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Four Nations NHS/HSC Compatibility Programme - Project Updates

 The four UK nations are committed to making it easier to carry out research in the UK.

The aim is to make the researcher experience of study set up the same across the UK. Working together, England, Northern Ireland, Scotland and Wales are developing compatible cross-border processes.

If you have any queries about the programme, please contact Mary Cubitt or the operational lead for your nation.

 

Latest Update - 16/04/2019

Setting up NHS/HSC research in the UK: preparing for change on 5 June 2019

A UK Local Information Pack will be introduced on the 5 June 2019 to support the set-up of NHS / HSC research in the UK. Researchers working with NHS / HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across the UK.

The UK Local Information Pack is the set of documents that NHS / HSC organisations use to formally start preparing to deliver the study. More information is given in the Local Information Pack section of IRAS Help but there are some key features: 

  • One new feature of the UK Local Information Pack is the Organisation Information Document, which will replace the current Statement of Activities used in England and Wales for non-commercial studies and the Site Specific Information Form, used in Northern Ireland and Scotland.  After this date the Statement of Activities and NHS / HSC Site Specific Information Form will no longer be in use.

    In outline format the Organisational Information Document will be a component of the IRAS Form submission and in a localised format will be required as part of the UK Local Information Pack for both commercial and non-commercial research. Organisation Information Document templates and associated guidance are available in IRAS Help.

    For non-commercial, studies that are not clinical trials or clinical investigations, the Organisation Information Document should also be used as the agreement between sponsor and participating NHS / HSC organisation.

  • Another feature of the UK Local Information Pack is the inclusion of a delegation log template, which is intended to be used at participating NHS / HSC organisations. This will allow NHS/HSC organisations to locally record who will be working on the study.

  • For non-commercial studies an IRAS Schedule of Events or a SoECAT will be a part of the IRAS Form submission and is used in the UK Local Information Pack as a way of providing clarity to participating NHS / HSC organisations on the cost attributions associated with a study.

Guidance on the use of the UK Local Information Pack has now been published in the Site-Specific page of IRAS Help to help applicants get ready for the change. If you are making an IRAS Form submission or planning to set up research in an NHS / HSC organisation from 5 June 2019 please read the transition guidance so that you prepare the correct materials.

To support researchers and NHS / HSC organisations make the transition to using UK Local Information Packs, change management activities will be scheduled throughout April and May, with continuing support following implementation in June. Webinars have been scheduled to support the change (if you have not previously used the new HRA Learning Management System please register for an account via the link).

Guidance and information is provided in IRAS Help and some explanatory questions and answers are available on the Four Nations Compatibility project web page.

13/03/2019 - A UK Local Information Pack will be introduced on 5th June 2019

13/03/2019

Setting up NHS/HSC research in the UK: A UK Local Information Pack will be introduced on 5th June 2019

Following on from the previous communication in February, it is confirmed that a UK Local Information Pack will be introduced on the 5th June 2019. From this date an Organisation Information Document will replace the current Statement of Activities used in England and Wales and the Site Specific Information form, used in Northern Ireland and Scotland.  After this date the Statement of Activities and Site Specific Information form will no longer be in use.

The Organisational Information Document will be required as part of the UK Local Information Pack for commercial and non-commercial research. Researchers working with NHS/HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across the UK. 

The Organisational Information Document template will be made available from end April 2019.  

Regular communications and updates will be available on the four nations NHS/HSC compatibility website. 

19/02/2019 - Implementing a UK Local Information Pack

19/02/2019

Setting up NHS/HSC research in the UK: Implementing a UK Local Information Pack


A UK Local Information Pack is being introduced in the summer of 2019.  Researchers working with NHS/HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across the UK.  A specific implementation date will be announced in March along with further guidance.

The current Statement of Activities used in England and Wales and the Site Specific Information form, used in Northern Ireland and Scotland, will be replaced by an Organisation Information Document.

Regular communications and updates will be available on the four nations NHS/HSC compatibility website. 

Work delivered so far

  • Use of the combined REC and R&D IRAS form across the UK (June 2017)
  • Interim step (ahead of development in IRAS) in Wales to use HRA paperwork to replace SSI forms and introduce confirmation of capacity and capability.

Work under development

  • Simultaneous e-submission to REC and Study wide review for Scotland, Wales and NI (already in place for England)
  • Introduction of a local information pack in IRAS to replace emailing local information pack in England, replacement of Statement of Activities for non-commercial studies, and use of SSI form use in Scotland, Wales, and Northern Ireland
  • NHS Permission with confirmation of capacity and capability for Scotland and Northern Ireland.