Clinical Research Approval Process

NHS clinical research

Student research

In September 2021, the Health Research Authority (HRA) introduced new eligibility criteria for standalone student research.

Eligibility criteria

Is my project classed as research?

The first step is to determine whether your project is classed as research by the HRA. Check the HRA Decision Tool to understand how your project is classified. It is important to get this correct to ensure your project goes through the correct approval process.

If you are still unsure about what your project should be classified as please contact the Senior Clinical Research Governance Manager who can assist you.

Does my project require NHS Ethics approval?

Most but not all research projects require NHS REC approval. Check the HRA Ethics Decision Tool to determine what type of external ethics approvals your project needs.

All SHLS projects must have approval from an SHLS ethics committee before seeking external approvals.

Integrated Research Approval System (IRAS)

IRAS is the single system for applying for the permissions and approvals for health and social care/community care research in the UK. New users will have to register for an account online. IRAS captures information needed for the following review bodies:

Indemnity and insurance

Researchers and students completing IRAS applications for external approvals will need to provide evidence that insurance/indemnity arrangements are in place for their research. GCU will provide insurance/indemnity cover when it is sponsoring the research. Copies of the insurance/indemnity documents must be included with your IRAS application and failure to submit the documents will delay the application process. When submitting the forms make sure they are in date, you have checked the exclusions in the insurance/indemnity (for example clinical trials involving a person known to be pregnant, clinical trials involving participants under five years of age) and that your research is covered by the insurance/indemnity.

Copies of the indemnity/insurance details of the Sponsor are an essential requirement of the application process. You can obtain these documents by contacting the Senior Clinical Research Governance Manager.

Obtaining sponsor approval for my project

Once you have obtained SHLS ethics approval and completed the IRAS requirements for your research project it needs to be signed off by the sponsor representative.

In SHLS, the sponsor representative is Professor Sharron Dolan – Associate Dean of Research. All IRAS forms must be sent to Professor Dolan via the IRAS system for projects sponsored by GCU.

To obtain sponsor sign-off you must have completed GCP training and the Data Protection Course on GCU Learn. Copies of these certificates should be emailed to the Senior Clinical Research Governance Manager who will keep them on file. Once these have been completed, SHLS ADR will be able to sign off your IRAS form to allow you to continue with the research application process.

Top tip – Ensure no further changes are needed to the IRAS application before sending for authorisation signatures. Changes invalidate signatures and require reauthorisation

Who to contact for assistance?

For any questions regarding the approval process, contact the Senior Clinical Research Governance Manager.

Helpful links