
Is my project research?
How to define your project
It is worthwhile checking that your project is research before you start, as there are different routes for approval or registering. It may be that it can be classed as an Evaluation or Quality Improvement.
You can use this decision tool to help you decide. Or, get in touch with hiowh.research@nhs.net and we will be happy to discuss this with you.
The different approaches:
Clinical research is conducted to provide new information/ knowledge about disease prevention, diagnosis, treatment or relief of symptoms, or wider health related issues.
Patients and healthy participants volunteer and then consent to be part of the project.
Clinical trials are a part of clinical research. They may use medicines, medical devices, or procedures and are designed to test or compare different treatments.
Other types of clinical research could include questionnaires, interviews or focus groups to understand patients’ experiences, or could be research involving biological samples or other clinical data.
The Health Research Authority has an interactive tool to help you assess whether a project is research: www.hra-decisiontools.org.uk/research
Quality Improvement (QI)
Quality Improvement normally involves the identification of a problem, followed by cycles of testing changes.
We structure this around the ‘Model for Improvement,’ which is essentially a simple and structured way of going about improvement. It asks three basic questions to start with:
What are you trying to improve?
How will you measure what has improved?
What changes will need to be made to do this?
It then uses a PDSA (Plan, Do, Study, Act) cycle to test small changes and see if they work; adjusting and testing until an improvement is made.
Clinical Audit
Clinical Audit is designed and conducted to check that we are achieving predetermined standards in care; aiming to assure quality and to improve standards.
Like Service Evaluation, it usually involves looking at existing data on patient care and outcomes, and often asks staff and patients for their feedback via interviews or questionnaires.