Once Sponsorship is awarded

You might need to  apply for the other permissions such as Research Ethics Committee (REC) review  and/or Health Research Authority (HRA) approval.

Instructions about REC meeting dates, review timelines and booking your  regulatory review can be found here. When you book your appointment you will be given a REC number if your study is going to be reviewed by a REC, 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 do an initial review of your document set and confirm whether it is valid. This will be followed by an initial review of the application and provide you with an initial review letter identifying any issues that 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 they may have.

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 (HRA instructions for site set-up are here). Once you have HRA approval, and an email from the site agreeing capacity and capability you can agree a start date and open at the Site. (Please note, the process is different for NHS sites in the devolved nations).

Before you open your first site please send an email to researchgovernance@contacts.bham.ac.uk, with the RG number in the subject bar and stating the date that your first site will open.

Good conduct during the study

Sponsorship from the University of Birmingham is conditional on meeting the requirements of your favourable ethics opinion, any other approvals and the University Code of Practice for Research.

In order to maintain the Sponsorship of your study, please remenber to do the following:

  • Send the final submitted 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.
  • Ensure that any substantial amendments are assessed and authorised by the Sponsor office and all stakeholders who initially reviewed the project are kept informed e.g. HRA, MHRA, RECs, NHS Trusts etc.

Detailed guidance on the amendment process is available on the Health Research Authority website and the IRAS site.

Submitting substantial amendments to the Research Governance Team

Amendments are defined as any changes that you would like to make to your protocol, supporting documents or any other information that has received approval.Amendments can be substantial or non substantial depending on the proposed changes. Please do not hesitate to contact a member of the Research Governance Team, if you are unsure of the substantiality of the changes you wish to make to your study.

All substantial amendments require the authorisation of the Sponsor. Steps to follow are shown below:

  1. Create a notice of substantial amendment form in IRAS.
  2. Send it to the Research Governance Team through the ‘authorisation tab’ on IRAS using the researchgovernance@contacts.bham.ac.uk email address when prompted.
  3. Send a copy of the study documents that have been amended to Rgapplications@contacts.bham.ac.uk. Please send the amended documents with tracked changes so it is clear what has changed in the document.

Providing regular updates of the study

Ensure that an annual progress report is submitted to the REC and to the Sponsor office within 30 days of the anniversary of the date on your favourable ethical opinion letter.

Reports should be sent to the following email address (or you can CC when you submit the report to the REC): rgreports@contacts.bham.ac.uk.

Once you have completed your study you will need to complete some end of study processes.

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