How to determine if your project is research, audit or service evaluation
Classifying your project correctly is an important place to start, as not all investigative projects undertaken within the NHS are classified as research, and the different categories are subject to different approval processes.
To help you decide whether your project is classified as research you should use the interactive HRA Decision Tool. You may also find the table below useful, as it enables you to compare the different project categories.
|Purpose is to derive new, generalisable knowledge||Purpose to produce information to inform delivery of best care||Purpose to evaluate current care|
|Designed to test a hypothesis or to identify themes following established methodology||Designed to address ‘Does this service reach a predetermined standard?’||Designed to address ‘What standard does this service achieve?’|
|Addresses clearly defined objectives||Measures against a standard||Measure current service without reference to a standard|
|Usually involves collecting data additional to routine care but may include data collected routinely||Usually involves analysis of existing data but may include administration of simple interview or questionnaire||Usually involves analysis of existing data but may include administration of simple interview or questionnaire|
|May involve allocating patients to intervention groups||No allocation to intervention||No allocation to intervention|
|Normally requires REC review||Does not require REC review||Does not require REC review|
If your project is research
If your project is clinical audit or service evaluation
If you determine that the project is clinical audit or service evaluation, it will not be managed as research within the NHS. Such projects do not require HRA Approval, ethical review by a NHS Research Ethics Committee, or management permission through the NHS R&D office.
Instead, the project should be registered with the Trust Safety and Quality team. Further information is available on the Trust intranet at https://nww.bsuh.nhs.uk/the-trust/safety-and-quality/quality/clinical-audit/ (only accessible from an NHS computer)