All research involving NHS patients will require approval from a national regulatory body before the project is conducted. This is to ensure the safety and well-being of patients as well as to ensure clarity and consistency of information.
Types of approvals vary with each project and type of study. Contact the Research Office, which will advise on the various approvals from a number of authorities.
- All research in England involving NHS patients or NHS staff will require approval from the HRA and confirmation of capacity and capability.
- Studies involving NHS patients will need to be reviewed by a research ethics committee, managed by the Research Ethics Service.
- Studies that involve medicines and devices may need MHRA approval.
- If you are using human embryos in research you will require HFEA approval.
- If you wish to undertake research on identifiable data from patients who are not yours and they have not consented to you seeing their data you may require Confidentiality Advisory Group (CAG) approval.
- Studies involving gene therapy will require review by the GTAC.
The HRA also has guidance on applying for various types of approvals.
Approval times vary for each regulatory body. We recommend allowing three months from submission to approval, taking into account any corrections that need to be made. The quicker you respond to the authority, the quicker they will get back to you.
The approval is valid for the life of the project.
How to get approval
Contact the Research Office to:
- start your feasibility review if you haven’t already done so. This is required for your submission
- obtain the necessary letters, forms and templates endorsed by the Trust for your submission
- gain sponsorship
- get guidance on the approval process appropriate to your study.
Complete the online Integrated Research Application System (IRAS) form. You will need to complete some core questions which can then be extracted by the system to populate the different forms required for approvals. This ensures consistency of information and means that you need to input the data only once.
UKCRN Portfolio studies
Studies that have been funded and peer reviewed as part of an open national grant call may be eligible for NIHR UKCRN portfolio adoption. See the IRAS page for further instructions checking eligibility and how to submit.