Step five - HRA approval

Roadmap step five

I have HRA approval...now what do I do?

In order to gain approval from the Health Research Authority (HRA) to carry out research at Solent NHS Trust, you must complete an IRAS application. Further details of the IRAS form can be found on Step three of the roadmap.

Once this application has been submitted you will receive an email from the HRA to confirm your application is valid. They will then begin governance checks of your project and may contact you for clarification of any issues. Review by the Research Ethics Committee (REC) (if required) will happen at the same time.

If you haven’t already done so, you must contact the Solent Research and Improvement Team in order to co-ordinate the HRA approval with the trust.

Before any research activity (including identifying potential participants) starts at a Solent NHS Trust site, you must receive confirmation of capacity and capability to conduct the research from our Research Governance office. In your HRA Approval Letter, this is referred to as ‘NHS Management Permission.'

As part of confirming capacity and capability the research governance team will require you to supply the following documents electronically to the Solent Research inbox (research@solent.nhs.uk). You do not need to wait until your study has received HRA approval to submit these.

These documents make up the Local Information Pack:

  • A copy of IRAS Form as submitted for HRA Approval.
  • Your study protocol and any changes or amendments you have made during the HRA approval process.
  • Participant information and consent documents (without local logos/headers).
  • Relevant agreements or contracts (if applicable).
  • Organisational Information Document and Schedule of Events/Schedule of Events Cost Attribution (SoECAT) templates (including known information) completed with as much detail as possible. Find out more information on the HRA website.
  • Copy of HRA Initial Assessment Letter (if one is issued), HRA Approval Letter (when issued), REC favourable opinion letter and final ethically approved documents (when issued/finalised - if REC approval is required).
  • Any other documents that support the set-up and delivery of the study.

Final confirmation that your study can start is provided by email by our research governance office once the study has received HRA approval (and REC approvals, where required) and all supporting documentation and contracts are in place. Once you receive the email from Solent’s Research Governance team, you are free to begin your study.