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Children can join medical trials

by
05 June 2015

The young often grasp the issues well, and testing benefits them, argues Robin Gill

NUFFIELD COUNCIL ON BIOETHICS

Asking: an image from an animation, Health Research: Making the right decision for me, produced by the Nuffield Council on Bioethics, available at www.youtube.com/watch?v=6yaKwLG_vlE

Asking: an image from an animation, Health Research: Making the right decision for me, produced by the Nuffield Council on Bioethics, available at www.youtube.com/watch?v=6yaKwLG_vlE

IS IT right to ask children to take part in clinical research, when it has no benefit to their own health? And even when it might have some benefit, is it right to trial innovative treatments with children, and not simply with competent adults? But, if children (who are not just mini-adults) are not included in clinical research, they might never receive properly researched medical treatment that is based on evidence.

As a member of the Nuffield Council on Bioethics, I was part of the working party that produced its report Children and Clinical Research: Ethical issues (nuffield bioethics.org/wp-content/uploads/Children-and-clinical-research-full-report.pdf).

At the outset, we were all aware of how important and difficult this ethical issue is. Evidence-based medicine depends on rigorous clinical trials. Yet a majority of medicines currently given to children have not been adequately researched specifically for children.

There are a number of reasons for the lack of clinical trials involving children. Drugs for children are not as profitable commercially as those for adults. Student volunteers can be recruited easily, with cash benefits, to test even potentially dangerous drugs.

But, above all, it is argued that medical interventions involving children can legally be given to them only if it is in their best interests. On this basis, non-therapeutic clinical trials involving children can never be allowed.

 

AS A working group, we listened carefully to young people who had taken part in clinical research related to their own medical conditions. We were impressed by their courage, passion, and articulacy. They argued that it was imperative that young people should be involved in the planning of clinical research, as well as in the research itself. They displayed high levels of altruism and knowledge. Some of them also argued that taking part in clinical research, after discussions with their parents, had been a part of their wider best interests, even when it did not deliver a specific health benefit to them.

Obviously, much depends on the age and stage of development of the young people. We distinguished be-tween the following three groups:

 

• Children who are not able to contribute their own views, such as babies, very young children, and those who are unconscious. 

• Children who are able to contribute, but are not yet able to make independent decisions.

• Young people with sufficient intellect and maturity who are able to make their own decisions, but are still considered legally to be minors.

 

The last of these groups was especially articulate and altruistic. I was also impressed, however, by a video of young people in the second group, who identified for themselves many of the ethical issues involved in clinical research. Surely, the greater the understanding of young people, the more they should be involved in decisions about including them in clinical research. That seems right.

This led to some of our key recommendations:

 

• We suggest that an understanding of children's long-term welfare should encompass the possibility of contributing to wider social goods. Such a contribution could take the form of participation in properly regulated clinical research, in order to contribute to the knowledge base necessary to improve health care for all children in the future. 

• We suggest that parental consent to research should be based on their confidence that participation in the proposed research is compatible with their child's immediate and long-term interests.

• An appropriate response by professionals to concerns about children's potential vulnerability in research is to ensure that they work in partnership with children, young people, and parents throughout the whole endeavour of research.

 

THESE recommendations would effectively endorse good practice that is already emerging in current clinical research involving children. A number of clinical researchers at places of excellence came to advise us. I hope, however, that it also encourages others to follow their lead.

In terms of ethics, we identified three key professional virtues that guided our discussions: trustworthiness, openness, and courage. 

There must be trust between researchers, young people, and their parents, if clinical trials are to develop. Openness on the part of researchers is also crucial: they need to share information clearly and honestly with young people and their parents at every stage of their research. And courage is needed by all. We were impressed by the courage of many young people, but we were also conscious that researchers need courage if childhood treatments are to be researched properly.

Of course, many agonising de-cisions about particular clinical trials remain unresolved - such as those faced by doctors who pioneered the successful treatment of children with leukaemia in the 1960s by increasing their chemotherapy to levels that others thought were dangerous.

This Nuffield report does at least give a framework for discussing such decisions responsibly.

After six years, my term on the Nuffield Council on Bioethics has now come to an end. I followed the Rt Revd Lord Harries of Pentregarth as a council member, and, in turn, I am being followed by the Revd Dr Michael Banner, and Professor Mona Siddiqui. It is encouraging that the Council still involves theologians in such important ethical deliberations.

 

The Revd Professor Robin Gill is editor of Theology and Canon Theologian of the Cathedral Chapter of the diocese in Europe.

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