National approvals

All research involving the NHS 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 and Innovation team, who 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 National 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.

Timescales

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. Any changes to your project will need to be registered with your study support officer.

How to get approval

Contact the Research and Innovation team to:

  • Start your feasibility review if you haven’t already done so
  • 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.

You may also need to complete the online Integrated Research Application System (IRAS) form.  If the University Hospitals of Leicester is the Sponsor you will need to complete IRAS, if your Sponsor is a different organisation and you are the Principal Investigator you won’t need to worry about IRAS but you will need to provide other information.