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What approvals and decisions do I need?

To understand what approvals and decisions you need from the HRA, firstly consider:

Is my project research?

One of the first steps in deciding which approvals you need for your project is to determine whether it is classed as research, and therefore whether it should be managed as such. The responsibility for determining whether a project is classed as research lies with the managing organisation. For studies that are determined to be research, the managing organisation would then accept the role of sponsor.

To assist organisations in determining whether a project is research, we have provided this decision tool. So long as the information you enter is correct, the outcome of the decision tool can be taken as authoritative, and you do not need to seek further confirmation.

Where a project will not be managed as research there is no need to apply for HRA Approval or to an NHS REC. However, you should contact the clinical governance or research and development (R&D) office of the organisation at which the project will be conducted to discuss what other local review arrangements or sources of advice may apply.  For example, there may be standard guidelines on the conduct of clinical audit. The Caldicott Guardian will be a source of advice on the use of patient data.

For both research and non-research, if your project will involve the use of patient data without consent you may still need a recommendation from the Confidentiality Advisory Group (CAG).

My project is categorised as research

If your research project is:

  • a Clinical Trial of an Investigational Medicinal Product (CTIMP) (with the exception of Phase 1 trials in healthy volunteers taking place outside the NHS)
  • a Clinical Investigation or other study of a Medical Device
  • a combined trial of an Investigational Medicinal Product and an Investigational Medical Device
  • a Clinical Trial to study a novel intervention or randomised Clinical Trial to compare interventions in clinical practice
  • a basic science study involving procedures with human participants
  • a study administering questionnaires/interviews for quantitative analysis, or using mixed qualitative/quantitative methodology
  • a study involving qualitative methods only
  • a study limited to working with human tissue samples (or other human biological samples) and data (specific project only)
  • a study limited to working with data (specific project only).

Then you will need to apply for HRA Approval

If your project does not fall into the categories above but is:

  • a Research Tissue Bank; 
  • a Research Database; or
  • taking place in a non-NHS setting (a Phase 1 clinical trial in health volunteers, for example)

Then you will not need HRA Approval but may still need approval from a Research Ethics Committee.

If your research project involves accessing confidential patient information without consent in England and Wales, you will need to apply to the Confidentiality Advisory Group (CAG).

For student studies undertaken primarily for the purpose of obtaining an educational qualification there is additional information available here.

If you are still unsure about what approvals and decisions you need from the HRA, please email the HRA queries line.