How many parents would say ‘yes of course!’ if asked to consent to their child being involved in a research study – perhaps involving extra blood tests or additional scans as well as the planned treatment? Many of us would hesitate, or refuse outright, concerned either about any associated risks, or about the additional and unnecessary (from this child’s perspective) discomfort or distress. And yet all of us hope and expect that, when our children are ill, they will receive treatment based on the best possible evidence as to its effectiveness – evidence that cannot be straightforwardly derived from adult studies because children are not simply ‘small adults’, and their bodies deal with medicines differently. Similarly, data from older children cannot simply be extrapolated to toddlers or newborns.
So, research with children is crucial if children themselves are to benefit from the best possible treatment when they are ill. But ethical problems abound – from the question of whether parents should or ought to allow their young children to participate in research that involves even minor discomfort or distress to, at the other extreme, the question of whether parents or children should have a right to participate in research – a right, for example, that may be claimed where a child is very seriously ill and a new, as yet-unlicensed, treatment is seen as being their ‘only hope’. And that’s before we start looking at the question of children’s own participation in these decisions: what part should a 6, 8 or 10 year-old child play in deciding whether or not to take part in research? Should we be encouraging our children to act altruistically, even at the cost of some temporary discomfort? Or should we be protecting them from any procedure that does not directly benefit their own health now? And how about the cases where research and treatment are inextricably combined, as in later-stage trials of new medicines – how much do we defer to the wishes of older children to participate or not in such research, when the decision may also have an impact on the child’s own health?
The Council is currently seeking ‘expressions of interest’ in a new project looking at these issues – not so much at the ‘nuts and bolts’ of research regulation but at the bigger picture of what is acceptable – and what not – to ask of children and their parents, and of how we can ever square the circle of ensuring children have access to evidence-based treatments while not exploiting individual child participants in the process. If you are interested in finding out more about this project or getting involved in some capacity – for example by contributing evidence or personal experiences, being considered for membership of the Working Party or as an external reviewer for the draft report – you can find out more here. We hope to set up the Working Party in time to start work in spring 2013.