Approving clinical research
Before starting your research or recruiting patients into an existing NHS or commercial study, all potential researchers need to apply for the necessary approvals.
The main approvals are shown below, but please ask for advice from Research and Innovation about what approvals will be needed for your research.
All trials will need approval by the Health Research Authority (HRA) which incorporates a review by a Research Ethics Committee (REC).
Medicines and Healthcare products Regulatory Authority (MHRA)
The MHRA is the regulator of medicines, medical devices and blood components for transfusion, responsible for ensuring their safety, quality and effectiveness. As part of this role, the MHRA reviews and offers approvals for clinical trials of investigational medicinal products (CTIMPs).
It is essential that the sponsor has received this approval for any CTIMP to begin recruiting patients.
Approvals at NUH
Many research studies will involve multiple departments throughout our hospitals. For example, the study may require additional outpatient appointments, CT scans, blood tests or ECGs.
It is essential when setting up a research project that these additional interventions are discussed with and approved by the department providing the service.
Research and Innovation Approval
All research trials at NUH must be approved by Research and Innovation.
This ensures that the research has received all of the other approvals and that the trial is appropriate for NUH.
Even if you haven't needed help from Research and Innovation before you reach this stage, approval must be completed before the study commences.