Your IRAS Application
What you need to know about filling in your Integrated Research Application System (IRAS) form which will be what you use for most of your regulatory approvals, including Health Research Authority (HRA) approval, NHS Research Ethics Committee (REC), 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 and generates all the forms you need to submit to the relevant bodies to gain approvals for your study to be 'NHS ready'. The web address is www.myresearchproject.org.uk and you must register for an account before you can start your application form. The IRAS form will allow you to generate information to submit to the for the HRA, NHS REC, the MHRA, for GTAC (Gene Therapy Advisory Committee), the ARSAC Board (radiological substance use). Once you have these approvals you can then submit to each individual NHS Trust for site level confirmation of capacity and capability.
The IRAS filter
The first few questions on the IRAS form for your study are the 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 before submission – here are some tips for the different sections;
Be clear about who is the Principal Investigator, the national co-ordinator and the Chief Investigator before you start – you don’t have to have all three.
Agree with the sponsor who their representative is before submission.
Be clear about what will happen with treatment at the end of trial - can the participants continue with the treatment they have received during the trial.
NHS indemnity will cover management and design of the study when the NHS is a sponsor.
NHS indemnity will only be extended to studies which are registered and confirmed 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.
- If you are applying to the MHRA – you must seek help from your sponsor and pharmacy
Radiation authorisation must be included in the IRAS form AND then must be confirmed locally at every site.
Samples (data, tissue, etc.) – you must what will happen to these at the end of the study? How will they be stored?
IRAS form authorisation is completed electronically. Once signed – if you alter any information prior to submission you will have to have the form re-signed!
The UK Policy Framework for Health and Social Care 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 confirmed 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. NHS: indemnity arrangements for clinical negligence claims in the NHS.
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.
IRAS Guidance for Researchers