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Apply for HRA, ethical, MHRA and other approvals

For lead site/single site studies at UH Bristol

Applications for regulatory approvals to conduct research in the NHS are made in the Integrated Research Application System (IRAS). This is a single application system which streamlines the process for gaining approvals (e.g from Medicines and Healthcare products Regulatory Agency (MHRA), Health Research Authority (HRA), Research Ethics Committee (REC) etc).

The system allows researchers to enter information about their study into a single data set and is designed to prevent duplication of information in separate applications for each type of approval.

Further instructions on how to complete the application form can be found on IRAS. However please note the following handy tips:

  • When you create a new study in IRAS you will be asked to complete a set of filter questions. It is important to answer these correctly as these are used to  generate the correct set of forms for your research.
  • If you would like your study to be considered for the NIHR Portfolio please ensure that filter question 5b is ticked "yes". This will create the Portfolio Adoption Form.  If in doubt, please click "yes".
  • 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 where you can see a list of forms that has 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 is called  "checklist". This will tell you which project specific documents you must submit with that form to create a valid application pack for each relevant agency. There is a second tab called "submission", which details the submission process to each of the agencies.

If UH Bristol is only a participating site you do not need to create the project on IRAS as this will be completed by the lead site/Sponsor.

FAQs

What regulatory approvals will I need?

This depends on your proposed research.  Please liaise with your sponsor for advice on what approvals are required. As a general guide please note the following (not an exhaustive list):

  • All research conducted in the NHS in England requires HRA approval 
  • For research conducted in sites outside England, national processes apply.
  • Most research in the NHS requires an NHS Ethics (REC) review. However some research is exempt from this under the Governance Arrangements for Research Ethics Committees (GAFREC), e.g. research only involving NHS staff as participants. Please use the HRA decision tool to determine whether your study requires REC review: http://www.hra-decisiontools.org.uk/ethics/
  • Research involving an Investigational Medicinal Product or an Investigational Device requires MHRA approval
  • Confirmation of Capacity and Capability is required at participating sites (as described in the HRA approval letter)
  • Other approvals may be required (e.g. for gene therapy trials etc)

What is Health Research Authority (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).

Please refer to the HRA website for further information

If after reading the guidance on the HRA website you still have queries please contact one of the Research Management Facilitators in R&I on 0117 342 0233.

What are Statement of Activities and Schedule of Events?

These are documents that must be completed per site type and submitted to the HRA through IRAS as part of the HRA approval process. When setting up participating sites these will form part of the local document pack.

Please note that for single site studies a Statement of Activities and Schedule of Events for UH Bristol site 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.  Please contact R&I as early as possible if you are unsure what documentation to complete on 0117 342 0233.

What is Capacity and Capability review?

An assessment of Capacity and Capability to undertake the proposed research at a participating site is required in accordance with the HRA approval letter for that study. Please refer to SOP_017 Confirmation of Capacity and Capability to deliver research at UH Bristol for further details on the process. The HRA website also contains further information.