Integrated Research Application System (IRAS) : An Introduction

If you're working in clinical research in the UK, you will likely have heard of "IRAS" - The Integrated Research Application System. IRAS is a web application ecosystem used in the UK for health and social or community care research. It enables multiple application forms to be created in order for relevant regulatory bodies to review.

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IRAS has become the gold standard for research applications in the UK since it saves time and effort of end users by reducing the need to create multiple forms for regulatory approvals, as well as produce tailored application forms for your work which remove redundant questions and minimise error risk.

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Who can use IRAS?

• People applying for research approvals or permissions
• People responsible for the review and authorisation of research projects
• Applicants for research tissue banks or research databases

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6 Key Features and Benefits of IRAS

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Single Integrated Application Form (IAF)

• The single IAF process of IRAS ensures that different review bodies can get the information they need without unnecessary duplication
• The risk of duplication errors is significantly reduced

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Modular Structure

• The Project Filter feature of IRAS allows a modular input of information into your application
• Since human participant research can be incredibly varied, IRAS can use a modular approach to strip out unnecessary sections, thereby simplifying the process for all users

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Collaborative Working

• With secure login functionality, IRAS brings together multiple people into one space, including research team members and stakeholders for application review
• Multiple users of different roles can take part in the review process simultaneously

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Version Control

• In order to comply with ICH-GCP, IRAS allows document versions to be recorded across multiple applications
• A major benefit of this is enabling transparency and accountability for all changes and updates during the application process

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Ethics modules

• IRAS is able to handle submissions of research proposals to research ethics committees (RECs)
• This module contains specific sections for detailed study information, participant involvement and ethical considerations

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The Approval Process : 6 Key Points

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You've filled in all the necessary project information - great -what's next? How long will it take for your project to be approved? This question is asked very frequently and, ultimately, depends on the nature of the project and the types or quantities of approvals that are required. Relatively simple projects that don't require many approvals can come together quite quickly. Here are some points to consider in the approval process

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Type of Approval

• Approvals you might need covered in the application process might come from many committees, to name a few: Confidentiality Advisory Group (CAG), Gene Therapy Advisory Committee (GTAC), Health Research Authority (HRA)

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Study Complexity

• Not all trials are born equal. Items which weight heavily on the study complexity might be (i) the number of arms or interventions, (ii) the number of sites, (iii) the number of languages, (iv) the number of collaborating institutions or companies, (v) the potential risks involved, (vi) whether complicated screening (e.g. SNP/demographic characterisation needs to happen beforehand)

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Committee Availability

• Many committee members will be working on a voluntary basis and might have other obligations or life commitments. These committees will also consist of specialists in variety of areas, and sometimes lay persons. Each members input is not only valid, but essential for a fair and objective overview of the approval process

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Completeness of the Application

• A well-prepared application will help reduce the number of steps involved in the review process. Oftentimes, committees will come back with questions, queries and suggestions. The more complete your application is int he first place, the fewer items will come back which need addressing

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Communication and Clarifications

• On a similar theme to completeness is communication and clarification. If the application is concise and coherent, key points can be checked off by the committee. Any ambiguity and vagueness will crop-up in questions from the committee, potentially dragging out the process

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Local NHS Trust Approvals

• If your study involves local NHS trusts for whatever reason (staff, resource, participation), this can significantly impact upon the approval timeline. The NHS is a busy institution with many staff members already fully committed to other job roles or items. Finding the time to gather essential personnel to review documentation can take some time.

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Overall, IRAS serves as a comprehensive and user-friendly system to facilitate the efficient and coordinated submission of research applications across various regulatory and ethical review bodies in the UK. It can be a lengthy process, but we must always remind ourselves of the most important consideration of human research - to protect the health and wellbeing or participants.