After Sponsorship is awarded

Instructions about NHS REC meeting dates, review timelines and booking your regulatory review can be found on the HRA online booking service page. When you book your appointment you will be given a REC number, which you should put on your IRAS form. That box is the only box on the form you can fill in without invalidating it and requiring you to get all the signatures again. Please note that ticking the little ‘box complete’ tick for that box will also invalidate the form.

The HRA and REC (if applicable) will initially check your document set and confirm whether it is valid. They will then review the application, following which you will be provided with an initial review letter identifying any issues which need to be resolved. You may also be invited to attend a REC meeting to discuss your study with the committee and answer any queries that the committee may have.

Should you be asked by the HRA/REC reviewers to make revisions to any aspect of the study, please copy researchgovernance@contacts.bham.ac.uk in on any responses so that the Research Governance team are aware and can update Sponsor records accordingly.

While this is going on you can send a copy of your protocol to sites to see if they are likely to want to be involved. Please see the HRA guidance on site setup for further information. Once you have received HRA approval, and an email from the site agreeing it has the capacity and capability to participate in the study, you can agree a start date and open at the Site. Further authorisation from UoB as Sponsor, for example what is sometimes referred to as a 'green light' for sites, is not required under the terms of Sponsorship and will not be issued. (Please note that the process differs in England and Wales, Scotland and Northern Ireland - information on the key differences is available in the site specific information section of the IRAS website).

Sponsorship from the University of Birmingham is conditional on meeting the requirements of your favourable ethics opinion and any other approvals. The University Code of Practice for Research sets out what the University expects of its researchers, as well as how it will respond to allegations of misconduct. Further information is also available on our Research Integrity page.

In order to maintain UoB Sponsorship and the relevant regulatory approvals of your study, please remember to do the following:

• Send the final HRA-approved documentation set, favourable ethical opinion letter from the Research Ethics Committee (REC) and the HRA approval letter to researchgovernance@contacts.bham.ac.uk, putting your RG number in the subject line. The specific approved document versions will be listed in the HRA approval letter.
  
  
• Ensure that any amendments to the research project are correctly submitted for approval and that all stakeholders who initially reviewed the project are kept informed e.g. HRA, MHRA, RECs, NHS Trusts etc. For detailed guidance on how to submit amendments, see the amendments section below.
  
  
• Effective as of the 1^st of Aug 2024, the HRA have removed the requirement for Annual Progress Report forms to be submitted to the REC. Updated HRA guidance is available via the `Important Changes to progress reports and safety reports’ link.
  
  For studies with Confidentiality Advisory Group (CAG) approval: Annual reviews should continue to be submitted to the Confidentiality Advisory Group (CAG) using the `annual review report template’ on IRAS.
  
  Researchers may still be required to submit annual updates to the Sponsor for certain study categories and the UoB QMS procedures for this are in the process of being updated with further instructions.
  
  In addition to the above, the HRA have also updated the process for how they acknowledge SUSARs, further guidance is available via the `Important changes to progress reports and safety reports’ link.
  
  MHRA-approved studies should also submit an annual Development Safety Update Report (DSUR) to both UoB and the MHRA. For further information, see the study updates section below.
• In the case of any unexpected events (for example any breaches of protocol), please contact the Research Governance team via researchgovernance@contacts.bham.ac.uk as soon as possible.

Amendments are changes to the protocol, supporting documents or any other information that has received external approval, for example from the HRA, REC or MHRA. The HRA website offers general guidance on making amendments, though for UoB processes, please see below.

Amendments are classified as either substantial or non-substantial depending on the proposed changes. The HRA provides guidance on which types of changes fall into which category, and further guidance is built into the amendment tool (see below). Please contact the Research Governance team via researchgovernance@contacts.bham.ac.uk if you are unsure how to categorise the changes you wish to make to your study.

Non-substantial amendments to CTU-managed studies should be processed according to CTU internal procedures. Please note that all relevant documents, amendment tools and regulatory responses (including those which simply confirm that no further review is required) should be forwarded to the RG team for logging as soon as possible.

All other amendments, including non-substantial amendments to any studies which are not managed via the CTUs, require the authorisation of the Sponsor prior to submission to the HRA/REC. The process for this is as follows:

1. Download and complete an amendment tool, available from the amendment tool section of the IRAS website. Do not attempt to sign or lock the tool at this stage - this will be done by the RG team following review of the amendment.
   
   When completing the tool, please note that near the bottom of section 1, clicking to indicate which nations had participating organisations will cause section 2 to appear. Section 2 is where details of the amendment can be entered, which in turn will produce a result in section 4 at the bottom of the tool. This result will show whether the amendment is substantial or non-substantial, along with the kinds of regulatory review which may be required.
   
   
2. Send the completed amendment tool and any relevant documents (e.g. any documents which are being altered as part of the amendment) to researchgovernance@contacts.bham.ac.uk. Please prepare the amended documents with tracked changes so it is clear what has changed in each document.
3. The Research Governance team will review the amendment. They will sign and lock the tool, and then return it to you ready for submission via IRAS.
   
   
4. Submit the amendment for regulatory approval via the IRAS system as outlined in the online amendment submission section of the IRAS website.
   
   When submitting the tool via IRAS, please be sure to include the researchgovernance@contacts.bham.ac.uk email address so that the RG team receive notification of the outcome and can log it in the study's Sponsor records.

Effective as of the 1^st of Aug 2024, the HRA have removed the requirement for Annual Progress Report forms to be submitted to the REC. Updated HRA guidance is available via the `Important Changes to progress reports and safety reports’ link.

For studies with Confidentiality Advisory Group (CAG) approval: Annual reviews should continue to be submitted to the Confidentiality Advisory Group (CAG) using the `annual review report template’ on IRAS.

Researchers may still be required to submit annual updates to the Sponsor for certain study categories and the UoB QMS procedures for this are in the process of being updated with further instructions.

Report templates are available via the above link, or via our templates page.

CTU-supported studies should follow CTU internal processes, where support is provided by the CTU. The same goes for the submission of DSURs for MHRA-approved studies.

All other studies will be supported by the RG team as required.

In all cases, please ensure that a final version of the report is sent to the Sponsor office by emailing researchgovernance@contacts.bham.ac.uk, either by CC when submitting the report to the REC, or separately following REC submission.

Once you have completed your study you will need to complete some further administrative steps to notify the Sponsor and any relevant stakeholders and approval bodies. Please refer to our page on end of study processes for further guidance.

If you have a complaint about a UoB research project or about the conduct of a University of Birmingham researcher please contact the Research Governance team via researchgovernance@contacts.bham.ac.uk.

Further information on UoB Research Integrity systems and processes is available on our Research Integrity page.