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
- Undergraduate level: Health and social care research applications from students working at undergraduate level are no longer being accepted for Research Ethics Committee (REC) review; HRA and Health and Care Research Wale (HCRW ) approval; and/or Research and Development (R&D) study-wide review in Scotland and Northern Ireland.
- Master's level: Applicants should complete the student research toolkit in the first instance to check eligibility. Some health and social care research applications from students working at master's level are no longer being accepted for REC review; HCRW) approval and/or R&D study-wide review in Scotland and Northern Ireland.
- Doctorate level: Applicants are eligible to complete health and social care research subject to relevant approvals being in place. Applicants may find it useful to complete parts of the toolkit to understand if HRA and HCRW approval (or equivalent in Northern Ireland and Scotland) and/or NHS Research ethics review is required.
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:
- Administration of Radioactive Substances Advisory Committee (ARSAC)
- Confidentiality Advisory Group (CAG)
- Gene Therapy Advisory Committee (GTAC)
- HRA and HCRW for projects seeking HRA and HCRW approval
- Medicines and Healthcare products Regulatory Agency (MHRA)
- NHS/HSC R&D offices
- NHS/HSC Research Ethics Committees
- HM Prison and Probation Service (HMPPS)
- Social Care Research Ethics Committee
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.