Research, Innovation & Engagement Support

WHAT IS IRAS?

WHERE CAN I FIND IRAS?

IRAS can be accessed here   https://www.myresearchproject.org.uk/

HOW DO I KNOW IF I NEED AN IRAS APPLICATION?

Generally speaking, if your study will involve the NHS in any way, then an IRAS application will usually be needed. For NHS research led from Scotland or Northern Ireland, it is used to apply for NHS ethical and/or NHS management approvals; for NHS research led from England or Wales, it is used to apply for Health Research Authority (HRA) and Health Care Research Wales (HCRW) approvals. 

Other review bodies that use IRAS include:

• Administration of Radioactive Substances Advisory Committee (ARSAC)

• Confidentiality Advisory Group (CAG) [England & Wales]

• Gene Therapy Advisory Committee (GTAC)

• Medicines and Healthcare products Regulatory Agency (MHRA)

• Her Majesty's Prison and Probation Service (HMPPS) [England & Wales]

• Social Care Research Ethics Committee

If you’re not sure if your study needs an IRAS application, students should speak to their Academic Supervisor/s, in the first instance; members of staff can contact the local NHS Research and Development/Innovation Department or the University Research Regulation & Compliance team for guidance.

 IS THERE TRAINING ON HOW TO COMPLETE AN IRAS APPLICATION?

 DO I NEED TO HAVE AN ACCOUNT WITH IRAS?

Yes, to complete an IRAS application you need to register for an account. 

It is essential that when ‘authorisations’ are required i.e., Chief Investigator/Academic Supervisor and Sponsor authorisations that they also have an IRAS account.  Note, that you will need to know which email address is associated with each user’s account as the system uses these, rather than names, to identify users.

 Top Tip:  if an individual is undertaking more than one role within your study eg Academic Supervisor AND Chief Investigator, they will need to provide authorisation for each role.

 WHAT ARE THE IRAS PROJECT FILTER QUESTIONS?

These are the initial introductory questions you’re asked about the type of study that determine which questions are later enabled/disabled in the form.  The answers you give here will customise the form and ensure that you’re only asked questions that are relevant to your study type so it’s worth spending the time here making sure the questions are answered correctly. For example, if you find yourself being asked about levels of ionising radiation exposure but your study does not involve X-rays, then there’s likely an error in the Project Filter Questions and you should revisit the answers you’ve given there. 

 WHAT IS THE IRAS ID?

 IS IT POSSIBLE TO TRANSFER THE IRAS FORM FOR OTHER TO REVIEW WHILST COMPLETING IT?

Yes, during the completion of the IRAS form, it or the Full Set of Project Data can be transferred to another IRAS user, a collaborator or your sponsor representative, for example, using the Transfer tab on the Navigate page.

Be mindful of the following:

• if you transfer the study to another IRAS user’s account, then you can’t access it until it is returned to you or you retrive it from the other user

• it can only be transferred to one other user at a time

• it’s not possible for any changes made to be ‘tracked’

 An alternative is to download a pdf of the application form (even if it’s blank or only partially completed) which can then be emailed as required. 

WHERE CAN I FIND GUIDANCE ON HOW TO COMPLETE THE FORM?

To help with the completion of the form, guidance is available in a number of places:

1. the IRAS home page has a link to a comprehensive  Help section,which includes information on using IRAS and how to prepare an application, as well as a link to

2. a Step by Step Guide on how to complete the form

3. Several questions within the system have question-specific guidance, which can be accessed via the green button ”i” alongside the question

4. The Research Regulation and Compliance Team has also created its own guidance document on how to complete specific sections of the IRAS form where queries are most common; it is intended to complement the official IRAS guidance.

Top Tip: Ensure that the information entered into the IRAS form is consistent with that provided in the other study documentation i.e., the Study Protocol, Participant Information Sheets etc.

The sponsor representative will review the completed IRAS form, along with all study documents to ensure that the information provided is acceptable and sufficiently detailed for the relevant committees and permissions. 

 WHAT DO I DO WHEN THE APPLICATION FORM IS COMPLETE?

PROJECT FILTER QUESTIONS

These are introductory questions about your study.  It’s vital that they are answered correctly, as the answers you give here will determine which questions are enabled/disabled in the ‘Full Set of Project Data’ fields

PROJECT FILTER QUESTION 4

Note CAG and HMPPS apply to England and Wales only, different processes apply in Scotland. If further advice is required, please contact the local NHS R&D/I department or the University Research Regulation and Compliance Team.

PROJECT FILTER QUESTION 7

If Yes, and the study will be led from Scotland, it MUST be submitted to Scotland A NHS REC for review

PROJECT FILTER QUESTION 9

If contributing towards an educational qualification, and that is the primary objective of the study, answer Yes.  If a student is part of the research team for a study that would be taking place anyway, answer No.

If Yes, a supplementary free text section is enabled.  DON’T answer, for example, ‘It’s for a PhD’ - that’s captured in Q9a.  Be descriptive - for example, the student will be the Principal Investigator undertaking research activities i.e., taking samples, conducting interviews, analysing data etc.

    TOP TIP

Most questions within the IRAS form include a green "i" symbol, which, when clicked, provides guidance on how to answer that question.

Here are some more hints and tips that might be helpful.

FULL SET OF    PROJECT DATA

PART A: CORE STUDY INFORMATION

      A2.1

A short CV is needed for any students listed, their academic supervisor/s and the Chief Investigator. IRAS provides a CV template for use.

For student research, ensure that box/es are ticked to indicate which academic supervisors have responsibility for which students.

      A2-2

In NHS GG&C, a student cannot be the Chief Investigator.

      A4

Confirmation should be obtained on who the sponsor representative will be, refer to the UoG Sponsorship policy document for guidance (currently under revision)

      A5.1

• The R&D number will be provided by the relevant Health Board R&D/I team (if applicable).

• Update protocol version number and date once the document has been finalised.

• Ensure Funder reference is not left blank, or the application will not pass the Verification stage. Either enter a Reference Number or “Not Applicable”.

• If registering with clinicatrials.gov, the reference number does not need to be completed prior to IRAS submission, however, this must be completed prior to the first subject being recruited and this will likely be a condition of NHS REC approval.

      A6.1

Ensure language is not too technical as REC will publish this description on their website and require simple language for readers and for lay members of the REC, it is not a copy and paste from the study protocol.  Consider treating it like an abstract for the study, obviously minus the results.

A6.2/A12/A13

Note the guidance in the IRAS form, the information required in these sections needs to be a summary and provided in lay language, it is not just a copy and paste from the study protocol.

      A15

If applicable, there is a “No upper age limit” option in the drop-down list. Don’t leave this blank.

      A24

If there are no direct benefits to participants, say that. 

Other wider benefits e.g., advancing scientific knowledge, improved healthcare of future patients, can then be described.

      A26

Include details of any safety requirements of the sponsor e.g., lab safety policies, lone study/working policies and procedures etc.

A27.1/A27.2/  A27.4/A29

There should not be any unsolicited contact with patients by the research team. The initial approach should come from the clinical team.

Usually, screening of medical records to identify eligible participants should be carried out by the clinical care team; researchers should not have access without express permission from the patient.   However, where the researcher(s) is part of the routine clinical care team and would have access to patient case notes for routine clinical purposes, then they can identify potential participants.

Once a patient has been identified as being eligible for the research, they can either:

• Be introduced to the researchers by the clinical care team.

• Give permission for their contact information to be passed to the research team (if given verbally, this should be documented in the medical records; completion of a simple ‘Permission to be contacted’ slip is an alternative)

• Be provided with contact information for the research team and invited to contact them directly if they wish.

      A33.1

If participant facing documents in languages other than English will be used, REC will expect to review these versions too.

If proposing the use of interpreters, ensure funding is available for this research cost.

   A36 & A37

Remember that:

• no identifiable patient data can be stored on university computer systems; data should be at least pseudonymised, with the code linking to identifiable information held separately

• portable devices such as laptops, usb drives etc should be avoided as storage locations; back up on a secure IT network and use VPN to access

• written consent forms are “manual files”

      A40

Include that sponsor representatives and regulatory bodies may require access for monitoring or audit purposes.

      A42

For student research, ensure this is the academic supervisor. 

      A43

If longer than 12 months, a justification must be provided.  Be mindful of the distinction between personal and research data.

      A44

University of Glasgow requires research data of long-term value, such as those supporting a thesis or publication, to be retained for at least 10 years after completion of the research study.  See the UoG Code of Good Practice in Research for more information.

      A50

This is currently a condition of NHS REC approval for the top 4 study categories in IRAS Project Filter Question 2.

Options include:

• clinicaltrials.gov (free)

• ISRCTN (incurs charge)

Speak to your sponsor representative for further guidance.

      A63

Ensure ALL collaborators named in the protocol are listed here.

      A64.1

Ensure the correct ‘commercial status’ is selected at right hand drop-down box.

Provide full details for the sponsor representative/s.

      A65

Ensure that details are provided for funding already secured, as well as funding applied for.  Award letters should be included in the submission.

      A66

Examples include:

• external laboratories

• courier companies

• transcription companies etc

Appropriate contracts will be required.

      A69.1

Ensure the planned start date is not in the past.

      A71-1

This is determined at health board level e.g., a study taking place at QEUH & GRI has two locations, but the research site is NHS GGC i.e., single centre.  A study taking place in two or more health boards e.g., QEUH and Ninewells Hospital, Dundee (NHS Tayside) is multicentre.

      A73

Tick Yes if some locations will ONLY identify potential participants.  These are known as Participant Identification Centres (PICs).  Supplementary questions will be enabled, if applicable.  More information can be found here

      A74

The study sponsor is responsible for this aspect of study management.  The specific form it takes will depend on the category and risk profile of the study.

Appropriate text will be provided by the sponsor representative.

      A76.1

This relates to who the study Sponsor is.

• Select “NHS” if NHS is the Sponsor.

• Select “Other” if UofG is the Sponsor

• Select both if the study is co-sponsored (this generally applies only to CTIMPs and a small number of other specific study types – you will be advised if this is applicable)

If University insurance applies, the relevant document and free text will be provided for inclusion in the submission.

       A76.2

This relates to the protocol authors (the design of the research):

• Select NHS if any of the protocol authors are substantively employed by an NHS organisation

• Select “Other” if any of the protocol authors are substantively employed by UofG or are UoG students

• Select both if applicable

If UoG insurance applies, the relevant document and free text will be provided for inclusion in the submission.

       A76.3

This relates to where the research sites for the study are and the conduct of the research.

The answer must be consistent with the sites listed in Part C of the IRAS application.

• Select “NHS” if NHS sites will be used

• Select “Research includes non-NHS sites” if non-NHS sites (e.g. University or community sites) will be used

• Select both if applicable

If UoG insurance applies, the relevant document and free text will be provided for inclusion in the submission

      PART B

Part B includes sections on medicinal products, medical devices, samples, radiation, adults unable to consent, children etc.  They will be enabled/disabled depending on the answers given to the Project Filter Questions.  If you’re being asked about an unexpected topic or you’re NOT being asked about an aspect you’d expect, check the Project Filter Questions.

      PART C

A research site is any place where research procedures from consent onwards will take place. 

The sites listed here should tally with the information provided at A72.

A named Principal Investigator or Local collaborator must be listed for each site.  For non-NHS sites, this might be the contact who has agreed management approval for that location.

If you have indicated at A73 that Participant Identification Centres (PICs) will be used, details for any that are NHS organisations should be included here.

OTHER HINTS AND TIPS

Each question of the IRAS form has a "tick" symbol in the top right-hand corner. Once clicked, it changes to green there and on the Navigate page.  It can be a useful way of keeping track of which questions you’ve still to complete.  However, it is not compulsory that it is used and if all or some are not ticked/green, it does not prevent you from submitting your application. Note that, once you have any electronic authorisations, clicking on any of these symbols will invalidate the authorisations and you’ll need to request them again.

Avoid leaving questions blank, it is not always clear which fields are mandatory for submission, therefore state N/A if necessary.