UK-wide Working

A combined IRAS Form that merged the REC and R&D Forms has been used since March 2016 for research projects where the lead NHS R&D office is based in England. For research projects created in IRAS from the evening of 28 June 2017, the single IRAS Form will also be used in place of separate REC and R&D Forms for projects where the lead NHS/HSC R&D office is based in Northern Ireland, Scotland or Wales. Projects already in the system will continue to use separate forms.

Release of the combined Form is part of the Four Nations NHS/HSC Compatibility Programme and contributes to making it easier for applicants to undertake research in the NHS/HSC. Adoption of the single IRAS Form UK wide will help build UK wide consistency and, importantly, save time and effort in terms of form management and sponsor authorisation.

Browsers supported by IRAS

In order to continue to develop the Integrated Research Application System (IRAS) and introduce enhanced functionality, the IRAS team have issued advance notice that from 18 October 2017, IRAS will officially support specific internet browsers and browser versions. Please refer to the IRAS ‘Supported Browsers’ help page for more information and to find out if this will affect you.

This decision was taken by the IRAS Partners Board following a user poll taken during July 2017 which demonstrated that 95% of the 400 users who responded to the poll used, or had access to, the supported browsers.  A small number of IRAS users will need to work with their IT departments to update their internet browsers’.

Applicants are encouraged to read the advice and guidance within IRAS and to seek support from their lead NHS/HSC R&D office.

Find out more:
IRAS Form UK wide June 2017 - DA coord functions and sw reviewers
IRAS Form UK wide June 2017 - DA RD offices
IRAS Form UK wide June 2017 - DA applicants and sponsors
IRAS Form UK wide June 2017 - UK Research Ethics Service

The following Questions and Answers have been compiled to support applicants, R&D offices and Research Ethics Service staff during the change.

Download a PDF of these FAQs here.

What is the Four Nations NHS/HSC Compatibility Programme?

 The Four Nations NHS/HSC Compatibility Programme is a series of projects being undertaken by the UK research approval bodies to implement:

• A consistent nationwide approach to sharing information between sponsor and sites
• A single ethics and R&D online submission from the Integrated Research Application System (IRAS), and
• An improved UK-wide approach to amendments.

The aim is to ensure compatible and consistent ways of working across England, Scotland, Wales and Northern Ireland further developing the UK as a cohesive and streamlined place to undertake research within the global economy.

The release of a combined REC and R&D Form is one part of the programme.

The Four Nations NHS/HSC Compatibility Programme is being undertaken for and supported by the UK Health Departments of England, Northern Ireland, Scotland and Wales.

Why are the REC and R&D Forms being combined into a single form?

The Four Nations NHS/HSC Compatibility Programme’s ambition is to support a more streamlined approach to setting up research in the NHS. The implementation of a combined form is a step along the way to having a simultaneous submission from IRAS for both ethical review (where applicable) and review against NHS standards. The REC and R&D Forms within IRAS were very similar in content and by creating one form, applicants have fewer forms to manage in IRAS and fewer authorisations to seek from sponsor representatives.

Has the IRAS project filter changed?

Yes. For all project based research (i.e. not Research Tissue Banks and not Research Databases), when England, Northern Ireland, Scotland or Wales is selected in IRAS Project Filter Question 3a the IRAS Form will display for selection in IRAS Project Filter Question 4. There will no longer be the option to select a REC or R&D Form.

When “This study does not involve the NHS” is selected at IRAS Project Filter Question 3a, the REC and R&D Forms will continue to be displayed as forms that can be selected.

The pop up associated with IRAS Filter Question 3a about HRA Approval for England has been removed and a new pop-up message will display when a country is selected in Question 3.

Please create test projects in IRAS so that you understand the change.

Has the document checklist in IRAS changed?

Yes. The document checklist for new projects created using the IRAS Form has changed. The IRAS Form checklist is a merge of the REC and R&D Form checklist. We have also taken this opportunity to refresh some of the checklist wording to better assist applicants to attach the correct documents to their applications. Sample checklists have been shared with those checking in study-wide reviews.

The update to the document checklist will not apply to existing IRAS Forms, REC or R&D Forms created in IRAS before the evening on 28 June 2017.

Has the submission tab changed?

Yes. For new IRAS Forms created from the evening of 28 June, the information provided on the submission tab of the IRAS Form depends on selections made in IRAS Project Filter Questions 3a and the red text question about the need for review by an NHS Research Ethics Committee (REC). There are 3 versions of the submission tab giving the appropriate instructions for the specific project.

1. If the project is led from England
2. If the project is led from Northern Ireland, Scotland or Wales and needs review by an NHS Research Ethics Committee
3. If the project is led from Northern Ireland, Scotland or Wales and does not require review by an NHS Research Ethics Committee (eg. projects involving NHS/HSC staff only).

There is no change to the submission tabs of IRAS, R&D or REC Forms already created before the update.

Does a single IRAS Form mean that there is one submission to REC and to the NHS/HSC?

For projects led from Northern Ireland, Scotland or Wales, although a single form will replace the separate REC and R&D Forms, this single IRAS Form will initially continue to be separately submitted for ethical review (where applicable) and review against NHS/HSC standards as per current processes. Applicants are advised to read the whole of the e-submission/submission tab before taking action.

The single electronic submission of the IRAS Form and accompanying documents for both ethical review and for review against NHS/HSC standards will remain in place for projects led from England.

Work is underway to make the single electronic submission of the IRAS Form and accompanying documents for both ethical review (where applicable) and review against NHS/HSC standards available for all studies in the UK. This will take time to develop.

As an applicant how do I submit an IRAS Form to the REC?

Instructions on how to submit applications are provided in detail in the IRAS Form e-submission tab; submission instructions will depend on the type of study as defined by the answers provided by the project filter. Additionally, a set of detailed step by step instructions is provided which can be linked to from the HRA Approval and NHS/HSC permissions pages in the” Preparing & submitting” applications section of IRAS Help. Applicants are advised to read the whole of the e-submission tab before taking action.

There is no change to how applications are booked and submitted to the REC. The applicant telephones the central booking service, answer some questions designed to make sure that the study is booked to the most appropriate REC and then electronically submits the application (form and documents) using the button in the e-submission tab.

The single electronic submission of the IRAS Form and accompanying documents for both ethical review and for review against NHS/HSC standards will remain in place for projects led from England.

As an applicant how do I submit an IRAS Form for review against NHS/HSC standards by the nation in which the lead NHS/HSC office is based?

Instructions on how to submit applications are provided in detail in the IRAS Form e-submission/submission tab; submission instructions will depend on the type of study as defined by the answers provided by the project filter. Additionally a set of detailed step by step instructions is provided which can be linked to from the HRA Approval and NHS/HSC permissions pages in the” Preparing & submitting” applications section of IRAS Help. Applicants are advised to read the whole of the e-submission/submission tab before taking action

There is no change to how applications are submitted for review against NHS/HSC standards.

For projects where the lead NHS/HSC R&D office is based in Northern Ireland, Scotland or Wales:

A. If the project requires review by an NHS/HSC REC - once the IRAS Form has been submitted to the REC it should be downloaded in PDF and XML format and emailed with accompanying documents to the lead nation. Email addresses are provided within IRAS Help. There are special arrangements for single centre projects taking place in Northern Ireland and Scotland. These are described within IRAS.

Applicants should email their submission for review against NHS/HSC standards as soon as possible after submission to the REC. Any delay could mean it will take longer to get studies up and running in the NHS/HSC.

Once an application has been submitted for review against NHS/HSC standards (study-wide review) applicants may submit SSI Forms to participating NHS/HSC organisations.

B. If the project does not require review by an NHS REC (for example, staff studies) – the submission tab in IRAS allows applicants to generate a version of the form which is downloaded in PDF and XML format and then emailed with accompanying documents to the lead nation. (This is the same functionality as R&D Form submissions previously). Email addresses are provided within IRAS Help. There are special arrangements for single centre projects taking place in Northern Ireland and Scotland. These are described within IRAS.

Once an application has been submitted for review against NHS/HSC standards (study-wide review) applicants may submit NHS SSI Forms to participating NHS/HSC organisations in Northern Ireland, Scotland and Wales and follow HRA Approval processes for participating NHS organisations in England.

For projects where the lead NHS R&D office is based in England:

The single electronic submission of the IRAS Form and accompanying documents for both ethical review and for review against NHS/HSC standards will remain in place.

Once an application has been submitted for review against NHS/HSC standards (HRA Approval) applicants follow HRA Approval processes for participating NHS organisations in England and submit NHS SSI Forms to participating NHS/HSC organisations in Northern Ireland, Scotland and Wales.

Cross-border studies
For projects which have indicated in IRAS Project Filter Question 3 that they have participating NHS/HSC organisations in more than one UK nation, the nation in which the lead NHS/HSC R&D office is based will share the application and outcome of review against NHS/HSC standards with the other participating nations. There is no requirement to submit an application to all participating nations.

What do I do if I already have an R&D Form and a REC Form created in IRAS?

The change will only apply to new projects created in IRAS from the evening of 28 June 2017.

If you have already submitted a REC and/or an R&D Form please do NOT deselect REC and R&D Forms in IRAS Project Filter Question 4 otherwise the form submission history and the ability to generate substantial amendments will be lost.

If you have not yet submitted or obtained e-authorisations for either a REC or an R&D Form or you may, if you choose, return to the IRAS Project Filter and deselect REC and R&D Forms at Question 4. The option to select an IRAS Form will then be available. You will not lose any of the data you have already entered into IRAS. If you are in the early stages of completing applications this may make your future applications easier to manage.

There will be an approximate period of 6 months or so before all new applications will need to transfer to the IRAS Form.

Where can applicants get additional help and support?

The first port of call for help and support for applicants should be the staff within the organisation sponsoring the study. Additional support can be obtained from the lead NHS/HSC R&D office (if different from the sponsoring organisation).

What changes will sponsors need to make?

Sponsors should review their procedures to make sure that they are up to date and in line with this change.

Other than terminology (the terms REC Form and R&D Form being changed to IRAS Form), the most significant change for sponsors is the reduction of two e-authorisations to one.

Where sponsors have different teams submitting REC and R&D Forms at present, they will need to work together to ensure that information and documents for both REC review and review against NHS/HSC standards are both ready and authorised.

Does a single form mean that the REC will review information previously reviewed by the NHS/HSC?

No. RECs will continue to review the ethical elements of the application in the same way. Additional questions and documents about funding, contracts and costings will be ignored by the Research Ethics Committee.

Does a single form mean that the review against NHS/HSC standards (the study-wide review) will review additional information previously reviewed by the REC?

No. Study-wide reviewers (and single centre study reviewers in Scotland and Northern Ireland) will continue to review the study against the UK-wide agreed study-wide standards and continue to take into account differences in legislation across the UK.

Where studies have participating NHS/HSC organisations across the UK, the nation in which the lead NHS/HSC R&D office is based will continue to share the study-wide review with other participating nations.

When will the other elements of the Four Nations NHS/HSC Compatibility Programme be implemented?

Development of the other elements of the programme is progressing.

The next planned element is a consistent nationwide approach to sharing information between sponsor and sites which will replace the use of NHS/HSC Site Specific Information Forms (SSIs) in Northern Ireland, Scotland and Wales and replaces the Statement of Activities in England. This will not be ready for several months.

• Future elements of the programme include:
  Making the single electronic submission of the IRAS Form and accompanying documents for both ethical review (where applicable) and review against NHS/HSC standards available for all studies in the UK
• Electronic submission of amendments from within IRAS
• Streamlining the amendment process across the UK.

Is there any change at the moment to SSI Forms for use with NHS/HSC organisations in Northern Ireland, Scotland or Wales?

Not now. Planned changes will be announced when there is a clear specification agreed across the UK.

Is there any change at the moment to the use of Statements of Activity and Schedule of Events template for use with the NHS in England?

Not now. Planned changes will be announced when there is a clear specification agreed across the UK.

Is there any change at the moment to the use of SSI Forms for non-NHS/HSC sites?

No. There are no plans to change how non-NHS SSI Forms for non-NHS/HSC sites are used across the UK.

Are there any changes to how amendments are submitted to the REC and for review against NHS/HSC standards?

No, there are no changes to the amendment submission process. Guidance on how to submit amendments to the NHS/HSC are provided in IRAS Help.

Where can sponsors and R&D offices seek additional support?

Where sponsors or lead R&D offices have additional queries they can contact the national coordinating function in their own country – these links are well established.