Your say on our draft statement on access to patient data for research

Posted on April 17, 2013 by

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We are revising our statement on the use of patient data for research. Late last year we held a workshop bringing our members together with invited speakers to talk about public attitudes to the use of personal data, how the regulatory system should balance protecting patient confidentiality and ensuring valuable research can go ahead, and to discuss our position on planned changes to the system.

From this, we have now developed a draft statement and supporting briefing. We need you to tell us whether we have struck the right balance between protecting individual patients’ rights and enabling research to go ahead. Have we got the right calls, or are there other actions we should be calling for? We are making our draft statement public for you to take a look and feed back.

Please get back to me with your thoughts by 31 May 2013.

Download our draft AMRC statement on access to patient data for research for consultation.

What are we proposing to say in our statement?

Patient records are a valuable resource for health research. Access to the data in these records helps researchers better understand disease and develop treatments that can save lives.

Regulations governing use of these data in the past have been ambiguous and as a result it can be difficult for researchers to use them. We believe that it is possible to encourage the safe and secure sharing of these data to facilitate research whilst protecting patient confidentiality. This needs a simpler and more agile regulatory framework, a concerted effort to publicise the important role patient data plays in research and better systems and infrastructure that encourage data sharing whilst preserving their security.

Our Summary Statement

1. Patient data is valuable

Researchers have made life saving advances using patient data and patients want their data to be used.

  • Researchers use patient data to better understand trends in conditions and the outcome of treatments, for example identifying the link between smoking and lung cancer. And access to data allows researchers to identify patients to invite to take part in trials of new drugs. Trials which we know people want opportunities to be involved in – 72 per cent of 1000 adults surveyed in 2011 would like to take part in research trials.

2. Protecting confidentiality

We can access patient data in a way that both respects people’s rights and allows us to conduct publicly valuable research.

  • We believe that all anonymised patient data should be made freely available to researchers and that key coded data (so called pseudonymised) should also be similarly available to researchers provided that the key that breaks the code is held separately and securely.
  • Identifiable data should only be accessed with consent from the individual involved. Where research is very important and it is not practical or possible to get consent from everyone, we believe the Health Research Authority (HRA) can regulate access to identifiable data effectively but is must explain clearly to the public how it will do this so that people have confidence in research processes.
  • Data sharing technologies and the governing regulations need to keep pace with technological advance so people can continue to feel their confidentiality is protected.

3. Public understanding and choice

It is important that people can understand how their data is used and their confidentiality protected. We need:

  • The NHS to publicise the NHS Constitution and develop supporting information to clearly explain how people’s data will be handled and each person’s rights.
  • NHS staff to be given information and training to understand the guidelines around the use of patient data and their responsibilities.
  • Tailored resources to help answer patient’s questions available on NHS websites including NHS Choices and the UK Clinical Trials Gateway; for example the UK Clinical Research Collaboration leaflet Health records save lives should be distributed more widely in GP’s surgeries and pharmacists.

A better system is needed that encourages patients to be involved in research and allows them to choose how they would like to be. We need:

  • Patients to be approached to take part in research by trusted individuals, usually their GPs, who can provide further information and answer their questions. This information could be collated on the UK Clinical Trials Gateway.
  • Opportunities for people to self-refer their interest in taking part in research without contacting their GP. Information on how to do this should be linked with the UK Clinical Trials Gateway.

4. Improving the system

We need better systems and infrastructure that encourage data sharing whilst preserving their security

We need a simpler regulatory framework:

  • Focusing Caldicott Guardians on facilitating the delivery of research studies that have gained approval to use data, rather than being involved in the approval process.
  • The UK government to engage with Europe as data protection legislation is updated to ensure this supports safe and secure access to patient data for research.

We need standardised models for gathering and sharing data. We need:

  • Health Education England to equip NHS staff with the skills to handle and use data.
  • NHS England to promote best practice in the handling, use and sharing of data by Clinical Commissioning Groups and the providers they commission services from.
  • GPs to be required to share their data with the Clinical Practice Research Datalink (CPRD).
  • The Clinical Practice Research Datalink (CPRD) to be extended UK-wide and to link with other datasets so researchers can safely access the data contained within them.
  • The NHS to work closely with the many disease-specific registries that already exist to ensure researchers can access this data, including those developed for example by disease-focused charities.

You can download the full draft statement as a pdf here here.

What next?

We’d like to know your thoughts by 31 May 2013, please email them to me at b.purvis@amrc.org.uk. We will then use your comments to produce the final statement.

Fiona Caldicott has been conducting a review of the balance between protecting patient information and its sharing, to improve patient care. AMRC gave evidence to this review and it is expected to report shortly – including making some recommendations for how individual’s patient data should be handled for research.

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