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The application process using IRAS and HRA approval

The application process using IRAS and HRA approval

For lead site/single site studies at UH Bristol:

Applications for approvals to conduct research in the NHS are made using the Integrated Research Application System (IRAS). This is a single system which streamlines the process for gaining ethics and other governance permissions and approvals (MHRA/HRA/REC). The system allows researchers to enter information about their study into one data set only and is designed to save time and effort by preventing duplication of information in separate applications for each type of approval.

Oncreating a new study within IRASyou will first be asked to complete a number of filter questions. Depending on your responses a suite of project specific application forms will be created. For example, if you tick that your study is a Clinical Trial of an Investigational Medicinal Product (CTIMP), the form required for applying to the Medicines and Healthcare Products Regulatory Agency (MHRA) will be created.

Please note if you would like your study to beconsidered for the NIHR Portfolioplease ensure that filter question 5b is ticked "yes". This will create the relevant Portfolio Adoption Form.

Once you have completed the filter questions and these have been saved, if you click on the "navigate" box this will take you to a screen whereby you will be able to see the list of forms that have been created for your project on the left-hand side.

When any of the individual forms are selected a number of tabs appear on the screen. One of these will be entitled "checklist". This will tell you which project specific documents are required to be submitted with that form to create a valid application pack to each relevant agency. There will also be another tab entitled "submission" which will detail the submission process to each of the relevant agencies.

Please note that for single site studies a Statement of Activities and Schedule of Events for the UH Bristol site will need to be submitted if the study is co-ordinated and managed by a dedicated trials unit/team who is separate from delivery staff. The latest versions of these forms can be downloaded from the HRA website: http://www.hra.nhs.uk/resources/hra-approval-applicant-guidance/statement-activities-hra-approval/  Please contact us as early as possible if you are unsure what documentation to complete on 0117 342 0233. Where UH Bristol is the lead site for a multicentre trial a Statement of Activities and Schedule of Events per 'site type' will need to be created for all the other sites.

If UH Bristol is only a participating site:

You will not need to create the project on IRAS as this will be completed by the lead site.

Help and FAQs

Please note there is a lot of help available within the IRAS system with a section on FAQs. There is also further guidance from the HRA: http://www.hra.nhs.uk/resources/hra-approval-nhs-organisation-guidance/

  Does my project need ethical approval?

The National Research Ethics Service (NRES) works with colleagues in Scotland, Wales and Northern Ireland to maintain the established UK-wide framework for ethical review of research carried out in the NHS.

NRES produced an algorithm to help researchers determine whether their project requires ethical review by a Research Ethics Committee. It should be noted that from 1 September 2011 changes were made to the Governance Arrangements for Research Ethics Committees (GAFREC) meaning that it is no longer necessary to submit to the National Research Ethics Service for review studies where the requirement is based solely on the use of NHS staff as participants or the use of NHS premises. Other changes will mean some studies involving only tissue or data may be exempt however a large number of exceptions necessitate review of each study against the guidance. This change relates only to the National Research Ethics Service, studies not requiring NRES approval may still require HRA Approval and/or University Ethics Approval and should still be processed through IRAS.

What is 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 NHS R and D office in England (previously called R and D approval).

Since the 31 March 2016, HRA Approval is the process for applying for approvals for all project-based research in the NHS led from England.

All NHS based studies in England, regardless of whether NHS ethical review is required, will need to apply for HRA Approval. In those instances where ethical review is applicable, this will be included in the HRA review. You will also need to seek confirmation of capacity and capability from participating NHS organisations in England as outlined in the HRA Approval letter.

HRA Approval applies only to the NHS in England. If your study has sites in Northern Ireland, Scotland or Wales the existing process of submission of SSI Forms, local review and NHS permission continues to apply to the NHS sites in the devolved administrations. 

You can read more about the development and implementation of HRA Approval on the  HRA website. In addition the HRA have released a Q&A document to address many of the queries researchers are likely to have.  The document can be found on the  HRA website

If after reading the guidance on the HRA website you still have queries please contact one of the Research Management team on 0117 342 0233

 Capacity and Capability review

Capacity and capability review is required for participating sites in accordance with the HRA approval letter. Please liaise as early as possible with the R&I department in order to initiate assessment of capacity and capability. Please note it is sponsor responsibility to arrange capacity and capability review with participating sites although they may delegate this to a member of their team.

Further details of how to arrange capacity and capability review at sites including the submission process can be found on the HRA website: http://www.hra.nhs.uk/resources/nhs-site-set-up-in-england/

What happens during capacity and capability review at UH Bristol

One of the R&I department's Research Management Facilitators will be allocated to your study and will use the applicable capacity and capability workflow on EDGE to carry out their review. They will be in touch with you and the sponsor/lead site regarding any queries. If you have an EDGE logon you will be able to view the workflow in the site level record.

When the review is complete the Research Management Facilitator will communicate via email to all applicable personnel whether UH Bristol has capacity and capability to deliver the research. After this email is received the sponsor may have a process for issuing green light to recruit at this site. Please note you cannot recruit until you have capacity and capability confirmation and where applicable sponsor green light.

If you have also applied for NIHR Portfolio adoption you should not recruit until confirmation of adoption is received. 

 

 

 

 

Submitting to REC
Find out more about applying for ethics via IRAS.
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Submitting to MHRA
Find out more about applying to the MHRA.
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Submitting to R&D
Find out more about applying for R&D approval.
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Submitting to other regulatory bodies
Find out more about applying to National Information Governance Board (NIGB) and other bodies.
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Research involving tissue
Find out more about research involving human tissue, blood, DNA etc.
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Research passports
Find out more about honorary contracts and letters of access.
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