Scientific advice and evidence in emergencies - Science and Technology Committee Contents

Memorandum submitted by Dr Christopher Verity, Ms Lesley Stellitano, and Ms Anne Marie Winstone (SAGE 06)

  Response from team performing two UK-wide health surveillance studies via the British Paediatric Surveillance Unit (BPSU).

  We are a team of three working at Addenbrookes Hospital in Cambridge—a 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 until 2013.

    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) study.

  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between GBS and swine "flu" vaccination in the USA in 1976, to the extent that the swine "flu" vaccine was then withdrawn.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 good—there 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 immediately—because 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 whole UK.

    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 given 08/09/09).

    5. R&D (Research and Development) approval is not that straightforward—our local R&D office led on this—as 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

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