e-Pathway: Project Setup

Ethics review is one of the keyways in which the University seeks to protect all stakeholders in its research projects, including both participants and researchers.  As such, the requirement for appropriate ethics review is part of the University’s Code of Practice for Research. All researchers intending to carry out research projects at the University of Birmingham should begin by applying through the UoB Research Ethics system.

Health Research Authority NHS Research Ethics Review 

Project that involve NHS patients or their carers will be reviewed via the NHS Research Ethics Committees in line with Health Research Authority processes and Governance arrangements for Research Ethics Committees.

At this point there are several possible choices dependent on what your research involves: 

1. Animals - see the Biomedical Services Unit (BMSU)
2. Healthy Volunteers - see accordion titled 'Healthy volunteers'
3. NHS Staff - see accordion titled 'NHS staff'
4. Human tissue and/or data only
5. NHS Digital Data 

If your project involves only students or healthy volunteers and your project is not a Phase 1 trial, please seek research ethics review via the University Research Ethics System.  For further information, please see the Healthy Volunteer & Medical Oversight SOP (UoB-HVM-SOP-001) (Word - 67 KB).

If the project also involves human tissue, please see the human tissue & data section. 

If the project involves NHS staff, please see accordion titled 'NHS staff'.

If your research involves NHS staff as participants and NHS resources will be used (including NHS staff time, facilities, etc.) your project will need University research ethics review. Further guidance on this process can be found on the Ethics team's web pages.

The project will also require HRA Approval through the IRAS system.

This will involve your project undergoing a joint review by the University Ethics team and the Research Governance team. Please note that for joint review applications, you will initially need to register your project with the Ethics Team via either the Worktribe ethics checklist or the new online ERM system, depending on the nature of the project (please see the Ethics team's guidance page for full instructions).

Following this, you will need to complete the IRAS form and this will be accepted for both ethics review and HRA submission.  After you have received both ethics and governance approval, the project can then be submitted for HRA approval through IRAS. 

It is good practice for all clinical research to be registered on a publicly accessible database. 

For certain types of project it is a requirement of ethical approval to register the project. These projects include CTIMPs, clinical investigations of a medical device, combined trials of an investigational medicinal product and an investigational medical device and other clinical trials to study a novel intervention or randomised clinical trials comparing interventions in clinical practice. Registration for these projects need to be in place before recruitment of the first participant. 

The Clinical Trials Oversight Committee at the University has developed some guidance on the different types of registries available for UoB sponsored projects (PDF - 218 KB).  Please contact researchgovernance@contacts.bham.ac.uk for further information. 

Currently, some projects submitted through IRAS are automatically registered on the ISRCTN Registry e.g. when Portfolio adapted (see separate section below) by the HRA.

Further information on project registration can also be found online:

• The HRA has guidance on Research registration and research project identifiers. 
• The HRA also produces guidance on Research Transparency.

Please contact researchgovernance@contacts.bham.ac.uk if you have any questions regarding project registration.

When working with external vendors (e.g. organisations, sites, IMP suppliers, external collaborators) consider the following: 

• Is a contract required?  If so, contact the Contracts Team.
  
• Is a vendor assessment required and how will oversight of the vendor be maintained? Ensure processes are aligned with the UoB Compliance Review SOP (UoB-CPR-SOP-001) (Word - 96 KB).
• Should a vendor change during the course of your project then the steps above will need to be repeated for the new Vendor.

The NIHR Clinical Research Network (NIHR CRN) Portfolio consists of high-quality clinical research projects eligible for consideration for support from the CRN. Portfolio adopted projects benefit from the following: 

• Access to the NIHR CRN Study Support Service for the planning, set-up and delivery of high-quality clinical research in England
• Provision of NHS support and/or the equivalent of NHS Support in other settings (e.g. research carried out in social care, care homes, hospices, or public health settings)
• Provision of Research Part B costs as defined by AcoRD (for projects funded by AMRC member charities only)
• Access to relevant research delivery training, including Good Clinical Practice training
• ISRCTN registration via the Central Portfolio Management System.

The clinical research e-Pathway provides a roadmap to the various stages and sub-stages that a researcher may follow during the lifetime of their research project. Click on a link to take yourself to the stage that is of interest, or you can use the roadmap image on each page to navigate through the process.  

From Idea to Proposal

Applying for Funding

Project Setup (current page)

• Governance & Ethics
• Essential Documents
• Human Tissue & Data

Green Light - Ready to Go?

Project Management

• Quality & Oversight
• Adverse Events & Deviations
• Amendments

Project End

• Maximising Impact

Need help with your project? See the 'who can help?' section. 

For an overview of the e-Pathway, return to the homepage.