Trial Approvals Phase

The IRAS station follows the Final Protocol station and CI Checklist Before Seeking Approval, and precedes the CTA Submission station. Applying to IRAS is good practice and is relevant to all trials. This station is part of the ‘trial approvals phase’ group of stations.

The Integrated Research Application System (IRAS) is a single system for applying for the permissions and approvals for health and social / community care research in the UK. This includes HRA/HCRW Approval (England and Wales) or NHS/HSC R&D Permission and NHS REC review (where required) for research led from Northern Ireland or Scotland).  In addition IRAS can be used to create ‘Notice of Substantial Amendment’ forms (see Substantial Amendment station).  There is now one consistent package to support study set-up and delivery across the UK. The Organisational Information document, in outline format, will be a component of the IRAS form submission and in a localised format will be required as part of the UK Local Information Pack for both commercial and non-commercial research.

IRAS can be used by anyone carrying out health and social / community care research in the UK, including all Chief Investigators and those with delegated responsibility for applying for research approvals and permissions.

Users of the system must have an IRAS account. On-screen instructions provide guidance on opening an IRAS account.

IRAS provides extensive guidance in the Help section and via Question Specific Guidance that can be accessed as the form is completed by clicking the green “i" buttons. IRAS also provides an e-learning module that is free to use and does not require registration. This module provides a simple overview of the system and its functionality.

Careful and considered completion of the project filter is essential as this will determine which permissions and approvals applications are created for the project and which questions are enabled and disabled. Questions that are not relevant to the type of project will be disabled in the project dataset. For example, indicating that participants will have exposure to ionising radiation would enable a group of questions in the project dataset about ionising radiation and additional declaration for Medical Physics Experts and Clinical Radiation Experts. It is important to be aware that the project filter is dynamic and so further questions may be enabled in the filter depending on the selections made.

It is suggested that all questions are completed in the ‘Full Set of Project Data’ (integrated dataset for all project forms) as this is the most effective way of populating all individual application forms. Not all questions are required in each form, so populating from individual forms will not guarantee that all required sections in other forms are completed. Please see Guidance for new and first time users of IRAS for further information.

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