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Oxford University Hospitals NHS Foundation Trust
Research and Development

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Ethics

Where to submit for Ethics Approval

The following information is given as guidance. However, if you remain unsure as to which Ethics application procedure you should follow, please contact the R&D team for advice.

National Research Ethics Service (NRES)

Not all research conducted within the UK requires approval from an NHS Research Ethics Committee (REC). To decide if you should be submitting to NRES, please check their website.

As a guide, the following do require NRES approval, but this is not a complete list.

  • Clinical Trial of an Investigative Medicinal product (CTIMP).
  • Research involving NHS patients and/or use of personal data.
  • Research involving ionising radiation.
  • Taking cellular samples and storage for >7 days before destruction or rendering acellular.
  • Inclusion of participants who do not have capacity to consent for themselves.
  • Use of a non-CE marked medical device or CE-marked medical device for a new purpose.

The NRES application process can be viewed on their website. Any application that is to be submitted to an NRES committee must be prepared using the Integrated Research Application System (IRAS).

IRAS is a single form-filling system for applying for the relevant approvals from the following review bodies:

Clear instructions as to how to complete the form, with question-specific guidance, is available on the IRAS website. R&D staff will be happy to provide advice.

Forms are web-based and can be worked on repeatedly prior to submission. Documents to submit to the REC are itemised on a checklist provided on IRAS. R&D will need to review all documents prior to submission where the OUH is acting as a sponsor for the research study. Please allow sufficient time for this and do not book a slot until advised by R&D to do so.

Documents you will need are listed on the front of the form.

These include the following.

  • Final version of the protocol.
  • Participant Information Sheet.
  • Participant Informed Consent Form.
  • GP Letter.
  • Advertisement (where appropriate).

Once R&D has approved your application you will need to book a slot for review with the Research Ethics Committee (REC). You will be given a REC reference to add to your forms. R&D will authorise your REC application form. Please note that the final forms (without the DRAFT watermark) are generated on the IRAS site via the 'Submission' tab.

Proportionate Review

Most studies will need a full review by a REC. However, studies with 'no material ethical issues' may apply for proportionate review which is usually complete within two weeks of submission. Further information, a tool kit to check eligibility and submission details are available on the HRA website.

(Oxford) Central University Research Ethics Committee (CUREC)

CUREC exists to review all low-risk research projects involving human participants that require ethical review but fall outside the remit of the Research Ethics System, as defined in the Governance Arrangements for Ethics Committees (GAFREC).

A submission to this committee will be on the advice of the Oxford University Clinical Trials and Research Governance Team, if there is an involvement of Oxford University with the Research or an equivalent committee at another institution.

Please see the CUREC website or contact them for advice.

Confidentiality

If your research involves the use of patient-identifiable information without consent, you will need to apply to the HRA Confidentiality Advisory Group (CAG).

Applications can be made via the Integrated Research Application System (IRAS) application process.

Access and approval for research using biological samples - OUH and Oxford Radcliffe Biobank / BioResource

For research studies that will be using the OUH Pathology and Laboratories Services will be managed by the Oxford Centre for Histopathology Research. The process for requesting samples and/or specifying sample preparation is outlined at the link below:

The process has been set up to facilitate access to pathology services, expertise and bioresources and to ensure that research use of pathology resources are costed and charged appropriately.

This applies to all studies using this service, both commercial and non-commercial. For all OUH and University sponsored studies this should be addressed at the protocol development stage.

Further information can be found at:

More information about the Oxford Radcliffe Biobank is available at: