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 ‘patient 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’)
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.
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.
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.
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.
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.
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.
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.
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. 
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.
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.
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. 
 
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.
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.
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.
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).
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 July 2015.
Last updated June 2013.

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