IRAS is the single place to submit ethics and regulatory applications in the UK. It asks you filter questions to assess which forms you need to fill in and which regulations are relevant to your project. The answers you give to your filter questions will determine much of the application process, so take some time getting them right. If you need to change your answers to the filter questions you might have to fill in totally different information and so it is worth checking your answers with the R&D Department if you don't know rather than guessing.

Set up an IRAS account

IRAS is the single place to submit ethics and regulatory applications in the UK. Set up your account at www.myresearchproject.org.uk Have a look round but make an appointment with R&D for assistance (email:research@rnoh.nhs.uk), because procedures change all the time....

Prepare IRAS applications

Done on IRAS, applications take time to prepare, and you'll need to have your forms authorized (usually electronically) AFTER any final amendments, by the Chief Investigator, the Principal Investigator and the Sponsor (Iva Hauptmannova, R&D Manager, on behalf of the RNOH).

What do you need?

1. Write your protocol first (request suitable templates from the R&D Department)
2. Complete IRAS forms, if you have completed the forms prior to PEP1 feedback these may require some editing (The top three are the mandatory forms).
   1. IRAS Ethics form
   2. IRAS SSI form (Site specific information)
   3. IRAS R&D form
   4. Any regulatory body forms necessary, for example, an MHRA form in a device or investigational medicinal product trial. For additional details on how to set up clinical trials see the Clinical Trials Toolkit.
3. Prepare additional documents- we have project document templates for the top two.
   1. Patient information sheet
   2. Patient consent form
   3. CVs of investigators and staff
   4. Any other documents requested by IRAS

Answering IRAS filter questions

Is your project research?

If you are deriving new knowledge (by addressing clearly defined questions with systematic and rigorous methods) then yes.

However, if your project is solely audit or service/therapy evaluation, then no it is not. It does not require ethical review, management permission through the R&D office or applications in IRAS. If you are unsure about what is classified as research, take a look at our guidance tool 'differentiating audit service evaluation and research'.

Select one category from the list below:

The type of project you want to do will determine much of the application process, so take some time getting the definition right. Not all research projects are classified as you might assume, especially in projects using in-house devices that are not being commercially developed where often researchers wrongly classify them as device trials. Don't waste your time, ask for advice on how to classify your research project.

• Clinical trial of an investigational medicinal product
  (Research using a medicinal product such as a drug either outside of it's marketing licence OR using an unlicensed medicinal product)
• Advance Therapy Investigational Medicinal Products (ATIMP)
  Research, which involves use of stem cells, if you are using stem cells in your study, please come and discuss this with the R&D Department as soon as possible.
• Clinical investigation or other study of a medical device
  (Do not select this if your research is involving low risk devices where the primary objective is NOT trying to improve the device for commercial purposes AND where the device will only be used in-house within the RNOH. Your project might qualify for an NHS exemption scheme, allowing certain low risk devices trials to abstain from MHRA authorisation. Instead select other clinical trial or clinical investigation)
• Combined trial of an investigational medicinal product and an investigational medical device
  These trials involve devices that incorporate medicinal products such as drugs or biological membranes into their functionality.
• Other clinical trial or clinical investigation
  (Research involving low risk devices being used in-house, NOT trying to improve the device itself or developing it for commercial purposes should select this option and double check with the R&D Department)
• Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology
• Study involving qualitative methods only
• Study limited to working with data and/or human tissue samples or other human biological samples (specific project only)
• Research tissue bank
• Research database
• Other study

For any other problems with IRAS, please contact the R&D Department at email:research@rnoh.nhs.uk. We will continue to populate this list with common problems and solutions as your questions arise.