Lots of reports on research using health data focus on confirming that patients support the use of their information for research. But they often seem to disregard important caveats that patients have raised in the reports about wanting to choose whether their information is used. This report changes that emphasis. Drawing on analysis of work with the public, and on what the authors have heard over time from Research Ethics Committees and the Confidentiality Advisory Group, we describe key principles to earn public trust in the use of patient information for finding and contacting people about research.
These principles draw on the principles and hall-marks of people-centred research that the HRA has described with patients, members of the public and researchers.
The principles aim to earn public trust in research and the use of patient information for research (including finding and contacting patients about research). The proposals in this report address some of the causes of public mistrust of the use of patient information by the NHS and government. (Developing a Data Pact: The relationship between the public, their data, and the health and care system September 2023.The Patients Association). They are also informed by recent national public engagement on data use and access (National public engagement on the use of health and care data, NHS England). For example, NHS England’s 2024 ‘Principles of Data Use and Access’ public engagement programme (cohort 1) found that while the NHS is highly trusted overall, confidence is lower on data security and transparency. People were most supportive of data use when the benefits were clear and tangible - particularly for improving patient outcomes, supporting research, and enhancing services - and confidence increased when participants better understood the safeguards, governance arrangements, and principles underpinning data use.
- Research teams should involve relevant people when designing the methods for identifying and contacting people about research. In particular, researchers should find out from relevant people what safeguards matter to them including views on who should access their data (e.g. local or national access, clinical or non-clinical staff), the types of organisations involved, and whether AI systems are used. They should also consider how factors such as the severity of the condition or the sensitivity of the data influence levels of comfort and trust.
- It must be clear to people why, when, and how their information is being used, and whether it is in identifiable or non-identifiable forms.
- It is important that researchers are always clear about the balance of benefits, risks, and burdens of research. Research teams should avoid referring to ‘giving people the opportunity to take part in research’. Using language that refers to opportunity could give the message that research is always going to give a benefit. Instead, they should talk about ‘giving people options to take part in research.’
- When commercial organisations, or other organisations outside the NHS, take part in any step of the process of finding and contacting people about research, it must be clear and visible what the organisation’s involvement is and what data it has access to and why. It should be clear if any individual or organisation receives payment from a company.
- Wherever possible, people must be offered choices about the use of identifiable confidential patient information. There are only limited exceptions when it is legally possible to use identifiable confidential patient information where no choices can be offered.
- People should be able to feel comfortable about making a choice not to take part in research.
- When researchers use patient information to find and contact people about research, researchers should consider the quality of that information, and whether it is likely to be up-to-date, and tailor their approach appropriately. Researchers often express the importance of accessing medical records to check eligibility before approaching potential participants. However, medical records may not hold accurate eligibility information when patients are on a waiting list, or are awaiting diagnosis, or not accessing healthcare. Contacting people to ask about symptoms may be a more accurate method of checking eligibility.
- It is important to strike a balance between the efficiency of narrowing down the group of people that are contacted by searching against specific criteria, against the risk of missing out eligible people who do not have up-to-date information in their records.
- Research teams should assess whether the methods that they will use for finding and contacting people will restrict the diversity of those being recruited to their research. Where possible, research teams should also try to review the diversity of those being recruited, to check whether any potential participants are inadvertently being excluded.
- Feedback during this project showed that some patients may be uncomfortable that GPs or consultants might make assumptions about whether they should receive invitations about research. This would suggest that it is generally not appropriate or necessary for GPs or consultants to check whether their patients may be worried or mentally or physically unable to take part in research. This sort of gatekeeping can prevent research from being diverse and inclusive. Messages contacting people about research should proactively address possible concerns and offer methods for queries to be addressed.
- When people feel that their information has been used inappropriately, they should have somewhere to go to raise concerns. In the first instance this should normally be through the organisation holding the information that has been used to contact an individual.