Help - FAQs - Frequently Asked Questions
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Frequently Asked Questions

Amendment

If a substantial amendment needs to be submitted to an approved study prepared in IRAS, do we make any updates to the REC form or project dataset if these are affected, or do we just submit the amendment form as usual?
Where substantial amendments are required following ethical approval, the Notice of Substantial Amendment form should be submitted to the REC. At your discretion you may submit a further version of the form from IRAS in support of this, but it is not normally required. See the guidance in IRAS for information on submitting amendments to other review bodies.

When to use IRAS

When is IRAS likely to be compulsory?
IRAS is the preferred system for applying to the review bodies included in IRAS. In April 2009 some previous systems, such as the NRES online form, closed to new applications. Applications for review by a Research Ethics Committee (REC) within the UK Health Departments' Research Ethics Service, applications for HRA Approval and for the multicentre review system in Scotland (NHS Research Scotland) only receive applications made through IRAS.

Training

Is there a set of "dummy" applications available?
A user can set up a dummy project, complete an entire application (transferring to collaborators if appropriate) and print it off in PDF format for reference or training use. The user can also delete this project from their account under the "Manage" tab. A user can take any project through a full cycle even to printing for submission. Please note that unless you actually submit an application to a review body, no-one else will view your data.
What training is being provided on IRAS?
IRAS is designed to be an intuitive system which all applicants can learn to use with the aid of comprehensive on-line guidance, supported by the Helpdesk and other published sources of advice on applications. If you are a new or infrequent user of IRAS then we recommend that you refer to the free IRAS online training module as this provides an overview of the system and the functionality offered.

EudraCT

Is a copy of the EudraCT application form still needed by RECs?
The requirement to provide a copy of the EudraCT application form does not apply in IRAS, as the information on IMPs is included as part of IRAS.

Using IRAS

What is the distinction between the forms navigation pages and the project dataset navigation page?
The navigate tab allow you to move to any particular question. The navigate tab shows the questions that are enabled within a particular part of IRAS. If the project dataset is selected, the navigate tab will display all the questions that will be enabled for all the project forms for a particular project. If a particular form, e.g. the R&D Form, is selected, the navigate tab will display only the questions that apply to that form. Different forms have different questions that are applicable to the different reviews conducted by the review bodies.
If there is more than one person from the same company likely to be involved in the preparation for an application, should they use one common login and password, or should they each have a separate log-in and password?
This is an internal company decision. Applicants should be aware, however, that using the same login and password for several people could result in a loss of control of the information in an application. Applications can be transferred to others for completion of different parts of an application or to permit review and collaboration.
I am no longer responsible for a project in my account - what should I do?
If you have a project in your IRAS account that you are no longer responsible for, or involved in, but which is still ongoing then you should identify someone else to take ownership for the project. Once a new IRAS project owner has been identified you should permanently transfer the project to them by following the instructions in the e-learning module for permanent transfers
How do I generate SSI forms in IRAS?
Before generating site specific information (SSI) forms you should check which form(s) are appropriate to generate for your project by referring to the guidance in IRAS Help. Where SSIs are needed they should be generated once the integrated dataset has been completed as there are elements of this study-wide information that populate the SSI forms. The method for generating SSIs is slightly different depending on whether the form is for an NHS site or non-NHS site and the lead nation for your project. Where your lead nation is Northern Ireland, Scotland or Wales the SSI Forms can be generated via the "Add SSI" tab, which is available when the R&D Form or REC Form is selected on the project Navigation Page. if your project is led from England then NHS SSI forms are generated using a button in Part C and non-NHS SSI forms are generated using the "Add SSI" tab associated with the IRAS Form. 
How long are the forms stored on IRAS for?
Any forms you generate will remain in your account until you delete them or arrange for them to be permanently transferred to another person. If you have created a submission for a form then the option to delete that form will not be available. 
How can I manage version control with different applications at different times for one project?
The owner of the application controls who the data is transferred to for collaboration, authorisation or review. Once an application has been printed for submission, any subsequent changes to data that has previously been submitted to a review body (even if in a different form for a different review body) will raise a warning in IRAS. The applicant will be warned that the change may require an amendment to a previous submission.
Will IRAS include progress and safety reports?
This is under consideration and may be included in IRAS at a later date. For now, applicants will need to follow the instructions provided by each review body on reporting requirements.
How can I check what changes a collaborator has made in IRAS after transferring the project?
There is currently no facility for track-changes or comments in IRAS. A system for version comparison to check changes at different points is being considered.
Can I use IRAS for applications like grant applications?
IRAS is continuing to expand the number of partners involved. We hope to extend the use of IRAS to other organisations that researchers need to provide information to, like funders and other review bodies.

Submitting applications

How do I send my application to a NHS R&D Office?
There are different arrangements in place across the UK for seeking permissions for research involving NHS/HSC organisations. Please refer to the guidance provided in IRAS Help for further information. 
What are the subsequent processes after submitting applications in IRAS?
Each review body has its own arrangements for reviewing applications and these are not affected by the introduction of IRAS. Guidance on how to submit the various applications is available within IRAS. You should make sure you are aware of the different submission processes.
What is the point of the submission history, how or by whom is this updated?
When you click on the "Proceed to submission" button, or the" E-submit application" button in applications that are electronically submitted, the system takes a snapshot of the data in that form and adds a submission code to the form. That snapshot is accessible from the submission history. If you subsequently change any data and select the "Proceed to submission" button the latest snapshot will be recorded in the submission history. You will therefore have an audit trail of the forms that you have created. Please note that the "Proceed to submission" button does not transfer your application to the review body; you must follow the submission instructions for each form. However an "E-submit application" button on an electronically submitted application will submit the form and documents uploaded to the checklist to the review body. In this scenario if you alter the form after electronically submitting it then these changes will not automatically be communicated to the review body and you should refer to relevant guidance about how to proceed in this case. 
Can applications be submitted electronically from IRAS?
There are separate submission requirements for each review body, details of which are provided on the submission/E-submission tab for that form. 
What authorisations or signatures do I need for IRAS?
Different authorisations are required in IRAS depending on the type of study and the review bodies that are applicable. Details of these are given within IRAS. IRAS does not change the requirements for review of any regulatory body or NHS organisation.
I have been told that my study is not eligible for the NIHR portfolio. How do I submit my applications to R&D offices?
If you have submitted a Portfolio Adoption Form and been informed that the study is not eligible for the NIHR portfolio then you cannot use NIHR CSP for your R&D applications. Please go back to the project filter and select No for question 5a to indicate that you are not applying through NIHR CSP, and then click on the Navigate button. When you select the R&D Form or SSI Form now, the submission tab will allow you to submit applications to R&D offices.

Student projects

For educational studies, should the student or the supervisor be named as Chief Investigator?
Please see the Question Specific Guidance for question A2 in IRAS.

Sponsor

As the sponsor of the trials, can we complete all of the applications?
Sponsors of trials may choose to support researchers by completing forms on their behalf. Where the CI or PI is responsible for signing off the application to a particular review body, they should satisfy themselves that their application is accurate. The individual CI or PI must also be in a position to communicate with the relevant review bodies about the application. Applications to MHRA are the responsibility of the sponsor.
Is IRAS only available to sponsors working in the NHS or does it apply to industry too?
IRAS is available for use for any research project that requires review by one or more of the review bodies below, whether the sponsor is a company or non-commercial organisation. Review bodies: Administration of Radioactive Substances Advisory Committee (ARSAC); Confidentiality Advisory Group (CAG); Gene Therapy Advisory Committee (GTAC); HRA Approval; Medicines and Healthcare products Regulatory Agency (MHRA); NHS / HSC research offices; NHS / HSC Research Ethics Committees (RECs); National Offender Management Service (NOMS); National Social Care REC.   
What does agreement in principle to act as sponsor mean?
The Sponsor is asked to declare in applications that it is prepared, in principle, to act as sponsor based on the information available to it at the time of preparing applications. It is recognised that sponsors cannot give a final confirmation of their ability to sponsor a study until further arrangements for the study have been made. Once sponsors have declared that they agree in principle to act as a sponsor, the sponsor is expected to make clear in writing to all parties if it no longer agrees to sponsor a study at any stage. It is therefore reasonable for all parties to assume that an organisation that has agreed in principle to act as sponsor is the final sponsor unless the organisation clarifies in writing that it is no longer the sponsor.

Review

How long is the process of obtaining approval using IRAS?
IRAS provides the system to apply for review by a range of regulatory and governance bodies. Each body has different timescales for review and approval. IRAS speeds up the overall process for researchers by eliminating duplication in form-filling, and encouraging parallel applications to review bodies.

Research Tissue Banks & Research Databases

How do I generate SSI Forms for a Research Tissue Bank or for a Research Database?
There is no need for Site Specific Information (SSI) Forms for Research Tissue Bank (RTB) or Research Database (RDB) applications. Organisations supplying samples and data to an RTB are not considered to be research sites but Tissue Collection Centres (TCC). Any NHS organisation supplying tissue and data to an RTB needs to agree to do so and approve the arrangements, but as they are not research sites this activity does not require permission for research in the same way as for specific projects. Similarly organisations supplying data to an RDB are not considered to be research sites but Data Collection Centres (DCC). Any NHS organisation supplying data to an RDB needs to agree to do so and approve arrangements, but as they are not research sites this activity does not require permission for research in the same way as specific projects. Therefore SSI Forms are not required and there is no facility to create SSI Forms linked to RTB or RDB applications in IRAS. In order to provide R&D offices with the necessary information about the bank please enter details about each TCC/DCC in Part C and submit a copy of the full REC application with the accompanying documents (see submission checklist) to the R&D office for each TCC/DCC. The role of the R&D office in TCC/DCC review is to agree information governance and material transfer arrangements. If additional collection centres agree to take part following initial REC approval of the RTB or RTB, add the details to Part C and submit to the R&D office at the new collection centre. Addition of new centres will not be a substantial amendment to the terms of the REC approval and there will be no need to notify the REC, unless there are also significant changes to the arrangements for collection, e.g. new classes of donor, revisions to information sheets and consent forms. TCCs/DCCs are not responsible for the research conducted by the RTB/RDB. Custodianship and accountability for research is handed to the organisation responsible for the bank. Once the bank is established, further ethical approval for specific projects will not be required provided these are within the terms and conditions of generic ethical approval. However, specific projects using the banked tissue and data will require permission from the researcher"s host organisation in the usual way. 

Participant Identification Centres

What is the difference between a Participant Identification Centre and a Research Site?
Research sites, as defined in IRAS, are organisations responsible for participant-related research procedures specified in the protocol including recruitment and informed consent. The following are not considered to be research sites: Clinicians or clinical units making referrals to the research team. Research units undertaking support functions, e.g. project management, site monitoring, data analysis or report writing. The purpose of the guidance in IRAS is to clarify that NHS organisations responsible for locations from which clinicians refer patients are not responsible for providing indemnity for the research activity. That is the responsibility of the site conducting protocol-driven procedures. The NHS organisation responsible for the Participant Identification Centre is expected to review the request to refer patients (including any resource implications and other issues such as data protection) and agree to this.


 
IRAS Integrated Research Application System, version 5.13, 22/07/2019, IRAS Dataset version 3.5.
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