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.