Information for researchers

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Research is governed differently from other studies and usually requires regulatory body approval and formal approval from the Research, Development and Innovation department at University Hospital Birmingham NHS Foundation Trust (UHB).

Clinical audits, service evaluations or public health surveillance are not classed as research and should not be portrayed as research in publications. Clinical audits and service evaluations are not subject to regulatory oversight.

To check if your project is defined as research, please use the decision tool on the NHS Health Research Authority (HRA) website:

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Key information

Approval process

The University Hospitals Birmingham NHS Foundation Trust (UHB) authorisation process ensures:

  • management have an opportunity to assess the full research implications
  • research complies with all regulations, particularly those which the Trust is legally liable
  • appropriate governance arrangements are in place once a study starts
  • the Trust complies with all external research reporting requirements (i.e. Department of Health, Care Quality Commission and regulatory authorities)

For all studies the Research, Development and Innovation department requires:

  • sufficient information to accurately assess the study implications for UHB
  • evidence of research sponsorship
  • confirmation of ethics and relevant regulatory approvals
  • satisfactory contractual agreements, particularly for commercially sponsored studies

Amendment process

The Research and Development (R&D) Governance team must be notified of any minor, substantial or urgent safety study amendments. Many study amendments will run in parallel with gaining R&D approval.

You can view and download our Training Matrix here: