pick one or two. And for some of the bigger commercial sponsors, so drug companies, they would if you had a potential patient who spoke a certain language they would pay for that information to be translated but it is quite an expensive thing to do. And apparently they, it has to be back translated so the information sheet has to go to translation services to translate it and then send it on to somebody else who back translates it and it has to be identical. And then the ethics committee obviously don’t necessarily speak the language so they give approval on a sort of certificate of approval. We would try and use, always try and use translation services within the hospital link workers which most hospitals have. But it’s generally not appropriate to get a family member to translate because we can’t, not that we don’t believe them, but we can’t be sure of what they’ve actually told them and that they’ve covered all the key points unless we understand that language ourselves. So generally we wouldn’t take family members translating for us, we would chose to pay for a translator within the trust.
 
Most parents we talked to felt they had been given very good, clear explanations and were able to make informed choices. On occasion a research nurse would visit parents and children at their home to provide more detailed information and answer any questions. When it was appropriate the nurse would demonstrate what was involved, for example, the use of Emla cream (a local anaesthetic) when blood samples were required. Nikki and Chris were invited to take part in a screening study for children with asthma who also take inhaled corticosteroids. It was a difficult time for them as their daughter was very poorly. They were pleased to have written information and the explanations from the doctors and nurses.
 

Nikki and Chris were very pleased with the information and support from the research nurse before...

Nikki and Chris were very pleased with the information and support from the research nurse before...

Age at interview: 38
Sex: Male
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 Nikki' We had something, something to read and we also had, as I say, the nurse phoned us and went through everything. And then when she realised that we, we were going to go for it, she came out. She came out twice, didn’t she? The first time she came out and it was, it was just to show Sarah. She got all of the things out, you know, the boxes that we were going to use, the cotton wool, the Emla, all of that. She got it out and sat down on the floor with her and went through everything, and then chatted with us and explained what the trial was about and how important it was that they did this. Because it meant that hopefully in the future they wouldn’t have to do blood tests on children. They could just rely on this, on the chewing of the cotton wool.

 
Chris' Saliva test.
 
Nikki' Which obviously, you know, would if, if it would have been able to be done for us, was, was great. So, as I say, we, we were all for it. And then she, she came out again the day before we started the trial to make sure that we were happy, went through everything that we had to do. You know, explained to us about, you know, “As soon as she gets up she’s to chew the cotton wool.” And Sarah was involved. It was, “Then, then you put it in the bag. Then put it in the freezer and keep it safe for me. And bring it back in on the third day.” And, and she also worked out what would be the, the best time for us starting it, you know, with having other children and things. We had to make sure that, you know, we could get to the hospital when we needed to, which was on that third day. So she helped us to work out when to, when’s best to start it. And she really did go through everything with us.
 
Nikki' She did and she was very down to earth. You know, she just came in, got on the floor and was like, “Right” you know. And that’s what you want, that’s what kids want. They don’t want somebody white coat sat there that they feel they can’t talk to. You know, Sarah asked her questions and felt like she could. Which, which has, you know, helped her because she, she knew, and if she had any questions we’d say, “Well, we’ll phone the, the nurse” you know. Because she knew her first name, that’s what, you know, “We’ll, we’ll phone her and put your mind at rest” or say, you know, “She’s coming out today to see you.” And so she felt a bit special, that somebody’s coming to see her and it’s her special nurse.
 
Chris' No, I think it; I don’t think we read anything that left us bemused.
 
Nikki' No, it was very well explained.
 
Chris' We understood the basis of what it was. And we did, I mean it very much was oral explanation alongside the written word.
 
Nikki' Yes, because the nurse, came in with us to the, the consultant visit and, and she went through everything with us and then, as I say, she phoned us and she left us the literature and said, you know, “I’ll phone in, in a couple of days” and went through it again. So it’s, it’s, so the only thing that, that, that put us off, because we were quite open to do anything like that, was Sarah’s reaction, which –
 
Chris' I can honestly say I don’t think there was any pressurisation or –
 
Nikki' No, it, when we –
 
Chris' It was very, “We’ll leave the papers with you. I’ll phone in a few days and if you’re interested we’ll carry on.”
Several people commented on how much they valued being able to talk face-to-face to a member of the research team and ask as many questions as they liked. This helped them build trust with the staff.
 
Linda’s daughter was born with a serious heart condition and was invited to take part in a randomised placebo controlled drug trial. Linda was happy to take part after having read the information and had received very clear and detailed explanations of what was involved from the nurse.
 

The nurse explained everything, even about the practicalities of parking, how long she would have...

The nurse explained everything, even about the practicalities of parking, how long she would have...

Age at interview: 43
Sex: Female
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 They did yes, very thoroughly I think I met with the research nurse for probably a good hour before I even saw the doctor and she explained everything very simplistically, you know. She was very clear about what was going to happen and how it would happen and even practicalities like, you know, parking and where I should park and remembering to zero my car so that they could pay me mileage for the, you know, very simple things and about the blood taking and things so.

 
What was involved for your daughter and you? [Yes.] Because you mentioned about having to travel?
 
Yes and the waiting you know and explaining about I would have to wait an hour but also being clear about why I would have to wait an hour to make sure that she didn’t have a reaction to the medication that they were giving her so.
 
I don’t remember them mentioning I think it was on the sheet they sort of sent us. There weren’t any that sort of flagged up red, you know, sort of where I went oh, you know, so but they certainly would have, I mean I would have remembered if they hadn’t because I would have sort of thought wait a minute all drugs have got side effects.
 
Some parents who took part in a vaccine trial received information via an email attachment or a letter in the post. However, the information was just as detailed and there were always contact numbers to ring for further information and questions.
 

Even though Ruth declined to enrol her son in a swine flu vaccine trial, she was satisfied with...

Even though Ruth declined to enrol her son in a swine flu vaccine trial, she was satisfied with...

Age at interview: 38
Sex: Female
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 It was an e-mail, it was an e-mail with various attachments of information which laid out first of all was; were you going to be eligible? So it was a sort of little quick questionnaire to see whether you’d be eligible, if you fitted the certain criteria and I think from memory the criteria were they had to be under three they had to have no underlying medical conditions that oh I can’t remember any of the others those are the only two I can remember off the information. But he did fit all of the criteria’s so I then went on to read all the rest of the information and it said it gave details about what the trial, what the trial was so the fact that they were testing two types of vaccine. So it wasn’t going to be something like a placebo trial you were going to get an active vaccine but it was either one vaccine or the other vaccine and then they were going to test the results between which one was more effective. And they gave information about what you would have to do, how many visits you would have to go and that, you know. You had to go over it was quite a few visits I think it was like six in all and various blood tests that they would take to measure the progress of the vaccine in, in George’s bloodstream to check whether it was effective or not effective. So yes I did feel that actually the information they gave was very thorough, I didn’t, you know, from that point of view as far as what bare bones of the trial was going to be and what it would involve I felt that that was fine and then very clearly at the bottom they had contact details for you to get in contact with them for further information and if you had any queries or questions. 

 
I suppose my only slight query would be that George was premature so I didn’t know whether or not they felt that might have been a risk factor. Actually he’s been perfectly healthy I mean he was a bit on the small side to start with but you know, he is perfectly healthy so I’d sort of discounted that in my mind but I thought well, you know, if I take it any further then obviously I’ll mention that to them to see whether or not I would still be eligible. 
 
So I did have a thorough look through the information that came through, they gave, or with the e-mail there was lots of attachments with the protocol and whether there were going to be, whether you’d be suitable, whether, you know, you could, you would match the criteria and all of that. And it looked like I matched all the criteria. I was interested in it.
 
 

It was explained to Tina that the vaccine had already been trialled in Europe and that they were...

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It was explained to Tina that the vaccine had already been trialled in Europe and that they were...

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 Okay, well I saw an advert in the Oxford Mail looking for volunteers, children aged between two and twelve to take part in the swine flu vaccine trial. I spoke to my two youngest children who were keen on knowing more about it. So we followed, we rang the, checked the website, rang the number. They got booked into the first session which I think was late on a Saturday afternoon, so pretty convenient. It was very good timing, it fitted with our other stuff. We came along to the [hospital] which my son knows quite well from various accidents and other medical events. And they told us to expect to be there for about two hours. We got there did not have to wait too long at all. The first session was with a doctor who took us through the purpose of the trial, the fact that there were two potential drugs being used, explained that they‘d been trialled in mainland Europe and that the preliminary results were that they were very safe and been very successful. And the trial was about understanding whether they should be given single or double dose, that it was random sample, but the two children would, had randomly been given one each so we’d have both.

 
Talked through the expectation of another two visits, potential, any potential side effects, although the likelihood of that was very low. The children were asked if they understood which they did. We then went to a second session which was going through medical history, again pretty straightforward, no issues at all with either children. Our only issue was we were due to go on holiday at the end of the second, after they’d had the second dose, and I just needed to check that that fitted, and that they had, had to have vaccinations for that, and just again a little bit of, I guess questions to whether that made the trial valid or not.
 
Well I said it was responding to an advert in the Oxford Mail. So, it was, they were asking for people. We responded saying we do fall into that sort of demographic and it was pretty comprehensive, it kind of explained in outline what was going to happen. So it seemed pretty straight forward.
 
So they sent you information?
 
Yes, yes, yes.
 
Yeah, and were you able to ask questions? 
 
Yeah again there was a website with a question line and yes, I mean our only questions really at that time were around would it be valid with us going away on holiday and just setting up appointments. So yeah, we found it pretty, it answered all the questions that we had at that stage, yes.
 
 

The information was all available on a website. Rachel was happy with this and her background in...

The information was all available on a website. Rachel was happy with this and her background in...

Age at interview: 35
Sex: Female
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 And when you were kind of accepted to take part, then did you get further information?

 
Yes, well, no, actually. I did, but it was only via the website, because it was quite a, it was a trial that happened very quickly, because they were obviously in a position where they were hoping to actually roll it out across the country. So the whole thing happened within a couple of months really, which as you’ll know is, is very unusual for a trial. So the patient information sheets were all on the website. So it was, there was a web link directing you to go and read all of it, and then if you were interested to sort of put your email and contact details down. And once we actually went for the initial interview, where they, they had their first vaccine, as well at that point, there was a long in-depth interview sort of explaining the pros and cons and just making sure that I fully understood.
 
And how did you find that, having to go to the website to find information about the trial?
 
It was absolutely fine for me. I mean I’m very au fait with that information, those trials and the kind of questions that you need to ask. I mean I looked on the RCTN [International Standards Randomised Controlled Trial Numbers], like I never can remember those acronyms, but the, the unique randomised numbers, so I looked at that information too. And so for me I found it very easy, but I don’t know if, but I was just, I knew a lot about it anyway. I knew where to look.
 
Laura saw a recruitment poster when waiting for a routine scan when pregnant with her second baby. The trial was on the prevention of eczema in babies. Because her first daughter has severe eczema she emailed the research team for more information.
 

A member of the research team first contacted Laura by telephone to see if she and her baby would...

A member of the research team first contacted Laura by telephone to see if she and her baby would...

Age at interview: 32
Sex: Female
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 So when we were pregnant with my second baby, we went to a routine scan one day and saw a poster in, in the waiting room and it, it was talking about prevention of eczema in babies and young children and it was called the BEEP study. And we thought, “Well, okay, if there’s anything that we can do to prevent our second child having eczema then let’s get involved. And at least we could get some information.” So we e-mailed them on the, the contact address. And they got back to us quite quickly and talked us through whether we were eligible, that we had a history of eczema in the family and, and that sort of thing, and that the baby hadn’t been born yet and all of those things, and said that they would, we were eligible for the study, they’d contact us. They’d be notified by the hospital when the baby was born, they’d contact us, make an appointment and come and see us.

 
No, I didn’t see them. They, we did most of it over the phone. And then in the later stages of my pregnancy one of the ladies came round to, to see me here and to talk me through all of the paperwork and exactly what would happen, and gave me forms to sign and, yes, say, to say that I, to say that I was interested and was happy to take part and I was going to abide by what they said.
 
Was it all verbal information or did you have some written things as well?
 
There was some written, written information as well.
 
 

Laura’s baby was also eligible to have a genetic test. Laura found it helpful to have written...

Laura’s baby was also eligible to have a genetic test. Laura found it helpful to have written...

Age at interview: 32
Sex: Female
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 And the other really good thing about it is that they’ve allowed us to do a genetic test, where they just took some skin cells from the inside of her mouth. And it was just a swab, well, we actually did it ourselves, this, in the end. And you get a sort of like a cotton bud swab thing and you wipe it around the inside of the baby’s mouth for a certain amount of time. And then you pop it back in the tube, send it off, and they tell you whether genetically she is likely to get eczema. So that’s also handy. And it’s been a very, very positive experience.

I think they explained everything extremely well. I probably asked, asked a few questions as we went along, just, just so that I was absolutely 100 per cent sure of, of what they meant. And, and I know I asked a few questions about the genetic testing. Because with that one obviously then, then your child’s genetic material is going to be out there, and, and so I was, I was keen to make sure that that wasn’t going to go any further. It was just [baby] that that was going to be used for the study only and couldn’t be identified. So it, it would never have her name on it, for example. Nobody would be able to tie it up to her apart from the people running the study. So it, I felt reassured by that that it was going to be safe.
 
I think that was fine because there was a, a lot of information. There was written information so that you could look at it in detail and, and really understand what was going on. And then there was also, they talked us through it as well. And that, that’s a comfort because then if you then realised afterwards that there was something that you’d missed, you’d got the written information to refer to, but also you could always pick up the phone and ask them or email them depending on, and like, and they have always been very nice and very patient.
 
Although parents were glad to have plenty of information, for some it was a little overwhelming and difficult to absorb. Having someone with you, or having someone to share and discuss the information can help. All the parents we talked to remembered being informed that they could withdraw their children at any time if they wanted to and most had plenty of time to read the information and make an informed choice. However, some parents had difficulty remembering what was in the information and sometimes they were uncertain of all the details. This was usually because it was a while ago that they had received it, or the trial had ended.
 

It was a year ago when Kathryn and her daughter were invited to participate in a trial and...

It was a year ago when Kathryn and her daughter were invited to participate in a trial and...

Age at interview: 39
Sex: Female
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 It was. And she was just, I think just randomly picking out some names, I think just different age groups. So Chloe was obviously in the higher age group, because there was lots of little ones there, isn’t there? So I think Chloe was in the higher age group. And she just came and said, “I’ve just picked you out of this sort of group of children. Are you happy to sort of do sort of this survey?” And we just found out more about it and just said, “Well, yes, yes.”

 
And what information did you have?
 
She didn’t give us that much actually on that one. Didn’t, it was just, she just said, I don’t think she actually give us anything really to read either. I don’t think there was anything like, if I remember rightly, because it’s, oh, it’s over a year ago. I think she just said, “Just, just fill this questionnaire form today.” So she showed us that, that questionnaire form about, and it was really about feelings as, you know, it wasn’t anything to do with the, the sort of condition itself. It said it was mainly about how you felt about it all. And I think it went on like, depending on what question it was, you either felt, “How would you feel like in a week?” or, “How would you feel like from a month from like a month ago?” and things like that. So there wasn’t a lot of information prior to being picked out for it. But then when we’d signed up for it, they give her, give Chloe quite a large packet, packet of things really that she could look through and, you know, quite fun things obviously because she was 13 then. So they gave her quite a good selection of stuff to look through. And then she got some vouchers at the end of it for her trouble as well.
 
I mean she did sit with us for quite, she did, on the day that she was telling us about it, she did sit with us, as she did with about you coming, she did sit with us for quite a bit while we were waiting to go and see the doctor. She did talk to us about what it involved.
 
John has enrolled his daughter in various clinical trials over the years and was used to having lots of information. More recently he was invited to enrol his daughter in a randomised trial after being admitted to intensive care. He was very pleased with how the trial appeared to be organised, how clear the information was and the support of the nurses.
 

Although there can seem to be lot of information to read, it can be essential if this is your...

Although there can seem to be lot of information to read, it can be essential if this is your...

Age at interview: 35
Sex: Male
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 They came in and spoke to me. The wife at the time wasn’t around so, he thought it best that like at least discuss it with her before saying “Yes, fine”. Gave us an information sheet which is quite detailed obviously, I’ll give you a copy of that, which answered any questions, he was on hand every sort of twenty minutes saying “Is there anything you want to ask us? You know is there anything you are concerned about?” Read through the information he gave us, within about an hour signed it over.

 
So you’ve had plenty of information?
 
Oh God yeah.
 
And plenty of opportunity to ask questions?
 
Yeah, if anything from my point of view it’s probably information overload. But, I guess if you haven’t got a child that’s being in and out, in and out of hospital and with underlying conditions anyway then it’s probably exactly what you need.
 
Karen received a letter from her local health authority about a meningitis vaccine trial for children under the age of three. Because there was a lot of information, she was pleased to have been given the time to read it all and make her decision.
 

Karen was happy with the information although found it a bit daunting as there was so much to read.

Karen was happy with the information although found it a bit daunting as there was so much to read.

Age at interview: 29
Sex: Female
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I think the, the information that we got answered everything in the first place. You know we weren’t left asking much more so.

 
When you first got that sort of letter? What sort of response was it?
 
Yeah, to be honest I’m so, I was very confused because it was so soon after Samuel being ill, to get a letter that just said, “Parent or Guardian of….” And then from the University, my first thought it was him. And then you open it up. I was confused. And then I looked at the envelope and realised it was Eloise. It was daunting. I think the amount of information was, it seemed a lot all at once, and it took sort of a week to kind of read it, digest it, sleep on it, that kind of thing. It was almost a bit scary at first, but once you read it and thought about it, it was fine.
 
Was that because it was a lot of written information?
 
Yeah, I mean it was a sort of eight page booklet. [Was it?] And it told you everything.
 
It is a lot to read.
 
Yeah, it’s a lot to take in one go, but, but you know over the course of a week, because I showed it to my husband and he was very much, “Can you read it and tell me what it’s about?”
 
Because also they, there was quite a gap between that initial contact and the first appointment that they, they wanted so yeah, there was plenty of time to think about it.
 
Although most parents felt they had enough time to read the information and make a decision, on one occasion Alison would have liked more time to read it. 
 

People like to read and digest information in different ways. Alison felt on one occasion she...

People like to read and digest information in different ways. Alison felt on one occasion she...

Age at interview: 39
Sex: Female
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 And I do remember actually being given at one clinic appointment loads of information. But it was almost like a bit too much. And I do think when you have piles of things, then to flick through in a hospital, actually I need to sit down, I need to do that at home quite quietly and calmly with a pen, I need to underline. Do you know what I mean? That’s how I work. I can’t do things as I’m walking down a corridor or thinking of something else, I really can’t, and so that, although the information was there and it was all about numbers and everything, I, for me that wasn’t the best way. I could have done with that information being given before, you know, like a month in the post before. And then maybe a follow-up phone call to say, “Have you read it? Do you have any questions?” Or an e-mail actually. Yes, I think so. I think time is, is a key thing. You need time to think about these things.

In contrast, John feels health professionals are almost ‘over apologetic’ for approaching parents and give too much information that may leave parents feeling a bit apprehensive to enrol their child.
 

Health professionals’ care in approaching parents and providing plenty of information may be...

Health professionals’ care in approaching parents and providing plenty of information may be...

Age at interview: 35
Sex: Male
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 Well I think what would probably make life a little bit easier is for people to stop being apologetic for what they’re trying to do, because they almost come across as like you know “Really sorry to ask you this” you know and they’re almost afraid to ask, you can see when they’re coming in to do it that they’re afraid to ask the question because they think “Oh, they’re in a traumatic time” you know. And the feedback from the nurse that was running the CHIP trial at [hospital] is “You know I wish more doctors would get would ask parents to take part, I wish more doctors would actually get on board with it” and I think they’re almost afraid to do that because either a) it gets in the way of what they’re trying to do or they think it will or they’re afraid they’re afraid of what the parent might say. You know just get on with it almost.

 
I suppose they deal with so many parents every day, like you say
 
Every parent is different etcetera.
 
and you have a lot of experience which, and some may not have so maybe 
 
Yeah, I appreciate that but when you’ve got when you’ve got somebody coming in to ask you to do something they’re almost building that apprehension up by “Really sorry, I don’t like to press you, you know would you like some time to think, you know, I’ll leave you, I’ll give you, read that” stepping they’re almost leaving information, stepping away as if to apologise for what they’re doing and it’s well just ask the question. Tell me what it does and you know, yeah its fine, if I have any questions I’ll ask but.
 
Jo was invited to enrol her son in a randomised placebo controlled drug trial for the treatment of migraine in children. Jo was pleased to have both written information and the explanation and support of the doctors and nurses. However, it can still be difficult to take all the information in when trying to understand what is involved and the potential side effects of a treatment.
 

Jo remembers the information being in ‘lay mans’ terms; however it was still daunting when there...

Jo remembers the information being in ‘lay mans’ terms; however it was still daunting when there...

Age at interview: 28
Sex: Female
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 The information they gave us at the start, it was more leaflets and stuff that obviously you, you read through from front to back, but as a non-medical person you’re never really going to understand them, even though they’re probably put in layman’s terms as, as much as they could, they, they can be. Obviously the, the list of side effects is scary on the, the drugs that are. But the list of side effects on paracetamol could be scary as well, and you have to look at it like that. It, it’s just difficult, I think, to choose to put a child on, on a medical trial.

Which bits do you think you didn’t understand well? Was it about the drugs?
 
No, I think, I don’t know. It’s just obviously, with migraines it’s not a condition that can, it’s a condition that can either stay with you throughout your life or it’s a condition that you can grow out of as you get older. I think we’re more, you don’t, there’s a lot of ‘don’t knows’ regarding migraines. And poor Dan is so poorly with them that, I don’t know. I just, it’s a little bit. 
 
Other parents would have liked a little more information and also felt the language used could have been simpler. When Alison was asked to enrol her son in a growth hormone trial she felt that the information was not always forthcoming. She also felt that the language used by health professionals and particularly the use of acronyms is often confusing and meaningless to parents. As a result Alison had a lot of questions to ask. 
 

In a crisis, it can be difficult to read and understand all the various terms used to explain a...

In a crisis, it can be difficult to read and understand all the various terms used to explain a...

Age at interview: 39
Sex: Female
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 Yes, yes, yes. I mean they do talk in hospital talk and I don’t know if that’s just a symptom of how hospitals work or whether it’s a symptom more of the department we were in which seems to have, be a department of precision, and absolute precision. Which is fine. I do sometimes have the feeling that they don’t, they, they don’t tell you absolutely everything. And if you want to know something, then you have to ask a question. So for example with the growth hormone and with the trial, and I should have found the email. But I, I remember emailing the research nurse with about seven questions which she replied back in absolute clarity and precision and detail brilliantly, but that information I had to ask to get.

 
What sort of information?
 
Well, I just wanted to know really, you know, about dosage levels, you know. And what, well, you know, in, in America it’s different to Europe, what happens to those children after the first year? They all go on to a weight-related dose. And the picture, you know, when we were asking is, is pretty sketchy. It’s just that you want your child to be on a, a low dose as possible. “What, you know, are there any dangers in having a higher, higher dose? And what are the benefits? And then just more generally, what are the benefits to the treatment?” you know. A good web, we looked at a good website actually, we got directed towards. It didn’t talk about clinical trials but it talked about growth hormone and the benefits. So that was helpful. And I think the more positive we felt about the treatment and making that decision to do it and getting into that, “Actually we are going to go ahead and do this. There are some positive things. This is really interesting, what I’ve just read, you know.” You then become in a more positive framework for moving on to the next stage of accepting a clinical trial. So I think you have to be in the right place. Because to begin with like it did feel like, “Gosh, this, this, yes, a big decision and maybe a step too far.”
 
That’s the other thing I would say. With all the acronyms that are used in medicine, I can’t even remember now what the name of the trial is. And I’m sure it just rolls off the tongue. And I think that is a little bit off-putting sometimes. You know, I think parents need things in very simple [terms]. Yes, yes, no, I know, I know. But then when you read them sometimes they are kind of quite, feel sometimes a little bit cobbled together. [And you’ve got to remember all the words.] Yes, in, in between, which, shall I move on to my next point? [Yes.] Which was, I was asked if I wanted to be a parent representative for a trial, a neonatal trial. This would have been in 2004, yes. It was just simply I knew one of the neonatal consultants. He, and I’d been involved in setting up a, a group for parents and it was kind of on the back of that really. “Would I...” there was another parent asked as well, “Be a parent representative on a clinical trial that, that was happening at the moment?” I said, “Yes.” Now I didn’t actually go to any of the meetings because I had a brand new baby, some were in [area], some were in [area], and actually my friend at that stage was quite happy to go. So, but I read most of the stuff that was sent. And what they were interested in was really as, as a parent, how it, what it feels like, and actually what they can do as staff to ease any anxieties which, which comes about. Now the trial was actually stopped as it happened, so it was actually quite a short period of time that [um] kind of, yes, reading all these emails and things. And I think kind of one of the things that was flagged up then is the confusion of names for parents. You know, it, it’s,it’s meaningless. It’s not meaningless if you’re a medic but, you know, if you’re not it just adds to confusion.
 
One of the big things you talked about was mortality and how you convey, you know, at the end of the day a parent wants to know whether their baby is going to live or die, and, you know, and how you convey and how you use those terms. So, yes, and it was to do with insulin and neonates with a low birth weight in different hospitals all around. So, but the doctors, as far as I know, that were heading the trial were all based in [area].
 
So this is for another trial?
 
Yes, this is for another trial, which we weren’t part of it. It was just simply whether we’d be [um] a parent representative. Which I think is a really good idea. The downside of it is the meetings are quite long. And I think in this case it was a group of absolutely lovely consultants meeting, who would make you feel incredibly welcome and really value your input. You do it for free, and it has to come at the right period of time when you feel you can do that. But I think it, in essence, it’s a really, really, really good idea because I think it’s very easy to lose sight, you know. You have all your tables and all your statistics and everything, and that’s how it needs to be of course. But actually there is a parent with a baby at the end of the day, and it’s a personal cost to them, you know. And nobody wants to be a, seemed that they are a set of figures or a box that you can tick.  You know, they’re a person. And I think the point we made was really, it was just trying to encompass parents’ needs. Having said that, the feeling I got from reading through things and certainly talking to my friend who went to more or less every meeting was that people were incredibly thankful for parents who took part and actually had the utmost respect, respect for them. So it wasn’t a thing you did, you know, and it was brushed aside. They were absolutely, you know, grateful and really respected that. 
 
 
Kathryn and her daughter were invited to take part in a randomised trial on children with diabetes. They were approached when waiting to see the doctor at a routine three monthly clinic visit.
 

Kathryn says that trying to take in all the information at a time when you are thinking about...

Kathryn says that trying to take in all the information at a time when you are thinking about...

Age at interview: 39
Sex: Female
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 Yes, yes, probably. Because when I’m at clinic I have my mind on questions I’m going to ask the doctor, you see. I don’t always take in things because I have my questions, because I always have questions when I go of things I want to ask the doctor. So it’s then somebody come in telling you a load of, for probably half an hour, she was there about half an hour talking, you don’t sort of take it all in, do you? really. Whereas if it’s written down and you can go away and read it in your own, at your own leisure, you take things on board a little bit better, don’t you? really, when you’ve got time to go away. I do anyway. I suppose not everybody’s the same, but I do. I have to read things, me, really, rather than just be told them. I probably would have still done it, but I might remember it a bit more [laugh]. I might remember it a bit more.

 
She, I mean, she, she was dead nice and she did come and explain everything to us. But again, because she did tell us a lot of information on the day, you, you sort of struggle sometimes to take it on board, don’t you? Because that’s not what, that’s not what we were, what we went for. So when you’re not expecting something, you, you don’t always prepare yourself, do you? And there, I remember there being a lot of information to take on, take in and I probably didn’t take it all in really about what they were going to do with it and what we were going to get out of it.
 
Paul was invited to enrol his son, aged 8, in a randomised trial to assess hospital versus home management in newly diagnosed childhood diabetes. Paul received lots of information about the trial and about diabetes, but like Kathryn above, he says it can be a lot to take in.
 

At the time of his son’s diagnosis there was a lot of information to take in, but the nurses were...

At the time of his son’s diagnosis there was a lot of information to take in, but the nurses were...

Age at interview: 29
Sex: Male
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The children’s hospital. They just said to me it would be good for research and obviously to help my son Liam. So we went ahead with it.

 
And did they give you lots of information to read?
 
Well, yes, yes, they, but obviously they give you booklets, everything about it, they give you. So you, obviously you know what’s going on. But it, it does help you a lot.
 
Did you feel that you had enough information to make the decision?
 
Well, yes, yes. Everything I thought was up, up to standard, the, the information, the way they help you out. I, like personally I thought they were good. Because obviously I was new with it, with my son just only being diagnosed. And it did help a lot.
 
And did you have any questions at the time?
 
I did, but I can’t remember now. I did have a, obviously you do have questions, but everything they answered with I was satisfied. Which you know, I haven’t had no problems. And everything’s been, like it’s been two years now, but everything’s been okay. I haven’t, haven’t had one problem yet, touch wood.

And I suppose that’s sort of one of the reasons I’m asking what do you remember. Because sometimes when you, when you have been recently diagnosed or your child has been and then they ask you to go on a trial, it’s very difficult to take in all the information when you, when you’re interested in more the care.
 
Well, yes, because you’re so, because you’re sort of trying, still trying to get your head around it in the first place. So it’s a lot to take in and you, you know, if you squeeze too much of it in you’re just going to explode. So some things, it’s like, it’s hard to explain, but it’s, you know, it’s very awkward on some of the, some things anyway.
 
But it sounds like they went through things with you.
 
Oh, yes, yes, yes, they did, they go through it. But, you know, it’s just, it’s a lot for you to take in.

 

 

Coping with her daughter’s diagnosis, it was hard to take everything in, but Ann didn’t mind...

Coping with her daughter’s diagnosis, it was hard to take everything in, but Ann didn’t mind...

Age at interview: 43
Sex: Female
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And how did they explain, you know, what was, be involved and that to you at the time? Did they give you information and that?
 
We were given a little pack of little information and stuff. And they, I had a quick read through it. I’ll be honest with you, I haven’t read it fully. But it’s, I don’t, like I understand bits of it, but you do get a bit side-tracked as the days go on. You think, “Oh, I’ll read that later” and you forget all about it.

So they explained the purpose of the trial to you and what was involved? Did they talk about what potential side effects at all?
 
Oh, yes, oh, yes. They, they really, they went through everything with me. Some of it registered at the time, some of it didn’t. But as the weeks have gone by I’ve picked up odd, like little bits and bobs. Because when you, when you find out that your child’s ill, nothing sinks in first. It just goes in one ear and out the other. Because you’re thinking, “Oh, my God. What’s happened? What’s go-, what’s going through?” “What, what’s going to happen next?” is, you know, the scariest. We didn’t know about the heart. We didn’t think that she’d be rushed in to hospital with, with heart problems. And it was just, “Oh, my God.” It just . . .
 
Was that before the trial or after?
 
It was just after.
 
Just after?
 
But we didn’t realise. Even now you forget the severity of it.
 
Is that common to have a heart complaint as well with the thyroid.
 
With the thyroid, yes. Everything, she’s got, I don’t think she’s skipped, a symptom. She’s got the eyes, she’s got the palpitations, she’s got the mood swings, hyperactivity, a heart problem, the tremors, everything. And it’s frightening. And it, it’s, it’s hard to watch, really hard to watch your child go from an active 11-year-old in to a child that you’re watching 24/7. It’s just…
 
So how old was she when she was diagnosed?
 
She was 11.
 
And how old is she now?
 
She’s just turned 12.
 
Did you have any questions at the time? You know, when they were going through the information and the trial to you was there anything you wanted to ask or is there anything you wished you’d asked?
 
No, not really. At the time my head was just so chocker with it all, it just didn’t, nothing registered.
 
And did you mind being asked at that time?
 
No, I didn’t. Because, as I said, if I can help somebody else go through what I had to go through that day, and then these past few months, it might help somebody, it’s a bonus, it’s a bonus.

Others also noted how words or terms can be misunderstood. One mother described how her daughter was told a teaspoon of blood would be taken and her daughter had visions of a spoon being used to scoop out her blood. This underlines the importance of checking each child’s understanding as Rachel describes.
 

How you communicate with children has to be tailored to each child’s needs, especially when blood...

How you communicate with children has to be tailored to each child’s needs, especially when blood...

Age at interview: 35
Sex: Female
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 I think you have to be so individual to the child, the age of the child and also their experiences of what, other experiences they’ve had of hospitals and of vaccines or jabs or whatever. So I think the skill is to be able to tailor what you’re saying to that child and to see what they need. I don’t think there’s a right way for every child. I mean I know my eldest, a long time ago he’d been in hospital, and the nurse there had a lovely description of the, catheters the wrong word entirely, cannula. And she was just saying, “It’s like a straw that we put medicine in.” And he, that was brilliant for him. But I don’t know whether that would have helped any other child. You know, another child might have got frightened about a straw being put into his arm. So it was, I think you just have to be very individual in what you say and have lots of, you know, potential things that you can say.

Before making a decision some parents would look for additional information on the internet, a good and relevant book and talk to family members and friends. However, parents recognise that information on the internet may be irrelevant, inaccurate and sometimes frightening. One parent talked about the value of seeing real experiences from other people who have been through something similar (as on the Healthtalk website).
 

Lisa was happy that everything, including side effects, had been explained in the information,...

Lisa was happy that everything, including side effects, had been explained in the information,...

Age at interview: 37
Sex: Female
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 I suppose it all depends like we’re quite lucky with this trial that, like it isn’t a lot of my time, and things like that, whereas I suppose some of the trials and different things would be time and be impact of what the trial is and I suppose it depends, because we were given a list of what the side effects could be. So I suppose it depends what the side effects would be, and weighing up what the side effects would be to the what they wouldn’t be.

 
And were there any side effects to your son’s treatment?
 
They did say that there was more risk of being on growth hormones that they, he could develop diabetes at a later on in life. But I have got diabetics in my family, who are insulin dependent, so Callum being a higher chance of getting diabetes anyway it wouldn’t stop me giving him the treatment, just to be diabetic, in case he got diabetes because the chances of him getting diabetes is probably high anyway so. And they said sometimes that can make their legs ache to start with because of being it’s growth hormones, growing pains. But we had none of that with Callum or, and they did say they could get extra headaches, but Callum didn’t have anything like that at all.
 
Well I did sort of look up bit’s about growth hormone on the internet and sort of educated myself that way before, why, because we did have a good few months of deciding if to say, and at one point I was like, we needed a little bit longer to think about it. So they gave us a bit longer because they first were going to put us on when I’d got my, just had, given birth to my little girl, so I said “I need actually, I’ve just had a baby, I need a bit longer”. So they actually gave us a bit longer to think about it.
 
And you were pleased about that?
 
Yeah, that was good that they actually like let us take more time, and that didn’t matter when I said, when they rung up and said, “It’s up to you.” And we had, because they had come out, but I got them to come out again and explain everything again, before when they come out and explained again.
 
 

Nikki had searched the internet for information on her daughter’s condition but the internet can...

Nikki had searched the internet for information on her daughter’s condition but the internet can...

Age at interview: 38
Sex: Male
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Nikki' And I think the likes of, of this that you’re doing, it’s a, a, a lot softer than, you go on the Internet like we did and you look up something like adrenal insufficiency and you just get hard information, a lot worst-case scenario. Whereas something like this, where it’s, it’s real, it’s happened to somebody and you can sort of, “Oh, yes, well, ours was like that” or, you know, or, “Oh, it’s not, it’s not going to be so bad” or, that, that would have helped us, wouldn’t it?
 
I think that’s just nice just what you said there, that it’s softer, and that that’s a nice way of putting it actually.
 
Nikki' Yes, because it, information that you get on the Internet is, it is –
 
Chris' Can be a little brutal.
 

Nikki' Yes, it is hard, isn’t it? I know, you know, another one of ours has got asthma and they thought for a while he had cystic fibrosis. And in between them thinking that and them doing the test, I did go on the Internet. And it, it frightens you to death, you know, because it does seem to be all the time, “Oh” and, “Worst case” and, you know, “This could happen” and, and that. Whereas if you, if you see people being interviewed and it’s real and they’ve come through the other side or you, you know, you’re reading a lot, a lot softer, I think it, it would, it would help a bit. Because you can’t help but go and look things up; if, if it’s there and especially if it’s about your child and health and things, you, you want to know. 

The process of informed consent should continue throughout the trial. The researchers should continue to give you information and answer your questions. They should let you know if any new relevant information about treatment comes up during the trial so that you can re-think your decision, and withdraw your child if you want to. 

Last reviewed September 2018.
Last updated June 2013.
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