Single electronic submissions of the IRAS Form

14th June 2018

Frequently asked questions on single electronic submissions of the IRAS Form for NHS/HSC studies led from Northern Ireland, Scotland and Wales are available at the Four Nations Compatibility IRAS page.

On 28 June 2018* an update to IRAS, the Integrated Research Application System, will introduce a single, e-submission of IRAS Forms and associated documents. This change applies to studies taking place in NHS organisations in Scotland and Wales and Health and Social Care (HSC) organisations in Northern Ireland where the lead NHS/HSC R&D office is in Northern Ireland, Scotland or Wales.

Single IRAS Form and document e‑submission are already available for NHS/HSC studies where the lead NHS R&D office is in England.

There is no change to how participating organisations are set up. IRAS Help provides advice on how to submit site-specific/ local information to sites:

What is changing?

The IRAS update will allow full e‑submission of the IRAS Form and associated documents for all UK nations. This means that:

All versions of the IRAS Form will have an e-submission tab
Applicants of multi-centre studies in Northern Ireland, Scotland and Wales will no longer need to email their application to the national coordinating function in their lead country
Applicants of single-centre studies in Wales will no longer need to email their application to the Health and Care Research Wales Permissions Service
Applicants of single-centre studies in Northern Ireland and Scotland will no longer need to email their IRAS Form and associated documents to the R&D office of that single centre.

How is it changing?

All NHS/HSC study applications will be booked in through the Central Booking Service. The IRAS Form e‑submission tab gives details on how to contact the Central Booking Service. Studies that require ethical review already use this service but it is new to applicants whose studies require NHS/HSC study-wide review only.

There will be no need to email IRAS Forms and supporting documents for NHS/HSC study-wide review in Northern Ireland, Scotland or Wales. NHS/HSC study-wide review is an assessment of whether or not the study complies with appropriate legislation and standards for undertaking research in the NHS/HSC (for example this review includes arrangements for handling tissue and/or data, mental capacity arrangements, and the contracting arrangements appropriate for the activities being undertaken). NHS/HSC study-wide review is undertaken once for the study as a whole regardless of the number of participating NHS/HSC organisations are taking part in the study.

Local site set up processes will remain and will involve e-mail communications.

What do applicants have to do?

Complete the IRAS Form
Upload all applicable study documents to the IRAS Form checklist
Make sure the application is ready to submit and passes the verification step. The IRAS Form e‑submission tab gives guidance on this
Book in the application for review using the Central Booking Service. If the study requires Research Ethics Committee (REC) review, the service will book the REC meeting slot at the same time as enabling e-submission. For non-REC studies the service will enable e-submission. Applicants will receive a confirmation email from the Central Booking Service
Add the booking information to the first page of the IRAS Form
Click the “E-submit application” button to submit the application.

NB. The Central Booking Service asks questions relating to the application in order to assign the application to the correct reviewers. Please make sure that the person making the call to the Central Booking Service understands the study.

What happens after e-submission?

The system will automatically send the IRAS Form and associated documents to the lead nation to carry out NHS/HSC study-wide review. If applicable, the system also sends the application to the Research Ethics Committee for their review.

The IRAS Form e-submission tab displays a history which will show what has been submitted and when.

The person undertaking NHS/HSC study-wide review and the Research Ethics Committee, where applicable, will contact the applicant as the application goes through the review process.

If the application indicates that the study will have participating NHS/HSC organisations in other UK nations, the lead nation will share the application with national coordinating functions of the participating nations.

Why are we making this change?

The change streamlines the submission of IRAS Forms. This will benefit applicants based in Northern Ireland, Scotland and Wales by:

Reducing the number of steps taken to make an application
Removing the need to email IRAS Form applications for NHS/HSC study-wide review
Removing some of the difficulties experienced with sending large emails across the NHS/HSC, though acknowledging that applicants still need to e‑mail documents as part of the local site set up. We are working on functionality for the future to further reduce reliance on email
Enabling NHS/HSC study wide review to take place at the same time as the REC review.

In addition, the change benefits applicants working on a number of studies across different lead nations as there will be a consistent process for submitting the IRAS Form for all NHS/HSC studies in the UK.

Is there anything that is not changing?

This change does not apply to applications for REC-only, Research Tissue Banks and Research Databases. The IRAS Form is not used for these studies.

This change does not apply to studies with no NHS/HSC involvement as indicated on IRAS project filter question 3a. The IRAS Form is not used for these studies.

There is no change to how studies are set up at a site level. See IRAS Help for more information.

Frequently asked questions are available at the Four Nations Compatibility IRAS page.

*Anticipated implementation day subject to final confirmation. Applicants are advised to follow the instructions on the submission tab in IRAS to ensure they follow the correct procedure for the date on which they are making an application.

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