UCL researchers with studies which fall outside of these categories should consult with UCL 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 will support UCL and UCLH 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 UCLH
- Research Databases and Research Tissue Banks
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 HRA website.
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 UCLH should follow the guidance set out here.
Studies which use anonymous data from UCLH (only) may be eligible for a combined sponsorship and AAC process called the DAP-R. DAP-R is relevant for studies sponsored by UCL or UCLH only. See our Data pathways at UCLH webpage for further information on the DAP-R and accessing data at UCLH.
Many studies will require statistical involvement. To find out about statistical support for research studies visit the Biostatistics group page.