If you plan on collecting data…

This tool assumes you are collecting data specifically for your project and not using existing data collected during routine healthcare delivery.

If you plan on collecting data directly from participants, you most likely need approval. There are national differences in approvals applications.

For England and Wales we recommend you:

• Visit the HRA website for resources on research planning, including on identifying participants to your study.
• Explore the student research toolkit (even if you are not a student) as it contains the relevant questions to assess whether collecting your data warrants a review by the Research Ethics Committee (REC) review and or by the Confidentiality Advisory Group (CAG).
• For information relating to site setup and local processes for the NHS in Wales please refer to the HCRW website
• For further information, researchers wishing to conduct research in the NHS led from England or Wales should refer to Health Research Authority (HRA) and Health and Care Research Wales (HCRW) Approval (‘HRA/HCRW Approval').

Scotland

If your project is a multi-centre study and involves access to identifiable patient data, you will need to obtain permission through the Public Benefit and Privacy Panel for Health and Social Care (HSC-PBPP). The HSC-PBPP is a governance structure of NHS Scotland (NHSS) to scrutinise and consider your application purpose for public benefit and information governance requirements. For further information please visit NHSS HSC-PBPP.

For single centre projects, applicants should go to their local Caldicott Guardian (a senior person responsible for protecting the confidentiality of an individual’s health and care information and to ensure that it is used properly). For further information please visit NHS Research Scotland, National Services Scotland and / or contact the lead R&D office for advice.

Northern Ireland

There is currently no legal basis to process patient identifiable data outside the care team. You will need to gain agreement from the local care team to support activity. For further information please visit Health and Social Care Northern Ireland. Full guidance is available on the Integrated Research Application System (IRAS) Website. For further advice, contact the HSC R&D Office (details of offices are available via the HSC website) or the Gateway (phone: (028) 7161 1126; email: research.gateway@hscni.net).

Understanding the data requirements for your project is the first step in your research journey. This tool should have assisted you in thinking about the essential considerations on the use of data for health and social care research. Please do ensure that you think about the most appropriate data you need for your study and whether your data access needs would meet the statutory and legal governance requirements in the UK. It is imperative that data used for the development of AI and data-driven interventions is accessed with the highest privacy and ethical standards. Spending time to identify the data you need, understand what data is available and consult the relevant people and organisations, may ensure that your project can get started as soon as possible with minimal delays.

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