Step three - using IRAS
How do I use the Integrated Research Application System?
To apply for the approvals you need to start your research you will need to use the Integrated Research Application System (IRAS). This is an online portal which generates all the applications needed for your study by the different regulatory bodies’ i.e HRA, Research ethics committee, etc.
To open an IRAS account, go to www.myresearchproject.org.uk and create an account using your email address and a password. You will receive an email confirming your details.
Once you are ready to start, click on ‘New Project,’ - the first page that appears is a ‘filter’ page. The answers you provide on this page will generate the approvals forms which are specifically needed for your study. It is really important that you answer these questions as accurately as you can.
Use the following guide to help you go through the IRAS approvals process:
For each of the questions on the form there is a small green ‘i’ to help clarify the content needed.
Once you have completed the full dataset form you will need to upload a number of documents to the system to complete your application i.e. your consent form, CV, participant information sheet, etc.
There is a checklist available to help you decide what is needed. To access this you will need to select the IRAS form from the project forms menu on the left (See the previous screen shot). You can then click on the checklist tab which provides you with lots of information about what documents to attach and how to do it.
This will ensure that all the appropriate documents are sent to the correct approval body with the IRAS form. We would suggest using appropriate file names to identify the content of the document, clear version control and dates for each document.
You will also need to upload the Organisation Information Document and the Schedule of Events/Schedule of Events Cost Attribution Template (oOECAT). These are required to clarify with the NHS trust you are working with needs to do in order to carry out the research i.e. the resource implications.
You will need an Organisation Information Document for each NHS site type i.e. if different ones for Recruiting Sites vs Participant Identification Centre (PIC). The Organisation Information Document sets out exactly what each site will be doing as part of the project as a whole. The Organisation Information Document also can be used as an agreement and covers lots of useful areas.
When completing these forms it is important not to add trust specific details and only generic study information. For more information about study documents including Organisation Information Document and SoECATs and for templates of these forms you can follow this link to the HRA website.
It is a really good idea to contact the Academy of Research and Improvement so we can assist in completing these forms which will speed up the approvals process.
If you need help with your form or want someone else to review it you can also transfer your form to another person using their email address, by clicking on the transfer tab. They can then return it to you, or you can request it back using the same tab.
When you are ready to submit, you will need to seek electronic authorisation from certain members of your study team including the sponsor and the chief investigator. In order to request this you will need to have fully completed the form.
Once you have their authorisation, you will be unable to change the content of the form in any way. If you do change the form, you will need to re-seek the electronic authorisations.
In order to request electronic authorisations, click on the relevant project form (i.e IRAS form) on the left hand side menu. When you are in a specific form, your will see an authorisation tab - click on this, and request their electronic signatures.
Once you have completed all of the steps above and are ready to submit, you will need to call the Central Booking Service on 0207 104 8000.
You will need to confirm that you are ready to submit electronically on the same day, have the IRAS form in front of you with the project ID and contact details of the CI and sponsor. The help desk will then book you into the appropriate REC (if ethical review is required).
RECs are situated around the UK and you can choose any one. Some RECs review specific types of studies and you can request one of these for your study if required. It is a good idea to attend your REC meeting and you can find more information about this on the HRA website.
Following the phone call, you will receive an email confirmation with a REC reference number; insert this in to your IRAS application on the first page of the form and submit your form using the e-submission tab. Entering this number in the REC details fields in IRAS will not invalidate your electronic authorisations.
Please contact the Academy of Research and Improvement at any point should you need assistance with this process via email.