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IRAS

On 28 June 2018* an update to IRAS, the Integrated Research Application System, introduced 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 has changed?

The IRAS update allows 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 has it changed?

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?

  1. Complete the IRAS Form
  2. Upload all applicable study documents to the IRAS Form checklist
  3. Make sure the application is ready to submit and passes the verification step.  The IRAS Form e‑submission tab gives guidance on this
  4. 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
  5. Add the booking information to the first page of the IRAS Form
  6. 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 the 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.

*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.

Frequently Asked Questions: Single electronic submissions of the IRAS Form for NHS/HSC studies led from Northern Ireland, Scotland and Wales

1. When will this change happen?

The change happened on 28 June 2018. 

2. What are the key changes for applicants?

  • There will be no need to email IRAS Forms and associated documents for NHS/HSC study‑wide review i.e. 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 taking part in the study
  • Applicants for studies that do not require REC review (e.g. studies involving NHS/HSC staff as participants) will telephone the Central Booking Service to enable their e-submission
  • There is no change to how sites are set up locally. Please refer to the guidance in IRAS
  • There is no change for applications where the lead NHS/HSC R&D office is in England.

3. What happens if I am part way through the application process on the date of the change?

If you have already e-submitted an IRAS Form application to the Research Ethics Committee but have not yet emailed the application for review against NHS/HSC standards, please email your application as soon as possible to:

If you have already emailed an application and need to supply additional documents or information, please continue to use the email addresses above.

Do not repeat your IRAS Form e-submission for ethical review.

4. Is there a change to how sites are set up?

No. There is no change to how sites are set up. IRAS Help provides guidance. Participating site set‑up continues to use existing processes.

5. If my study does not require booking to an NHS/HSC Research Ethics Committee, why do I need to telephone the Central Booking Service?

The Central Booking Service enables the e‑submission button on the e‑submission tab of the IRAS Form to allow you to submit your application. 

Please note: For studies that do not require NHS/HSC Research Ethics Committee review, the IRAS submission history will indicate that the study is “non-REC”.

6. What do I do if my study has sites in more than one UK nation?

IRAS project filter question 3 asks you to indicate those countries where there are participating NHS/HSC organisations. The lead country (as indicated in IRAS project filter question 3a) will share your IRAS Form and associated documents with other participating nations.

7. How does this change affect studies where the lead NHS R&D office is in England?

There is no change for studies where the lead NHS R&D office is in England. This functionality is already in place.

8. What do I do if I need to update or re‑submit documents during the approval process?

You should contact the NHS/HSC Research Ethics Committee or National Coordinating Function to discuss this. Contact details will be provided to you.

9. Is there a contact point for applicants with further information or queries?

Applicants can contact their local NHS/HSC R&D office for advice and support about undertaking research. 

Alternatively, you can contact the relevant national coordinating function for advice:

If you experience a technical fault with IRAS or wish to give feedback, please contact the IRAS Helpdesk at iras.queries@nhs.net.

10. Does this change apply if my study does not involve the NHS/HSC?  For example, if it is taking place in a non‑NHS Phase 1 Unit.

No. This change applies only to IRAS Forms. Studies that do not involve the NHS/HSC do not use IRAS Forms.

11. Who has been involved in making this change?

This change is part of the Four Nations Compatibility Programme. It follows from the introduction in June 2017 of the single IRAS Form which replaced the REC and R&D forms for studies taking place in the NHS/HSC and where the lead NHS/HSC R&D office was based in Northern Ireland, Scotland or Wales.

FAQs for NHS/HSC R&D and Ethics staff

12. What does the change mean for those receiving the IRAS Form and associated documents in Northern Ireland, Scotland and Wales?

For multicentre studies: The national coordinating function will receive the IRAS Form and associated documents through HARP, instead of by email. 

The national coordinating function will be alerted of applications received in HARP and will collect applications from HARP. The application is then handled as per current process. The only change is the way in which the IRAS Form and associated documents are received. Study-wide reviewers are unlikely to experience change.

Where applicants are required to re‑submit any additional information, this will also be shared through HARP.

For single centre studies: For England and Wales, the existing processes will continue.  For Scotland and Northern Ireland, the national coordinating function will collect the IRAS Form and associated documents from HARP as opposed the applicant emailing these directly to the NHS/HSC organisation.  The national coordinating function will make these available to the NHS/HSC organisation. 

Where applicants are required to re‑submit any additional information, this will also be shared through HARP.

13. How does the change affect Research Ethics Committees?

This change has no implications for Research Ethics Committee members.

Research Ethics Committee staff should be aware:

  • That their national coordinating function colleagues will collect applications from HARP.  Applications need to be imported as soon as possible after submission
  • Alerts in HARP will inform national coordinating functions when an updated submission (form or documents) has been made so please ensure that updates are made via e-submission from IRAS and not manually uploaded into HARP
  • All of the documents on the IRAS Form checklist will be imported into HARP. This will include documents that are not REC reviewable such as Industry Costing Templates, template agreements, template delegation logs, and (for studies with sites in England and/or Wales) statements of activities and schedules of events. Please untick these documents as REC reviewable
  • The only difference in documents between studies led from Northern Ireland and Scotland and those led from England and Wales is that the statement of activities and schedule of events for non-commercial studies will usually not be provided (unless there are sites in England and/or Wales)
  • Joined up validation continues for studies led from England and Wales. For studies led from Scotland and Northern Ireland work is ongoing to introduce joined up validation in the coming months
  • The functionality to alert national coordination functions that an application has been made works on the basis of e-submission.  Please do not locally book any studies that are taking place in the NHS/HSC (Filter question 3a)
  • Exceptionally in the case of a re-submission following an unfavourable opinion or otherwise agreed by a senior manager a local booking is made. In such cases, and where relevant, please ensure that the national coordinating function of the lead country is alerted by email so that they can collect the study. For studies with participating sites in England or Wales please also ensure that the HRA Approval box at the bottom of the references tab is ticked so that the assessor/study-wide reviewer can access the study.

14. How does the change affect NHS/HSC R&D Staff?

There is no anticipated impact on local NHS/HSC staff other than providing updated advice to researchers about how to make submissions (and this may include updating local websites or information leaflets).

For local R&D staff based in Northern Ireland and Scotland who additionally perform the role of single-site study-wide reviewers, the mechanism through which applications are received may be slightly different. I.e. applicants will no longer email the IRAS Form and associated documents to the R&D office – you will receive them through your national coordinating function. Your national coordinating function will work with you to ensure that processes are clear. SSI forms will continue to be emailed as we work towards being able to handle local information electronically.