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Updates to IRAS


20 December 2016: Version 5.4

All projects in IRAS have been updated to this version. As well as implementing some fixes, this release includes updates as set out below. The updates in this release do not affect electronic authorisations.

ORCID identifier

A new field for the ORCID identifier has been added to the contact fields for National Coordinating Investigator/Principal Investigator and Chief Investigator. The ORCID identifier is being integrated into the manuscript submission process by publishers and several funders, such as the NIHR, plan to use it to streamline the research management process. An ORCID identifier belongs to a researcher throughout their research career as a unique, persistent identifier that over time will reduce repetitive entry of biographical and bibliographical data in multiple systems. More information is available at http://orcid.org/

Update of the ODS look up in Part C (applicable to England-led projects)

The ODS look-up that is provided in Part C for project-based research led from England has been updated. In these projects the look-up is available for NHS sites in England. Applicants should note that the pop-up ODS search box has been updated to incorporate an initial filtering question about whether the site is a primary care site. The response to this question will determine the site types available via the search function. In addition to this change the ODS reference data itself has been updated and includes up to date site types. Please note that any ODS codes that were applied to datasets prior to this release have not been changed by this version release. More information is provided in the accompanying guidance, which is accessed by clicking on the green “i" button.

Project filter updates

Some updates have been applied to logic that is used to enable/disable the application form types displayed at filter question 4.

Minor updates to embedded guidance

This version updates the embedded guidance associated with some questions within integrated dataset Part B2/MHRA Devices PCA2 application form. Please ensure that you refer to the guidance that is provided when preparing your forms in IRAS.

7 September 2016: Version 5.3.2

All projects in IRAS have been updated to this version. As well as implementing some fixes and internal system updates, this release includes updates to existing functions and content in the system as set out below. The updates in this release do not affect electronic authorisations.

ARSAC Research Certificate Application (RCA) form creation in projects with, or seeking, HRA Approval

The application to the Administration of Radioactive Substances Advisory Committee (ARSAC) is split into a project (“Preliminary Research Assessment (PRA)”) form and a shorter site specific (“Research Certificate Application (RCA)”) form. These forms are generated whenever the project filter has been completed to indicate that the study involves exposure to radioactive substances.

In earlier versions of IRAS, the RCA form could only be created in association with a site specific information (SSI) form. Whilst this dependency is helpful in many cases, it is not suitable for participating NHS sites in England in projects that have, or are seeking, HRA Approval as NHS SSI forms are not required for these sites. In IRAS v5.3.2. functionality has been added to allow ARSAC RCA forms to be created from the rows in Part C that are for NHS sites in England, without the need to create a linked NHS SSI form. It should be noted that where applicants choose to create an NHS SSI form for these sites, using the ‘Create NHS SSI form’ button, an NHS SSI form and ARSAC RCA form will be created simultaneously. In both instances applicants should complete information in the fields in Part C before clicking the button to create form(s). The creation of ARSAC RCA forms for NHS/HSC sites in Northern Ireland, Scotland and Wales and for non-NHS sites remains unchanged and linked to the creation of the relevant SSI form. More information on applying to ARSAC is provided in IRAS Help.

Removal of option to create new minimal dataset projects

The minimal dataset functionality was introduced in August 2009 to allow those who had applied in systems that pre-dated IRAS to create site specific information forms and manage substantial amendments to their projects. Given the restricted role of these projects the functionality within them is very limited compared with full projects. Additionally, as several years have now elapsed it is expected that minimal datasets have been created in all cases where they are needed. For these reasons, IRAS v5.3.2 removes the option to create new minimal dataset projects.

Any minimal dataset projects created prior to this version release will remain available in individual IRAS accounts and may be identified by text in the header area of the Navigation Page for the project which states “Created as a minimal dataset project”. Please note that if responsibility for the project has changed since the minimal dataset was created then ownership of the project may be permanently transferred to another IRAS account holder – please refer to the IRAS e-learning module for instructions.

Addition of new project filter question 5c

This new question will only be activated for projects where filter responses indicate that the project: involves NHS organisations; and will include sites in England; and is led from Northern Ireland or Scotland or Wales. This new question 5c asks applicants whether, for the research site(s) in England, they want the study to be considered for NIHR Clinical Research Network (CRN) support and inclusion in the NIHR Clinical Research Network (CRN) Portfolio. More information is provided in the accompanying guidance, which is accessed by clicking on the green “i" button.

Addition of registry reference number field to non-CTIMP Notice of Substantial Amendment Forms

An additional read-only field to capture registry reference numbers associated with the project has been added to the Notice of Substantial Amendment form that is generated in non-CTIMP projects (i.e. all project categories except CTIMPs and Research Databases/Research Tissue Banks). Applicants should note that this field is populated by information that has been completed in A5-1 of the integrated dataset.

Minor updates to embedded guidance

This version update includes some minor amendments to the guidance provided in: the pop-up guidance in the project filter triggered by selection of an application to the Social Care REC; and the link within the guidance associated with the CTIMP Notice of Substantial Amendment form in minimal dataset projects. Please ensure that you refer to the guidance that is provided when preparing your forms in IRAS.

7 June 2016: Version 5.3.1

All projects in IRAS have been updated to this version. This update is primarily a maintenance release to implement some fixes and internal system updates. However it does also include minor updates to some existing functions and content in the system; these are set out below. The updates in this release do not affect electronic authorisations.

Applications to ARSAC – Preliminary Research Assessment (PRA) form

The application to the Administration of Radioactive Substances Advisory Committee (ARSAC) is split into a project (“Preliminary Research Assessment (PRA)”) form and a shorter site specific (“Research Certificate Application (RCA)”) form. The forms are generated whenever the project filter has been completed to indicate that the study involves exposure to radioactive substances.

In earlier versions of IRAS, the PRA form could only be created in final pdf format for submission to ARSAC after the NHS REC application had been submitted. In IRAS v5.3.1 this dependency has been removed and so now the PRA form may be created for submission at any time. However, applicants should note that there remains a part of this form that will only be populated once the application for ethical review has been booked and electronically submitted. Therefore if you choose to submit the PRA form prior to submitting your application for ethical review this section of the PRA form will remain blank. More information on applying to ARSAC is provided in IRAS Help.

Question A6-3 Proportionate review of REC application

This question was enabled for projects in IRAS that, through responses entered in the IRAS Project Filter, were identified to be potentially eligible for the Proportionate Review Service (PRS) provided by the UK Health Departments’ Research Ethics Service. As part of the IRAS v5.3.1 update this question has been removed from the integrated dataset, and from forms, as eligibility for PRS is now identified as part of booking your application for ethical review.

Minor updates to embedded guidance

This version update includes some minor amendments to the guidance provided in: the amendment tab for the IRAS Form; the submission tab for the MHRA Devices application form; and the pop-up guidance in the project filter that is triggered when an application may be eligible for HRA Approval. Please ensure that you refer to the guidance that is provided as part of preparing your forms in IRAS.

20 May 2016: IRAS e-learning module updated.

The revised module, which is free to use and provides an overview of the functionality in IRAS, can be accessed via the horizontal toolbar at the top of this page.

8 April 2016: IRAS Terms & Conditions and Privacy Policy statements updated.

To review the current statements please click on Terms & Conditions and Privacy Policy.

3 April 2016: Version 5.3

All projects in IRAS have been updated to this version, which includes the updates noted below. Any electronic authorisations that were in place prior to this version release will not have been affected by the update.

HRA Approval

From 31 March 2016, HRA Approval is the process for applying for approvals for all project-based research in the NHS led from England. HRA Approval brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with the independent Research Ethics Committee (REC) opinion provided through the UK Health Departments’ Research Ethics Service (where required). It replaces the need for local checks of legal compliance and related matters by each participating organisation in England. This allows participating organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study.

Users are reminded that as HRA Approval is now the process for the NHS in England, the NIHR Coordinated System for gaining NHS Permission (NIHR CSP) has been closed and the interface between IRAS and the NIHR CSP Module for submission of R&D forms and NHS SSI forms has been disabled. Please refer to the NIHR CRN announcements for more information.

If your study involves participating NHS organisations and is led from England:

The action(s) you may need to undertake depend on where in the application process your project has reached. Please refer to the IRAS Help page for HRA Approval for further information.

If your study involves participating NHS/HSC organisations and is led from Northern Ireland, Scotland or Wales:

These studies will continue to submit NHS/HSC R&D forms according to the NHS/HSC permission processes that apply in each country. Please refer to IRAS Help page for NHS/HSC R&D Permission  for more information. Where ethical review is required, an NHS REC form should also be submitted.

The specific updates that have been included in this version of IRAS are:

Revision of IRAS project filter question 4
Question 4 has been edited to refer to ‘applications’ instead of ‘review bodies’ and the option to apply for HRA Approval has been relabelled from ‘HRA Approval’ to ‘IRAS Form’.

Revision of IRAS project filter questions 5a and 5b.
The wording of these questions and associated guidance has been updated. Please click on the green “i" icons to access the latest information.

Declarations section has been removed from the integrated dataset
The integrated dataset is the same as the full set of project data and is not an application form and it will not be submitted at any point. To avoid potential confusion the declarations section is now only visible in application forms.

28 January 2016: Version 5.2.1

All projects in IRAS have been updated to this version. This update is a maintenance release that includes some fixes and internal system updates. It does not amend or add to existing functions or content in the system but it does include system updates that affect electronic authorisations for some specific form types. Please refer to information below for more information.

Projects in all filter question 2 project categories except research tissue banks and research databases

Part of this release is an update to the questions related to information about the research sponsor(s). This has appeared as a version of question A64 in all datasets except the application for the Confidentiality Advisory Group (CAG) where it appears as question 62. This update is to gain consistency of data fields across form types and the integrated dataset. If you are currently preparing application(s) for submission then please ensure that you check these fields as part of reviewing the completeness of your application prior to submission.

Electronic authorisations that were in place at the point of the system update to v5.2.1 will not have been affected by the release except where the form is an application to either:
  • The Social Care Research Ethics Committee; or
  • The Confidentiality Advisory Group (CAG).
Electronic authorisations applied to these form types will have been invalidated by the release and so you will need to seek these electronic authorisations again if you are preparing to submit these forms.

Electronic authorisations for other form types are not affected by the release. However please remember that if you add to, or revise, information within a dataset after seeking electronic authorisation(s) then this data change will invalidate the authorisation(s). This is why you are strongly advised to check the completeness and accuracy of the content of your application prior to seeking electronic authorisations.

Users should note that any electronic authorisations that were applied to applications that have been submitted at the point of system update will continue to be shown in the copy of the submitted form (i.e. when you refer to the copy of the form saved in submission history).

Applications for ethical review of Research Tissue Banks

This release includes a system update to correct the logic for enabling the Designated Individual (DI) declaration and associated DI electronic authorisation. If you are preparing a REC Research Tissue Bank application you are strongly advised to review your application for completeness and to ensure that you have gained all applicable electronic authorisations.

29 November 2015: Version 5.2

All projects in IRAS have been updated to this version, which includes the updates noted below.

Updates in IRAS to support next phase of roll out of HRA Approval.

The IRAS v5.2 release has been timed to coincide with, and support, the third phase of roll-out of HRA Approval, which commences on 30 November 2015. For information about HRA Approval and its phased implementation please refer to the HRA website pages for the HRA Approval Programme.

IMPORTANT: If you are applying for HRA Approval then please ensure that you refer to the Guidance for Applicants provided on the HRA website as part of the process of preparing your application. This is important as the HRA’s guidance includes detailed information about the activities that you are expected to complete as part of the preparation for applying for HRA Approval as well as templates and standards that are part of this new process.

The specific updates that have been included in this version of IRAS are:

Addition of a sub-question option at IRAS project filter question 4 to indicate that ethical review is not needed as part of HRA Approval

For some categories of projects, as defined by IRAS filter question 2, the project may require management permission in the NHS but not require ethical review by a Research Ethics Committee (REC) within the UK Health Departments’ Research Ethics Service. Where these types of projects are within scope of current roll-out of HRA Approval and an application for HRA Approval has been selected at IRAS filter question 4 this will trigger a sub-question 4b which will allow you to indicate that you believe your application does not require from REC review. If you proceed to indicate that REC review is not required then you will be provided with a series of descriptions of types of research that would be exempt from REC review and you should tick the check boxes for the appropriate description(s) for your project. Please refer to the question specific guidance, which is accessed by clicking the green “i" button, for more detailed information.

Revision of guidance associated with project filter questions 5a and 5b.

The guidance associated with these questions has been updated. Please click on the green “i" icons to access the latest information.

Functionality to create NHS Site Specific Information (SSI) forms for studies seeking HRA Approval.

It is now possible to create NHS SSIs for projects that are seeking HRA Approval. Please ensure that you refer to the “HRA Approval: Guidance for Applicants” to check for current information and detailed guidance. A UK call for comments on the standard information package to be provided to sites between 23 November and 18 December 2015 will explore potential improvements to site level information requirements.

HRA Approval for research in the NHS in England and IRAS Terms & Conditions.

Applicants for HRA Approval should note that with the introduction of Cohort 3 studies there will be new data flows through secure HRA-provided portals to enable the effective and efficient review, approval and set up of studies in the NHS. The IRAS Terms & Conditions will be updated as part of HRA Approval becoming fully implemented to reflect these changes and the associated system changes to ensure continued UK-wide compatibility.

HRA Approval is being rolled out for studies in the NHS in England and the HRA-provided portal for NHS staff in England is only enabled for studies that are seeking HRA Approval. For more information about this data flow please contact the HRA Approval Programme Team. Where a study has sites in across the UK, the national permission coordinating functions of England, Northern Ireland, Scotland and Wales will securely share information to remove duplication for applicants. Where a study is applying for support from the NIHR Clinical Research Network (CRN) in England, CRN coordinating centre staff will have secure portal access to applications in order to determine eligibility for the NIHR CRN portfolio. It should also be noted that members of Research Ethics Committees (RECs) within the UK Health Departments’ Research Ethics Service have secure portal access to applications that are assigned to a meeting that they are scheduled to attend.

9 October 2015: Version 5.1

All projects in IRAS have been updated to this version, which includes the updates noted below.

Update of National Offender Management Service (NOMS) application form.

The v5.1 release has substantially revised the dataset that makes up the NOMS application form. This has included the addition, deletion and modification of questions contained within Part B Section 10 of the integrated dataset. The NOMS application form is composed of Part B Section 10 and some data drawn from Part A of the integrated dataset.

Electronic authorisations for the NOMS form given prior to implementation of v5.1 have been invalidated as a consequence of this IRAS update.

If you created a NOMS form for submission prior to the IRAS v5.1 update then the authorisations will still be shown in the pdf file saved in the submission history for the form.

If you are preparing a NOMS form for submission you are strongly advised to review your entire NOMS application form to ensure that it is fully completed and make any additions or revisions to the form before you proceed to seek electronic authorisations and before you submit your application.

Confidentiality Advisory Group (CAG) application: update of supporting documentation list

The list of supporting documentation for the CAG application form has been updated. Please select the CAG application form and then select the Checklist tab for this form to see the latest list.

Integrated dataset questions A36 and A72: update of check box options

This version release has made an update to the check box options provided for these questions. This is to ensure absolute consistency across all applications that use these questions. If you are in the process of preparing an application we recommend that you check the completion of these questions to ensure that your check box selections are appropriate. However, please remember that if you have already gathered electronic authorisations for your application and then change or enter responses to this (or any other questions) this action will invalidate your electronic authorisations.

10 August 2015: Version 5.0

All projects in IRAS have been updated to this version, which includes the updates noted below.

Addition of a new single application form for projects seeking HRA Approval.

HRA Approval is being implemented in phases so please refer to the information about implementation of HRA Approval provided on the Health Research Authority (HRA) website to check whether your project is eligible for HRA Approval before selecting this option in IRAS.

Applications for HRA Approval must use the new single application form (the ‘IRAS form’), which is enabled through selections made in the project filter. This form replaces the need for separate NHS REC and NHS R&D application forms for these projects. The IRAS Form and supporting documentation must be electronically submitted from IRAS to the HRA. Guidance for applicants is available in IRAS and via the HRA website.

Revision of A68-2 to update the drop-down list to the current Local Clinical Research Networks (LCRNs).

This revision affects the NHS REC form and integrated dataset in projects that are eligible or potentially eligible for NIHR Clinical Research Network (CRN) portfolio adoption. Selections made in this question’s drop-down list prior to the v5.0 release have been cleared as part of this update. Please note that any electronic authorisations you had in the NHS REC form, which were valid at the time of v5.0 release, have not been automatically invalidated as a result of the update.

If you submitted your NHS REC form prior to IRAS v5.0 release, and had this question enabled, then any selection you made at A68-2 will be shown in the relevant record(s) in your NHS REC form submission history. Note: should you need to submit an updated version of the NHS REC form at any time, please be aware that A68-2 will be incomplete unless you revise your selection as pre IRAS v5.0 drop-down selections are cleared.

If you complete, or update, A68-2 selection after gaining electronic authorisations for your NHS REC form this will be recognised by the system as a data change and it will invalidate your electronic authorisations for this form.

1 April 2015: Version 4.0

All projects in IRAS have been updated to this version, which includes the updates noted below.

Update of Sponsor declaration statements

The statements in the Sponsor declaration page for NHS REC, GTAC, Social Care REC, NHS R&D and CAG forms have been revised in accordance with the Health Research Authority’s (HRA) announced transparency agenda plans. As the declaration statements have been changed, electronic authorisations that were in place for this declaration have been invalidated by this version update.

If you are preparing application(s) and had obtained electronic authorisation for the Sponsor declaration prior to 1 April 2015 you will need to ask the Sponsor to re-review and electronically authorise the updated declaration before submission. We apologise for any inconvenience this may cause.

Sponsors electronically authorising form declarations on or after 1 April 2015 will be agreeing to the latest statements and no additional actions will be needed.

Where an application form was created, electronically authorised by the Sponsor and then submitted prior to this update, both the electronic authorisation and the terms of the declaration at that time will be visible in the pdf of application form, which is accessed via the submission history area of the Submission/E-Submission tab for the form.


My Projects page improvements

Two new functions have been added to the My Projects page in IRAS in response to user feedback. These are intended to assist users with multiple projects and/or authorisation requests in their account:

New project search function – A new tab labelled ‘Project search’ has been added to the right of the projects list tab. When you click on this tab you will access a new search feature that will enable you to find projects through a search on short title, full title, IRAS ID and research reference numbers entered at A5-1. Please click on the question specific guidance on the tab for further information and instructions.

Addition of column sorting – It is now possible to order projects, project search results, authorisation requests and authorisation history tab contents by the column headings. Ordering by a particular column heading is triggered by clicking on the column heading text (e.g. ‘IRAS Project ID’). The column heading your list is currently sorted by will be identified by presence of a small arrow icon.


IRAS Project Filter Question 3 – selection of countries where research sites are located

The default selection of research sites in all countries at IRAS filter question 3 has been removed. This change affects all projects created on or after 1 April 2015 and you should ensure that have selected the countries where your research sites will be located so that appropriate questions and guidance are enabled. Any projects created before this date are unaffected by this update.


IRAS Accounts – revised password requirements and alteration to forgotten password function

Password requirements – Users creating new accounts and those updating their passwords will now be required to create a password containing a minimum of 8 characters. When you enter your password you will see an indication of the strength of your password; you are strongly advised to choose a password that rates a minimum of ‘good’.

Forgotten password – The forgotten password function has been updated so that you will now be emailed a link to reset the password for your account. This link is valid for 24 hours. If the link is not used within this time you will need to re-request the reset link. Please be aware that some email systems may send the reset email from IRAS to your junk or spam folders so please check these if you have not received the email a short time after submitting the request.


National Information Governance Board (NIGB) references revised to Confidentiality Advisory Group (CAG)

The Health Research Authority’s (HRA) Confidentiality Advisory Group (CAG) is responsible for providing advice on whether an application to process patient information without consent should or should not be approved. This function was formerly provided by NIGB. We have now replaced all references to NIGB with CAG, including changing the ‘NIGB form’ in IRAS to ‘CAG form’. Any information you have entered for NIGB/CAG applications and electronic authorisations for the CAG/NIGB declarations are not affected by this update. However, please note that CAG form Sponsor declarations are affected by the Sponsor declaration update within this version release.

23 February 2015: Version 3.5.5

All projects in IRAS have been updated to this version, which includes the minor updates noted below.

Revision of terms & conditions and privacy policy statements

These statements have been revised to ensure they are in line with current law and good practice. You can view the current statements at any time by clicking on the Terms & Conditions and Privacy Policy links in the area at the footer area of the IRAS website.

Removal of checklists provided for reference in Help section

The example checklists that were provided in the Help section have been removed to avoid confusion. Applicants are advised to refer to the ‘Checklist’ tab associated with the relevant form(s) in their projects to obtain information about the supporting documentation that should accompany a submission to a review body.

Update of Amendment tabs

Some minor revisions have been made to the guidance provided in the form ‘Amendment’ tabs. These revisions are intended to make the guidance clearer and bring the information, including weblinks, up to date.


30 September 2014: Update to IRAS Sponsor Declaration

From 30 September 2014, the Sponsor Declaration to a NHS Research Ethics Committee (REC) will be a mechanism to check compliance with NHS REC favourable opinion conditions introduced on 30 September 2013. That is, studies for which registration is mandated (the first four categories on the IRAS filter question number 2, namely: Clinical trial of an investigational medicinal product, Clinical investigation or other study of a medical device, Combined trial of an investigational medicinal product and an investigational medical device, and Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice) have been registered in a publicly accessible database or that a deferral agreed by the Health Research Authority (HRA) is still valid.

The addition of this confirmation changes the terms of the Sponsor declaration and so any electronic authorisations that were in place for this declaration were invalidated at the time of the update. Therefore if you are preparing application(s) and had obtained electronic authorisation prior to 30 September 2014 you will need to ask the  Sponsors to re-review and electronically authorise the updated declaration before submission. 

We apologise for any inconvenience this may cause.  

Note that where an application form was created for submission prior to this update and the Sponsor declaration had been electronically authorised  both the electronic authorisation and the terms of the declaration at that time will be visible in the pdf of application form, which is accessed via the submission history area of the Submission/E-Submission tab for the form.

Where an application is submitted for ethical review after 30 September 2014, and the Sponsor electronically authorises the REC form declaration after this date, the Sponsor will not need to take any action.

Sponsors should note that from 01 April 2015, the requirement to register clinical trials will extend to all trials in active recruitment, including trials that received a favourable opinion before 30 September 2013.

Further details of the HRA’s Transparency agenda can be found at http://www.hra.nhs.uk/about-the-hra/our-plans-and-projects/transparency/


19 May 2014: REC and Non-NHS SSI applications now enabled for full e-submission

NHS REC Form, GTAC Form, Social Care REC Form and Non-NHS SSI Form are now enabled for full electronic submission.

These application forms and their associated supporting documentation are now electronically submitted from IRAS to the REC. Please read the guidance provided on the E-submission tab for the form for information about preparing your application and submitting it. You may also find it helpful to refer to information on HRA website, including the step by step guide and other detailed resources.

Please note that applications must now be submitted on the same day as the booking for REC review is made.

Notice of Substantial Amendment forms created in IRAS for submission to REC are not enabled for full electronic submission at this time. These forms and any supporting documentation should be emailed to the REC. Refer to the HRA website for more information.

Booking applications for REC review

 

All applications for REC review, with the exception of applications to the Social Care REC, must be booked via the Central Booking Service (CBS). Social Care REC applications must be booked with the Social Care REC. Phase 1 studies in healthy volunteers may continue to be booked directly with the REC, if preferred.

Further information

Please refer to the HRA website for more information about these changes and detailed guidance.


28 April 2014: Electronic authorisation has become mandatory for declarations in some forms

Forms generated in IRAS for submission to Research Ethics Committees (RECs) across the UK

From 28 April 2014, all forms generated in IRAS for submission to RECs must have the declarations electronically authorised. This change affects all variants of the NHS REC form (including forms for GTAC, Research Databases, Research Tissue Banks) and the Social Care REC form. It also includes the Site Specific Information (SSI) form for non-NHS sites and Notice of Substantial Amendment forms generated in IRAS for submission to RECs.

Forms generated in IRAS for submission to NHS R&D

It is anticipated that in the near future electronic authorisations will also become mandatory for applications for NHS permission processed via the NIHR Coordinated System for gaining NHS Permission (NIHR CSP). This change will affect the NHS R&D form and NHS SSI form; further announcements will follow in due course.

Other NHS permission systems recommend the use of electronic authorisations.

Preparing for these changes

To electronically authorise an application in IRAS, the authoriser must have an IRAS account. So please check whether everyone who may need to authorise your applications has an IRAS account. If they do not have one then ask them to set up an account using the “Create Account” function. If they do have an account then make sure you know the email address that they have registered to the account as you will need it to request their authorisation.

If you are not familiar with the electronic authorisation functionality then please refer to the IRAS guidance for further assistance.

April 2013

From April 2013, Primary Care Trusts (PCTs) no longer exist in England. Arrangements to support primary care research will continue throughout England. Although PCTs no longer exist, IRAS will continue to include reference to historic PCT names and allow applications to be made with the historic PCT site name. This is in recognition of the importance of providing continuity to applicants using well-known geographical boundaries. Guidance on applications for primary care in England is available here.


Version 3.5 (25 March 2013)

This version includes an update of the electronic authorisations functionality and a series of changes to forms, datasets and submission process in IRAS as set out below.

Mandatory update of all existing projects to IRAS v3.5

This IRAS version has been implemented as a mandatory upgrade. This will ensure that all projects and forms in the system are working in IRAS v3.5 and using the latest datasets and functionality. All users are strongly advised to review the information about this version update below to understand how existing projects may be affected. If you have active applications that were created in versions prior to 3.4, please also read the relevant update information for all the previous releases.

It is important that all projects are operating in the current version of IRAS as the implementation of IRAS v3.5 marks the point where IRAS will be maintained while the next generation of the system is developed – please refer to http://www.hra.nhs.uk/hra-news-and-announcements/ for more information.

Update of electronic authorisations functionality

The v3.5 release includes an important update of the electronic authorisations functionality.

Electronic authorisations given prior to implementation of v3.5 will be invalidated as a consequence of this update. Therefore, you will need to request or give (as appropriate) these authorisations again should you still need to submit or need to resubmit your application.

For forms that have had a submission created prior to the IRAS v3.5 update, all authorisations will still be shown in the pdf file saved in the submission history for the form (see the bottom of the relevant submission tab).

Authorisations obtained after the release will function as normal.

All users are reminded that electronic authorisations should only be sought once you are satisfied that your application is complete and ready for submission. Any change to the dataset after it has been authorised will result in the invalidation of that authorisation.

Applications for NHS permission through the NIHR Coordinated System for gaining NHS Permission (NIHR CSP)

Projects created in IRAS before IRAS v3.3 (18 July 2011) and any projects created as a duplicate of these pre v3.3 projects that include applications for permission through NIHR CSP.

This version update enables full electronic submission for applications to NIHR CSP within these projects. This replaces the current email submission process for these applications. For general information about full electronic submission, please refer to the information provided for IRAS v3.3 below.

Site information entered in Part C prior to the version update will be retained as the free text entries. Where further sites are added in the project and further rows are added to Part C, you will notice a slight change in format to the rows. This is to provide look-up information for NHS sites in England and to enable the function to create NHS Site Specific Information (SSI) forms from Part C. Please refer to the guidance provided.

If you have previously created your NHS R&D form for submission then this will be recorded in the submission history for the form. Should you need to submit or resubmit this form then please follow the instructions provided on the E-Submission tab.

NHS SSIs that have already been created within the project will be retained along with any associated submission history. Should you need to submit an existing NHS SSI for a site in England then please carefully follow the revised instructions on the E-submission tab for the form.

Where a site has been listed in Part C but no NHS SSI has been created then a new row will need to be added to Part C and information re-entered before clicking the create NHS SSI button. This will create an NHS SSI for the site that is automatically populated with the details as entered in Part C. Instructions for how to submit this NHS SSI are provided on the E-Submission tab for the form.

Projects created in IRAS since IRAS v3.3 (18 July 2011)

The submissions to NIHR CSP in these projects are unaffected by this version update and continue to be fully electronically submitted.

Applications to the Administration of Radioactive Substances Advisory Committee (ARSAC)

The application to the ARSAC has been split into a project (“Preliminary Research Assessment (PRA)”) form and a shorter site specific (“Research Certificate Application (RCA)”) form. This is the first step in a sequence of planned changes to streamline and improve the application process for research involving the administration of radioactive substances.

The PRA and RCA forms are automatically generated whenever the project filter has been completed to indicate that the study involves exposure to radioactive substances. Both forms are automatically populated from data entered in the integrated dataset for other applications, particularly the NHS Research Ethics Committee (REC) form. The PRA form should be submitted by the sponsor’s representative to the ARSAC Support Unit as soon as the application for ethical review has been submitted. The RCA form(s) may then be submitted by the local certificate holder(s).

The following changes in IRAS accompany the introduction of the revised forms and submission process:

  • A new subsidiary question has been added at filter Q2, which asks whether the study involves exposure to radioactive materials. This question is enabled when it has been confirmed that the study involves ionising radiation.
  • Where the new subsidiary filter question is answered yes, then application to ARSAC is selected at filter question 4 and an ARSAC PRA form is automatically created under Project Forms.

Please refer to guidance provided in IRAS, including that accessed via the green “i" buttons, and to the guide provided in the help section

NHS Site Specific Information Form Question 23 has been revised

This revision replaces the requirement for individual signatures for local services, with a single assurance that the applicant has contacted the relevant NHS R&D office. Applicants should note that the guidance associated with this question has also been updated. This revision is intended to facilitate early engagement with local R&D, which is key to successful, efficient and quick study set-up at a local site.

Further updates

Checklists (supporting document lists) for NHS/HSC Permissions have been harmonised

The lists for supporting documentation to support NHS R&D and NHS Site Specific Information (SSI) forms have been updated and harmonised following agreement through the UK-wide R&D Compatibility Group. This improves consistency across the UK.

IRAS Project Number is now displayed as soon as a project is created.

This ID is now displayed next to the project title on the My Project page and in the navigation bar at the top of each screen for an individual project. This enables early use of this project number as a unique ID, which in turn should help support robust identification of research in the UK.

Template Statement of Insurance Cover added for Phase 1 (CTIMP) studies involving healthy volunteers

Sub-question 2 of the IRAS project filter has been revised for Clinical Trials of Investigational Medicinal Products (CTIMPS) and CTIMP/device combined studies to clarify whether project is a commercially sponsored Phase 1 or Phase 1/2a study involving healthy volunteers. Where studies are within this category a new question A76-5 will be enabled. This question replicates the template Statement of Insurance Cover, which was published alongside industry guidance on insurance and compensation for Phase 1 clinical trials in June 2012. The information gathered by this question is intended to confirm whether trial insurance complies with the published guidance

National Offender Management Service form now used for all applications to conduct research in prisons and probation trusts

All applications to conduct research in prisons or probation trusts should now be made using the National Offender Management Service (NOMS) form. As a result, the Ministry of Justice (MoJ) application form has been withdrawn from IRAS. Please refer to the guidance provided for the NOMS form. Note that any MoJ forms created in IRAS before the version update is implemented will still be accessible for future reference from the Project Forms area of the project.

Revision to A68 in REC form

For projects processed through NIHR CSP, the associated REC form has been revised to include an extra field to enter the Lead Comprehensive Local Research Network (CLRN). This will help to improve communication between the REC and the CLRN when reviewing the study.

Revision to REC form declaration

The CI Declaration in the REC form has been revised to include reference to applications being sent to REC members by email.


Version 3.4 (18 October 2011)

This version includes updates to the project filter to align options in IRAS with latest GAfREC and extension of the remit of Social Care REC. Also the process for submitting applications for NHS permission, which are processed via NIHR CSP, has been changed for forms in projects created before 18 July 2011. Minor updates have also been made to MHRA Medicines (EudraCT) form, NRES Notice of Substantial Amendment form, the National Offender Management Service form and question A65 of the integrated dataset. Details of all of these updates are provided below:

Project Filter Updates

Studies requiring NHS/HSC R&D Permission but not review by a Research Ethics Committee within the UK Health Departments Research Ethics Service

The latest version of Governance Arrangements for Research Ethics Committees (GAfREC), which came into effect in September 2011, has revised the requirements for ethical review by a Research Ethics Committee within the UK Health Departments Research Ethics Service. However although ethical review may not now be required in some circumstances, NHS management permission is still required where these studies are undertaken in or through an NHS organisation. The IRAS project filter has been updated to align with these changes and to increase the range of options available at project filter question 4b to describe the type of study. Please note that the accompanying question specific guidance has also been updated.

Social Care Research Ethics Committee (Social Care REC) applications

The remit of the Social Care REC has recently been expanded so that it now reviews adult social care research study proposals, intergenerational studies involving adults and children or families and some proposals for social science studies situated in the NHS. The Social Care REC reviews studies taking place in NHS settings with patients where the approach to data collection uses social science methods, provided that the research involves no change in treatment or clinical practice. Consequently, the IRAS project filter has been updated so that applications to the Social Care REC are now possible for a wider range of project categories and for studies that involve children. Applications to the Social Care REC are now expected to fall into one of the categories below:

  • Basic science study involving procedures with human participants.
  • Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology
  • Study involving qualitative methods only
  • Study limited to working with data (specific project only)
  • Research databases
Applicants are reminded that the Social Care REC is also flagged to review research with adults lacking capacity

 

NHS R&D Applications created before IRAS v3.3 and processed via NIHR CSP - Change to submission process

The process for submission of applications for NHS permission processed via the NIHR Coordinated System for gaining NHS permission (NIHR CSP) has been changed for NHS R&D applications in projects created in IRAS before IRAS v3.3 (i.e. before 18 July 2011). Previously, the application form was electronically submitted from IRAS and supporting documentation was emailed. Now pdf and xml versions of the application form must be created in IRAS and submitted by email along with supporting documentation to the NIHR CSP Unit. Applicants are strongly advised to refer to the guidance provided on the submission tab for these forms.

Projects created since IRAS v3.3 are unaffected by this change, which is part of the rollout of a new system for the processing of applications for NHS R&D permission via NIHR CSP.

Please direct any queries about this process to crncc.csp@nihr.ac.uk. For further information about NIHR CSP and the new system that NIHR are introducing for processing of applications please see www.crncc.nihr.ac.uk.

NRES Notice of Substantial Amendment form - Declaration added for Sponsor's Representative

The NRES Notice of Substantial Amendment (NOSA) form in IRAS has been updated to include a declaration of support for the substantial amendment by the sponsor's representative. Electronic authorisation has been enabled for this new declaration and the statement in the CI declaration to confirm that they have notified the study sponsor of the proposed amendment has been removed. These changes do not affect the separate Notice of Substantial Amendment forms in IRAS for CTIMPs (EudraCT Annex 2 form), research tissue banks or research databases.

MHRA Medicines (EudraCT) application form - Addition of look-up for MedDRA terms

A tool has been added to the MHRA Medicines (EudraCT) application form at question E1-2 (MedDRA information), which enables applicants to search the MedDRA terms database. This tool allows applicants to select terms to add to their clinical trial application form.

NOMS application form - update of prisons and probation establishments

The lists of prisons and probation establishments and offices at question 10 of the National Offender Management Service (NOMS) application form have been updated.

Update of Integrated Dataset Question A65 (external funding for the project)

This question has been updated so that applicants are only asked to classify the type of external funding for the research project once instead of providing this information with the details of each funding application made.



Version 3.3 (18 July 2011)

This update adds new document handling functionality to support the phased introduction of full electronic submission of applications to the individual review bodies. This rollout starts with projects created after v3.3 release, which are applying for NHS permission through NIHR CSP.

New document handling functionality

New functionality is being phased in to enable full electronic submission of applications to individual review bodies. For detailed information about this functionality refer to the guidance https://www.myresearchproject.org.uk/Help/OtherIRASGuidance.aspx

Electronic submission of documents to the review body

Where electronic submission of documents and application forms (or "full electronic submission") is possible for a particular review body, the checklist associated with that application form has a function enabled to attach documents to the form checklist. This functionality is similar to the mechanism for attaching documents to an email. The files attached to the checklist are then passed, with your application form, through secure electronic submission to the review body when you submit your application.

Document storage

To support the electronic submission of application packages, two types of storage have been created in IRAS:

  • 'My documents', which is accessed via the navigation bar at the top of the page in IRAS. This area is primarily intended for storage of documents that may be used as supporting documentation in a number of projects e.g. CVs
  • 'Project documents', this is intended for storage of documents that may be used in the supporting documentation of a number of applications within the same project e.g. the research protocol. Project documents are accessed through the projects document tab that is visible in the navigation page view.

Storing documents in IRAS is similar to the functionality used for attaching documents to an email. You simply need to choose the document you wish to upload, complete some information about the document and click an upload button. The use of this document storage is optional. You will still be able to electronically submit documents with your application, where enabled, without saving documents in IRAS.

Please make sure you carefully follow the instructions in the submission tab for your application(s) to ensure that you are submitting the application and supporting documentation through the correct process for that review body at that time.


Introduction of full electronic submission of applications for NHS permission being processed through NIHR CSP (new projects only)

Projects created after the release of IRAS v3.3 that are applying for NHS permission via the NIHR Coordinated System for gaining NHS permission (NIHR CSP) will need to electronically submit their application for NHS permission and supporting documentation from IRAS. These applications will be submitted to the new CSP Module of the NIHR R&D Management Information System. For more information about the introduction of the CSP Module please see http://www.crncc.nihr.ac.uk/about_us/processes/csp/rdmis_cspmodule.

The following changes in IRAS accompany the introduction of this new submission process:

  • Amendment of project filter questions 5a and 5b and associated question-specific guidance
  • Part C of the NHS/HSC R&D form has additional fields to clarify whether each site is an NHS site or a non-NHS site. Where the site is an NHS site located in England the details about the site must be entered using a new organisation search tool. In addition NHS Site Specific Information (SSI) forms are now created using the button next to each site in Part C. Information entered about the site and the investigator are automatically populated into the NHS SSI form that is created. Users should continue to use the 'Create SSI' tab associated with the REC form to create SSI forms for non-NHS sites.
  • Documentation to support R&D and NHS SSI forms must be attached to the checklist using a function similar to that used to attach files to an email. The files attached to the checklist are automatically electronically submitted at the same time as you submit your application form.
  • Documents that need to be updated or added after submission of the form (including notices of amendment) should be attached to the checklist and then submitted electronically using the submit new/amended documentation button on the submission tab.
  • The submission history shown on the submission tab for the application allows you to review the documents that you have submitted in addition to the usual links for the application form. Also the submission history will allow you to monitor the progress of the study through NIHR CSP through the status updates that are shown.

Projects created before the release of IRAS v3.3 that are applying for NHS permission via the NIHR Coordinated System for gaining NHS permission (NIHR CSP).

These applications will be submitted and processed as before. For these applications you will need to continue to send supporting documentation separately. At a later stage all existing projects in IRAS that are using NIHR CSP will be able to make use of the full electronic submission facility.



Version 3.2 (12 July 2011)

This version contains a number of updates including revision of a number of existing application forms and the IRAS project filter. It also extends some existing functionality, such as that for electronic authorisation, and adds new features such as a search tool in help.

All electronic authorisations are now enabled for CTIMP studies

Following discussion with MHRA, electronic authorisations have now been enabled for the MHRA Medicines (EudraCT) application form. In addition the Chief Investigator (CI) is now able to electronically authorise REC, NHS/HSC R&D and GTAC applications. An ink signature by the CI is no longer a requirement on these applications.

Project category types (project filter question 2)

A series of updates and additions have been made to the project categories and supplementary questions available at project filter question 2 in order to clarify types and further tailor the resulting dataset. Specifically:

  • "Clinical investigation or other study of a medical device" sub-categories have been revised. A new supplementary filter question 2a checks whether the study is sponsored or funded by a manufacturer or commercial company. This selection leads to a series of new device study sub-categories which are more specific than before, which in turn means that the dataset is more specific. Existing studies have been provisionally allocated to the nearest equivalent commercially sponsored sub-category. Users preparing new applications should check the selection at Q2a in the filter, taking account of the Question-Specific Guidance, and amend as appropriate.

  • "Study limited to working with data and/or human tissue samples or other human biological samples (specific project only)" has been replaced by two new categories:
    • Study limited to working with human tissue samples (or other human biological samples) and data (specific project only); and
    • Study limited to working with data (specific project only).
    This change is to distinguish more clearly those studies involving data only. All existing studies have been provisionally allocated to the combined category for tissues plus data and the dataset is unchanged. Applicants whose studies are limited to working with non-identifiable samples or data will find that the project filter question 7 (adults unable to consent) is now disabled. This is because statutory requirements relating to research involving adults lacking capacity do not apply in this case.

  • "Other clinical trial or investigation" has been replaced by two new categories:
    • Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice; and
    • Basic science study involving procedures with human participants.
    All existing studies in this category have been provisionally allocated to the revised "other clinical trial" category and the supplementary project filter questions and the dataset are unchanged. Applicants preparing new applications can change their project to a basic science study, if appropriate. This will remove a number of questions from Part A that are not relevant to this type of study. An additional supplementary filter question will check whether the study involves any clinical procedures, and this will determine whether A19 applies. Question-Specific Guidance is available on the new sub-categories.

  • Supplementary questions have also been added to the project filter for some project categories, which improve specificity of the dataset. These include:
    • Will the study involve the use of any medical device without a CE Mark, or a CE marked device which has been modified or will be used outside its intended purposes? This applies to clinical trials other than those already identified as device studies.
    • Is this a commercially sponsored Phase 1 or Phase 1/2a trial? This applies only to CTIMPs and is linked to changes to the Site-Specific Information Form for non-NHS sites (see below).

Proportionate review of REC application

Where the responses to the project filter questions indicate that a study may be suitable for proportionate review by a REC sub-committee, a new question A6-3 is enabled in the dataset. This question asks the applicant whether they wish to apply through the proportionate review service or if they consider there are significant ethical issues that require consideration at a full meeting. Please refer to the Question-Specific Guidance and to http://www.nres.nhs.uk/applications/proportionate-review/ for more detailed guidance.

Non-NHS Site Specific Information (SSI) form

Where site specific assessment (SSA) is being undertaken by a different REC to the main REC undertaking ethical review, background information about the study is now populated in read-only format from Part A into a "Summary of Study" section of the non-NHS SSI form. No extra information needs to be added in this section. This means that there is now no need to supply the SSA REC with copies of the main application and protocol. The update also allows some questions to be disabled for Phase 1 trial sites with MHRA accreditation. These changes follow discussion with RECs, industry bodies and Contract Research Organisations in the NRES/AAPEC Phase 1 Advisory Group. Electronic authorisation has also been enabled for the Site Management Organisation (SMO) declaration.

Research Tissue Bank Form

This form has been revised in the light of feedback from RECs and applicants. Questions 15-17, 27, 34-35 have been added to provide RECs with information about governance of data held alongside biological samples. Questions on sample collection and consent arrangements have been modified for banks identified in the filter as being established within NHS diagnostic archives. A "Summary of the Application" is included at the end of Part A to facilitate publication on the NRES website following ethical review. Alongside the declaration, the applicant is invited to name a contact point for more information whose details can be published alongside the summary. A CV for the applicant (now referred to as the Tissue Bank Manager) is required for all applications.

IMPORTANT: Users preparing applications for submission are advised to review their application carefully and ensure all questions are completed. Where an application has already been submitted, it is not necessary to revise it but the summary for publication may be completed retrospectively.

Research Database form

The form has been modified in the light of a review by the National Information Governance Board of existing guidance on research databases, in consultation with stakeholders including NRES and flagged RECs for database applications. A CV for the applicant is required for all applications. The section on "Use of Data by Researchers", previously replicated for uses within the Research Database team and by external researchers respectively, has been streamlined into a single set of questions (15-25) to simplify the form. A "Summary of the Application" is included at the end of Part A to facilitate publication on the NRES website following ethical review. Alongside the declaration, the applicant is invited to name a contact point for more information whose details can be published alongside the summary.

IMPORTANT: Users preparing applications for submission are advised to review their application carefully and ensure all questions are completed. Where an application has already been submitted, it is not necessary to revise it but the summary for publication may be completed retrospectively.

Applications to the National Information Governance Board (NIGB)

Where applications are made to the NIGB Ethics and Confidentiality Committee for support under Section 251 of the NHS Act 2006, the NIGB application has always included some additional information (in particular at Part B Question 8) beyond that in the REC application form. Most of this information will now be included in the REC form to inform any discussions which may be needed between the two committees about issues arising in the application and resolve any differences of view. However, the REC will not have access to the confidential information in Part B Section 9 (Information Security Measures). There is no change to the overall dataset completed by the applicant.

Other minor changes to form content

Some other minor changes have been made to the content of forms, including:

  • For CTIMPs, inclusion of details of any placebo in Part B Section 1 of the REC and NHS R&D forms; and, in the R&D form only, details of sites where the QP certifies batch release of IMPs and placebos and the establishment responsible for certification for release;
  • For CTIMPs and other types of clinical trial, amendment to the wording of Question A75-1 about data monitoring arrangements;
  • For research involving adults lacking capacity, inclusion of an additional question in Part B Section 6 for studies involving recruitment prior to informed consent / consultation due to the urgency of the treatment.

Contacts

An additional, optional field has been added to the contacts list in IRAS so that you can identify the type of the contact e.g. Chief Investigator, Sponsor etc. This has been designed to make it easier to search for a particular contact when you have an extensive address list.

Search tool added to Help section of IRAS

A simple search tool is now available for the Help section of IRAS. It can be accessed by clicking the "Search Help" link that is located above the menu on the left hand side of the pages within the help section.

Site Specific Information (SSI) form duplication

It is now possible for SSI forms to be duplicated by a recipient of a transferred SSI form. This means that a study coordinator, for example, can prepare SSI applications separately from the Chief Investigator who has prepared study-wide applications.



Version 3.1.2 (01 June 2011)

This version updates IRAS to EudraCT v8.

MHRA Medicines (EudraCT) form update

IRAS has been updated following the roll out EudraCT v8 on 10 March 2011. Applicants who have MHRA Medicines (EudraCT) forms in IRAS will find that these applications have been automatically upgraded to the EudraCT v8 form. Data that had already completed has been migrated to the updated form.

The update from EudraCT v7 to v8 is substantive and so applicants are advised to carefully check their forms prior to submission to ensure that all fields are complete.

MHRA will continue to accept the MHRA Medicines (EudraCT) form in the version 7 format until at least 10 June 2011.


Version 3.1.1 (21 February 2011)

This update introduces some new features in IRAS, which have been implemented in response to user feedback. In addition minor modifications have been made to a few questions and weblinks and contact details have been updated, where necessary.

 

Privacy Policy and Terms & Conditions of use of the IRAS website.

 

As part of this update we have added these statements to the IRAS website. They can be accessed from anywhere in the IRAS website via the links at the bottom of the page. In addition users creating new accounts will be asked to read and accept the privacy policy and terms and conditions of use as part of the account creation process.

 

Search function and alphabetical sorting added to My Contacts

 

In response to user feedback we have introduced functionality to enable users to sort their contact list alphabetically and jump to a particular letter of the alphabet. This sorting is available for first name, last name and organisation fields. A search function is now also available for the contacts list.

 

Changing registered email address / login

 

In IRAS a user’s registered email address is also used as the username or login for the account and the address where notifications from IRAS are sent. Following feedback from users a tool to the My Account section of IRAS to enable users to change the email address of their account. As with creating an account, users will be sent an email containing an activation link to confirm the change. This activation link must be used within 24 hours of issue.  

 

Addition of multiple students and/or multiple academic supervisors to a single project

 

This update includes functionality that enables more than one student and/or more than one academic supervisor to be named within one project, if required. Within question A2-1 buttons have been added that allow the student and academic supervisor fields to be replicated. In addition the Academic Supervisor declaration at D3 and the associated electronic authorisations have been configured to allow for signatures of all the named academic supervisors.

 

Question modifications

 

The following questions have had minor modifications. Please check your form before submission:

  • Project Filter Q10:  When this question is answered “yes” a new question (A5-3) is enabled in the NHS REC and NHS/HSC R&D Forms for the applicant to provide basic details of their application for a US DHHS grant.
  • MHRA Devices Form - PCA 2 Question 5: The wording of the second part of this question has been modified to make clear that the application should include information about software as set out in the MHRA’s guidance note.
  • Part B Section 12 Question 4 – Two new checkbox options have been added at the start of the question for the applicant to state whether the holder of the samples is “NHS pathology department(s)/diagnostic archive(s)” and/or “Other research tissue bank(s) or sample collection(s)”. The current fields of this question will now only be enabled if the “Other research tissue bank(s) or sample collection(s)” is selected. In addition the current sub-question “Is the bank/collection a NHS diagnostic/clinical archive” has been removed.


Version 3.1 (31 October 2010)

The EudraCT Annex 2 form for notification of substantial amendments and the National Offender Management Service (NOMS) form have been added to IRAS. In addition some minor changes have been made to the National Information Governance Board (NIGB) form and the REC Form submission guidance.

Notice of Substantial Amendment Form for clinical trials of investigational medicinal products.

EudraCT Annex 2 is the form for notification of substantial amendments to the ethics committee and/or MHRA for clinical trials of investigational medicinal products. The form is accessible from the Amendment Tab of the REC form and the MHRA Medicines form after submission of the initial application.

It is the sponsor's responsibility to determine whether an amendment is substantial and if so who should be notified. The European Commission has published guidance as part of the document "Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2010:082:0001:0019:EN:PDF"

Under the Commission guidance, substantial amendments should only be notified to the REC or MHRA if the amendment is both substantial and relates to the application to that body. Copies of the substantial amendments should not be provided to the other body for information only.

Applicants should read the instructions in the relevant Amendment Tab before submitting any substantial amendments.

National Offender Management Service (NOMS)

A new application form has been added to IRAS. The National Offender Management Service (NOMS) is an executive agency of the Ministry of Justice, and brings together HM Prison Service and the Probation Service. Applications to conduct research within NOMS must be made using the standard form available in IRAS. For more information about NOMS see http://www.hmprisonservice.gov.uk/abouttheservice/noms/

National Information Governance Board (NIGB)

A number of minor changes have been made to the application to NIGB for Section 251 support to improve the clarity of the questions and guidance. In addition, there are three additional questions in the NIGB Form:
A14-3 (NIGB Form 15-2) What changes have you made to your study as a result of your service user involvement?
A30-4 (NIGB Form 31-2) Is there a method in place to record individuals' dissent from the use of their records for research purposes? How will the rights of dissenting patients be respected?
A30-5 (NIGB Form 31-3) Please specify how you intend to move away from the use of patient identifiable data without consent.

If you have an application in progress you are advised to check your form carefully prior to submission.

NHS REC Form

Some minor changes have been made to the Submission Tabs of the NHS REC Form. This is to improve the clarity of the instructions and guidance provided. Applicants are advised to read the guidance provided before submitting their application forms.



Version 3.0 (31 May 2010)

This update adds some new features to IRAS but will not affect any existing applications. Thank you to the users who have given feedback requesting these additional features to improve IRAS.

Password

This is a new function to improve the security of your IRAS account. Once you have logged in you may get a pop up box with a reminder about changing your password. The password reminder is set for every 6 months. Old passwords can be re-used.

Layout

The layout of the Navigation Page has been changed to make it more intuitive. There are instructions in italics next to the forms on the left hand side of the screen. On the right hand side all the sections of the Full Project Dataset (integrated dataset) have been separated out with topic headings to match those within the form to make it easier to navigate directly to a set of questions. Also one SSI Form is created by default to act as a prompt to applicants.

Notes

A user can add reminders or notes to a screen. On any screen with questions you will see that the toolbar at the top has changed. There is a new button called Notes. The button is grey by default. Click on the Notes button and a pop up window allows you to add notes and save them, edit them, and delete them. This can be used for reminders about things to look up or revise, or to give instructions or ask questions of collaborators when you transfer a form to them. When you close the window the button is now yellow to show that notes are present. The notes only apply to a particular page and the specific form where they were created.

Completion tracking

This option provides a quick visual check from the Navigation Page of which questions have been completed. Next to each question (except in the project filter) you will see a small grey circle with a tick. When you want to indicate that the question is completed, click on the tick icon next to the question. The circle will turn green. When all the questions on a page have been completed the relevant boxes in the Navigation Page will also turn green. If only some of the questions on a page are complete it will remain white. Note that this system is entirely optional and applicants can choose not to use it.

Check your form

This option allows the user to check their form is complete before submitting it. A new button has been added to the Submission Tab. If you click on "Check your form" a popup box appears that shows which questions in this form have been completed and which are not complete. This checking is optional and only works if the applicant has chosen to use the completion tracking tool described above.

Authorisation History

This allows any authoriser to keep a record of all projects they have authorised. Select My Projects from the menu bar at the top of the screen. You will see a new tab next to the Requests for Authorisations called Authorisation History. All authorisations made by you are listed in date order. Select the arrow next to an authorisation to expand the row. You can now view and print the form you authorised so that you have a record of the content of the form you authorised along with the electronic authorisation statement.

Transferring SSI and ARSAC forms to subsequent users

Transfer of the SSI and ARSAC Forms is no longer restricted. The transfer option is available by selecting the SSI Form or ARSAC Form and selecting the Transfer tab. When you transfer an SSI Form or an ARSAC Form from the project owner, the recipient is now able to transfer the form on to another IRAS account. The original project owner who created the SSI Form can retrieve the form from whoever now has the form, even if it has been transferred on several times. A sender other than the original owner can only retrieve the form from the user they directly transferred it to. A recipient can pass the form back to the person who transferred it to them. The original owner can track the full transfer history of a form in the transfer history section of the Transfer tab.



Version 2.5.1 (26 October 2009)

Some modifications have been made to IRAS to improve the options for importing data from EudraCT into IRAS for clinical trials of IMPs. If you plan to import data into IRAS, you are strongly recommended to read the updated guidance on MHRA applications in the Help section at https://www.myresearchproject.org.uk/Help/OtherIRASGuidance.aspx. This modification only affects the import mechanism.



Version 2.5 (5 October 2009)

MHRA Devices PCA2 Checklist Form

The PCA2 section of the MHRA Devices Form has additional questions as a checklist for applicants. The PCA2 checklist is available when the MHRA Devices Form is selected in the navigation pane. If you are about to submit an application to MHRA Devices, please review the checklist before submitting.

ARSAC Form

Some minor changes have been made to the ARSAC Form and to the section of Part B Section 3 that populates the ARSAC Form. In particular, there is an additional question relating to pregnancy. Chief Investigators are asked to ensure that, for any applications not yet submitted to the REC, Part B Section 3 is reviewed before submitting the REC Form and asking Principal Investigators to complete ARSAC Forms. Where the REC Form has been submitted, Part B Section 3 should not be updated as the ARSAC Forms should be based on the information reviewed and approved by the radiation authorisers and the REC.



Version 2.4.1 (21 September 2009)

Change to question A4

Question A4 has been changed, in response to feedback, from asking about study coordinator details for clinical trials, to request a correspondence contact on behalf of the sponsor for all studies. This contact will receive copies of all correspondence from REC and R&D reviewers that is sent to the CI.

The contact may be the Sponsor, a Project Manager, Trial Manager, Clinical Research Scientist or Study Coordinator. Where a Contract Research Organisation (CRO) has been delegated to handle applications on behalf of the sponsor, the contact at the CRO should be named here. Where a study coordinator is named, it is expected that the sponsor will make their own arrangements with this person to pass on correspondence as necessary as part of this co-ordinating role.

Where details are provided in A4, letters from the REC will be copied to this contact instead of the sponsor named in A64, otherwise the contact in A64 will be used. Letters from the REC will continue to be copied to the lead NHS R&D contact named in the REC application.

Changes to applications through the NIHR CSP

The Portfolio Adoption Form has been renamed the NIHR CSP Application Form, to better reflect its function. It should continue to be used in the same way to determine whether the study is eligible for review through NIHR CSP.

The NIHR CSP Application Form has a few changes:

  • new question 5.2 which matches A4 described above.
  • Minor changes to questions 3 and 10
  •  



    Version 2.4 (14 August 2009)

    Minimal dataset function for old studies

    IRAS now includes the facility for creating Site-Specific Information Forms and managing amendments for studies that were submitted for REC review outside IRAS. This is in preparation for the closure of the NRESform system on 1 September 2009. Where application forms for ethical review were completed in the NRESform system or prior paper-based systems, IRAS now includes the option to create a 'minimal dataset' with sufficient data to enable SSI Forms, amendment forms and ARSAC forms to be created. For details of how to use this function, please see the guidance on the Help page.



    Version 2.3 (3 July 2009)

    Social Care Research Ethics Committee Form

    A new application form has been added to IRAS. The Social Care Research Ethics Committee was established in June 2009. The new REC will deal with proposals which concern research taking place among users and staff of social care services. This may have many different designs, from experimental trials to qualitative interviews or surveys. At present, some of these proposals are reviewed by healthcare RECs, others by University RECs and some are probably not reviewed at all. The new national Social Care REC will provide an additional service to supplement the work of other RECs (not to replace them). For more information about the remit of the committee see www.screc.org.uk

    The Social Care Research Ethics Committee (SCREC) Form in IRAS should be used for all new applications to the committee. Applications already in preparation using the REC Form will continue to be accepted. We welcome feedback from users of this new form. Please send your comment to iras@nres.npsa.nhs.uk.

    Changes affecting other forms

    In creating the SCREC application form we have taken the opportunity to revise question A64 (sponsor) and Part C (research sites). There is no longer any need to identify a sponsor contact in the UK so A64-2 has been removed. For studies other than clinical trials of investigational medicinal products, the sponsor question (A64-1) clarifies the arrangements for legal representatives.

    For studies other than clinical trials of investigational medicinal products, Part C has been simplified.

    E-learning

    An e-learning module has recently been added to IRAS. This is a free, online package available to anyone who wishes to understand how to use IRAS. There is no need to register to use the e-learning package. It is available from the top menu bar anywhere in IRAS or by following this link: www.myresearchproject.org.uk/elearning.

    Functionality for special characters

    IRAS now allows use of certain special characters that are not part of the standard keyboard, but which may be required in explanations of scientific or statistical information. The characters are available by clicking an icon next to free text fields. To support this function, IRAS has a new mechanism for generating pdf files. Please let the helpdesk know if you encounter any difficulties with these functions: helpdesk@myresearchproject.org.uk.

    Fixes

    We are in the process of implementing a number of fixes. Some have already been done, and others will be completed over the next few weeks. Please bear with us and let us know if you encounter any temporary problems with the site while we update it: helpdesk@myresearchproject.org.uk.


    Version 2.2 (13 April 2009)

    Two main updates have been completed in IRAS:

    • all references and guidance relating to the Patient Information Advisory Group (PIAG) have now been updated to reflect the transfer of PIAG's functions to the National Information Governance Board (NIGB)
    • a number of fixes and improvements have been made to the application to MHRA Devices

    In updating IRAS to Version 2.2 all projects will now include the updates in Version 2.1.

    A new feature on the Help section is a page for Frequently Asked Questions - please check this page before sending queries to the Helpdesk or IRAS queries line.


    National Information Governance Board (NIGB)

    From January 2009 the NIGB took over administration of applications under section 251 of the NHS Act 2006. Section 251 of the NHS Act 2006 (originally enacted under Section 60 of the Health and Social Care Act 2001), allows the common law duty of confidentiality to be set aside in specific circumstances where anonymised information is not sufficient and where patient consent is not practicable. This function was formerly carried out by the Patient Information Advisory Group (PIAG) which was abolished on 31 December 2008.

    All references to PIAG have been replaced with NIGB. New contact details and revised guidance have been provided.

    This update will not affect applications that are in progress. Please check the updated submission instructions before submitting applications.

    Any queries about the requirements for applying to NIGB or completing the NIGB application form should be directed to the NIGB Secretariat by contacting eccapplications@nhs.net or 0207 633 7011.


    Medical Devices

    This update has improved the functionality and guidance relating to additional investigational devices and sterilisation details. Some Question Specific Guidance has been revised and improved.

    If you are currently preparing an application to MHRA for a study that involves medical devices please check your application carefully before submitting it. No action is required in relation to applications that have already been submitted.


    Clinical Trials of Investigational Medicinal Products

    All projects upgraded to Version 2.2 will incorporate the updates from Version 2.1. Version 2.1 includes the full dataset for applications to MHRA for Clinical Trials of Investigational Medicinal Products (CTIMPs). The upgrade to Version 2.2 will result in a number of changes to existing applications that are in progress.

    If you do not wish to use IRAS to complete your application to MHRA, you should only complete the questions in Part B Section 1 that are in the REC and R&D Forms. You do not need to complete the additional questions in Part B Section 1 as they only apply to the MHRA application.


    Transfer of SSA to NHS R&D for NHS sites

    IRAS was updated on 1 April to reflect the transfer of Site-Specific Assessment (SSA) to R&D offices for NHS sites. There is now no need to submit SSI Forms to RECs for any NHS sites. SSI Forms must be submitted as part of the R&D application for all NHS sites for all study types. For further information see the bulletin for applicants.


    Version 2.1 (9 March 2009)

    Version 2.1 completes the functionality to prepare applications to conduct clinical trials of investigational medicinal products (CTIMPs) using the EudraCT dataset. Until now, it has only been possible to complete part of the EudraCT dataset in IRAS and export this data to EudraCT to complete the remainder of the application using the EU website.

    Version 2.1 allows applicants to prepare applications to MHRA Medicines for a Clinical Trial Authorisation using IRAS. Once a EudraCT number has been obtained, the applicant will no longer need to use the EudraCT website to prepare the application.

    Minor changes have been made to Part A of IRAS to ensure relevant data fields are compatible with EudraCT. Additional information for EudraCT not previously captured in IRAS is included within Part B Section 1 for CTIMP applicants only.

    Guidance to support applicants preparing EudraCT applications through IRAS is available from the Help page or can be downloaded from here.


    Version 2.0 (18 December 2008)

    A number of changes have been made to IRAS in response to issues reported by users and review bodies during the initial consultation-in-use phase. These are mostly related to improved functionality and guidance for users and will have minimal impact on applications in progress, except for Research Database applications (see detailed guidance below).

    All projects created in previous versions of IRAS have been converted to Version 2.0.

    Further clarification of any of the changes in Version 2.0 may be sought from the IRAS Project Team by writing to iras@nres.npsa.nhs.uk. The Project Team continues to welcome all feedback on IRAS and will consider the need for further changes as experience with IRAS increases.

    Electronic authorisation

    The main enhancement in Version 2.0 is a system of electronic authorisation as an alternative to ink signature for most declarations required in IRAS.

    Electronic authorisation can be arranged by means of a secure transfer between the project owner and the person giving the authorisation ("the authoriser"). This person must have an account in IRAS in order to access the form and record their authorisation.

    Wherever electronic authorisation is enabled in IRAS, review bodies will accept this as an alternative to ink signature.

    Use of electronic authorisation is not mandatory and users may continue to arrange for ink signatures to be provided if preferred. There is no need to obtain both ink signature and electronic authorisation.

    In the following cases ink signatures will continue to be mandatory to meet legal requirements:
    • The Chief Investigator's declaration on the REC or GTAC application form for clinical trials of investigational medicinal products (CTIMPs) only (D1 on the REC/GTAC form)

    • Notifications of a clinical investigation of a medical device to the MHRA Devices Division (Form PCA1).
    Detailed guidance on electronic authorisation and step-by-step instructions are available here.

    Other improvements to IRAS functionality

    Other significant changes to IRAS functionality in Version 2.0 are summarised below. (In addition, a number of minor modifications have been made in response to user feedback. These are not listed in full.)

    Submission of REC forms

    Changes have been made to allow more time to collect signatures and authorisations for the REC application form prior to final submission.

    When the application is booked for review, it is now possible to enter the name of the REC and REC reference number on the version of the form stored in the submission history without creating a new version with a different submission code. This means that the project owner can print the form and collect signatures prior to booking the application. It avoids the need to book the application first, then print the form with the REC details included and arrange for signature within the four days allowed for final submission.

    ARSAC research forms

    Improvements have been made to ARSAC form functionality.

    ARSAC research forms are populated almost entirely from data in Part A and Part B Section 3 of IRAS. This data will be read-only. The certificate-holder should enter their name and, if applicable, complete the open field to indicate any local variation in clinical practice affecting the dose assessment at the site. The form can then be submitted to the ARSAC Secretariat together with the rest of the certificate-holder's standard ARSAC form package. Further guidance is available under the submission tab for the ARSAC form.

    Access to REC and R&D forms by local investigator/collaborator

    Once a version of the REC or R&D application form has been submitted (as recorded in the submission history), it is possible for Principal Investigators and local collaborators to access and download the form in read-only format to help prepare the Site-Specific Information Form for local submission.

    The functionality is only available to those PIs and local collaborators who have received a transferred SSI Form for this project from the owner.

    Where there is more than one version of a form in the submission history, access will be to the latest version.

    Site-specific assessments (SSA)

    The status of applications for SSA is now transmitted to IRAS from the Research Ethics Database and recorded against each SSA on the Navigation page.

    Save/print tab

    A new Save/Print tab has been added on the Navigation page to provide easy access to all save/print options and clearer guidance for users.

    Proceed to submission

    Changes have been made to the pathway under the Submission tab to provide clearer guidance for users. The button Print for Submission has been renamed Proceed to Submission and an information button added to explain the process for recording submissions in IRAS and saving/printing forms for submission to review bodies.

    Contact details

    Where a new contact is entered for the first time, it is possible to save the details directly to My Contacts by clicking on this icon .

    Study duration

    IRAS now calculates the duration of the study automatically from the start and end dates.

    Guidance

    Question-specific guidance has been updated. Revised collated versions are available from the QSG tab on the Help page. A collated version of all guidance on Project Filter questions is now available.

    A new tab IRAS Index has been added on the Help page. Users can now access a table of the contents of Parts A-D in the main project dataset in IRAS. Further documents will be added here in future, e.g. for the Site-Specific Information Form, Research Tissue Bank and Research Database forms.

    A new tab Other IRAS Guidance has been added to the Help page to provide easy access to a range of other guidance within IRAS. The following documents are now available from this tab:
    • Collated versions of all guidance under the Submission and Amendment tabs for each form in IRAS

    • Collated guidance on issues relating to student projects

    • Guidance on electronic authorisation

    • Guidance on import/export functionality for EudraCT applications.
    Research Database form

    Version 1.0 of IRAS introduced a new type of application form for ethical review of a research database, i.e. a register/collection of patient data designed as a resource to facilitate future research projects.

    NRES has reviewed the design of the form in consultation with a stakeholder group, taking account of feedback from users. A number of changes have been made to form content. These changes have been applied to existing forms not yet submitted.

    A copy of the specification for Version 2.0 is available here. In summary, the main changes are as follows.
    • The term "Data Custodian" has been replaced with "Data Controller". A declaration by the Data Controller is added in Part D of the form.

    • A new Question 8 asks how data subjects and patients/public will be informed about the results of research.

    • In Question 10 (previously Question 8), a checklist of identifiers is included, based on the list in the NIGB application form. Free text already entered by applicants has been retained under "Other identifiers (please specify)".

    • New Questions 17 and 24 seek information about the conditions under which data will be shared with researchers within the Database team or external researchers respectively.

    • Question 15 in Version 1.0 has been deleted (with any text in existing forms moved to Question 11-1)

    • Question 24 in Version 1.0 has been deleted (existing text moved to Q28)

    • In Question 25 (previously Question 22), the Yes/No options have been removed. The free text box has been retained.

    • Question 27 in Version 1.0 has been deleted (existing text moved to the new Q24)
    In addition, the order of some questions has been changed and the text of some questions slightly modified.

    Database applicants are advised to check their forms carefully before submission and ensure that all questions are completed. Where applications have already been submitted, there is no need to submit a revised application unless requested by the REC.

    Other changes to application forms

    Questions A2 (Chief Investigator) and A3 (Student project details) have been switched around. A new question A2-1 has been added with check-box options to indicate who will act as CI for a project including an educational component. Revised guidance about this and other aspects of student projects is available under Other IRAS Guidance on the Help page.

    Question A4 (Details of Project Co-ordinator) is now included in the REC application form where applicable.

    Question A19 (Details of clinical interventions) is now included in applications relating to studies involving questionnaires/interviews or qualitative methodology where the Project Filter indicates that new tissue samples will be taken.

    Question 49 (Notifying GPs and other healthcare professionals) is now generated for studies involving questionnaires/interviews or qualitative methodology.

    Question A64-4 (Legal representative for non-EU sponsors) is now generated for clinical investigations of medical devices requiring notification to the MHRA.

    In the Chief Investigator declaration on the REC application form (at D1), permission is now sought to include a contact point in the published research summary on the NRES website. Further guidance about arrangements for publication of research summaries is available here and at Question A6-1.

    The declaration by the academic supervisor (at D3) is now generated for doctoral as well as non-doctoral research.

    In the Site-Specific Information (SSI) Form for NHS sites, Question 15 (Contact points for further advice) has been split into two parts in the interests of clarity. There are now separate sub-questions dealing with advice about the project itself and sources of general advice about participating in research. The same change has been made to Question 18 in the SSI Form for non-NHS sites

    For Research Tissue Banks and Research Databases with a favourable opinion from a REC, a customised version of the NRES Notice of Substantial Amendment form is now available under the Amendment tab.

    Forward look

    Version 2.1 of IRAS will make amendments to reflect the re-constitution of the National Information Governance Board for Health and Social Care as a sub-committee of the new National Information Governance Board with effect from 1 January 2009. This will involve changes of name throughout IRAS but no change to form content. Version 2.1 is expected to be released during January 2009.

    Version 2.2 will introduce changes to complete the import/export functionality between IRAS and EudraCT for applications to conduct clinical trials of investigational medicinal products (CTIMPs). Minor changes will be made to Part A of IRAS to ensure relevant data fields are compatible with EudraCT. Additional information for EudraCT not yet captured in IRAS will be included within Part B Section 1 for CTIMP applicants only. It will become possible for the entire EudraCT dataset required to apply to the MHRA for clinical trial authorisation to be completed in IRAS and exported as an XML file. These changes will be tested early in 2009 and released as soon as possible.


    Version 1.2 (18 November 2008)

    IRAS has been updated to provide a single gateway for researchers to apply to the new NIHR Coordinated System for gaining NHS Permissions (NIHR CSP). NIHR CSP has been introduced from 18 November 2008 for NIHR Clinical Research Network Portfolio studies in England. IRAS Version 1.2 provides the facility to submit application forms from IRAS directly to NIHR CSP.

    1. From 18 November 2008, researchers submitting a new application for NHS permission for a study that is automatically eligible for the NIHR Clinical Research Network Portfolio, or that requires formal consideration prior to acceptance on the Portfolio, should apply for NHS permissions via NIHR CSP.
    2. Where a study has NHS sites and the lead R&D office is in England, a new question will appear in the Project Filter, inviting applicants to say they wish their study to be processed through NIHR CSP. Further guidance is available from the information button next to this question.
    3. Where the option is selected, IRAS will generate a short NIHR CSP Application Form which can be sent electronically to the CSP Unit. Applicants wishing to apply via CSP are encouraged to complete and submit the NIHR CSP Application Form before embarking on other applications. Further guidance on the CSP process will appear under the Submission tab for the NIHR CSP Application Form and the R&D form.
    4. Initially, NIHR CSP will not be available for studies not included in the NIHR Clinical Research Network Portfolio. Researchers whose study is not eligible for the Portfolio should continue to seek permission directly from the NHS Trusts involved in the study.
    5. The eligibility criteria for inclusion of studies on the NIHR Clinical Research Network Portfolio have been set out by the Department of Health and this guidance can be accessed at: http://www.ukcrn.org.uk/index/clinical/portfolio_new/P_eligibility/mainColumnParagraphs/00/document/Eligibility.pdf.
    6. Further information on NIHR CSP is available at: www.ukcrn.org.uk.  Please email queries to csp@ukcrn.org.uk.
    Researchers who have started to complete applications in IRAS but have not yet made applications to R&D offices should contact the NIHR CSP Unit at csp@ukcrn.org.uk for guidance.

    Investigators based in Scotland, Wales or Northern Ireland and conducting a study with sites in England should contact the NIHR CSP Unit at csp@ukcrn.org.uk for guidance.



     
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