Clinical trials: Parents’ experiences

Involving children in decisions: child assent

When you are approached to give consent for your child to take part, you may also be given an assent form for your child (see below). Children under 16 cannot give formal legal consent, which has to be given by a parent or guardian, but they can and should be involved in the decision as far as possible.
Assent means children give their permission or agreement to take part in trials. It requires that children understand the research process and are informed about what they are expected to do. In considering assent, children can talk about their views and any worries about participating in trials. Doctors need to listen to the opinion and wishes of children who are unable to give full consent to a trial, and do their best to gain their assent. All children have the right to receive information given to them in a way that they can understand, and to consider assenting, or not. Both consent from parents and assent from children is needed if a child is to take part in a trial.
 
For the majority of parents we talked to, consent was their responsibility because their children were under the age of 16 years. Most of them felt that it was important to involve children in the decision in some way, unless they were babies or toddlers, but the extent to which people felt this was possible varied. (See also ‘Making the decision about enrolling your child: parental consent’.)
As with Alison above, some parents said they will involve their children in the decision to take part in trials as they get older and are able to communicate their feelings. Linda’s daughter’s first trial was as a baby.
Lisa’s son was four when first approached to take part in a growth hormone trial. Lisa recalls the aim of the trial was to find the best dosage of growth hormone for different children.
Tina was keen for her two children to take part in a swine flu vaccine trial. She had responded to an advert in a local newspaper looking for volunteer children aged between 2 and 12 years. Tina spoke to both her children who were keen to know more about it.
Kathryn and her daughter were invited at a routine clinic appointment to participate in a randomised trial on managing diabetes in children and young people. The nurse explained the trial and gained their consent while they were waiting to see the doctor. It helped knowing they would remain anonymous and could withdraw at any time.
Some parents talked about their children having their own pack of information. Sometimes the health professionals would come to the child’s home to explain the trial to them. Sometimes they would demonstrate what was involved, for example using Emla cream (a local anaesthetic) when blood samples were required. This involvement of children by health professionals was important to parents and gave children the opportunity to express their concerns and views. In Nikki’s and Chris’s case, their daughter was diagnosed with asthma at the age of 18 months; she is now aged 6 years. They were invited to enrol their daughter in a research study on children with asthma who also take inhaled corticosteroids.
In some cases children were also asked to sign an assent form.
At the age of 16 years, children can give consent to take part in a trial. Alison talks about the time her son reached 16 and was himself able to consent to take part in a trial. Some parents had considered this as something they may have to face in the future.
The Department of Health have two booklets: Consent – what you have a right to expect; A guide for children and young people’ and ‘Consent – what you have a right to expect; A guide for parents’ - see our resources page for links to these booklets.

Last reviewed July 2015.
 

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