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°×С½ãÂÛ̳ researchers with studies which fall outside of these categories should consult withÌý°×С½ãÂÛ̳ ethics.
There are typically four stages of approval that must be considered and in place before conducting a clinical research project:
The Joint Research Office willÌýsupport °×С½ãÂÛ̳ and °×С½ãÂÛ̳H researchers through the stages and approvals required to obtain any of these approvals:
- HRA approval
- NHS ethics approval
- MHRA approval
- CAG approval
- Permission to start at °×С½ãÂÛ̳H
In some cases, a study will require a sponsor’s legal representative in the UK (Clinical Trials with a sponsor outside of the UK) or for some medical devices, a designated UK Responsible Person.
A description of the responsibilities and requirements of each can be found on the .
Studies which require Sponsorship, a Legal Representative or other UK responsible person or organisation should follow the guidance on grant applications and sponsorship.
Studies which require NHS Site Assess, Arrange and Confirm approval at °×С½ãÂÛ̳H should follow the guidance set out here.
Studies which use anonymous data from °×С½ãÂÛ̳H (only) may be eligible for a combined sponsorship and AAC process called the DAP-R. DAP-R is relevant for studies sponsored by °×С½ãÂÛ̳ or °×С½ãÂÛ̳H only. See our Data pathways at °×С½ãÂÛ̳H webpageÌýfor further information on the DAP-R and accessing data at °×С½ãÂÛ̳H.
Many studies will require statistical involvement. To find out about statistical support for research studies visit the Biostatistics group page.
