The Research Governance Procedure
The process for researchers is summarised in a one-page flow diagram. Thie web page provides step-by-step guidance on the procedure.
1. The initial decisions stage:
1.1. Decide if the project is a 'health care research' project.
1.2. Decide which organisation should be the project's 'research governance sponsor'.
1.3. If you are non-NHS staff wishing to carry out research in the NHS, decide whether you need an NHS Research Passport.
2. Registration stage:
2.1. Always register the project with the University, i.e. on the University Research Management System (URMS) - always required - even when there are no costs or even when the University is not the project's research governance sponsor.
2.2. Only if the project involves the NHS: register the project with the NHS Trust(s) and/or Primary Care Trust(s) which are involved
3. Apply for the necessary approvals:
3.1. Apply for scientific approval (the research governance sponsor should advise you of the requirements)
3.2. Apply for ethics approval (the research governance sponsor should advise you of the requirements - if applying for NHS ethics review & the University is the sponsor then the ‘declaration by the sponsor’ section on IRAS must be authorised by a wet ink signature or electronic authorisation)
3.2.1. Ensure the project has adequate insurance.
3.3. Apply for NHS R&D review in order to obtain NHS permission/R&D approval
Additional step that only applies to clinical trials where the university is the research governance sponsor: Complete and return 'Risk Assessment Checklist for University Sponsored Clinical Trials' (you will be contacted by Research & Innovation Services with details once independent ethics approval has been obtained)
4. Project is authorised to start:
Research governance sponsor officially authorises your project to start (a template of the letter is provided here)
5. Post award:
Setting up a Site File and Monitoring arrangements and Reporting Adverse Events
Archiving requirements for health care research projects