e-Pathway: Project Setup

If you are conducting health and social care research then the system to use to apply for approvals and permissions is called The Integrated Research Application System (IRAS). The IRAS website includes an online guide with instructions on how to use the system.

For CTIMPs please use the Combined Review Service (CRS).

For information on Sponsorship Approval, please see the Sponsorship and insurance section of the e-Pathway.

Depending on what is involved in a research project, other types of approvals may also be required.  

• ARSAC: For Administration of Radioactive Substances outside of routine standard care, ARSAC will be required. Guidance on this can be found within the IRAS help section. 
• IRMER: Where Ionising Radiation is involved that is outside of routine care, then REC approval is required as defined under Ionising Radiation (Medical Exposure) Regulations (IRMER).  Further information on IRMER and related matters is available from the ionising radiation page of the HRA website. 
• Primary Care Settings: For research involving primary care the HRA has issued some guidance on HRA approval in primary care settings (PDF - 599 KB).
• Confidentiality Advisory Group (CAG): Where research involves access to confidential patient or service user information CAG provides expert advice to the HRA and Secretary of State for Health on whether such applications should be approved. CAG also approve research involving access to Human Fertilisation and Embryology Authority (HFEA) data.  
  • Contact researchgovernance@contacts.bham.ac.uk in the first instance if it is believed CAG approval may be required. For further guidance please refer to the IRAS help page on preparing and submitting applications to the Confidentiality Advisory Group.

For additional guidance please see the UoB Project Set-Up SOP (UoB-SET-SOP-001) (Word - 346 KB) and Essential Documents Development and Maintenance SOP (UoB-ESD-SOP-001) (Word - 401 KB).

Training and Curriculum Vitae (CV) also need to be up to date as these will be checked as part of the approvals process. Details on types of training required, how it can be accessed and how it should be evidenced is covered in the UoB Training SOP (UoB-TRN-SOP-001) (Word - 82 KB). There is also an employee CV template (UoB-TRN-QCD-001) (Word - 113 KB) and training record template (UoB-TRN-QCD-002) (Word - 114 KB) available to use.

If your research involves NHS sites, you will need to obtain NHS R&D management permission (or confirmation of capacity and capability). See the UoB Site Management SOP (UoB-SMA-SOP-001) (Word - 317 KB) for further information. 

You can find the contact details for R&D staff and your local Clinical Research Network (CRN) by visiting the NHS R&D forum website. 

Additionally, if you will deliver research activities locally, but are not employed by the participating organisation, you will need to work with the individuals responsible for research management at the site so that HR arrangements can be put in place in accordance with HR Good Practice Resource Pack (research passport guidance).

All participating investigator sites will undergo a process of site initiation before commencing recruitment. The site-initiation checklist template can be used to ensure the site is fully prepared to conduct the project.

• Site Initiation Checklist (UoB-SMA-QCD-002) (Word - 294 KB)

NHS organisations can be used to identify potential participants, and these are referred to as Participant Identification Centres (PICs). They are not research sites and are not treated in the same way. If you are using a PIC site, you will still need to ensure that appropriate contractual agreements are in place with the NHS PIC. For further information refer to IRAS.

For research involving organisations which are partners in Birmingham Health Partners (BHP), it may also be helpful to consult the BHP website.

See also the Site Management section of the e-Pathway.

HRA Approval brings together the assessment of governance and legal compliance, with the independent ethical opinion by a Research Ethics Committee (REC).

The HRA website includes an overview of the HRA Approval process.

See the UoB Project Setup SOP (UoB-SET-SOP-001) (Word - 346 KB) for further information.

Combined review is the way research teams seek approval for new Clinical Trials of Investigational Medicinal Products (CTIMPs) and combined medicine and device trials (effective from 01-Jan-2022).  A ‘combined review’ brings together the assessment of governance and legal compliance, with the Competent Authority (MHRA) and the independent ethical opinion by a Research Ethics Committee (REC). For further information, see the Combined Review Service website.

See the UoB Project Setup SOP (UoB-SET-SOP-001) (Word - 346 KB) for further information.

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

• Governance & Ethics (current page)
• 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.