1.  EXECUTIVE SUMMARY

  1.1.  The UK Clinical Research Collaboration (UKCRC) is a partnership of organisations working together to establish the UK as a world leader in clinical research. The UKCRC brings together the key organisations that shape the clinical research environment and includes the main UK funding bodies, academia, the NHS, regulators, patients and industry. Its key drivers are to improve national health and increase national wealth.

  1.2.  We have a unique opportunity to access data from a National Health Service (NHS) providing healthcare to a population of more than 50 million patients in order to conduct high quality research for patient benefit. This opportunity has been identified by numerous stakeholders as a unique selling point for health research in the UK and one in which the UK should be in a position to take a global lead.

  1.3.  If this is to be achieved we need to ensure that the NHS Care Records Service (CRS) is developed in a way that facilitates high quality research and we also need to ensure that robust and transparent mechanisms are in place to protect the rights, safety and dignity of the people whose data is held on the NHS CRS.

  1.4.  The UKCRC R&D Advisory Group to Connecting for Health (CfH) was established under the sponsorship of Professor Sally Davies, Director of Department of Health Research & Development Directorate and Richard Jeavons, Director of Implementation for CfH. Chaired by Professor Ian Diamond (CEO of Economic and Social Research Council) the role of the Advisory Group is to consider the feasibility of using the NHS CRS to conduct high quality research for patient benefit. The Group have recently commissioned a series of simulation exercises to investigate the feasibility of using the NHS CRS as a platform for health research. The resulting report considers the technical, operational and governance issues that need to be addressed in order to facilitate high quality research for patient benefit. It demonstrates the immense potential that linked electronic records have to enable research across a very wide range of applications which will have the potential to impact positively on patient health and safety. The report includes recommendations for change and is currently being considered by the Group's sponsors.

  1.5.  In parallel with the work of the UKCRC R&D Advisory Group to CfH, complementary work has been conducted by a subgroup of the Care Records Development Board (CRDB) on secondary uses of patient data. This multi-stakeholder group, chaired by Sir Robert Boyd has concentrated on consideration of the appropriate governance arrangements needed to enable secondary uses of the data. Robust information governance will need to be responsive to the needs of research that relies on access to data that may need to be linked (using a unique identifier) at a patient level (identifiable data).

  1.6.  Facilitating access by the research and public health communities to electronic patient records has substantial benefits for patients and the health service. Since research shares a mission of improving patient care and patient safety it is integral to patient benefit. Access to patient data for this purpose should be considered a primary and not a secondary use.

2.  BACKGROUND

  2.1.  The UK Clinical Research Collaboration (UKCRC) is a partnership of organisations working together to establish the UK as a world leader in clinical research. The UKCRC brings together the key organisations that shape the clinical research environment and includes the main UK funding bodies, academia, the NHS, regulators, patients and industry. Its key drivers are to improve national health and increase national wealth.

  2.2.  The UKCRC was established by the Chancellor of the Exchequer in his 2004 Budget and the Partners have been working together for a little over two years focusing activity on five main areas: Building up the infrastructure for research in the NHS; Building up the research workforce; Developing incentives for research in the NHS; Streamlining the regulatory and governance environment; and Coordinating research funding.

  2.3.  Key achievements over this period include:

—  Establishing a UK-wide infrastructure within the NHS to underpin clinical research, the UK Clinical Research Network (UKCRN).

—  Launching a £134 million coordinated initiative to build a national framework for experimental medicine research, supported by a range of funders.

—  Agreeing major initiatives to streamline the regulatory and governance environment and starting to implement change.

—  Developing, funding and implementing a new integrated and flexible training pathway for clinical academics.

—  Carrying out the first ever UK-wide analysis of health research funding.

—  Developing a joint £20 million initiative to fund Public Health Research Centres for Excellence in the UK.

  2.4.  An important part of the UKCRC's work is to promote cultural change and develop new ways of working, in particular with the bioscience, healthcare and pharmaceutical industries.

  2.5.  In 2006 the UKCRC commissioned McKinsey and Company to carry out a study in order to build on the work of Pharmaceutical Industry Competitiveness Task Force and Healthcare Industry Task Force to identify those factors that could make the UK unique internationally for later phase clinical research in the eyes of the bioscience, healthcare, devices and pharmaceutical industries.

  2.6.  The study concluded that if UK plc, and its National Health Service, aspires to be a leader in commercial clinical research it must develop a distinctive value proposition, namely—'A single system that reliably delivers distinctive quality and rapid access at reasonable cost'. A key part of this aspiration would be Industry's ability to access patients and expertise at the right pace, through a comprehensive and flexible healthcare IT system. Building on the asset of a single national healthcare provider, the UK could create the world's largest integrated patient record IT system.

3.  INTRODUCTION

  3.1.  In January 2006 the Department of Health in its research strategy[62] made a commitment to ensure that data collected via the NHS Care Records Service (NHS CRS) and supporting infrastructure could be harnessed to meet the needs of the research and public health communities to confer benefits for the UK. "...The National Programme for IT transforming our ability to recruit patients to clinical trials and gather data to support work on the health of the population and the effectiveness of health interventions... " www.dh.gov.uk/researchstrategy

  3.2.  At the same time reports from the Council for Science and Technology[63] and the Academy of Medical Sciences[64] highlighted the potential of the NHS CRS to accelerate our understanding of health and disease by enhancing public health research on a national scale.

  3.3.  The UKCRC R&D Advisory Group to Connecting for Health (CfH) was formed under the sponsorship of Professor Sally Davies, Director of Department of Health Research & Development Directorate and Richard Jeavons, Director of Implementation for CfH. The Advisory Group chaired by Professor Ian Diamond (CEO of Economic and Social Research Council) commissioned a series of simulation exercises to investigate the feasibility of using the NHS CRS as a platform for health research and examine the technical, regulatory and governance issues raised by areas of health research that use patient data.

  3.4.  The report of these simulations is currently in draft format and will be available later this month. It demonstrates the immense potential that linked electronic records have to enable research across a very wide range of applications which will have the potential to impact positively on patient health and safety and makes a number of recommendations around data quality, data availability and data access as well as recommendations that highlight the need for engagement with the National Programme for IT (NPfIT) advances made in other parts of the UK.

  3.5.  Our focus in this response is therefore on the research aspects of the Committee's Inquiry and our submission concentrates on the three most relevant areas of your terms of reference: Who will have access to locally and nationally held information and under what circumstances; Whether patient confidentiality can be adequately protected; How data held on the new systems can and should be used for purposes other than the delivery of care e.g. clinical research.

4.   Who will have access to locally and nationally held information and under what circumstances?

  4.1.  Whilst medical records are obtained to support and improve individual patient care, there is a wider use for these records. These are often described as secondary uses. The secondary uses that we wish to discuss in our response are to support and improve public health and treatment using evidence from research.

  4.2.  The benefits of research using patient data include enabling more evidence based practice in the NHS (improving quality and safety of care) and evidence based policy (including public health policy).

  4.3.  The draft report of the UKCRC/ CfH research simulations which is likely to address these issues will be available next month.

5.   Whether patient confidentiality can be adequately protected?

  5.1.  In parallel with the work of the UKCRC R&D Advisory Group to CfH, complementary work has been conducted by a subgroup of the Care Records Development Board (CRDB) on secondary uses of patient data. Whilst the remit of this working group is wider than research, many of the issues raised by the secondary uses of patient data (initially provided for the purpose of personal care) are identical. There have been close links between these two groups.

  5.2.  The secondary uses working group was formed to advise the CRDB and through it the NPfIT, on how the potential for the National Care Record Service to support research, population health and NHS management can be realised in compliance with the Care Record Guarantee[65] and the secure and ethical use of patient records.

  5.3.  The terms of reference of this working group include consideration of anonymisation of patient data (removal of identifiers), direct communication with the public, professionals on behalf of the research and public health users of this data; and consent for the use of this data.

  5.4.  Whilst it is not appropriate to comment on specific aspects of recommendations in the draft report, it is likely to address issues of patient consent and anonymisation of patient data for secondary uses.

  5.5.  The report of this working group will be presented to the Patient's Tsar—Mr Harry Cayton, Chair of the Care Records Development Board and then published in April 2007. Harry Cayton was also chair of a Ministerial taskforce on the NHS Summary Care Record[66]. The report of this taskforce also makes some useful recommendations regarding patient consent.

6.   How data held on the new systems can and should be used for purposes other than the delivery of care eg clinical research?

  6.1.  Both the Council for Science and Technology and the Academy of Medical Sciences (AMS) reports outline in some detail the potential of the NHS IT systems to support research that seeks to understand disease and public health. The AMS report in particular considers the merit of research and the level of constraint on the use of health information.

  6.2.  Both the UKCRC simulations and the CRDB secondary uses reports discuss the need for robust information governance that is also responsive to the needs of research. This is particularly important as although much research can be conducted using information about patient groups rather than individuals, data may need to be linked and comprehensive at a patient level in order to have the maximal value. This process relies on the use of a unique identifier which in turn will require identifiable data to be accessible at some stage in the process.

  6.3.  Much discussion around enabling access to patient data for purposes other than direct individual care currently centres on the use of the Secondary Uses Service (SUS). SUS is being delivered as part of the CfH programme and is "... a system designed to provide timely, pseudonymised, patient-based data and information for management and clinical purposes other than direct patient care ...". The simulation report from the UKCRC will discuss opportunities to build on existing expertise to enhance the service to the research community from that currently proposed for the SUS.

  6.4.  There is a real opportunity to develop an enhanced infrastructure that can link and integrate patient information, in a secure format to provide a comprehensive service producing direct benefits for patients.

UK Clinical Research Collaboration

16 March 2007

63   Better use of personal information: Opportunities and risks (Council for Science and Technology, November 2005). Back

64   Personal data for public good: Using Health Information in Medical Research (Academy of Medical Sciences, January 2006). Back

65   Care Records Guarantee www.connectingforhealth.nhs.uk/crdb Back

66   Report of the Ministerial Taskforce on the NHS summary Care record www.connectingforhealth.nhs.uk/publications/care_record_taskforce_doc.pdf Back