A STATEMENT BY THE ROYAL FREE
AND UNIVERSITY COLLEGE MEDICAL SCHOOL AND THE
ROYAL FREE HAMPSTEAD NHS TRUST
We are
entirely satisfied that the investigations
performed on the children reported in the
Lancet paper had been subjected to
appropriate and rigorous ethical scrutiny.
Because the nature of the condition affecting
child behaviour and gastroenterological
symptoms was unknown and required
elucidation, the investigation of these
children was properly submitted to and fully
discussed by the Ethical Practices Committee
at the Royal Free Hampstead in 1996.
Specifically, that committee was a
sub-committee of the then Camden and
Islington Health Authority Research Ethics
Committee (subsequently incorporated into the
new Central Office for Research Ethics
Committee arrangements) whose decisions were
independent of the university and hospital.
The committee, after clarifying a number of
issues including that the children’s
investigations were defined by the clinical
symptomatology and diagnostic requirements,
and having taken expert advice, approved the
protocol submitted.
The
clinical management and investigation of
these children was performed at the Free by a
dedicated team of consultant paediatric
gastroenterologists, in full consultation
with and agreement of the parents of the
affected children. The investigations were
those thought appropriate in the light of the
severity of the children’s symptoms
according to the clinician’s judgment at
the time.
Had the
advice of the Institutions been sought at the
time concerning conflict of interest, they
would undoubtedly have advised that any
potential conflict should be declared, so
that others could judge whether such
conflicts were real.
Professor Humphrey Hodgson
Vice-Dean and campus director,
Royal Free and University College Medical
School