Your IRAS Application
What you need to know about filling in your IRAS from which will be what you use for most of your regulatory approvals, including ethics, MHRA and radiation (IRMER) if needed.
Where is IRAS and what is it for?
IRAS is a web portal which acts as a single point of entry for study data that will generate all the forms you need to obtain the relevant approvals for your study to open in the NHS. The web address is www.myresearchproject.org.uk and you will have to open an account to process a study. The IRAS from will allow you to generate information for the REC, for the MHRA, for GTAC (Gene Therapy Advisory Committee), the ARSAC Board (radiological substance use), for NHS and HSC R&D offices and others.
The IRAS filter
The first few questions on the IRAS from for your study are the IRAS filter questions – please take care to fill these in correctly. These questions will influence the rest of the form, so if you indicate you are using radiation it will make sure the appropriate questions are asked and data collected to assess the use of radiation in the study.
Tips for IRAS
It is really important to complete your form in as fully as possible but you can go back to it as many times as you need – here are some tips for the different sections;
- Be clear about who is the Principle investigator, the national co-coordinator and the Chief Investigator before you start – you don’t have to have all 3.
- Agree with the sponsor who their representative is before submission.
- Ensure your trail is registered on a public database such as ClinicalTrials.gov or ISRCTN – this is a condition of approval.
- Be clear about what will happen with patient treatment at the end of trial.
- Think about the logistics of storing your study information for the time prior to entering it onto IRAS!
- Indemnity –
- NHS indemnity will cover management and design when the NHS is a sponsor.
- NHS indemnity will only be extended to studies which are registered and approved by the R&I department.
- NHS indemnity WILL NOT Cover non-negligent (no-fault) harm.
- You will only need non-negligent harm cover if it is a high risk drug / device trial and the sponsor should provide evidence. of this. An NHS sponsor will not be able to sponsor a trial where this is needed – eg a phase I drug trial.
- Part B – MHRA – seek help with this section from your sponsor and pharmacy
- Radiation sign off needs to be done nationally AND then locally at every site.
- Samples (data, tissue, etc.) – what will happen to these at the end of the study?
- IRAS form sign off can be managed electronically. Once signed – if you alter any information prior to submission you will have to have the form re-signed!
The Research Governance Framework requires that insurance or indemnity arrangements for negligent and non-negligent harm are made clear before a piece of research can commence. The Clinical Trials Regulations that govern trials of medicinal products makes it a legal requirement for the sponsor and the lead investigator to ensure that adequate arrangements are in place to address insurance/indemnity for the trial.
The Trust NHS participates in the Clinical Negligence Scheme for Trusts (CNST), run by the NHS Litigation Authority, which pools the risk of clinical negligence claims. The Trust will only extend NHS indemnity cover (for negligent harm) to its employees, both substantive and honorary, taking part in projects that have been approved by the R&D Department. The Trust can't accept liability for any activity that has not been properly registered and managerially approved.
A useful summary can be found on the DH website. E Research in the NHS: indemnity arrangements.
This note summarises the current position on NHS indemnity for NHS bodies involved in research. It is a guide to managing the risks associated with research that involves NHS staff and/or NHS patients, including their organs, tissues or data. Further details can be found on our R&D Approvals - Indemnity advice page.
IRAS Guidance for Researchers