We’ve published a new report on the legal, policy and ethical issues in using patient information to find and contact people about taking part in health and care research.
This work follows recommendations from Lord O’Shaughnessy’s independent review on commercial clinical trials in the UK, which called for clearer arrangements to make it easier for patients to hear about research options in ways that are trusted and transparent.
The Department of Health and Social Care (DHSC) commissioned the HRA to establish a common approach to contacting patients about research, as set out in the Government’s response to the Lord O’Shaughnessy review.
This report addresses the issues raised by that commission. It does so by setting out position statements to resolve key questions, and by making recommendations and outlining actions where further work is needed.
This builds on earlier thinking set out in our blog 'can we make it easier for people to hear about research this is relevant to them?', which raised many of the issues explored in this report.
We have taken those ideas further, providing detailed guidance and clear operational standards for sponsors, NHS organisations and researchers.
In our report we conclude that changes to legislation are not needed, but that clearer standards and guidance can make it easier for patients to be offered research options while maintaining public confidence.
Key findings from the report
The report highlights that:
- some types of research, such as clinical studies of treatments, diagnostics or prevention, can form part of a patient’s care pathway – described as research as care
- professionals directly involved in providing, supporting or advising on care through research have a legitimate relationship with patients. In principle, they can rely on implied consent to use confidential patient information to find and contact patients, provided conditions and safeguards are met
- standards are needed for patient research registers and digital intermediaries to make sure these services are approved by Research Ethics Committees and operate in consistent and transparent ways
- safeguards such as the role of Research Ethics Committees and the Confidentiality Advisory Group remain essential to balance patient and public perspectives
The report also reflects learning from public contributors, recent public dialogues and the work programme of the National Data Guardian on Creating Reasonable Expectations.
What this means for people working in health and social care research
If you work in health and social care research, here are some practical things that you need to be aware of from the report:
- research as care - if a study is testing a treatment, diagnostic, or preventative measure that is relevant to a patient, this can be considered part of their care pathway. Staff directly involved in providing or supporting this care can, in principle, rely on implied consent to use confidential patient information to approach people about research, provided safeguards are in place
- registers - where people have signed up to hear about research, sponsors and sites can use these registers if they meet the new standards and have approval from a Research Ethics Committee. Once approved, studies can adopt these registers without needing to submit an amendment
- digital intermediaries - the same approach applies to digital services that help identify potential research participants. If the service meets the standards and has REC approval, studies can use them without amendment
- safeguards remain central - Research Ethics Committees, and in England and Wales the Confidentiality Advisory Group, continue to play a key role in protecting confidentiality and public trust
Next steps
The report was developed on behalf of partners in the Recovery, Resilience and Growth (RRG) Programme, which is now part of the UK Clinical Research Delivery (UKCRD) programme. Programme partners will decide which recommendations to take forward and how to prioritise them.
The HRA will publish detailed guidance for taking these findings forward.
Changes to research studies should not be implemented until the guidance has been published.
Janet Messer, Director of Approvals Service"Research can be part of care, and patients should be able to hear about options to take part in ways that they trust. This report provides clarity about the legal and ethical boundaries and sets consistent standards for services that connect people with research.
"We hope this will make it easier for patients to find out about research that is relevant to them, and have the choice to participate."