Clinical trials: Parents’ experiences

Making the decision about enrolling your child: parental consent

Before you can give consent for your child to take part in a trial it is important that you are given enough information to make an informed choice and an opportunity to ask as many questions as you like. Staff cannot enter your child in a trial if you do not give your consent. The UK Clinical Research Collaboration booklet on ‘Understanding Clinical Trials’ (see resources), has a checklist of questions you might like to ask. You can print off the pages which includes space to jot down your own notes (see ‘Information parents receive when invited to enrol their child’ for more information).
 
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. Depending how old they are and how much they can understand, your child may also be involved in the decision-making process
Alison talks about being invited to a growth hormone trial for her son. She found this a difficult decision to make, knowing that nothing is medically wrong with her son, but also recognising that, as they are a minority group of children, it's important that researchers can find out more about the condition.
Although many of the parents we talked to were happy to give their consent, for some it was also a worrying time. Feelings when first approached varied from uncertainty about the trial to feeling a sense of control. Parents’ first instinct is to protect their children, and they were very aware of the responsibility of making a decision on their behalf.
In Nikki and Chris’s case the trial was to find a non-invasive screening tool to determine if children with asthma who take inhaled corticosteroids are at risk of adrenal suppression (when the adrenal glands do not produce enough steroid hormones to regulate organ function). As a result of tests taken during the trial, it was discovered that their daughter had severe adrenal insufficiency and required urgent medical treatment. Nikki says “But we were told that it was only thanks to doing that trial that we found out. Basically her life was in danger and we had no idea until we’d done this trial what was wrong with her”.
 
Kathryn and her daughter were approached at a clinic visit to take part in a randomised trial on the management of diabetes in children and young people. Kathryn says she would have liked more time to make the decision and some written information to take away and read. (See also ‘Information parents receive when invited to enrol their child’ and ‘Involving children in decisions’.)
How parents were approached was important at a time when they may be feeling vulnerable. For parents who had worked in healthcare or research, this helped them to understand the process of recruiting people to trials and consent and they felt it made them more likely to take part. However one parent who is a nurse and whose husband is a doctor thought having a health professional background might lead researchers to make some assumptions. She said, “I’m a nurse so he [Consultant] thought he could appeal to our medical sentiments to let us take part.”
 
In all cases and situations and however little time is available to make a decision, there should never be any pressure on parents to give consent for their children to take part in trials. All the parents we talked to recalled being told it was their decision, and most remembered being given plenty of information and explanation about the trial without influencing their decision. On occasion parents sensed that health professionals were really hoping they would say yes, even if they didn't say so out loud. As Alison says, “There was a research nurse who was extremely helpful and made herself extremely available, but also very obviously wanted us to sign up”. Parents may feel unspoken pressure to be helpful.
Clinical trials are done because there is a possibility that a new treatment will be better than the existing or comparison treatment, and it may have already been shown to work for other conditions or other groups of patients. However, trials are just as likely to find that new treatments are worse than existing treatments. Parents who desperately want their child to get better may interpret doctors’ words in a way doctors do not mean, or, ‘read between the lines’. This underlines the importance of staff being very careful about what they say and how. Parents may feel that there are benefits from participating, such as extra monitoring and appointments, or a feeling of helping others. However, parents need to make these decisions based on unbiased information about the trial.
 
For many parents it was important to make the decision with their partner and some parents talked to family members. When Alison’s son was in neonatal care it was a very difficult time and although she was happy to consent for her son to take part in a trial, she could not have made the decision by herself.
In a randomised trial, people are allocated at random to one of the treatment comparison groups, so that each group has a similar mix of people of different ages, sex and states of health and can be compared fairly with the other groups. (See also ‘Why do we have clinical trials in children and young people?’) Randomised trials are done when we don’t know which treatment is best, in other words when the relative merits and disadvantages of different treatments are uncertain. It is important to realise that in about half of trials, the new treatment will turn out to be better, but in the other half it will turn out to be worse.
 
The majority of parents understood about the need for random allocation (randomisation) to a treatment group. However, when making the decision to enrol their children in trials, first and foremost was their children’s health and safety. When drugs were involved parents wanted to know that they had undergone preliminary testing and were considered to be safe for their children to take part. 
The parental instincts were to give their children the best care combined with protecting their children against harm.
In contrast Alison felt assured that the risk of her son taking part was a “limited risk” because of the strict guidelines on clinical trials in children. However, taking part in a trial can involve extra appointments and tests for your child. Knowing what is involved in a trial and time commitments and money was something that Alison considered before giving her consent. 
Vaccine trials often require healthy people to take part. For these types of trials, most parents we spoke to either received a letter and information about the trial from their local health authority, or an email at their place of work, usually University and NHS employees. The email came with attachments providing information about the trial. Others saw media advertisements. Like parents whose children are ill, parents of healthy children will be weighing up possible risks and benefits before they consent. 

See also ‘Involving children in decisions’. 

Last reviewed July 2015.
Last updated July 2015.

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