Research that recruits NHS patients and service users, NHS staff or takes place on an NHS site is likely to require external approval by the Health Research Authority (HRA). Research recruiting patients will also require a favourable opinion from one of the HRA's Research Ethics Committee. An application for HRA approval (with or without REC approval) is made via the Integrated Research Application System (IRAS).
Researchers considering research with the NHS should first contact email@example.com to discuss what approvals may be required.
Research recruiting NHS patients and service users falls under the remit of the UK Policy Framework for Health and Social Care Research. The Policy sets out certain expectations including around management and good practice of research, including roles of the Chief Investigator and participating research sites. The Policy also requires the research to be overseen by a 'sponsor' who takes on overall responsibility for proportionate, effective arrangements being in place to set up, run and report on a research project. DMU will normally act as the sponsor for studies led by DMU staff or students once a project has been approved through our sponsor review process (see SOPs below).
What does and doesn't require HRA approval:
HRA approval is only required where your project meets the HRA definition of 'research' using the following tool: http://www.hra-decisiontools.org.uk/research/. Audits and service evaluations will not require HRA approval but may still require DMU ethics approval and local approval at any collaboration NHS site.
If your study is considered research, and you are recruiting patients or service users, you can then establish if you need HRA REC approval: http://www.hra-decisiontools.org.uk/ethics/. Important: this tool should not be used if your study only recruits NHS staff.
Students, including post-graduate taught and PhD students must first use the HRA's student toolkit to establish their eligibility to apply for HRA approval: https://www.hra.nhs.uk/planning-and-improving-research/research-planning/student-research/student-research-toolkit/
Establishing what requires HRA approval, and what doesn't, isn't always clear and you are strongly advised to discuss your plans with the Research Governance Team (firstname.lastname@example.org).
Note: Staff conducting research with the NHS will need to complete data security and information governance training on an ANNUAL basis. Confirmation that this has taken place has to be provided by DMU to NHS Digital each year.
Accessing Confidential Patient Information Without Consent:
Accessing confidential patient information without consent falls under the remit of HRA's Confidentiality Advisory Group who will consider whether there is a legal basis. A researcher who is not part of a patient's direct care team therefore cannot access such information without CAG approval. This applies independent of whether your project is considered 'research' or another activity such as audit or service evaluation. For example, if a researcher wants to access medical records to identify potential participants for a study, approval may be required from both a HRA REC AND CAG.
Please also see HRA guidance on using patient data.