Setting up a new study? What approvals do you need?
Does your study involve health or social care and involves NHS patients, their tissue or data?
Does your study involve the testing of a drug or device in any human being?
Is your study considered to be clinical research by the Health Research Authority?
If the answer to any of the above is yes, and you are affiliated to UCL or UCLH, then it is likely that your study requires an approval from UCL or UCLH and potentially a regulatory body before it can start.
There are typically three stages of approval that must be considered before conducting clinical research:
The JRO and UCL Clinical Trials Units (CTUs) will support researchers with the set-up of research studies.
If you are a UCL or UCLH researcher conducting research in these categories, it is likely that you will need a sponsor.
Granting of sponsorship does not automatically confirm regulatory approvals or approval for a study to take place at UCLH (NHS site Assess, Arrange and Confirm). All three stages are required. Each stage will provide a confirmation. Do not begin your study until all stages are in place.
If you are a UCL or UCLH researcher, conducting research at UCLH or UCL and have already obtained sponsorship (UCL, UCLH or other such as commercial or other university), you will still need NHS Site Assess, Arrange and Confirm approvals.