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Oxford University Hospitals NHS Foundation Trust
Research and Development

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Approvals processes

All clinical research must adhere to the Department of Health (DoH) Research Governance Framework (2005).

Clinical trials, a subset of clinical research, must also adhere to the Medicines for Human Use (Clinical Trials) Regulations, 2004 (and amendments).

A number of other Acts of Parliament also have implications for research conduct, for example:

  • the Data Protection Act (1998)
  • the Health and Social Care Act (2001)
  • the Human Tissue Act (2004)
  • the Mental Capacity Act (2005).

The R&D department can provide assistance with project planning to ensure that appropriate regulatory requirements have been considered and implemented.

With very few exceptions all clinical research requires approval from a research ethics committee (REC). In addition you will need NHS permission from the Health Research Authority if your study involves NHS patients, staff, resources or facilities.

Confirmation of the capability and capacity of OUH to participate in all research projects is undertaken by R&D as part of the Trust Management Approval process. If you are including non-NHS sites, Site Specific Assessment (SSA) is done by the REC committee.

Site specific assessment (SSA) for NHS sites is undertaken by R&D as part of the Trust Management Approval process. If you are including non-NHS sites SSA is done by the REC committee.

This section of the website helps you through the various stages of approval required for a research study from initial concept to NHS permission to start.

If you have developed an idea for a research project or clinical trial, and Oxford University Hospitals has agreed to act as sponsor, you will then need to apply to the appropriate bodies, as advised, to gain approval.

For more information about applying for sponsorship from the Trust, please see the Sponsorship page:

Further information

Please use the links below for information about our approvals processes.