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Determine whether your study is research

The Research Governance Frameworks for Health and Social Care (HRA webite) set out the responsibilities and standards that apply to work managed within the formal research context.

For the purposes of research governance, ‘research’ means the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods.

Although some research projects include evaluation, where a project is considered to be solely audit or service/therapy evaluation, it will not be managed as research within the NHS/HSC or social care. Such projects do not require ethical review by a NHS/HSC or Social Care Research Ethics Committee or management permission through the NHS/HSC R&D office. Under these circumstances, there is no need to submit applications to the NHS Research Ethics Committee (REC) or NHS/HSC R&D office or HRA Approval.

To help you decide whether your project is classified as research you should refer to the Health Research Authority (HRA)  Decision Tool

The HRA also provide additional and more detailed guidance (HRA website)