Memorandum submitted by Dr Christopher
Verity, Ms Lesley Stellitano, and Ms Anne Marie Winstone (SAGE
Response from team performing two UK-wide health
surveillance studies via the British Paediatric Surveillance Unit
We are a team of three working at Addenbrookes
Hospital in Cambridgea paediatric neurologist, a research
nurse and a study co-ordinator. We are carrying out two studies
in UK children via the monthly surveillance card that is distributed
to all UK Consultant Paediatricians by the British Paediatric
Surveillance Unit, which is based in the Royal College of Paediatrics
and Child Health. Both of our studies are funded by the English
Department of Health. They are:
1. The study of progressive intellectual and
neurological deterioration (PIND) that started in 1997 to detect
any children in the UK with variant CJD and is scheduled to continue
2. The study of Guillain-Barre/Fisher syndrome
that started in September 2009. This is the study that is relevant
to the Science and Technology Select Committee at present.
The Guillain-Barre/Fisher syndrome (GBS/FS)
This study was set up to identify all UK children
developing GBS/FS, a possible complication of swine "flu"
disease and of swine "flu" vaccination. There had been
concern about the association between GBS and swine "flu"
vaccination in the USA in 1976, to the extent that the swine "flu"
vaccine was then withdrawn.
In the context of the H1N1 pandemic and the
need to vaccinate those at high risk in the population the Department
of Health funded the surveillance. This was discussed in a meeting
of the Joint Committee on Vaccination and Immunisation when all
four UK Chief Medical Officers were present and was strongly supported.
The study is being performed jointly with Professor Elizabeth
Miller of the Health Protection Agency (HPA). It is necessary
for us to obtain identifying information about the children that
are reported to us so that we can share this with Professor Miller's
team at the HPA and thus obtain accurate information about any
vaccines administered to these children.
In view of the public health urgency of this
study it went through a "fast-track process" in order
to get it under way. We started this process at the end of July
2009. The process was complex and whilst some of the steps were
taken quickly others were much slower and more time consuming.
This can be summarised below:
1. We thought that the British Paediatric Surveillance
Unit (BPSU) process was quick and efficient. We were not slowed
up at all by that.
2. Even though we were already experienced in
obtaining ethics consent and PIAG consent the IRAS (Integrated
Research Application System) form presented a major challenge
in terms of time and complexity. We were at it almost full time
for a couple of weeks.
3. The REC (Research Ethics Committee) consent
process was goodthere was a recognised fast track for getting
our application into the first available REC slot (in Derby on
03/09/09) and the chairman took action to ensure that we got approval
in time for the distribution of the BPSU monthly notification
card in September 2009. It helped that the PIND team had the time
to go to the REC meeting in person and the committee gave verbal
approval immediatelybecause we asked for it in the meeting!
REC approval is OK for all of the UK. This is the only part
of the process that has been streamlined and centralised for the
4. Initially quick NIGB (National Information
Governance Board) approval looked as if it might be a problem
because they did not have a committee meeting before the September
deadline. However after a few phone calls we clarified that we
would use the NIGB/BPSU application form rather than the IRAS
NIGB form and they did take it forward quickly, (19/08/09: NIGB/BPSU
meeting gave 1st approval pending REC approval, final NIGB approval
5. R&D (Research and Development) approval
is not that straightforwardour local R&D office led
on thisas is generally the case. There is no central R&D
mechanism. The local R&D office was happy to support the study
when REC approval had been obtained. However they took advice
from the DH and were told that they had to inform all R&D
offices in England. R&D approval is different for Wales and
our R&D dept led on this, but Northern Ireland and Scotland
were different (see below). We were still getting a trickle of
queries from English R&D offices in May 2010. Annual monitoring
forms continue to arrive from all the R&D offices.
6. R&D approval and NIGB approval are not
covered by Northern Ireland and Scotland. Whilst the Chief Medical
Officers for both were supportive there is no central mechanism
for these in either country. We had to approach all four Trusts
in Northern Ireland and 14 health board Caldicott guardians in
Scotland to obtain consent to share identifying data without parental
approval and to get R&D consent. Different people dealt with
these things in different sites and in different ways (sometimes
several different forms had to be filled in for the same health
board!). In Scotland we also had to go to the CHI (Community Health
Index) committee for approval after obtaining consent from all
the health boards. We obtained the final approvals from Scotland
in February 2010 (five months after England and Wales).
These are our conclusions, based on our experience
of setting up and running these two studies. Whilst some processes
are more streamlined than they were, particularly in England,
the bureaucracy involved in getting consent for a health surveillance
study of national importance means that it was not possible to
establish our UK-wide surveillance in a timely manner. Even though
we were already experienced in obtaining the relevant approvals
it took us seven months before we obtained consent to carry out
the study in the whole of the UK.
Dr Christopher Verity
Consultant Paediatric Neurologist
Ms Lesley Stellitano
Public Health Researcher
Ms Anne Marie Winstone
Public Health Researcher
PIND/GBS Research Team
6 September 2010