Clinical trials & medical research (young people)
Withdrawing from a trial
Having injections and starting high school were some of the reasons that Courtney decided to...
Having injections and starting high school were some of the reasons that Courtney decided to...
Courtney got upset each time she had to have her growth hormone injections. Having the trial...
Courtney got upset each time she had to have her growth hormone injections. Having the trial...
Robert had considered withdrawing because the intervention was unpleasant, but knowing it was...
Robert had considered withdrawing because the intervention was unpleasant, but knowing it was...
Alexander sometimes thinks about dropping out because of unpleasant side effects of the trial...
Alexander sometimes thinks about dropping out because of unpleasant side effects of the trial...
Joanna was worried that forgetting to take her medication would affect the trial results and...
Joanna was worried that forgetting to take her medication would affect the trial results and...
It was reassuring for Lauren to know that if she chose to withdraw all her information would be...
It was reassuring for Lauren to know that if she chose to withdraw all her information would be...
Because of an infection, Katie was advised to stop the trial. She didn't want to, but knew it was...
Because of an infection, Katie was advised to stop the trial. She didn't want to, but knew it was...
It is important families understand how clinical care and research fit together. The process of...
It is important families understand how clinical care and research fit together. The process of...
In clinical trials for adults, the adult gives consent to take part. But for children taking part in studies the situation is very different, because the consent is given by an adult parent or carer who is not themselves the person who is going to undergo the trial and the benefits and the risks. So the situation is different. And researchers need to explain that carefully to families to under- to ensure that they understand that. Of course parents and carers consent for their child’s care in general, and this process of consent is similar for research. But it’s important that they receive and understand carefully the written or other information that’s provided to them, so they’re clear which parts of the care are research and which parts are part of routine care. Older children who understand what is being suggested can also take part in the process of agreeing for research. We call this assent, and it’s a process whereby a child gives a positive response about taking part in research. And this concept of assent varies actually from different countries. Some countries don’t even recognise it. And the age at which assent is appropriate varies from country to country. But in general terms, assent is something, is a process that should be sought by a researcher in a child who has a, an understanding of the research process. It’s also important to recognise that this process of consent and assent is an ongoing process. It’s not just a one-off ‘yes’ at the time of signing a piece of paper. It’s ongoing through the study and can be withdrawn at any stage, and researchers will respect that.
Helena explains the age at which children can give assent and consent and what may happen when...
Helena explains the age at which children can give assent and consent and what may happen when...
At what age can, what age do children assent to take part?
For some studies information sheets produced from children from three which are three to five which are basically pictures. And if you’ve given information sheet there’s a lot of the sponsors who are running the studies like the children to give their assent. So they like them to say yes okay I’ll do this. It’s debatable at what age is appropriate and that’s something that varies from people to people and from researchers to researchers. But obviously fifteen year old knows their mind and as long as they’re given the right information you will always get assent from them but because it’s a clinical trial you wouldn’t be able to give consent you would still need to speak to the parents. And then if there’s a difference of opinion that’s something that needs to be discussed locally and decided on whether you’re going to put that patient in the study or not.
So sort of aged sixteen and over, under sixteen they still have to have, even if they agree, they’ve still got to have parental consent?
Yes, until the child's sixteenth birthday, if it’s a clinical trial of a drug, the clinical trials regulations state that parents give consent and if the child is aware enough about the study and are able to we would take assent from them, once they’ve been given all the information as well.
(See also ‘Making the decision to take part and giving assent and consent’.)
Last reviewed March 2017.
Last updated July 2014.
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