Has the European Clinical Trials Directive been a success?

The children’s age of autonomy, 7 years, was presumably set with the
child’s interests at heart. But, does such a young age always benefit the
child? Not all children will demonstrate such capabilities at such a young
age, and so who makes the decision as to who should have autonomy is very
important, yet usually made by the consulting doctor, who may have never
met the child before the consultation.

In a recent episode of Embarrassing bodies (Channel 4, Wednesday 7th
April 2010), a child of just 8 years was told by a doctor who they had
seemingly never met before, of the explicit risks entailed in a possibly
life saving procedure. Should the doctor have made the decision as to when
and how the child was told these explicit details? Or, should the parents
have made this decision.

On taking my own daughter, aged 7 years, for a swine flu vaccination,
as part of the UK children’s swine flu study, my daughter was clearly told
by the consulting clinician that the decision as to whether to participate
in the study and to have the vaccination, was her decision. She was then
asked whether she would like the jab. She said no. Whether vaccinating
against swine flu, is or is not, efficious might never be known. But, back
in September, my informed choice was to vaccinate my children by including
them within this study. I explained to my 7 year old my reasons for this
choice before taking her to the trial and she had agreed that she wanted
the jab. Could my 7 year old daughter may a more informed choice as to
whether the risks outweighed the benefits? Because, by asking her whether
she wanted to participate, this is what she was implicitly being asked. In
fact, my daughter had no qualms about participating in the trial, to this
day she wishes she had taken part. Her only concern was the fear of the
needle penetrating into her skin. For a 7 year old, this exaggerated fear,
at that very instance, prevented her from seeing the bigger picture.
Perhaps if she had not been asked whether she had wanted to participate,
she may have had the injection swiftly, like my 4 year old.

Is it always in the child’s best interests to hand over autonomy at
such a young age, or is this very minimum age being used too frequently?

Competing interests:
None declared