AMRC has been invited to give evidence to the Caldicott review next Tuesday, 10 July, as they explore how and why researchers might need access to personal health information and patients’ views on this. This is our opportunity to represent the views of your supporters and patients.
The public tell us they want to be involved in research to improve healthcare, and they want opportunities to share their data to help achieve this – 80% of patients polled would like to be offered the opportunity to allow researchers access to their data. But central to public support for this research is confidence that this will be done as safely and securely as possible, with respect for everyone’s confidentiality.
We think three key areas need to be got right:
- We need a system which fully reflects the huge value of sharing personal health information for research and adopts a proportionate approach to enable this to go ahead.
- We need to get the regulatory system right for patients and researchers so we can all be confident that our personal information will be protected.
- We need to talk about this so everyone can take part in the discussion and make an informed decision about how their data is used.
Work is already underway to develop a system to deliver this and we want to see this moving forward. The Caldicott review is a crucial step to ensure we get this right.
Outlined below are some of the issues we plan to raise on the 10th. This is your opportunity to feed in too; we would like your thoughts. Can you tell us what your patients and supporters think about their data being accessed by researchers? Are they already taking steps to share their data? Or are they concerned about the consequences of personal information being seen by researchers?
As part of the new information Strategy for the NHS, the government has asked Dame Fiona Caldicott to review how we balance protecting personal health information with its sharing, allowing researchers to access it to improve patient care.
Dame Fiona has recruited a panel to help her conduct this review including Sir Mark Walport, Director of the Wellcome Trust, and Jeremy Taylor, CEO of National Voices.
The review panel kicked off with their first meeting in April and are now inviting organisations to give oral evidence. There is a full timetable of evidence sessions here. 10 July is focused on research , aiming to explore some of the issues around how and why researchers might need access to personal health information and what patients think about this. You can see all the areas they are hoping to cover on the 10th here.
What will AMRC talk about on the 10th?
AMRC will be there to represent the views of you, our members. As medical research charities, you have a unique relationship with your supporters and patients who donate money to enable research to go ahead. You represent the public who want valuable research to go ahead but may also be concerned over how and why their information might be used for research and the safeguards that are in place to protect them.
AMRC’s statement on the use of patient data for research (http://www.amrc.org.uk/news-policy–debate_policies-positions-and-briefings_policy–position-statements) summarises our position. Our evidence will build on this, reflecting recent progress. We will cover three areas:
- The value of sharing personal health information for research
- Getting the regulatory system right for patients and researchers
- Enabling the public to be part of the discussion and make an informed decision
I’ve outlined some of the issues we plan to raise below so that you can feed in your views and help us respond to the panel.
The value of sharing personal health information for research
With the details of almost every person in the UK, NHS patient records are a globally unique resource for researchers. Access to data about people’s health helps researchers find the most effective ways to care for them, and better understand the causes and frequency of conditions.
AMRC’s statement outlines our firm belief that while confidentiality should be respected at all times, the use and sharing of personal information for research purposes is an important foundation of the work that medical research charities support to improve health and wellbeing.
The All-Party Parliamentary Group on Medical Research is holding our summer reception the day after we attend the Caldicott review and it’s all about data. Lots of charity-funded researchers will be there to demonstrate how they are using data to improve healthcare.
1) Are you supporting any projects which will collect personal health information about individuals?
2) Have you been approached by initiatives or commercial companies coordinating data collection for research? Have you worked with them?
Getting the regulatory system right for patients and researchers
NHS patient records contain personal information about people’s health. This means that they must be handled very carefully and accessed safely and securely with regard for people’s confidentiality.
We need a system that we can all have confidence in to look after our data. But we also need a system which allows valuable research to go ahead; the current system is complicated, leading to inconsistency and delays without increasing security.
We welcome steps to develop an appropriate regulatory system that balances these two considerations. The Caldicott review is valuable in developing this system to ensure we get this balance just right.
2008’s Data Sharing Review made recommendations on how to improve the regulatory structure for research accessing patient records, including the creation of ‘safe havens’ to hold information and anonymise this for researchers to use, minismising the risk of identifying individuals. We supported these recommendations and when the Academy of Medical Science recommended how to improve the regulation and governance of health research in the UK, they re-iterated these. (page 68)
3) What are your thoughts on the current regulatory system?
4) Have you funded projects which have been limited in scope by the current regulations?
Work is already underway to improve the regulatory system. The government has set out its ambition to put life sciences at the core of UK growth and opening up access to data is at the heart of this. They have established the Clinical Practice Research Datalink and are proposing to move to an opt-out system of consent to simplify the system, protecting people’s confidentiality but opening up opportunities for them to be involved in research.
The different types of data a researcher may access include:
Identifiable data – includes information about the patient which identifies them such as name, address and NHS number.
Key-coded data (also known as pseudonymised) – no identifiable information is made available to the researcher using the data but a “key” held by a custodian can be used to identify the original patient record it comes from. This is useful when researchers want to link up with data held elsewhere about the same person or need data to be updated over time.
Anonymised data – all identifiable information is removed from the data. There is no information that could be used to find the individual that it comes from.
Researchers do not usually need to know the actual identity of the individuals involved.
The new Clinical Practice Research Datalink (CPRD) will link up patient records from GP and hospital care bringing together information on an individual’s entire journey through the care system. It anonymises this information for researchers to use.
The government is proposing a move to an opt-out system –a default assumption that patients are happy for their records to be used for approved research with appropriate protection for patient confidentiality, and patients are content to be invited to take part in research studies relevant to them unless they have chosen to opt-out of their data being used in this way. They will consult on this in the autumn. This move would mean patients have the opportunity to choose whether to be involved in research but difficult to access groups would not automatically be left out of research projects.
Patients choosing not to opt-out will have implicitly consented for their data to be included in the CPRD database.
5) It is really important for patients to be able to exercise their right to choose whether their records may be accessed for research and this could be achieved through the proposed opt-out. What are your views about such a move?
A move to an opt-out would make it easier to offer patients opportunities to be involved in research projects relevant to them. Currently, to recruit patients to research trials, researchers may need to look at information from medical records to find patients that are eligible to invite to take part in a clinical trial. However, if they need to see identifiable information, such as date of birth or postcode, patients must give their consent first. This leads to a situation where patients have to be approached to indicate that they are happy for a researcher to look at their records, and then approached again to invite them to take part in a trial. This leads to significant delays and can prevent important studies happening.
6) Do you think a move to implicit consent to be invited to take part in research studies would be welcomed by your patients and supporters? Do you have thoughts about how patients should be contacted?
We believe that for this consultation – or any future change to the NHS constitution – to earn public confidence, it should be accompanied by awareness raising so that every NHS user can understand how information about them might be used and have a say in any change.
7) How should we engage with the public to ensure they have a say in whether we move to an opt-out?
Enabling the public to be part of the discussion and make an informed decision
It is important that every NHS user can understand how information about them might be used and have a say in this.
Public opinion appears broadly in favour of researchers accessing patient records to improve healthcare.
- In 2009 a survey of 1,179 UK adults found that 74 per cent were willing to allow access to their personal medical records for medical research.
- An Ipsos MORI poll of nearly 1000 adults in 2011 found that 80 per cent would like their doctor to offer them the opportunity to allow a researcher confidential access to their medical records with no other involvement from them.
- The British Heart Foundation got a similar result when they asked just over 2000 people in a YouGov poll this year. 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 – and an additional 7 per cent were happy for records to be shared with identifiable elements of the data left in.
People are also keen to be offered opportunities to take part in research relevant to them – to offer this, researchers need access to their health records.
- An Ipsos MORI poll of nearly 1000 adults we conducted in 2011 found that 72 per cent would like to be offered chances to take part in research trials.
- Of 1.2 million UK women contacted to take part in the UK Collaborative Trial of Ovarian Cancer Screening, only 32 complained they had been contacted.
We held a workshop in May – Starting a conversation about the use of patient records for research – to explore how to raise public awareness about the use of patient records and what the main issues might be. This highlighted:
- Public attitudes – public attitudes to the use of patient records for research depend on how the question is framed. How the data may be used is particularly influential, for example concerns may be greater surrounding commercial involvement. These attitudes are changing rapidly with the advent of social media – e.g. facebook and google.
- Communiciation – If asked about a move to an opt-out system, will people understand what they are opting in or out of? There is a need for much greater awareness and information through multiple mediums to ensure everyone can make an informed choice. Individuals must be able to access as much or as little information as they wish. This information must be clear and honest about how personal data will be managed, the benefits, risks and options.
- What should an opt-out look like? – Is a simple opt-out sufficiently nuanced? Individuals may be concerned about some uses of their data but willing to opt in to other uses. But is a more nuanced approach practical or would it become difficult to understand and operate?
This discussion made it very clear to us that the words we use to talk about this research are very important. Anonymised, pseudonymised or key-coded and identifiable data; these are all good terms for researchers but do they mean much to everyone else? Getting the language right is key to making this discussion accessible, ensuring the public really understand how their data will be managed and can have a say in this, enabling us to develop a system we can all have confidence in.
8) Do you think the level of understanding of how patient records might be used for research is high/moderate/low/negligible among your patients and supporters?
9) Have you asked your supporters for their views on how their personal health information could be shared for research? Have you discussed the benefits and risks of sharing this information with them?
10) Are you aware of your supporters proactively seeking opportunities to share their health information?
11) Have your supporters expressed concerns about their data being shared? How can these be addressed?
We can send supplementary information in addition to the oral evidence session on the 10th so please share as much information as you can with us.
We will gather your responses to inform the evidence we give on 10 July.
Ahead of the consultation on the NHS constitution expected in the autumn, AMRC intends to work with you to revise our statement on the use of patient data for research and develop a joint statement we can all support –much as we developed a cross-medical research community statement on research during debate of the Health & Social Care Act 2012 which gave us a powerful joint voice. This will give us a louder voice in the discussion and give us a good starting point to coordinate a joint response to the consultation when it is launched.