Evidence submitted by the Wellcome Trust
1. The Wellcome Trust is the largest charity
in the UK. It funds innovative biomedical research, in the UK
and internationally, spending around £500 million each year
to support the brightest scientists with the best ideas. The Wellcome
Trust supports public debate about biomedical research and its
impact on health and well being.
2. The Wellcome Trust considers that the
use of electronic patient records offers huge benefits in improving
patient care and safety and that a secure system of access for
biomedical researchers should be seen as an integral part of patient
record use that contributes to these patient improvements.
3. One of the unique selling points for
biomedical research in the UK is access to a National Health Service
(NHS) with more than 50 million users. The National Programme
for IT (NPfIT) being delivered by Connecting for Health (CfH)
bring patient data into an electronic
format, enhance patient safety and take patient care into the
provide an individual electronic
care record for all England's 50+ million users, securely accessible
to patients and their carers;
enable researchers to access patient
health information that is comprehensive, standardised, accurate,
up to date and can rapidly be analysed on a large scale; and
help to ensure that the UK maintains
and builds on its global lead in biomedical research, attracting
inward investment from the bio-pharmaceutical research sector.
4. Developing an appropriate infrastructure
to enable secure access for biomedical researchers to NHS data
is something the Wellcome Trust supports and we are committed
to working, in partnership with others, to develop a programme
of e-health research activity using electronic patient data, including
that available through the NHS Care Records System. The forthcoming
Research Simulation Report of the UK Clinical Research Collaboration
(UKCRC) R&D Advisory Group to CfH is highly relevant here
and we would recommend that report to this Committee when it is
published in March. Richard Jeavons, Director of IT Service Implementation,
CfH and Sally Davies, Director General for Research and Development,
Department of Health were the sponsors of this report.
5. Establishing public confidence and support
for the use of electronic patient records in patient care, for
patient safety and for research, is a key priority and needs to
be given further attention. From work recently commissioned by
the Wellcome Trust we found that public awareness of the use of
electronic patient records is low and there is a limited amount
of research to understand public opinion in this area. Further
research needs to be done to inform policy decisions.
What patient information will be held on the new
local and national electronic record systems, including whether
patients may prevent their personal data being placed on systems
6. The UK Clinical Research Collaboration
(UKCRC), of which the Wellcome Trust is a member, has recently
commissioned a series of research simulation exercises to scope
out what the research requirements for patient data available
from the NPfIT are that would enable a wide range of public health
research to be undertaken. The Report of Research Simulations,
due to be published in March, will set out a number of recommendations
pertinent to this inquiry including what research can be done,
and the health benefits that can be realised, with anonymised
data. It will also give examples of where the use of identifiable
data will be beneficial for public health. The recommendations
Inform future development of the
NHS Care Records Service (NHS CRS).
Highlight technical, regulatory and
Inform plans for any further simulations
and full pilots to test the capacity of the infrastructure, using
real patient data with appropriate safeguards when this becomes
7. The Wellcome Trust would recommend this
report to the Committee and considers that a presentation of its
findings from Professor Ian Diamond (Chief Executive of the Economic
and Social Research Council (ESRC) and the Chair of the UKCRC
R&D Advisory Group to Connecting for Health) would be highly
relevant to the scope of this inquiry.
8. The Care Record Development Board (CRDB)
Working Group on the Secondary Uses of Patient Information is
also preparing a report that will make a number of recommendations
on consent and governance issues. The Wellcome Trust would welcome
further work to improve the guidance for researchers in this area.
Who will have access to locally and nationally
held information and under what circumstances
9. Biomedical researchers should be seen
as core, not secondary, users of patient records. Active research
use of patient data improves the quality of the patient record
and subsequent patient safety and care. An electronic record and
the use of unique identifiers enable large-scale studies to be
undertaken integrating data from different sources to answer questions
important for public health.
10. For example a study in Denmark cross
referenced data on the Danish Civil Registration System, which
assigns a unique identification number to every live-born infant
and new resident in Denmark, with MMR-vaccination status obtained
from the Danish National Board of Health and combined that with
children's autism status obtained from the Danish Psychiatric
Central Register. This study, on more than 500,000 cases, provides
strong evidence against the hypothesis that MMR vaccination causes
11. In a study in Scotland researchers used
linkage of national pregnancy and perinatal death registries to
undertake a retrospective cohort study of more than 130,000 women
having a second birth in Scotland whose first infant was liveborn.
This study, unable to be undertaken by any other method, indicates
that complicated first births of liveborn infants are associated
with an increased risk of unexplained stillbirth in the next pregnancy.
12. The UKCRC R&D Advisory Group to
CfH Research Simulation Report will cover these areas in some
Whether patient confidentiality can be adequately
13. The UKCRC report and the CRDB Working
group on the Secondary Uses of Patient Information report both
make recommendations in this area and in deciding the appropriate
governance structure to allow access for researchers to patient
information a balance will need to be struck between preserving
individual confidentiality and establishing practical mechanisms
to enable public benefit research to be undertaken.
14. The Wellcome Trust has recently commissioned
a research team from the University of Surrey to undertake a study
on "Understanding Public Perspectives on the Governance of
Biomedical Research: a qualitative study in a deliberative context".
This report is currently undergoing peer review and will be completed
and published after this.
15. From this work, and in a recent survey
of public attitudes on the use of identifiable medical data from
the National Cancer Registry published in the British Medical
it is clear that there is strong public support for medical research,
particularly for research into cancer. There appears to be little
evidence to support the policy position that the public will prioritise
privacy over the use of their patient records for health research.
16. Therefore, it would appear that more
engagement with the public is required to understand public attitudes
to the use of their records for research; otherwise there is a
danger that an overly restrictive governance framework is put
in place that prevents the full range of beneficial health research
to be undertaken.
How data held on the new systems can and should
be used for purposes other than the delivery of care eg clinical
17. Recent reports from the Council for
Science and Technology
and Academy of Medical Sciences
have highlighted the potential of the CfH programmes for accelerating
our knowledge and understanding of health and disease and improving
the potential for conducting public health research on a national
18. If the development of the CfH programmes
engages researchers appropriately then it will provide research
opportunities in the following areas:
Improved understanding of patient
epidemiology and disease burden/unmet needs (especially when linked
with disease registers, hospital episode statistics, Local Service
Exploring the underlying causes of
ill-health and health damaging behaviour from links with non-health
data (eg housing, economy, environment).
improved analysis of the effectiveness
of different interventions/treatments (eg new vaccination schedules,
screening programmes, devices etc).
All of the above by specific groups
(by age, geography, ethnicity).
Health Services Research
Improved analysis of effective service
delivery systems through linkages with other information such
as clinical audit data.
Clinical Trials and Pharmaceutical Development
Improved feasibility study and identification
of the target size of a disease population.
Recruitment of suitable patient groups
Potential to directly link NHS records
into a clinical trail database.
event reporting (identification of side effects, drug interactions
and rare events).
When combined with information from
cohort studies, use of platform technologies and other developments,
the patient data available through the Secondary User Service
could improve our understanding of the heterogeneity of diseases
and population, accelerating the move towards pharmacogenetics/personalised
19. Following the UKCRC research simulation
exercise one of the emerging recommendations is to build on the
existing databases and clinical registries that currently provide
a valuable resource to biomedical research in the UK using electronic
patient records. For example, the General Practice Research Database
(GPRD) and Q-Research as well as a number of ongoing population
and cohort studies. The information on the Secondary User Service
will add to this data but is not able to provide a complete solution.
Therefore, there is a need and a real opportunity in the UK to
develop a federation of databases that can link and integrate
patient information, in a secure format to provide a more comprehensive
and effective research service for public health.
20. The Wellcome Trust is committed to working
with others in developing a roadmap to set out the physical and
governance infrastructure for research using electronic patient
records under an "e-health" programme banner. In developing
such a roadmap all appropriate stakeholders in both academic and
industry research will need to be engaged as well as taking into
account the need to ensure patient confidentiality and maintain
public support for biomedical research.
21. We would support the development and
fund the research that would use such a service and would look
to Government to provide a similar commitment within the next
Comprehensive Spending Review to provide the resources to put
in place the infrastructure to deliver such a research service
including data on the Secondary User Service.
Current progress on the development of the NHS
Care Records Service and the National Data Spine and why delivery
of the new systems is up to two years behind schedule
22. No comments to make.
Director, The Wellcome Trust
16 March 2007
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