Determine whether your study is research

The Research Governance Frameworks for Health and Social Care  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 or social care. Such projects do not require ethical review by a NHS or Social Care Research Ethics Committee or management permission through the NHS 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.

If the project is audit, service evaluation or public health surveillance, or some other type of non-research activity such as case study, system / equipment testing or satisfaction survey, you should check with the clinical governance office for the NHS organisation what other review arrangements or sources of advice apply to the project.  For example, there may be standard guidelines on the conduct of clinical audit.

To help you decide whether your project is classified as research you should refer to the HRA Decision Tool. For additional and more detailed guidance please refer to the resources provided in the Resources.

If your project is classified as research then you are likely to need to make one or more applications via the Integrated Research Application System (IRAS).

To prepare applications in IRAS, you will need an IRAS account. Each project in IRAS is allocated an IRAS ID. This identifier may be used as a point of reference when seeking advice.