Help - Preparing & submitting applications - HRA Approval
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HRA Approval

HRA and HCRW Approval



On 31 March 2016, HRA Approval was introduced as the process for applying for approvals for all project-based research in the NHS led from England. As of 16 April 2018 this has been extended to include all project-based research in the NHS in England or Wales, and is referred to as "HRA and HCRW Approval".

HRA and Health and Care Research Wales (HCRW) Approval is the process for the NHS in England and Wales that brings together the assessment of governance and legal compliance, undertaken by dedicated HRA and HCRW staff, with the independent REC opinion provided through the UK Research Ethics Service. It replaces the need for local checks of legal compliance and related matters by each participating organisation in England and Wales. This allows participating organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study.

For any new studies that are led from Scotland or Northern Ireland but have English and/or Welsh NHS sites, the national R&D coordinating function of the lead nation will share information with the HRA and HCRW Assessment teams, who can issue HRA and HCRW Approval for English and Welsh sites and thereby retain existing compatibility arrangements.

HRA and HCRW Approval applies only to the NHS in England and Wales. Studies led from England or Wales with sites in Northern Ireland or Scotland will be supported through existing UK-wide compatibility systems, by which each country accepts the centralised assurances, as far as they apply, from national coordinating functions without unnecessary duplication.

The guidance on this page is split into the following sections:



Which projects apply for HRA and HCRW Approval through IRAS


You apply for HRA and HCRW Approval if your project meets all of the following criteria:
  • The lead NHS R&D Office is in England or Wales (IRAS project filter question 3a answered “England” or "Wales").
  • It is a project-based study type. That is a study described by any of the IRAS filter question 2 categories except “research tissue banks” and “research databases”.
  • NHS premises and/or NHS patients and/or NHS staff in England and/or Wales are participating in the project (IRAS project filter question 3 includes selection of “England” and/or "Wales").

If your project meets the above criteria then you will need to apply for HRA and HCRW Approval. See the section below “New projects in IRAS – Applying for HRA and HCRW Approval”.

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New projects in IRAS - Applying for HRA and HCRW Approval


When creating a new project in IRAS you should always start by entering information about your research in the project filter. Wherever you are uncertain of the appropriate selection to choose or information to enter please refer to the question specific guidance, which is accessed by clicking on the green “i" buttons.

If you are applying for HRA and HCRW Approval then you will need to ensure that you have selected specific options in the project filter to generate the correct application form. Please follow the following steps:
  • Enter a short title for your project and ensure that you have selected the appropriate options for your project at questions 1 and 2.
  • At question 3 your selection(s) should include “England” and/or "Wales" and at question 3a you should select “England” or "Wales"
  • At project filter question 4 select the option for “IRAS Form". If you need to apply for other reviews, such as MHRA or CAG, then these should be selected at this point.
  • At project filter question 5, select yes to confirm that your project involves NHS research sites and/or NHS Participant Identification Centres (PICs).
  • Complete all remaining questions in the project filter
  • Once the project filter is fully complete click on ‘Navigate’ in the toolbar. This will move you to the ‘Navigation Page’ for your project.
Once in the ‘Navigation Page’ view you should see that under the ‘Project Forms’ list you have a form labelled “IRAS Form” – this is the application that you will complete and submit to apply for HRA and HCRW Approval. Any other application(s) that you have selected will also appear in the list. None of the following form types should appear in this list if you have correctly completed the project filter: “NHS R&D Form”, “NHS REC Form”, “GTAC Form”, “Social Care REC Form”. If any of these form types are shown then you should go back to the project filter, using the link provided in the section above the ‘Project Forms’ list and review the options that you have selected.

Please refer to the IRAS 'Step by Step Guide' for further guidance about how to enable and prepare the IRAS Form.

You can find Question Specific Guidance (QSG) throughout the IRAS Form, which will help you in completing your application. This is accessed by clicking the green "i" icons next to the questions. We recommend that you also refer to our tips for a successful application.

When you are ready to submit your application (IRAS Form and supporting documents), you should follow the instructions provided on the E-submission tab for the IRAS Form. Please note it is important that the guidance on this tab is read and followed carefully to ensure your application is submitted correctly.

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Expectations for site level information for participating NHS organisations in England and Wales under HRA and HCRW Approval


NHS Site Specific Information (SSI) forms are not required for NHS sites in England or Wales.

For non-commercial studies, you will need to complete 'Statement of Activities' and 'Schedule of Events' templates for each type of NHS research site. You should upload the completed templates to the IRAS Form checklist and electronically submit them as part of your application package.

The HRA provides a free e-learning module explaining the HRA Schedule of events which can be accessed from their website.

If you have already sought NHS R&D Permission at some NHS sites in Wales prior to 16 April 2018 and you now want to open additional NHS sites in Wales then please contact Health and Care Research Wales at research-permissions@wales.nhs.uk for advice on how to proceed.

For commercial studies, you will need to prepare the draft template agreement you propose to use with sites, the costing template and the template delegation log. Where studies are part of the National Institute for Health Research (NIHR) Clinical Research Network (CRN) Portfolio, the lead CRN must validate the costing template before you submit it. You should upload the completed templates to the IRAS Form checklist and electronically submit them as part of your application package.

Following the submission of the IRAS Form, HRA or HCRW staff will be in touch with you to tell you when you can formally email a Local Information Pack to participating NHS organisations in England and Wales. Information on how to work with participating organisations in England and Wales is provided on the HRA website.

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Expectations for site level information for participating NHS/HSC organisations in Northern Ireland and Scotland under HRA and HCRW Approval


Please note that you should continue to use the NHS/HSC Site Specific Information (SSI) Forms for NHS/HSC sites in Scotland and Northern Ireland.

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Projects involving NHS/HSC and led from Northern Ireland or Scotland with participating NHS Organisation(s) in England and/or Wales


If your project is led from Scotland or Northern Ireland and involves NHS/ HSC sites in England and/or Wales then you do not need to submit a separate application for HRA and HCRW Approval. You should apply through the appropriate NHS/HSC permission process for that lead nation. Compatibility arrangements are in place so that HRA and HCRW Approval will then be issued for the English/Welsh sites. Please contact:

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Tips for a successful application


There are a number of errors that are often seen in applications for HRA and HCRW Approval. 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 project-based research. The current version of these standards is publicly available on the HRA website.

If your application for HRA and HCRW Approval includes ethical review you may also wish to check whether your application is likely to meet the relevant validation criteria for ethical review by referring to the Research Ethics Service Standard Operating Procedures (SOPs). The SOPs are publicly available on the HRA website.

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Amendments


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

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Contacting the HRA and HCRW Approval Teams


If you have a query about applying for HRA and HCRW Approval not covered here please refer to: If these resources do not answer your question(s) then you can find contact details here.

If you have already created your project in IRAS then please quote the IRAS Project ID when you contact the team.

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The Four Nations NHS/HSC Compatibility Programme



The Four Nations NHS/HSC Compatibility Programme is a series of projects being undertaken by the UK research approval bodies to implement:
  • A single ethics and R&D online submission from IRAS;
  • A consistent nationwide approach to sharing information between sponsor and sites; 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, which took place 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 documents for both ethical review (where applicable) and review against NHS/HSC standards for all studies in the UK.

All Four Nations have agreed a consistent set of principles relating to the process of setting targets for recruitment to commercial contract studies, which forms part of site set-up.

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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Page last updated: 18 October 2018


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