The government is updating the NHS Constitution. This includes adding extra detail laying out how peoples data will be shared and used for research. Patient data collected in the everyday running of the NHS is a valuable resource for researchers so these changes are important to funders of medical research.
AMRC plan to say:
- Patient involvement in decisions about care and treatment should include information and access to appropriate opportunities to be involved in research.
- Clear information about how data will be handled is welcome but putting this information in the NHS Constitution is not enough. People need to see how and why their data will be used and the safeguards in place to protect this personal information. Raising awareness of the constitution and providing supporting information will be vital.
We want to ensure we reflect your thoughts. Please let us know your comments on this and any further issues you think we should raise. You can download some background information and more detail on our planned response here. Send to me on firstname.lastname@example.org by 7 January 2013
The NHS Constitution is a summary of all the legal rights and duties that exist in legislation on patients, NHS staff and the public and what these mean in practice. It sets out the principles, values, rights and responsibilities that underpin the NHS and outlines what patients, staff and the public should expect and how they should act.
The Department of Health are planning to update the NHS Constitution to better reflect the legal framework. They also plan to raise awareness of the constitution, so people can access this information on what their rights and responsibilities are.
The government’s plans to update the Constitution were published on 5 November 2012 – A consultation on strengthening the NHS Constitution
The deadline for comments is 28 January 2012. Emailed to NHSConstitution@dh.gsi.gov.uk
The government are also planning a further consultation next year exploring how individuals can take action if their treatment does not match up to that promised in the Constitution; basically looking at how to give the Constitution teeth.
What are the proposed changes?
The government are planning changes in ten areas:
- Patient involvement
- Duty of candour
- End of life care
- Integrated care
- Patient data
- Staff rights, responsibilities and commitments
- Dignity, respect and compassion
The changes to the constitution around patient involvement and patient data are particularly interesting to medical research charities. As are steps to raise awareness of the Constitution and the information within it.
The NHS Constitution begins with a statement of seven key principles that guide the NHS. The government plan to make clear that the NHS not only conducts research but uses it to improve services for patients in Principle 3 The NHS aspires to the highest standards of excellence and professionalism to include:
and through its commitment to innovation and to the promotion, and conduct and use of research to improve the current and future health and care of the population.
AMRC plan to say that we welcome the additional recognition of the value of research and the findings of research to improve healthcare in the overarching principles.
The government plans a number of changes to reflect that patients own and manage decisions about their care. Commissioners now have a duty to promote the involvement of individuals, their carers and representatives in decisions about their own care and treatment.
The consultation asks – What are your views on the proposed changes to strengthen patient involvement in the NHS Constitution?
AMRC plan to say:
- We welcome the focus on patient involvement in decisions about their care and treatment.
- We will emphasise that this duty should include offering patients an opportunity to make informed decisions about taking part in research. The Constitution now includes a commitment to inform you of research studies in which you may be eligible to participate. For patients to be meaningfully involved in decisions about research studies, they must be given support and information to make an informed decision.
- We will therefore ask for clarification whether the promise: “you have the right to be given information about the test and treatment options available to you, what they involve and their risks and benefits” includes a right to information about opportunities to be involved in research where appropriate.
The government suggests changes to the wording of the Constitution to clarify how patient data is handled by the NHS within the current legal framework. They are not suggesting any changes to the law governing the handling of patient data.
Information about patients is routinely collected by the NHS to support individual care and to deliver and improve health and care services.
This data is very valuable for:
- Providing each individual with the care they need
- Sharing appropriately with other providers of social care and welfare to ensure each individual receives the care they need
- Conducting research to improve care
Researchers might need access to patient data:
- to find the most effective treatments and healthcare methods, and better understand the causes and frequency of conditions.
- to identify eligible individuals to offer them the opportunity to be involved in trials of new medicines and treatments.
Many patients are not aware that this information is collected, how their confidential data may be used and the opportunities they have to have a say over how it is handled. These updates seek to rectify this.
The constitution currently says:
you have the right to privacy and confidentiality and to keep your confidential data safe and secure.
You have a duty to protect the confidentiality of personal information that you hold unless to do so would put anyone at risk of significant harm
The proposed changes introduce the following:
Patients and the public – your rights and NHS pledges to you
You have the right to be informed about how your information is used.
You have the right to request that your confidential data is not used beyond your own care and treatment and to have your objections considered, and where your wishes cannot be followed, to be told the reasons including the legal basis.
The NHS also commits:
- to ensure those involved in your care and treatment have access to your health data so they can care for you safely and effectively (pledge).
- To anonymise the data collected during the course of your treatment and use it to support research and improve care for others (pledge)
- where identifiable data has to be used, to give you the chance to object wherever possible (pledge)
- to inform your of research studies in which you may be eligible to participate (pledge); and
- to share with you any correspondence sent between clinicians about your care (pledge)
Staff – your responsibilities
You have a duty to protect the confidentiality of personal information that you hold.
You should aim:
- to inform patients about the use of their confidential data and to record their objections, consent or dissent and
- to provide access to a patient’s data to other relevant professionals, always doing so securely, and only where there is a legal and appropriate basis to do so.
The consultation asks – Do the proposed changes to the NHS Constitution make clear how the NHS will safeguard and use patient data?
We plan to say:
- We welcome the changes made here – many of the difficulties around the handling of patient data for research arise from a lack of clarity over how this should be handled. The proposed changes provide a very clear summary of how personal information will be handled which will be good for patients and researchers.
- With this in mind, we would welcome further clarification of the definitions of the terms used: ‘confidential’ and ‘identifiable’
- We will emphasise that it is not sufficient to provide this clarification in the NHS Constitution. Patient data is personal information provided by patients, and it is important that patients trust those using their information, and trust that their wishes and confidentiality will be respected.
- To earn this trust it is important that people are supported to understand how and why their records may be accessed and their rights. In addition to the proposed changes to the Constitution we need:
- Awareness raising so people understand that sharing of data is relevant to them and where they can find information about this.
- Information about the benefits of sharing data in this way – the research this enables and how this can improve healthcare. A really good booklet, Health Records Save Lives has been produced but we need to do more.
- Information about the safeguards in place to protect peoples confidentiality.
- An opportunity to ask questions
- Information and support on how to find out more and raise objections
- The proposed changes include a right for patients:
- The proposed changes include a right for patients:
to request that your confidential data is not used beyond your own care and treatment and to have your objections considered, and where your wishes cannot be followed, to be told the reasons including the legal basis.
It is important that information is available for people to find out how to make this request should they wish to and health professionals are supported to answer their questions. It will also be important to provide information about the process by which their objections will be considered and, in cases where these wishes are not followed, clearly communicate the basis for this decision.
Raising awareness and embedding the NHS Constitution:
A survey in 2012 found that public awareness of the NHS Constitution stood at 27% and staff awareness at 54%.
The NHS Commissioning Board has a new duty to promote the Constitution, especially for staff awareness,
The consultation contains proposals to work with NHS bodies to develop detailed communication plans to raise awareness of the Constitution. These will aim to raise staff awareness first and build follow-through to public and patients, using points of contact already to share information.
The consultation asks – Have you seen further examples of good practice in raising awareness and embedding the NHS Constitution that should be taken into account in these plans?
Do you have further recommendations for re-launching, rolling out and embedding the Constitution from next spring?
We plan to say:
- It is important that people understand how and why their information is used. The detail in the NHS Constitution is a good step towards this but is not sufficient. Success in raising awareness of the NHS Constitution will be vital.
- It will also be important to provide supporting information explaining what the pledges mean and why they are important. In particular for the use of patient data for research – an important factor in earning people’s trust is not just to tell them how their data will be handled but also to provide further information explaining why researchers want to do this and how this will help them improve healthcare in future.
- Staff awareness is a valuable first step. Staff should be supported to answer questions about the commitments made in the NHS Constitution.
- Many patients have a good relationship with patient charities and support networks – it would be valuable to work with these groups to raise awareness of the Constitution.
AMRC will pull together all your thoughts to respond to the Department of Health by the deadline of 28 January. We are also developing a statement on the use of patient data for research, emphasising the importance of people being able to trust that those handling their personal information will respect their wishes and confidentiality and how we can move towards that.
Fiona Caldicott’s review exploring the balance between protecting the confidentiality of personal information and ensuring it can be shared to improve healthcare is due to report soon.
And all of this discussion is brought into focus by David Cameron’s announcement on Monday of plans to sequence the genomes of 100,000 people with cancers and rare diseases to combine this information with health data to help us better understand these conditions. This is a really welcome step but also raises questions about how this data can be safely and securely handled and kept confidential. Engaging with the public as these systems develop is going to be vital to underpin public trust.