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Brighton & Sussex Medical School

What is my study? Research, service evaluation or audit?

What is my study?

Is my study: 'Research', 'Service Evaluation' or 'Audit'?

Some projects present a challenge for determining whether they are ‘research’, ‘service evaluation’ or ‘audit’. It’s important to correctly categorise a project to determine the appropriate ethical and governance approval pathway, as pathways can differ substantially, particularly for studies taking place in the NHS.

Research

How to define research

Your study is classified as research if you are trying to generate new knowledge about patients or conditions or healthcare services that will be generally true across a wider population than you are actually studying.

Example

For example, you want to know if people who undergo Test X within two weeks of referral to dermatology for suspicious skin lesions have lower mortality from skin cancer. You could follow up patients in a range of clinics (observational study) or design a randomised controlled trial (experimental study), and infer that the results would be true for all skin patients across the country. 

Ethics Review 

If your project is research, click below to read our research ethics decision tree. 

Read more >

BACKGROUND IMAGE FOR PANEL

Service evaluaton

How to define service* evaluations

Your study is a service evaluation if you want to evaluate or assess some part of a local healthcare service, with the view of improving the service based on the evidence that you collect. Results from your evaluation will only feed back into this particular service, they will not apply to patients, or services, across the country. Any method can be used to evaluate a service (retrospective patient notes review, patient survey, staff survey, interview), but it will still be service evaluation if results are purely used to inform future planning of the service. This may also be called a “quality improvement project”. 

*this category also applies for curriculum evaluations, where a new educational initiative is being assessed.

DOWNLOAD THE DETERMINING SERVICE EVALUATION FROM RESEARCH FLOWCHART >

Example

For example, you want to see if outcomes within your dermatology service are better for patients who get Test X within two weeks of referral for a suspicious skin lesion. If they were better, you might try to redesign the service so more, or all, patients get the test within the two weeks. 

Ethical Review 

Service Evaluations do not usually need ethical review. However, you can ask the BSMS Research Governance and Ethics Committee (RGEC) to review your service evaluation if: 

i) You intend to publish in a journal. Many journals now require evidence of ethical review for audit/service evaluation/improvement studies and review via the RGEC will cover researchers intending to pursue publication.

ii) A vulnerable population, medical students, or sensitive topics will be involved.

Read more on our RGEC page >

Registration

Most NHS Trusts want to keep a record of any service evaluations so these should be registered with Trust R&D departments. An employee of the trust should be the one to make this registration.

*this category also applies for curriculum evaluations, where a new educational initiative is being assessed, and results are being fed back into improvements in curriculum design only.

Clinical audit

How to define an audit
An audit is a special type of service evaluation where you are evaluating your service against a specific reference or guidance, e.g. new NICE guidance. Where you find evidence your service is falling short of the guidance, you would implement changes to make it work closer to the guidance.

Example

For example, NICE have released new guidance saying that all patients should receive Test X within two weeks of referral for suspicious skin lesions. You audit the patient notes in your dermatology clinic to see if you are meeting this target, and implement changes to the service if you find you are not. 

Ethics review 

Audits do not usually need ethics review. 

Registration

Most NHS Trusts want to keep a record of any audit so these should be registered with Trust R&D departments. An employee of the trust should be the one to make this registration.