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New report on improving access to patient data

Joseph Clift is a policy officer at the British Heart Foundation, one of AMRC’s member organisations.

As any regular readers of this blog will already know, there’s plenty happening in the world of patient data at the minute. We’re adding to the mix today with our new policy report, Clear and present data.

This is a really important research policy issue for the medical research community – not least the British Heart Foundation. We wanted to highlight to policy-makers just how the information in patient records can help to make life-saving discoveries – and how we can ensure this information is more readily available to researchers.

Background

In the report, we’ve highlighted some of the past discoveries in cardiovascular research made possible through patient data. Back in the 50s, Sir Richard Doll and Austin Bradford Hill looked at data from the hospital records of patients in London and were able to highlight the link between smoking and cancer – with further study establishing the link between smoking and heart disease. Other studies that looked at medical records later found the link between high blood pressure and heart disease – both life-saving discoveries.

Today, patient data from a large number of patients are necessary to help researchers find new links between lifestyle and disease or to identify a large group of people suitable for a clinical study. Within the UK, we should be at a particular advantage given the vast number of patient records that have been collected since the birth of the NHS – a potential data treasure trove for researchers.

We were interested to know how researchers are finding the process of obtaining access to patient data. We therefore went and surveyed just over 70 of our clinical and epidemiological researchers for their experiences – with several followed up by interview for a bit more detail.

What did our researchers tell us?

It was quite clear in reading the responses just how important the issue of access is, and in particular the frustrations they have experienced. Well over half of the respondents had seen some or considerable difficulty accessing data, including issues obtaining consent, inconsistency and duplication in the approvals process, and the sheer complexity of the legal framework.

The issue of ‘consent for consent’ – where patients give consent to be invited to take part in research – has been raised in a number of previous reports, most recently in the excellent Academy of Medical Sciences review of regulation and governance. It’s still a major barrier – 59 per cent of respondents to our survey identified it as such. Professor Sir Rory Collins, who was part of the working group on the Academy’s review, identified issues that he experienced within the Heart Protection Study – and more recently on UK Biobank, which was placed at serious risk due to delays around ‘consent for consent’.

The various governance involved at an NHS level was also widely criticised, in particular NHS R&D approvals. This was one of the central stumbling blocks that we highlighted in our response to the Academy’s review, and we welcomed their recommendation that these permissions become part of the remit of the new Health Research Authority (HRA). Unfortunately, the signs from the Government are that these will remain outside the HRA. This remains one of the key barriers researchers experience – and not only for those requiring access to patient data. We’re hoping as the HRA develops this will be reconsidered.

Added to these concerns is the somewhat nightmarish legal framework around patient data, which continues to cause confusion for researchers, for those deciding on requests for data, and of course for people that work in policy too!

The combined effect is an environment that is not facilitating the access to patient data that researchers need, leading to delays to projects and resultant costs – not just financial, but social too.

This is particularly frustrating when you consider that the public are broadly very supportive of sharing their data to help develop new treatments. Alongside the report, we’ve also asked YouGov to poll the UK public on the issue. 72 per cent said they would be happy to share their entire medical records with researchers under certain conditions, such as if the data were anonymised or key-coded (pseudonymised) – and an additional 7 per cent were happy for records to be shared with identifiable elements of the data left in.

It’s clearly vital that safeguards be in place to protect patients, but these do need to be proportionate to patient risk. We need to create an environment in the UK that protects the interests of patients while at the same time enables researchers to gain access to the data they need to help develop treatments that save lives.

What’s next?

The report makes 6 recommendations for the UK Government to take forward, which can be summarised as the following:

  1. Ensure the new EU Data Protection Regulation is facilitative of accessing patient data for medical research

This is due to hit the European Parliament later this year, and we’ve supported a joint statement coordinated by the Wellcome Trust on the issue. Some of the provisions in the draft regulation could really improve data protection requirements for researchers, but other aspects need to be clarified.

  1. Eliminate duplication of approvals for patient data and streamline existing governance

The HRA is already set to take on the functions performed by the NIGB around identifiable data, and we think it is perfectly placed to reduce and streamline the multiple approvals researchers must go through at present for accessing data.

  1. Following passage of the EU Data Protection Regulation, provide a clear legal framework for accessing patient data for research

There needs to be a serious effort to clarify and simplify the legal framework, and we think the Government needs to lead on this in collaboration with the Information Commissioner, HRA, and key stakeholders.

  1. Change the NHS Constitution to introduce an opt-out system for use of anonymised data in research

As announced at the end of last year, the Government has committed to consult on this issue, which received overwhelming backing from the researchers we surveyed. This is an important change that would really help researchers that use this type of data.

  1. Replace the system of Caldicott Guardians with one of centralised approval

Dame Fiona Caldicott is currently leading an independent review of the balance between protecting patient information and its sharing, with recommendations to the DH expected by the end of the year. We believe the role Caldicott Guardians currently perform in approving use of identifiable patient data is unnecessary given the other checks in place. We agree with the Academy’s recommendation that they should focus instead on facilitating release of data to research studies that have gained the necessary approval.

  1. Bring NHS R&D permissions within the remit of the HRA

We were disappointed that, contrary to the Academy’s recommendations, the Government decided not to include this within the function of the HRA. This remains a key problem for researchers, not only for those requiring access to data, and we’re recommending this be reconsidered as the HRA is developed in primary legislation.

You can view the full report at www.bhf.org.uk/patientdata, including a short film we’ve produced on patient data, and find out more about our research at www.bhf.org.uk/science. The Times cover the launch of the report today NHS red-tape is strangling life-saving medical research (£)

There are plenty of opportunities coming up in the coming months for the Government to address many of these issues, and we’ll be looking at how we can work with the AMRC and others to help to ensure researchers can access this life-saving information.

Comments

Sharmila Nebhrajani, AMRC chief executive, has responded to the report on our website:

"The 124 member charities in the Association of Medical Research Charities (AMRC) collectively spend £1bn on medical research projects every year - projects funded by donations from patients, carers and families. It really is the patient voice in research. We welcome this BHF report which helps to develop the thinking on how best to use patient data to support research in the UK.

What's really interesting about this report, and the other analysis in this area, is that researchers and patients actually want the same thing: clear, streamlined access to patient data to speed medical advance. And the report's conclusions support our own observations across the charitable sector which show that 80% of patients polled would like to be offered the opportunity to allow researchers access to their data. In fact just recently, out of 1.2 million women contacted to take part in an Ovarian Cancer Screening Trial only 32 individuals objected to that contact.

So - patients understand the value of their data and want researchers to have access to it in order to support medical research. Now we need a proper framework that balances that access with safeguards on confidentiality and security. There are lots of initiatives underway right now - the Caldicott Review, the adoption of the EU regulation and coming up, the consultation on patient data in the NHS Constitution. All are welcome but they need quickly to lead to a clear and pragmatic legal framework that simplifies and streamlines the use of data and that ensures that consent issues are tackled in a sensible and proportionate way. These issues around the use of patient data have been around for quite a long time - the Academy of Medical Sciences produced their report on patient data tackling many of the same issues - more than six years ago. We need to devise a workable system now that finds a way that balance the risks of doing research with the very real risks to patients of not doing that potentially life saving research."

http://www.amrc.org.uk/news_2012_response-to-bhf-report

Absolutely agree with this article on the importance of improving and streamlining NHS R&D approvals. Like you, I hope that the Health Research Authority (HRA) will eventually take this on. Above all, regulators should be framing their guidelines in terms of what is in the overall best interests of the patients. I simply cannot believe that, when consulted about such processes, patients themselves felt that this was an appropriate, engaging and effective way to enable research to be conducted.