Help - Preparing & submitting applications - HRA Approval
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HRA Approval

HRA Approval



HRA Approval is the process for the NHS in England that brings together the assessment of governance and legal compliance, undertaken by dedicated HRA 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. This allows participating organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study.

From 31 March 2016, HRA Approval is the process for applying for approvals for all project-based research in the NHS led from England. For any new studies that are led from outside England but have English NHS sites, the national R&D coordinating function of the lead nation will share information with the HRA Assessment team, who can issue HRA Approval for English sites and thereby retain existing compatibility arrangements.

Studies which have already applied for REC review but have not applied for R&D review, or need to add new NHS sites in England, or have new amendments, should follow the specific HRA Approval processes for these situations so that NHS sites can work with sponsors in the new way.

HRA Approval applies only to the NHS in England. Studies with sites in Northern Ireland, Scotland or Wales 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.

For more information please refer to the HRA website at: http://www.hra.nhs.uk/about-the-hra/our-committees/hra-approval/  

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



Which projects apply for HRA Approval through IRAS


You apply for HRA Approval if your project meets all of the following criteria:
  • The lead NHS R&D Office is in England (IRAS project filter question 3a answered “England”).
  • 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 are participating in the project (IRAS project filter question 3 includes selection of “England”).

If your project is a student study (i.e. a study being undertaken primarily for the purpose of obtaining an educational qualification) and it is led from England then you should refer to the guidance provided on the HRA website for student studies and HRA Approval.

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

If your project meets the above criteria and you have already sought and/or gained NHS Permission and/or NHS Research Ethics Committee (REC) review then please refer to the section below on “Existing projects in IRAS – converting to HRA Approval”.


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New projects in IRAS - Applying for HRA 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 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 at question 3a you should select “England”
  • At project filter question 4 select the option for “IRAS Form" (this is the application for HRA Approval). When you select this option you should ensure that the options for “NHS R&D” and the “NHS REC” (including options for GTAC and Social Care REC) are not selected, if they are available. If you need to apply for other reviews, such as MHRA or CAG, then these should be selected at this point.
  • 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 electronically submit to apply for HRA 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 should prepare your application for HRA Approval in accordance with the HRA’s guidance, which is available at: http://www.hra.nhs.uk/research-community/applying-for-approvals/hra-approval/ . 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.

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Tips for successful application


There are a number of errors that are often seen in applications for HRA 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 al 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.
    • The HRA cannot access the form or the documents until the application has been booked and electronically submitted
    • If you change the content of the form and/or the documents in the checklist after submission then these changes are not sent to the HRA. You will need to liaise with the HRA to submit these updates.
  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 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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Existing projects in IRAS - transition to HRA Approval


Your project will be managed under HRA Approval processes if it meets the criteria set out in “Which projects apply for HRA Approval through IRAS”. Any actions that you will need to complete will be dependent on whether you have already sought and/or obtained NHS Permission and/or NHS REC favourable opinion. Please refer to the section below that describes your situation.


If you have already created a NHS REC form and NHS R&D form, but not yet submitted either of them:

If you have already created your project and have separate NHS REC and NHS R&D Forms, you can easily switch your project to apply to HRA Approval by going to the project filter and selecting the options described in the section above “New projects in IRAS - Applying for HRA Approval” .

Any information you have already entered in the separate forms/integrated dataset will be retained and combined into the IRAS Form which will now be visible on the ‘Navigation Page’ for the project. To apply for HRA Approval you will electronically submit the IRAS Form and supporting documentation to the HRA.

Please note that if you have already obtained electronic authorisations for the separate NHS R&D /NHS REC forms then changing the project filter will invalidate those authorisations and you will need to seek them again.


If you have either:
  • already submitted your NHS REC form but not your NHS/HSC R&D form; or
  • already submitted your NHS/HSC R&D form but not your NHS REC form.
From April 2016 all new and ongoing studies led from England (i.e. NIHR portfolio and non-portfolio studies) use HRA Approval. So if, at this time, you have still not submitted your NHS R&D form, or you have already submitted your R&D form but need to set up more NHS sites then you will use HRA Approval arrangements. This does not mean that you need to go back and apply for HRA Approval but it does mean that you should follow the specific HRA Approval processes for these situations so that NHS sites can work with sponsors under the new arrangements. Details of the process are published on the HRA website.



If you have already gained NHS Permission through pre-HRA Approval processes

If you have already obtained NHS Permissions for your study at some NHS sites in England you will not need to go back and apply for HRA Approval. However, if your study is ongoing and you need to add new participating NHS organisations in England to your study then you should follow the specific HRA Approval arrangements for this situation. Details of the process are published on the HRA website.

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


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

If you are seeking HRA Approval and have not previously sought NHS R&D Permission the please refer to the HRA website for guidance on the site level information that you will need to provide.

If you have already sought NHS R&D Permission at some NHS sites in England through pre-HRA Approval processes and you want to open new NHS sites in England then please refer to the HRA website for guidance for pre-HRA Approval studies

Please note that you should continue to use NHS SSI Forms for NHS/HSC sites in Scotland, Wales and Northern Ireland.

Note: The HRA is building on the experience of using the Statement of Activity and Schedule of Events templates in the NHS in England and working in collaboration with colleagues in Scotland, Wales and Northern Ireland to develop a UK-wide NHS/HSC Local Information Pack that will be incorporated into IRAS. More details will be available in due course.

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


If your project is led from Scotland, Wales or Northern Ireland and involves NHS/ HSC sites then you will not apply to the HRA. You should apply through the appropriate NHS/HSC permission process for that lead nation. Please contact the HRA for support in working with NHS organisations in England (email: hra.approval@nhs.net). Note: If Sponsor(s) of a cross border study explicitly requests to use NHS SSI(s) for sites in England the HRA will accept them so the same form option is available UK wide. 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 for cross-border studies" and contact hra.approvalprogramme@nhs.net

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Amendments for all studies led from England


Amendments(s) to all studies where the lead NHS R&D office is in England with HRA Approval, or which gained NHS permission through pre-HRA Approval processes, should refer to the IRAS Help guidance on amendments to research conducted in NHS/HSC.

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Contacting the HRA Approval Team


If you have a query about applying for HRA Approval please refer to the HRA’s guidance in the first instance: If these resources do not answer your question(s) then please contact the HRA Approval Team. 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 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. The implementation of a combined form is a step along the way to having simultaneous submission from IRAS for both ethical review (where applicable) and review against NHS standards. The REC and R&D Forms within IRAS were very similar in content and by creating one form, applicants have less forms to manage in IRAS and fewer authorisations to seek from sponsor representatives.

For projects led from Northern Ireland, Scotland, or Wales, although a single form will replace the separate REC and R&D Forms, this single IRAS Form will initially continue to be separately submitted for ethical review (where applicable) and review against NHS/HSC standards as per current processes. Applicants are advised to read the whole of the E-submission/Submission tab before taking action.

The single electronic submission of the IRAS Form and accompanying documents for both ethical review and for review against NHS/HSC standards will remain in place for projects led from England.

Work is underway to make the single electronic submission of the IRAS Form and accompanying documents for both ethical review (where applicable) and review against NHS/HSC standards available for all studies in the UK. This will take time to develop.

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.

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Page last updated: 17 August 2017


 
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