When we started our project looking at the ethical issues of clinical research with children back in June, we got a very strong message from children and young people that the first thing to do was to involve them properly in our own project.
Adults often worry about asking children to take part in research, especially research to do with their health – is it ‘fair’ to ask them to give up their time, or do something a bit uncomfortable, in order to help improve health care for other children in the future? The young people in our ‘stakeholder’ (advisory) group told us firmly that we should not just be worrying about ‘protecting’ children – we should be treating them as equals and involving them properly in all these discussions. Perhaps we would be surprised to hear what they really thought.
So, with the support of our stakeholder group, we launched an internet survey to ask young people what they thought about taking part in research. We’re in the middle of producing a short film about research to improve the care of children with asthma, with the aim of encouraging children to discuss what kind of research they think is acceptable. (We’re particularly interested to find out whether they have the same reactions to the suggested research as the adults in the film). And last week, with some trepidation (and the kind help of my colleague Kate), I went into my local primary school to find out what the 60 children in Year 4 (aged 8-9) thought about all this.
We began with a discussion about what ‘ethics’ means (“working out the right thing to do”) and how the ‘right’ thing to do is not always obvious. Would you let your friend copy your maths homework in order to keep them out of trouble? (Hands over ears for the class teacher at this point!). One of the school rules is “We are caring” – but is it caring to keep your friend out of trouble today, or caring to make sure they don’t get in the habit of just skipping work? A show of hands indicated that opinions were pretty evenly divided. One child pointed out you could help your friend do the work quickly, or let them copy just the once but never again. Ethical questions rarely have simple ‘yes’ or ‘no’ answers.
We then moved on to talk about research, with the aid of the fantastic “chocolate trial” devised by the National Institute for Health Research. We first established that you never say ‘yes’ to taking part in research unless you know what it’s about – what if the research was going to compare chilli-flavoured chocolate with snail-flavoured chocolate?! We then read through a ‘Participant Information Sheet’ together to find out the information necessary to make a good choice. This explained that those taking part would be allocated randomly (by chance) to either Group 1 or Group 2. Those in Group 1 would taste, and comment on, a piece of white chocolate. Those in Group 2 would do the same for a piece of dark chocolate. Only children could take part (sorry again, teachers!), and participants could opt out at any point. The trial results pointed to a strong liking for white chocolate, with nevertheless a vocal minority preferring the dark. Three abandoned Group 2 feedback forms suggested that the participants had clearly understood the message you could drop out at any time!
The chocolate trial provided a great basis for discussing research methods. We discussed why the trial had been done in that way. Why not just ask one person what kind of chocolate they prefer? Why was it important to read the information sheet first? Why were the children put into Groups 1 and 2 by chance instead of being allocated in another way (why not boys in Group 1 and girls in Group 2, for example)? Then we applied all this to health research, imagining that instead of comparing two kinds of chocolate we had been comparing two kinds of medicines.
Finally, it was time for me to stop talking and get the children to take over. They were asked to imagine they were being invited to take part in research about the common cold. This would be unlikely to help them directly at the time, but perhaps might help other children in the future. The imaginary research would involve taking a big tablet: some children would get the real medicine, while others would get a ‘pretend’ tablet (and it would be chance which you got – just like the dark and white chocolate). They would also miss school for half a day to do various tests, like pedalling on an exercise bike and having a blood test to provide more information about their health to the researchers. Would they do it? Why? What would put them off? What would they like to change?
Invited to write their comments on paper table-cloths (and with only brief arguments about which colour pen to grab), the children gave us their opinions with alacrity. A few said frankly they would not like to take part: “it might be unsafe”; “you don’t know what it will do to you”; and “it could make my cold worse”. The majority expressed enthusiasm for varying reasons. Lots said they wanted to “benefit loads of others”, help “people in danger” or “help doctors be able to find out if it will work”. Others liked the idea of “getting involved in stuff”, found the idea cool or fun, or thought “it would be really awesome to do this with lots of other people”. The idea of missing school seemed remarkably appealing.
Perhaps predictably many disliked the idea of a blood test: “I’m worried about the needle”; “I don’t like the idea of getting pricked on the arm”; and “will it hurt when they take some of my blood?” The size of the medicine was also off-putting (“I might choke on the tablet”), and so was the uncertainty (“I don’t know what will happen after”). However, the children were keen to suggest practical ways in which the research could be made child-friendly. As well as the popular option of missing out the blood test altogether, there were lots of suggestions for making the medicine easier to deal with: “Half the tablet, and give you one half and later give you the other half!”; “tablets that melt in water”; and “different flavours that I like!” One child clearly had dealt with blood tests before (“I would like a numb spray before they put the needle in the spot”) while others pragmatically suggested “you should not be able to see them taking blood”.
And who should make the decision about being involved in this research? The responses were split fairly evenly between those who felt they should make the decision on their own (“Me!” “I think I should decide because it’s my own risk”) and those who felt it should be a shared decision (“All of you together because you might not know what question to ask” and “me and my family … because they know how I will feel because they know me”). A few preferred to leave the decision to their parents (“because they have more experience”) while others emphasised that while they might involve their parents, the final decision should be their’s: “Well, you should let your parents maybe give an opinion but it is your choice!”
We came away from the classroom with little doubt that many eight and nine year olds are more than capable of contributing to adults’ discussions about the ethics of involving children in research. One pithy contribution from the afternoon could perhaps be taken to heart by researchers: “Well, I want to help children (but could they make the tablet smaller?).”
With thanks to the children, staff and headteacher at Bishop Gilpin CoE Primary School, Wimbledon
Find out more about our project on the ethics of involving children in research.