Integrated Research and Application System (IRAS)

IRAS is the online system which facilitates applications for:

• Administration of Radioactive Substances Advisory Committee (ARSAC)
• Confidentiality Advisory Group (CAG)
• Gene Therapy Advisory Committee (GTAC)
• Health Research Authority (HRA) for projects seeking HRA Approval
• Medicines and Healthcare products Regulatory Agency (MHRA)
• NHS / HSC R&D offices (using NIHR Local Clinical Research Network Portfolio)
• NHS / HSC Research Ethics Committees
• National Offender Management Service (NOMS)
• Social Care Research Ethics Committee

For the EMULSION study, we used IRAS for:

• NHS / HSC R&D offices (using NIHR Local Clinical Research Network Portfolio)
• NHS / HSC Research Ethics Committees

IRAS has clearly streamlined the process for applications to regulatory bodies where previously multiple applications were required for each body. This is done through distilling down the common elements of all of the applications such that each body can retrieve the elements of the application that are pertinent to their approval.

This is clearly a very good and efficient system but I will offer some health warnings for using it:

• Once you have submitted the form to one of the bodies, the sections relating to that submission are locked, and therefore if that section is used by another body, the same information will be sent to that second body with no opportunity for editing (I got caught out with the initial NIHR Portfolio application, although luckily it was basically just the name for the study was set)
• Identify who it is in your organisation who will ‘sign’ the form at the end and what information they will want prior to signature. This prevents you compiling all of the information diligently (a big piece of work) and then having it sit there whilst you track down the right person to sign it.
• Get all of your paperwork ready in advance. It wasn’t until we started the IRAS application that I realised how many documents we needed (see below) and if this process had been started off in advance I would have been in a much better position
• Read through the form early on to make sure you know what you need to compile – unexpected documents I had to source included the University’s Insurance Certificate!

Having said that, the system it quite useful to navigate. It is clear which section will feed into which form and there are (?) icons throughout to help you understand what each question is asking. There is also an e-learning course to teach you how to navigate through the system which I would recommend.

To give you a flavour of the range of documents you might need to generate – our IRAS application for NHS Ethics included 24 documents in addition to the form itself including:

1. REC Covering Letter
2. Evidence of sponsor insurance or indemnity (University of Sunderland as sponsor)
3. Prescriber notification of patient participation
4. Topic guide for pharmacist interviews
5. Topic guide for patient interviews
6. Topic guide for prescriber interviews
7. Letter from funder
8. Invitation letter for participation in interviews for healthcare professionals
9. Invitation letter for participation in interviews for patients
10. Invitation letter for participation in focus groups for healthcare professionals
11. Invitation letter for participation in focus groups for patients
12. Invitation letter to prescribers to recruit patients into the study
13. Information for prescribers to recruit patients into the study
14. Consent form for participation in interviews for healthcare professionals
15. Consent form for participation in interviews for patients
16. Consent form for participation in focus groups for healthcare professionals
17. Consent form for participation in focus groups for patients
18. Participant information sheet for interviews for healthcare professionals
19. Participant information sheet for interviews for patients
20. Participant information sheet for focus groups for healthcare professionals
21. Participant information sheet for focus groups for patients
22. Funder review panel comments (scientific critique report)
23. Research protocol
24. Summary CV for Chief Investigator

Links

IRAS portal: https://www.myresearchproject.org.uk/

IRAS e-learning: https://www.myresearchproject.org.uk/ELearning/IRAS_E_learning.htm