Before you write your IRAS form we recommend that you write your Protocol using the template available on the HRA Website. This is because the consistency of information is key and your Protocol is the ‘manual’. Once you’ve written your Protocol you’ll be able to complete IRAS with ease.
All projects need to be entered into the Integrated Research Application System (IRAS) in order to apply for national and local permissions. The system:
- Is a single system for applying for the permissions and approvals for health and social care / community care research in the UK
- Enables you to enter the information about your project once instead of duplicating information in separate application forms
- Uses filters to ensure that the data collected and collated is appropriate to the type of study, and consequently the permissions and approvals required
- Helps you to meet regulatory and governance requirements
Starting your application
After you login to IRAS and create a new project, the first thing you are required to do is complete the project filter questions.
It is very important that this is done correctly as it determines the core data required for your submission. Getting it wrong may mean that you answer a lot of irrelevant questions and your application may be invalid.
Applying to the UKCRN Portfolio
Studies that have been funded and peer reviewed as part of an open national grant call may be eligible for NIHR UKCRN portfolio adoption.
To check if your project is eligible, you will need to answer ‘yes’ to 5b on the IRAS filter. Selecting this generates a Portfolio Adoption Form which will need completing and submitting, following the instructions in IRAS. The Portfolio Adoption Form can be submitted at the same time as applying to REC and the HRA through IRAS.
Once you have completed your Portfolio Adoption Form (PAF) and have uploaded all of your supporting documentation you can proceed to the ‘E-Submission’ tab. You will need to pick the correct CRN from the drop down menu. For all sites of University Hospitals of Leicester NHS Trust please select East Midlands LCRN.
Please do not submit your PAF until authorised to do so by the Sponsor.
Documentation for national approvals
REC and HRA
Your application to REC and the HRA will need to be prepared and submitted using IRAS. The application will be submitted to both the REC and the HRA in parallel. A favourable opinion from REC and a HRA approval letter will need to be obtained from both regulatory bodies.
For UHL sponsored studies
Email your draft IRAS application form along with all supporting documents and a completed feasibility form Feasibility Form to firstname.lastname@example.org
Your study will be allocated to a representative of the sponsor who will undertake a review and support the Chief Investigator (CI) and study team to prepare the documentation for REC/HRA submission.
Where University Hospitals of Leicester is also a research site, the SSO will incorporate assessing, arranging and confirming the capacity and capability to deliver the study as part of this process.
Once your application has been prepared, reviewed and approved by the Research and Innovations team it will need to be electronically authorised by the Sponsor Representative for UHL. A REC meeting can then be booked via the Central Booking Office and the application submitted via the IRAS system along with all supporting documentation. Your application will be sent to both REC and the HRA for review.
Submitting to MHRA
For application to the MHRA for University Hospitals of Leicester CTIMPS, please contact the Research and Innovation team. For device studies requiring MHRA approval, please speak with the Research and Innovation team who can advise you further.