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Clinical trials: Parents’ experiences

Deciding not to enrol your child and when your child may not be eligible

Everyone who is invited to take part in a trial is free to decline, and should not feel under any pressure to take part. You are also free to leave a trial at any time and without giving a reason; see ‘Withdrawing your child from a trial.’ Reasons for deciding not to enrol a child in a trial varies from parent to parent.
 
Ruth had considered enrolling her son in a swine flu vaccine trial partly because she thought it might help protect her husband, who was in the ‘at risk’ category because he has asthma. She also wanted to protect her parents as they often helped to take care of her son. After reading the information and talking to her husband and work colleagues, Ruth began to doubt her initial reasons. She became worried about the possible risk of side effects for her son. It was important for her that it was a joint decision with her husband. There was plenty of time to make the decision and finally she decided to decline. However, Ruth is supportive of clinical trials and would certainly consider something similar in the future.
 

Ruth thought enrolling her child in a swine flu vaccine trial might help protect her husband, who...

Ruth thought enrolling her child in a swine flu vaccine trial might help protect her husband, who...

Age at interview: 38
Sex: Female
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 I suppose, I mean, the main reason I was probably interested with the swine flu was because my son is 22 months and he, well as soon as he went to nursery we caught everything going, I mean, every little sniffle, cold, bug and I’m just and I just knew that if swine flu was going to kick off in a big way that we’d get it through George from nursery. So I thought well, you know, if I could get him vaccinated then, you know, maybe that would avoid us getting ill. And I suppose it wasn’t from my point of view so worried but more for my husband and for my parents. Because my husband is one of the at risk categories, he’s asthmatic, and so I was a bit worried about that. And also my parents, although they’re not the more elderly, they’re not supposed to be as at risk, they you know, I just thought it was a bit unfair because they kept getting ill as well [laughter]. Because my mother looks after George a couple of days a week and so, you know, everything that he gets they get too, so you know, it’s not just us so I thought well, you know, if I took part in it then, you know I might be avoiding everybody catching it.

 
I sat and thought about it for a couple of days and then I printed all the information off and had a chat with my husband to see what he thought about it. He wasn’t so keen. More from the fact that he just thought from all the information that we had, swine flu wasn’t actually as big a deal as it was being made out so much in the media. And that the likelihood you’d have of a severe case was quite small and therefore he wasn’t worried on behalf of himself and he said “Well, you know, if they are worried about his particular at risk category then they would be vaccinating him” and so he would have had the vaccine, so I wouldn’t have to worry about him. And as my parents aren’t in the at risk category he said well, he didn’t think it was necessary to sort of stick George with a [laughter] with a jab when it wasn’t totally necessary. 
 
 

Talking to others made her think differently about the balance of risk and benefit.

Talking to others made her think differently about the balance of risk and benefit.

Age at interview: 38
Sex: Female
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 But he said he’d, he said he’d have a look at the information and have a read and I was still pondering it so then I sort of happened to, I came into work sort of the next day and I was setting out my lunch and we were chatting away with all of our colleagues and it was really interesting actually because there was some very negative reactions about taking part in the trial, about the swine flu vaccine and that giving it to children, using children as guinea pigs was very frowned upon. Some were very positive but the overall reaction from people when I said I was considering it was that “Well are you sure you really want to do that, you know, stick your child with something that’s not necessarily been proven?” And so that sort of put a bit of doubt in my mind. So originally I was sort of was a bit, you know, quite positive about taking part and going for the trial and then I started thinking “Maybe are they right, are they wrong” and so I thought well I’ll have a little bit more of a look into it and I spoke to my sister who also she has a science background and she was saying “Oh I’m not sure about this particular one” because the information that she’d heard through people, certainly from the people that had taken part in the Australian trial, was that they were using the same basis sort of for the actual vaccine that had been used for what we call, what they thought was a dodgy batch of MMR vaccine. So it had a very small amount of mercury preservative in it. And she said “Well that’s the thing that would really worry me about doing it, was because the basis of this vaccine, you know, hadn’t necessarily had the greatest of track records”. But, you know, this is all heresy it’s not necessarily, you know, this wasn’t from the co-coordinators. 

 

Ruth felt a sense of relief after making the decision not to enrol her child in the trial....

Ruth felt a sense of relief after making the decision not to enrol her child in the trial....

Age at interview: 38
Sex: Female
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 So you know I wasn’t a 100% sure. I mean, but I thought mmm do I or do I not take part. And I’m still umming and erring and it’s about a week and a half later or after, after the initial invitation came round and then my husband got called up for coming in to have his own swine flu vaccine. So I thought oh well actually the urgency’s not really there now because, you know, he’s going to be covered and I thought well, you know, it is a big sort of, you know, am I doing it for the right reasons or, you know, am I thinking of George’s best interests or am I thinking of my best interests and is it, you know, is it that, is it that bad to have a little bit of flu considering we’ve had so much flu to be honest, you know, a year and a halfish say since he’s been at nursery. So I thought oh no, so I thought no, I thought actually having reviewed the information I’ve had very mixed reactions from, you know, from my family and from colleagues at work I thought no I don’t think I want to take part, so that’s my story in a nutshell [laughter].

 
Once I’d made the decision I think I felt very relieved and I thought actually I’m maybe being a nicer person because I’m thinking of George first and not of ourselves and as I said, you know, what’s another little bit of flu [laughter] and so I just thought, you know, why not, yes.
 
Other parents who decided not to enrol their children in trials also said they were still very supportive of medical research in general and would consider enrolling their children in trials in the future. The decision not to take part felt right for them and their children at the time.
 
Shortly after her son was discharged from a neonatal unit, Catherine received an invitation to consent for him to take part in a five-in-one vaccine trial. On this occasion she declined. She had recently taken part in a trial during her stay on the neonatal unit and her son was having further treatment for two hernias. It was the wrong time for her and her son.
 

An invitation to enrol your child to a clinical trial may just come at the wrong time.

An invitation to enrol your child to a clinical trial may just come at the wrong time.

Age at interview: 27
Sex: Female
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 Yeah, well I can’t remember when I got the letter; it must have been through the G.P. because it was about a trial for a five in one vaccine, as part of the immunisation programme. I think we first got the letter when Mikey had just come home and I probably put it to one side and thought I’d look at that later because I had a new born baby at home all of a sudden having spent three and half weeks in hospital was like in chaos. And then they wrote to us again and after Mikey had came home he actually had a hernia, inguinal hernia on one side and then an inguinal hernia on the other side, so he was in an out of hospital having operations for the next eight weeks I think.

 
But I know I talked to I talked to my husband about that and he sort of said, “I just don’t think we should do anything to him that we don’t need to do”. Everyone’s baby is really precious, this was a baby we’d tried for five years we never thought we were going to have. Then we had him early, then he was poorly and I just think we were sort of, like we just can’t put him through anything that he’d had a rough start in life anyway. And maybe had he been a healthy full term baby with no complications I might have said “Yeah, try it” but it was just the place we were at I suppose was sort of like.
 
I mean did they talk about any side effects at all? Can you remember?
 
No the side effects, yeah it said the side effects the side effects being the same as they are for the other jabs, you know just sort of the grizzly baby for a couple of days. But I guess if you’re trying a new thing then you don’t know necessarily what the side effects are going to be do you, so, I’m not sure, I think the link between the MMR and autism is fairly anecdotal but you you’ve got to, I always think when I say that and I lecture on that and I talk to people about that at work and stuff and then I think imagine being a mum though and your baby’s healthy and then you take it for a jab and it comes back a different baby. And it may be coincidental and it may be a whole other range of factors but imagine how that would feel just living with that even if it isn’t and people telling you it isn’t would probably just make it even harder [laughs] so, yeah. It’s sort of; it’s quite controversial isn’t it.
 
 

Catherine decided not to enrol her son, who had been born prematurely, in a vaccine trial because...

Catherine decided not to enrol her son, who had been born prematurely, in a vaccine trial because...

Age at interview: 27
Sex: Female
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 So then all that sort of kicked off and he was quite, he was really poorly and I think they wrote to me again and just sort of looked at it and I thought you know what, I’m all for vaccinations. I work with people with post polio syndrome so I know and I’ve been to Africa and I know how they benefit everyone and I just thought this is my baby who’s been through so much and I’m just not convinced I can feel comfortable letting him have a vaccine trial, giving him five in one, why do we need to give him five in one, he can [noise] have all the ones he needs anyway and I just said no on the occasion. And he was, I mean he was back in and out of the hospital anyway so I don’t know whether we’d even been able to do it. But I guess, and you know, you hear all the horror stories about vaccines and I’m not sure that there’s an awful lot in them but I just thought why would I take that risk at this point when we’ve just got him home and we’ve just got him healthy, sort of [laughs]. I just thought I couldn’t live with myself if I made the decision that caused him a problem so.

In vaccine trials, parents are generally weighing up the risks and benefits of exposing an otherwise healthy child to something which has not yet been fully tested.

There is no scientific evidence of a link between MMR and autism, but this is something that parents still worry about. For further information see our section on Immunisation.

In other cases, parents are making a decision about a child who is already ill. Many trials compare a new treatment with the current standard treatment by setting up two groups of people. One group of people will receive the new treatment and one group will receive the current standard treatment. If no standard treatment exists a placebo will be given. A placebo is a treatment with no active ingredient which is designed to appear very like the treatment being tested. By comparing people’s responses to the standard or the placebo treatment with the new treatment, researchers can tell whether the treatment is having any real benefit, rather than simply feeling better because ‘something is being done’.
 
(Sometimes you may hear the new treatment group called the ‘experimental group’, ‘trial group’ or ‘intervention group’. This can be confusing, as all the groups, including the control group, are part of the trial, and people in the control group may also be given an intervention, in the form of the standard treatment or placebo.)
 
A trial may involve invasive procedures and tests, and parents and children may worry about this. Nikki’s daughter did not want to take part in a research study in children with asthma because it involved a cannula insertion (a fine tube put into a blood vessel) to take blood for testing. They decided not to take part in the trial this time.
 

Nikki’s daughter did not want to take part in a clinical trial because of a previous bad...

Nikki’s daughter did not want to take part in a clinical trial because of a previous bad...

Age at interview: 38
Sex: Male
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 Well, we’d, we’d gone to the hospital for one of her routine visits with her consultant. And the clinical trial nurse came in and, and said to us that she would be a good candidate for going on this trial, could she get in touch with us afterwards? Which, we, we let her and she, you know, she phoned and she came out to the house and she went through everything. But, you see, the minute that she said it was a blood test, she just wouldn’t.

 
Well, that was exactly the same trial but, as I say, because Sarah had had such a bad experience with the blood test she absolutely refused to have another one. And we really couldn’t force her. Because she’d had a traumatic time having the, the blood test done at the hospital that in her head no way was this going to happen. And you can understand that. And at the time we, we weren’t as concerned as we became about her immune system. We didn’t realise what the drug that she was taking for her asthma could potentially do to her. We just noticed that her immune system was down a bit. But we had no idea that we were about to find out that she was so ill. So, so we got asked to go into the trial. And just, it was, you know, once it was explained to her, she just, “No way am I having a blood test.” And so we just declined.
 
Both Lucinda and Nikki agreed to enrol their children in trials when given a second opportunity. Their experiences show that even if you decide not to enrol your child in a trial there may be other opportunities for the same or other trials in the future.
 
Helena is a senior research nurse. She says that part of her role is to ensure that parents understand they can decline and that this decision will not affect any future opportunities to participate in research, or that their children will receive the best known care.
 

Parents need to know if there is an alternative treatment if they decide not to enrol their child...

Parents need to know if there is an alternative treatment if they decide not to enrol their child...

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 If parents don’t want to take part in the study then you would go back to what the normal care at that hospital and that department was. And that’s something that when we’re explaining about the research, it’s something that we always explain what the alternative would be. So if you chose not to go on this study, what would happen to me and so that’s when the medical team would explain like “We think you need treatment so we would either do this or there’s this study and we would give you something on the study”.

All trials have a set of guidelines about who can take part. These guidelines are called eligibility criteria. They ensure that a trial includes the people considered likely to benefit from the treatments and to protect participants from avoidable risks. The inclusion criteria help researchers decide who can take part in a trial, and the exclusion criteria indicates who cannot take part. Sometimes children will be tested to see if they are eligible and to ensure that they are unlikely to be harmed by treatment.
 
Alison’s first experience of being invited to enrol her baby in a trial was during her stay in a neonatal unit. At the time, she and her baby were very poorly. Her baby’s growth had stopped in pregnancy, so it was likely the baby would need to be put on a ventilator after birth. The trial was a randomised trial to determine the most effective type of ventilating machine. So Alison and her husband agreed to take part as it all seemed straightforward. 
 

Alison’s preterm baby was not eligible to take part in a trial comparing different ventilators...

Alison’s preterm baby was not eligible to take part in a trial comparing different ventilators...

Age at interview: 39
Sex: Female
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 And when our eldest child was born there were a number of complications in the pregnancy, and our eldest child ended up being delivered at 30 weeks with a very low birth weight. So he was less than a kilo. And because of that we spent quite a long time in a neonatal unit and also in a paediatric ward, and we became suitable and eligible for a, a number of clinical trials. The first trial we were, the first trial we were offered was a trial to do with ventilators, in that because our baby was going to be very preterm and growth had stopped in pregnancy, it would seem very likely that when they delivered him he was going to need to be put on a ventilator. So we were signed up for a trial to do with types of ventilators. We were given quite a lot of information in a very short space of time which was all right. The consultant who was heading it up was absolutely lovely, made himself very available so we could ask him about lots of questions, but actually answered I think a lot of our questions, and was very reassuring that it was all kind of run-of-the-mill stuff for them. It wasn’t anything out of the ordinary. It was simply to do with one machine versus another and they just wanted to, to look at that. So we signed up and said, “Yes, that’s absolutely fine.” On reflection it was, you know, an incredibly difficult time. I had a, a very high-risk pregnancy and I was also losing a lot of blood as well as the, the problem of the baby not growing. So I actually did leave a lot of decisions to my husband. I wasn’t really in a fit state to be able to do very much. However I do feel happy that we agreed to do this. The slight problem was when our child was born he was breathing unaided, so we didn’t need to be part of the trial. So we’d had kind of a lot of information to think about and then suddenly we weren’t at the ventilating stage at all. So that was the first trial, we were happy to be part of but actually we weren’t needed. So everyone kind of went away.

For Alison the fact that her son was no longer eligible for the trial was good news, but sometimes not being eligible can be disappointing. Julie’s baby was not eligible to take part in a study of babies and young children developing food intolerance. Julie was keen for her baby to take part and was disappointed when she was told he did not meet the inclusion criteria. Julie herself takes part in clinical trials as a healthy volunteer. She believes it is important it is to take part to advance medical knowledge and improve the health of children and adults.
 

When your child does not meet the inclusion criteria to take part in a clinical trial, it can be...

When your child does not meet the inclusion criteria to take part in a clinical trial, it can be...

Age at interview: 45
Sex: Female
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 I was I was invited to take part via the Bounty e-mail newsletter and it’s the EAT study looking at babies and young children developing food intolerances and because I have some food intolerances myself it was something I was quite interested in, and so the babies had to be less than three months old I think, be completely breast fed and you had to be able to get up to London once a year. And unfortunately I didn’t qualify because my baby had three bottles of formula when he was in hospital so we were turned down.

 
Right and how did you feel about that?
 
A little bit miffed. A little bit disappointed because I was interested in the trial and I thought it could potentially be of use to me and my baby because I have these mild food intolerances so anything which would help me manage his weaning and his diet would be of interest to me.
 
So I was invited to take part via the Bounty e-mail newsletter for new mums and it’s called the EAT study and it’s about food intolerances in babies and young children. And as far as I remember they carefully introduce foods when babies are weaning and look for reactions to those foods and that’s why they need babies who have been completely breast fed so that there isn’t for example a hidden reaction to formula.
 
Well the EAT study it was in an e-mail which went out, I presume to lots and lots of new mums who sign up for the Bounty Packs and their newsletters. And so it just gave a brief explanation of the study and the criteria and I sent an e-mail just on that information alone. So I never got as far as looking at the information pack. Yes, yes. And saying your baby had to be less than three months old completely breast fed and able to go up to London once a year.
 
Oh right, okay. So did you, so at that point when you read the information, was it at that point you thought no I’m not eligible did you?
 
No I thought I would be eligible but I did tell them that my baby had had three bottles of formula while he was in hospital and they rang me to say that unfortunately that disqualified him from the study.
 
Yes, but you would take part in other studies if there was something?
 
Yes, yes suitable things. I think for my baby I would be even less inclined to do things which required physical discomfort for him, for example taking blood tests and things like that. I’ve volunteered to do that myself with some of the studies I’ve done. When I had an MRI I had to have two cannulas inserted, you know, which is, which is mildly uncomfortable. But I would think twice before I volunteered the baby for that kind of thing. I think in his case there would have to be a much more direct benefit for him for example to have blood taken than just the warm fuzzy feeling you get from helping out with research, which might with research which might ultimately not have a direct impact on your own health or wellbeing.
 
So it’s quite a different thing isn’t it to volunteer yourself to take part than to volunteer your child to take part?
 
Yes I think so yes and I know that the, the medical and healthcare that brought him into this world and is keeping him healthy is important and it’s very often research based and so on. But I think I have a duty of care to him to think carefully about what I might be subjecting him to. And of course in the case of my baby I would also have to discuss it with his father before I volunteer him for anything. But for example I’ve volunteered him for the local university to do some psychology studies which are non invasive and usually they’re a
Catherine had experienced recurrent miscarriages and was invited to join a trial of a hormone (progesterone) before her son was born. However. The eligibility criteria meant she could not take part.
 

Catherine understands the need for eligibility criteria in medical research.

Catherine understands the need for eligibility criteria in medical research.

Age at interview: 27
Sex: Female
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 No I think going back to my experiences in doing psychology and things like that, you, researchers have got to have criteria, they, they’ve got to have criteria that fits because otherwise it becomes irrelevant and you can lost in data that doesn’t mean anything. It wouldn’t be fair to put me in a fertility study with other people because there’s a reason that that my outcomes would be different and so that doesn’t teach anyone anything and then that’s not useful research and it doesn’t inform future practice so it’s sort of, there needs to be eligibility criteria. Yeah, otherwise it’s not, it becomes irrelevant doesn’t it. Its, and then it, and then it doesn’t improve anything it just, sort of, becomes a pointless task of everyone collecting data that just means nothing. 


Last reviewed September 2018.
Last updated 
July 2015.

 
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