IRAS Applications

What is IRAS?

IRAS is the Health Research Authority's (HRA) online ethics application system.

Who needs to make an IRAS application?

IRAS is used for research projects involving the NHS, social care or the criminal justice system.  These partners will notify you when an IRAS application is required (also see HRA Governance). Typically in staff projects, the NHS will sponsor the project and IRAS applications will be co-ordinated by a clinical research office within the partner Trust (these do not need additional university ethical review - please though use the Approval Given Elsewhere function on the university's review system to log the NHS approval). However doctoral projects are generally 'sponsored' by the University, so will need support from Research and Innovation Services.  It is the policy of both the NHS and the University that Masters and Undergraduate projects do not go through IRAS; instead they should be designed as service evaluation/audit projects (see below).  

I am a doctoral researcher/supervisor of a doctoral project, will the University sponsor our project?

Sheffield Hallam will generally act as a sponsor for research projects and take on the responsibilities of the sponsor as set out in the Department of Health Research Governance Framework.  However, each project is assessed on a case-by-case basis and must have received Sheffield Hallam University ethical approval, and confirmation of indemnity cover, before authorisation can be given.

How long does IRAS approval take?

IRAS applications involve several stages: application development, internal ethical approval, confirmation of indemnity, REC review and contractual collaboration arrangements.  Combined these can take approximately three months.  It is therefore vital that doctoral researchers begin their application in a timely fashion, to ensure the process does not delay their studies.  

What steps do I need to take to submit an IRAS application?

1) Complete the online IRAS application. There is an online guide to completing the form. It is important that the email given for sections A4 and A64 is ethicssupport@shu.ac.uk. Once complete however, do not submit it; instead download it as a PDF.

2) Obtain Sheffield Hallam ethical approval through the University's Ethics Review System, by uploading the draft PDF that has been downloaded to the appropriate IRAS pathway.  This stage is estimated to take two weeks.  

3) Seek sponsorship and indemnity cover from the University's Research and Innovation Service.  This is triggered automatically when you press 'Send Request' to authoriser button on the IRAS system.  This stage can take up-to a week.

4) Submit final IRAS application to the HRA.

What happens after I submit?

1) You will need to book a REC review appointment through the booking system (using the 'e-submission' tab on IRAS).

2) The REC will review the application and seek further information/request amendments, as necessary.

This stage can take several weeks.

The contracting stage

A collaboration agreement will need to be drawn up between the University and the relevant Trust.  This can begin in parallel with the REC review.  

The University is typically unable to use the NHS's basic contract known as an Organisation Information Document (OID).  Instead we will request to use a modified version of their full contract, known as an Model Agreement for Non-Commercial Research (mNCA). This must be used in conjunction with this rider.

The doctoral researcher, with the support of their supervisor, should complete the document in co-operation with the Trust's R&D department and the University's Research and Innovation Services (ethicssupport@shu.ac.uk).

A Schedule of Events (SoECAT) should also be completed in co-operation with each site.

This stage can take up to a month.

Post-approval

Once the project has been 'green lit', researchers should maintain an investigator site file for the life of the project.

Masters and Undergraduate Projects

Universities and the NHS have different definitions of research - universities use a broader interpretation, while the NHS uses a more specific one.  The NHS divides projects into research, service evaluation and audit (see: www.hra-decisiontools.org.uk/research/). Under the Research Governance Framework, projects not classified as research by the NHS are not managed as research by them (though they still are by universities). 

Masters and Undergraduate projects should be designed to fall under the NHS definition of either service evaluation or audit (i.e. no changes in patient treatment, no randomised controlled trials).  The NHS and the University will not support these projects through IRAS.  

Projects not classified as research by the NHS do not require REC approval; though they may require other NHS management arrangements. The input of the NHS Trust R&D office should be sought. Audit and service evaluation still requires standard University ethical approval (UREC1-4 forms) before the work commences.