Summary findings
This report focuses on using patient information to let patients know about research options. Health and care research has a number of strong safeguards that balance patient and public perspectives and aim to build public trust. These safeguards include the role of Research Ethics Committees and (in England and Wales) the Confidentiality Advisory Group. These safeguards are what make certain approaches possible in research; they do not necessarily apply to other secondary uses of patient information.
This report identifies that certain types of research form part of the care pathway.
Research can be part of the care pathway for a patient where the research is testing a treatment, or a diagnostic procedure, or a preventative measure that is relevant to the patient. Other sorts of research such as surveys, interviews or analysing data would never give individual care. Further detailed information is provided to define ‘research as care’.
People who are directly involved in providing, supporting or advising on individual care delivered through research have a legitimate relationship with the patient and should, in principle, be able to rely on implied consent to use identifiable confidential patient information to find and contact people about research, subject to certain conditions and safeguards being met. Further detailed information is provided on the boundaries of legitimate relationships and the safeguards that apply.
The report sets standards for registers where people sign-up to hear about research they can take part in, including approval of a Research Ethics Committee research database application. New arrangements will be put in place so that studies can adopt use of registers that meet the standards after regulatory approval without needing to submit an amendment for approval.
The report sets standards for digital intermediaries that offer services that can allow researchers to find potential research participants, including approval of a Research Ethics Committee research database application. New arrangements will be put in place so that studies can adopt use of digital intermediaries that meet the standards after regulatory approval without needing to submit an amendment for approval.
Implementing the findings and recommendations of this report does not require any change in legislation but should make a real difference to making it easier for people to have the choice to participate in research.
The importance of working in partnership with people and communities runs through the report. Building and maintaining public trust often requires considering the specific context - such as the nature of the research, the condition being studied, how the research interacts with NHS care, the level of sensitivity of the healthcare information, and how important people perceive the research to be. What readers take from the guidance, recommendations, and next steps in this report should be informed by an appreciation of that context and by recognising the essential role of ongoing public engagement and involvement in ensuring approaches remain trusted.
Executive summary
In February 2023, the UK government announced an independent review, led by Lord James O’Shaughnessy, into the UK commercial clinical trials landscape. The review aimed to support the life sciences sector to improve UK growth and investment opportunities and suggest resolutions to the key challenges in conducting commercial clinical trials in the UK. The report recommended that improvements to the methods for finding and contacting people about research should be found. It also suggested that there should be public consultation about how patient information could be used for research in a way that the public trust.
The government at the time accepted both recommendations. In May 2023 it asked the Health Research Authority (HRA) to work with its Confidentiality Advisory Group, the National Data Guardian, the Information Commissioner’s Office, DHSC and NHS England to:
- agree arrangements that simplify the processes to find and contact patients about research
- suggest how the public should be consulted about the use of patient information for research
- decide whether a change in legislation is needed to make it easier to find and contact people about research
This report was drafted by the HRA on behalf of, and for, the Recovery, Resilience and Growth Programme (RRG) Partners. The RRG programme has subsequently been replaced by the UK Clinical Research Delivery (UKCRD) Programme. The report makes recommendations for actions that aim to earn public trust and make it easier to offer people options to take part in research. The UKCRD Programme partners will determine which recommendations to accept and prioritise the recommendations for immediate action.
The HRA set up a small UK-wide project group including public contributors to advise on this work. This was a short piece of work that mostly involved interviews and reviewing earlier work. We are grateful to those who gave time for individual and small group discussions at short notice. Interview participants included researchers, clinicians in primary and secondary care, organisations supporting research and policymakers.
We started by drawing on the principles and hallmarks of people-centred research that the HRA has described with patients, members of the public and researchers. This helped us to describe key principles to earn public trust in the use of patient information for finding and contacting people about research. Those principles have then informed our work.
The project reviewed the existing law, taking account of the original intentions of existing legislation as shown in parliamentary debates. It also looked at academic work on confidentiality, consent, and research. Most of the academic work on patient and public perspectives asks for views about very broad uses of patient information for research and does not separate out views about different uses. The report tries to balance the different views and perspectives from patients and the public.
The report concludes that, in general, current legislation strikes the right balance between respecting privacy and enabling research that is in the public interest. The project found that there was not yet sufficient evidence of public support for changes in legislation to widen access to confidential patient information for the purposes of finding and contacting people about research. There is also a risk that the process of creating new legislation could have unintended consequences. New legislation could remove current safeguards and protections, which could harm public confidence in the use of patient information for research. Alternatively, legislation could become overly bureaucratic and burdensome, or limit future policy options. However, the project found that different interpretations of the law in certain areas could be clarified. This would make it easier for researchers to do the right thing, and for patients to understand how their information is used. There is separate work underway to revise the Health Service (Control of Patient Information) Regulations 2002 that applies in England and Wales primarily for non-research purposes. However, this may provide an opportunity to consider specific research purposes in line with the recommendations below.
Current policy highlights a distinction between use of a patient’s information to support their individual care, and what are called ‘secondary purposes’ including research. Before now there has been little guidance on when the rules that apply to use of patient information for ‘individual’ (also known as ‘direct’) care apply to research. This report clarifies the widely agreed concept that some types of research can (in certain circumstances) be part of the care pathway for a patient where the research is testing a treatment, or a diagnostic procedure, or a preventative measure. This means that those who are directly involved in providing, supporting or advising on the provision of such care through research can access patient information when it is necessary to support an individual’s current care or to plan their future care through research. In this report we refer to this type of research that is part of the care pathway as ‘research as part of care’ and ‘research as care’. Examples of research types that would never be capable of giving individual care, by contrast, include surveys, interviews or analysing data.
As part of this work the HRA has been working with the National Data Guardian and the devolved administrations to explore how to implement the concept of research as part of the care pathway. The aim of this wider work is to help make sure that there are consistent arrangements across the NHS that patients can trust and to resolve the different interpretations of the law. We are agreed that reasonable expectations are key to the common law duty of confidentiality.
We have also worked with colleagues in Wales on a public dialogue exploring expectations relating specifically to finding and contacting people about research. This helped to inform the conclusions of the report and provides a basis for further public engagement and involvement work.
In this report, we set out the HRA’s thinking around the necessary safeguards required to maintain public trust and clarify expectations under existing arrangements. These include reminding researchers why it is important to involve patients and members of the public in their research, drawing attention to how researchers need to think and work in people-centred ways when designing how they will find and contact potential participants.
This report also sets standards for registers for people to sign up to be contacted about research options, and for digital intermediaries that offer services that can allow researchers to find potential research participants. These standards will make sure that these services work in consistent ways so that researchers know how to make best use of them. These consistent standards will also make it easier for people to understand how their information is used by researchers and those with a legitimate relationship with patients for their care to help earn public trust.
Our project group had UK-wide representation, and we have tried to make sure that, where possible, this report is applicable across the UK. At the same time, legislation, policy and practice are different across the UK nations and so we recognise that each nation may need to make its own decisions in response to this report’s recommendations.
This report deals with complicated and technical matters that have not been resolved for many years. It is therefore both lengthy and detailed. Separate communications and activities following the report will draw out specific aspects for relevant audiences.