The Research Governance Procedure

The process for researchers is summarised in a one-page flow diagram. This web page provides step-by-step guidance on the procedure (NB. Clinical trials of investigational medicinal products, and studies involving medical devices including apps, have additional regulatory requirements. Refer to the MHRA for guidance).

1. The initial decisions stage:

1.1. Decide if the research governance procedure applies to your project.

1.2. Decide which organisation should be the project's 'research governance sponsor' (NB. The University cannot sponsor clinical trials of investigational medicinal products)

1.3 If the University is the research governance sponsor, decide if your study is classed as a 'human interventional study'

1.4. 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:

Always register the project with the University, i.e. via the Online Costing Tool - always required - even when there are no costs or even when the University is not the project's research governance sponsor (student research projects should be registered by a member of staff under a specific section for student research governance).

3. Apply for the necessary approvals (the following refers to the University's requirements where it will be the research governance sponsor - other sponsors' requirements may differ):

3.1. Apply for scientific approval

3.2 Ensure the project has adequate insurance.

3.3 If your research involves the NHS: Apply for HRA approval there is a guidance leaflet available which advises when HRA approval is required.

3.4 Apply for ethics approval  (If your HRA approval includes review by an NHS research ethics committee you do not require additional ethics approval.)

An additional step that only applies to studies involving medical devices (including software/apps) where the University is the sponsor: notify the MHRA as soon as possible, and submit full details for assessment at least 60 days before starting the investigation in order to obtain a 'notice of no objection'.

An additional step that only applies to human-interventional studies where the university is the research governance sponsor: Complete and return 'Risk Assessment Checklist for University Sponsored Human-Interventional Studies'

4. Project is authorised to start:

Research governance sponsor officially authorises your project to start (a template of the letter that is provided when the University is the research governance sponsor can be seen here)

5. Post award:

Setting up a Site File and Monitoring arrangements and Reporting Adverse Events

Archiving requirements for health care research projects

Who to contact

Anita Kenny (A.J.Kenny@sheffield.ac.uk, 21400) is the first point of contact for enquiries relating to healthcare research governance.

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