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National Patient Safety Agency
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IRAS Well Received by Research Community

24 July 2008

 

The consultation-in-use phase for IRAS (Integrated Research Application System) finished at the end of June and received very positive feedback. This first phase of the system’s introduction has been deemed to be successful by the numerous organisations involved in this collaborative project.

 

Launched on 29 January 2008, IRAS is the new central system that collates all information researchers need for various regulatory bodies’ permissions and approvals to conduct health and social care research in the UK. Researchers had previously been critical of the time consuming and frustrating process involved in completing many separate applications.

 

Researchers using IRAS to submit their applications to the various regulatory bodies were encouraged to give feedback on their experiences with the system. Many suggestions were received and either have been, or will be, incorporated into the system.

 

“We are delighted with the response from the research community,” says Dr Janet Wisely, Director of the National Research Ethics Service (NRES), the organisation tasked with developing the system for the collaborative project. “The amount of feedback received from researchers was considerable and, more importantly, it was exceptionally positive. IRAS is proving to be the time-saving application system researchers were looking for.”

 

This positive feedback provides reassurance to researchers that IRAS is a robust and effective system that they can use with confidence.

 

Dr Wisely commented that the uptake of IRAS was also pleasing. “Already 31% of applications for research ethics approval have been submitted via IRAS. Other regulatory organisations involved in IRAS are also reporting good usage.”

 

Further improvements and functionality are being added to IRAS on an ongoing basis. This includes the remaining data fields for full European Clinical Trials Database (EudraCT) functionality. Stage 1 of the EudraCT import export functionality to IRAS for applications to the Medicines and Healthcare products Regulatory Agency is working well and was welcomed by researchers when it was added to IRAS in early May.

 

IRAS is not yet mandatory, however researchers are strongly urged to begin new applications on IRAS to take advantage of the increased functionality and benefits of the integration the system offers. As data cannot be transferred from the old ethics online application form to IRAS, and as IRAS will be the entry point to systems including the National Institute for Health Research Coordinated System for Gaining NHS Permission (NIHR CSP) in England, researchers and research managers are strongly encouraged to familiarise themselves with the system and start using IRAS now. IRAS will fully replace existing systems in due course.

 

Access IRAS directly

 


 

Notes for editors:

 

Media enquiries to Amelia Lyons in the NPSA Communications Department on 020 7927 9580 or amelia.lyons@npsa.nhs.uk.

 

Access IRAS directly for further guidance and information.

 

IRAS captures information needed to submit for the relevant approvals for the following review bodies:

 

  • Administration of Radioactive Substances Advisory Committee (ARSAC)

  • Gene Therapy Advisory Committee (GTAC)

  • Medicines and Healthcare products Regulatory Agency (MHRA) – Medicines and Devices

  • Ministry of Justice (National Offender Management Service)

  • NHS / HSC research offices

  • NRES / NHS / HSC Research Ethics Committees

  • Patient Information Advisory Group (PIAG)

 

IRAS is a collaborative initiative supported by:

 

  • Academy of Medical Sciences (AMS)

  • Administration of Radioactive Substances Advisory Committee (ARSAC)

  • Cancer Research UK (CRUK)

  • Medical Schools Council

  • Department of Health for England

  • Gene Therapy Advisory Committee (GTAC)

  • Human Fertilisation and Embryology Authority (HFEA)

  • Ministry of Justice

  • Medical Research Council (MRC)

  • Medicines and Healthcare products Regulatory Agency (MHRA)

  • National Institute for Health Research (NIHR)

  • National Research Ethics Service (NRES)

  • NHS R&D Forum

  • Patient Information Advisory Group (PIAG)

  • R&D Office Northern Ireland

  • Scottish Government Health Directorates

  • The Forum of NHS Wales for R & D Management in Health & Social Care (FORWARD)

  • UK Clinical Research Collaboration (UKCRC)

  • UK Clinical Research Network (UKCRN)

  • Welsh Assembly Government

  • Wellcome Trust

 

The National Research Ethics Service, a division of the National Patient Safety Agency, works with colleagues in the UK to maintain a UK-wide system of ethical review that protects the safety, dignity and well being of research participants, whilst facilitating and promoting ethical research within the NHS. NRES is leading collaborative work with other organisations involved in research regulation to integrate and harmonise the information required from applicants; IRAS is one initiative that has resulted from this work.

 

This initiative is part of a broad area of work by the UK Clinical Research Collaboration (UKCRC) to promote a streamlined regulatory and governance environment in the UK that facilitates high quality clinical research whilst protecting the rights, dignity and safety of patients. The UKCRC, established in 2004, is a partnership of organisations working together to establish the UK as a world leader in clinical research by harnessing the research potential of the National Health Service (NHS). The Partners include the key stakeholders that shape the health research environment, including research funders, the NHS, government, industry, academia, regulators, charities and patients. The UKCRC Partners are working together to address a broad agenda of issues affecting clinical research through several interconnected areas of activity. These are: developing the infrastructure to underpin clinical research in the NHS, building up an expert workforce to support clinical research, streamlining the regulatory and governance environment, developing incentives for research in the NHS and coordinating research funding. The Partners have already implemented many of the changes needed to transform the clinical research environment in the UK. Detailed information on UKCRC activities can be found on the UKCRC website: www.ukcrc.org

 

The bureaucratic burden for research and the need for effective collaboration between all stakeholders including industry, regulatory agencies and Government, has been described in a number of reports, including:

 

 

The UK Health Departments are implementing a series of measures to unify and streamline research administration and management. These are stated in their respective R&D Strategy Documents:

 

  • England - Best Research for Best Health (2006)

  • Northern Ireland - Research for Health and Wellbeing 2007-2012 (2007)

  • Scotland - Research Strategy for Health and Healthcare (2003) (under revision)

  • Wales – The strategy document is under review. For further information contact the Wales Office of Research and Development for Health and Social Care (WORD).

 

Excerpts from feedback received on IRAS:

 

From R & D offices

“One the whole, IRAS appears to be easy and straightforward with very helpful guidance associated with the forms and specific questions.”

 

“The feedback we have received from researchers has been mostly positive – the fact that they no longer have to lock the ethics form is especially well received.”

 

From Researchers

“I have just completed my first submission using IRAS on behalf of one of our investigators.   It is a great system and it was very useful to be able to input information once for both ethics and R & D.”

 

“We have conducted a test of part of the form (IMP section) and can report back that it is quick and easy to use and works!”

 

From Clinical Trial / Research Co-ordinator

“I just wanted to say that this is a really great tool and will save lots of time and duplication.”

 

From independent consultant

“I have just imported EudraCT application form data into the IRAS form and it works wonders.  Thanks for developing this time saving feature!”

 

General feedback

As a first time user of this kind of system, I thought it was fairly clear and helpful.”

 

“The size of the forms and the volume of help information to read through may be off putting to some, but I don’t think much more can be done about it, I found it all very relevant.”

 

“I thought the system looked good, I found the navigation relatively straightforward and the “help” information was very good.”

 

“In some respects, it is similar to the existing NRES forms, but I personally thought it was quite user friendly, with more options to choose from.   I think it will make life easier for our overworked research staff, and I liked the idea of an on-line helpline for queries.”