Approving clinical research

Before starting your research or recruiting patients into an existing NHS or commercial study, you will need to apply for and confirm all of the necessary approvals.

How we can help

Our Research Governance, Quality & Integrity team can advise you what approvals will be needed for your research.

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. You will also need to ensure that you have agreed plans for data access, sharing and management.

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 & Innovation Approval

All research trials at NUH must be approved by the Research & Innovation department.

This ensures that the research has received all of the other approvals and that the trial is appropriate for patients at NUH.

Even if you haven't needed help from Research & Innovation before you reach this stage, approval must be completed before you begin.

NUH research documents

Find all of the documents, templates, policies and procedures for carrying out research at NUH here. 

Ethical Approval

All trials involving NHS patients need approval from the Health Research Authority (HRA) which incorporates a review by a Research Ethics Committee (REC).

Integrated Research Application System (IRAS)

Most applications to regulatory review bodies can be made via IRAS. IRAS was developed to bring all the research regulatory application forms together in one place.

By completing a checklist of questions, the system will generate the forms you need to complete based on your responses.

These include:

  • Portfolio Adoption Form
  • Research Ethics Committee Form
  • Research & Innovation Form
  • Site Specific Information Form
  • MHRA Form

You can find more information on how to use IRAS and set up an account on the IRAS website.

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).

The sponsor must receive this approval for any CTIMP to begin recruiting patients.