Help - Preparing & submitting applications - NHS/HSC R&D Permissions
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NHS/HSC R&D Permissions

NHS/HSC R&D Permissions



If your research involves undertaking the research on the premises of a NHS/HSC organisation, with NHS/HSC patients or with NHS/HSC staff, then you should always contact the local NHS/HSC R&D office as early as possible.

All applications to conduct research in or through NHS/HSC organisations use the 'IRAS Form'.

From 28 June 2018, this involves a single electronic submission of the IRAS Form and associated supporting documentation. From this date the process for submission is the same regardless of which UK nation the research is led from and whether or not NHS/HSC Research Ethics Committee (REC) review is required.

For more information about how to prepare and submit your application please refer to the 'Step by Step Guide'.

Detailed guidance on how to apply to conduct research in NHS/HSC organisations is provided in the relevant section below and is based on where the lead NHS/HSC R&D office is located. For studies with sites in more than one UK nation, there are compatible arrangements across the UK to ensure that reviews applicable to the study as a whole are shared across all sites. Information should be provided to each NHS/HSC participating organisation in accordance with the guidance provided by the relevant nation (see relevant section below).

The guidance on this page is set out under the following sections:



England / Wales

Researchers wishing to conduct research in the NHS led from England or Wales apply through Health Research Authority (HRA) and Health and Care Research Wales (HCRW) Approval (‘HRA/HCRW Approval').

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Northern Ireland

For all research studies, whether multi-centre research (studies involving more than one HSC Trust in Northern Ireland or involving one or more other UK nations) or single centre(involving only one HSC Trust in Northern Ireland) you should electronically submit the IRAS Form according to the instructions provided in the step by step guide (see above).

Applicants part way through submitting applications on 28 June 2018:
If your research requires REC review and you have already electronically submitted the application for this review then you should now email the IRAS Form (PDF and XML), supporting documents and completed checklist as soon as possible to the HSC R&D Application Gateway (email: research.gateway@hscni.net).

If your research does not require REC review you will now be able to submit your IRAS Form electronically.

For further advice:
Contact the HSC R&D Office (details of offices are available via the HSC website) or the Gateway (phone: (028) 7161 1126; email: research.gateway@hscni.net).

For further guidance on seeking HSC R&D Permission in Northern Ireland please refer to HSC website.

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Scotland

For multi-centre and single-centre research led from Scotland you should electronically submit the IRAS Form according to the instructions provided in the step by step guide (see above).

Applicants part way through submitting applications on 28 June 2018:
If your research requires REC review and you have already electronically submitted the application for this review then you should now email the IRAS Form (PDF and XML), supporting documents and completed checklist as soon as possible to nhsg.NRSPCC@nhs.net.

If your research does not require REC review you will now be able to submit your IRAS Form electronically.

For further advice:
For further guidance on seeking NHS R&D Permission in Scotland please refer to the NHS Research Scotland Permission Coordinating Centre website or contact the lead R&D office for advice.

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Tips for a successful application

There are a number of errors that are often seen in applications. These usually delay the progress of an application and in some instances may lead to the application being rejected. Below are some tips to avoid some of the common application errors:
  1. Project filter
    • Make sure that you completed all the questions in the project filter and that your selections accurately represent your project. Incomplete or inaccurate selections will mean that the dataset you generate is not appropriate for your research.
  2. Questions in the dataset
    • Make sure that you complete all fields in the form. You can review the form page by page online or create a pdf of your draft form.
  3. Supporting documents
    • Make sure that you upload your supporting documents to the Checklist tab for the form. Documents uploaded in either Project Documents or My Documents areas are not automatically added to the form checklist.
    • The checklist provides a list of the documents that are normally expected to support the application. Use this as a guide to the documents you should include although those marked as mandatory are expected in all cases. Where you are not including a document that is listed, enter a reason in the "reason not supplied" box. Please note that there may be some additional documents that are not listed but which are applicable to your project. If you want to include a document that is not listed then add a row to include it by using the add row function at the bottom of the checklist.
    • When you upload documents make sure you enter the correct file title, version number and date.
  4. Authorisations
    • Make sure that you have electronic authorisations in place for all declarations in the form and that they are shown as valid.
    • Do not add electronic authorisations until you are certain the application is complete. Any changes made to the dataset (except adding the booking reference number and date to page 1 of the form) will invalidate any authorisations that are already in place.
    • If your form requires multiple authorisations be aware that if one of the authorisers changes the form before they authorise it then any authorisations that were already in place will be invalidated and will need to be sought again.
  5. Submitting your application
    • You must book your application before you electronically submit it. If you do not book the application it will be rejected and the submission history will show that your submission was invalid as no booking was made.
    • If you change the content of the form and/or the documents in the checklist after submission then these changes are not automatically sent and so you will need to liaise with your point of contact.
  6. After submitting your application
    • Ensure that you or someone else familiar with the research is available to be contacted in the days after submission. This will enable quicker resolution of any queries about the application.

Applications will be assessed against a set of criteria and standards, which apply to NHS/HSC project-based research.

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Cross-border studies in the UK - provision of NHS/HSC R&D local site-specific information

Operational and policy leads from England, Northern Ireland, Scotland and Wales (the “Four Nations”) are continuing to work closely to ensure the compatibility of NHS/HSC research approval systems across the UK. If your study involves UK sites located outside the lead nation, please refer to the section on the IRAS Help page for Site Specific Information about “Cross-border arrangements for provision of NHS R&D local site-specific information".

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The Four Nations NHS/HSC Compatibility Programme



The Four Nations NHS/HSC Compatibility Programme involves all four devolved nations and has undertaken a series of projects to implement:
  • A consistent nationwide approach to sharing information between sponsor and sites;
  • A single ethics and R&D online submission from IRAS; and
  • An improved UK-wide approach to amendments.

The aim is to ensure compatible and consistent ways of working across England, Scotland, Wales and Northern Ireland further developing the UK as a cohesive and streamlined place to undertake research within the global economy.

The UK-wide release of a combined REC and R&D Form (the ‘IRAS Form’), as part of the IRAS v5.5 update on 28 June 2017 is one part of the programme. A year later the IRAS v5.9 update enabled a single electronic submission of the IRAS Form and supporting documentation for both ethical review (where applicable) and review against NHS/HSC standards for all studies in the UK.

The Four Nations NHS/HSC Compatibility Programme is being undertaken for and supported by the UK Health Departments of England, Northern Ireland, Scotland and Wales. Further information about this programme is available at: https://www.nhsresearchscotland.org.uk/services/uk-wide-working.

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Amendments


Amendments(s) to all studies involving the NHS/HSC should be notified according to the IRAS help guidance on amendments to research conducted in NHS/HSC.

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Page last updated: 28 June 2018


 
IRAS Integrated Research Application System, version 5.9.1, 23/07/2018, IRAS Dataset version 3.5.
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