Today the Department of Health has published plans to update the NHS constitution and is asking for our comments.
The proposed changes include some that are valuable for medical research: they make it clear how patients can expect their data to be used to improve healthcare and to offer them opportunities to take part in trials of new drugs and treatments.
Researchers need access to patient data if they are going to study the causes of disease, and to identify patients in order to invite them to take part in trials of new drugs and treatments.
At the moment the regulatory system is very complex and most patients are not aware how their data is handled and the safeguards in place to protect their confidentiality.
Clearly we need to improve the system in order to increase the opportunities for people to take part in research, and to help the 72% of people that told us they want to be involved in trials of new medicines or treatments.
There’s a good deal of work already under way to develop systems which enable research while maintaining people’s confidentiality, including the creation of the Clinical Practice Research Datalink.
We will respond to the consultation, making a strong case for the government to do more to ensure all NHS patients understand how and why their information is used. We have to get this right to enable research that will benefit people while respecting their confidentiality.
The NHS Constitution outlines what staff, patients and the public can expect from the National Health Service.
It includes important commitments on research
3. The NHS aspires to the highest standards of excellence and professionalism:
…through its commitment to innovation and to the promotion and conduct of research to improve the current and future health and care of the population.
Providing information to support choice is a major priority for the NHS.
Important developments to the handbook that supports the constitution include:
Procedures to ensure that patients are notified of opportunities to join in relevant ethically approved research and are free to choose whether they wish to do so. Research is a core part of the NHS. It enables the NHS to improve the current and future health of the people it serves. The NHS will do all it can to ensure that patients, from every part of England, are made aware of research that is of particular relevance to them.
Access to patient data for research is vital to help deliver these commitments. Researchers use data to:
- better understand the causes and frequency of conditions to find the most effective ways to care for people and improve healthcare.
- to identify individuals with a particular condition and offer them opportunities to be involved in trials of new medicines and treatments.
In the Strategy for UK Life Sciences, the government committed to improve access to patient data for research. This included considering changes to the NHS Constitution to clarify how each NHS users data will be accessed and how they would be invited to take part in research relevant to them.
We will support patients to have access to novel treatments, and be part of the development of wider patient benefits by consulting on an amendment to the NHS Constitution so that, whilst protecting the right of an individual to opt out, there is a default assumption that:
- data collected as part of NHS care can be used for approved research, with appropriate protection for patient confidentiality; and
- patients are content to be approached about research studies for which they may be eligible, to enable them to decide whether they want a discussion about consenting to be involved.
What is the government proposing?
The government is proposing amendments in ten areas of the constitution: patient involvement; feedback; duty of candour; end of life care; integrated care; complaints; patient data; staff rights, responsibilities and commitments; and dignity, respect and compassion.
The revisions on patient data clarify existing legal rights that patients have, and reflect the parallel information governance review by Dame Fiona Caldicott
There has long been a concern that clinicians were being advised that the best way to protect patient data was to refuse to share it, even with other clinical experts. The revised constitution makes a commitment that the NHS will:
‘anonymise the data collected during the course of your treatment and use it to support research and improve care for others (pledge)’ (Section 2a – p7)
There has also been a concern that patients are not aware of the steps available to make their data private and confidential. The revised constitution also makes clear that:
‘where identifiable data has to be used, to give you the chance to object wherever possible (pledge) ’ (Section 2a – page 7)
Why is this so important?
This revision to the NHS constitution is vital as it allows patients to benefit from research using their data. We know that patient data saves lives.
The deadline for responses is 28 January 2013.
The updated constitution will be published by 1 April 2013, when the majority of new organisations in the NHS take on their full functions. Alongside this, the Department will publish a Handbook to the NHS Constitution and a new Statement of NHS Accountability.
AMRC will respond to the consultation and will also develop a new statement on the use of patient data for research.