As for any research project at the University of Birmingham, you will need to complete the online ethics Self-Assessment Form.
If this form identifies that Sponsorship is required, then a project will automatically be set up for you on the Research Governance Database and a member of the Research Governance Team will be in touch.
To apply for Sponsorship by the University please follow the steps outlined below:
- Step 1 - Complete the SAF to obtain an Ethics Reference Number (ERN).
- Step 2 - Complete the IRAS form. The idea of IRAS is that you complete one set of data, which can then populate most of the forms that you need to complete. The 'HELP' link at the top of the IRAS form has useful resources if this is your first time through.
An online training course on making an IRAS application is available.
Template and University specific answers and support are available online and from members of the Research Governance Team.
Please ensure that your RG number (if this is not available then please use your ERN) is in the subject line of all communications with us.
Your complete sponsorship application document set is:
- Everything you are sending to the Research Ethics Committee (there is a checklist on the IRAS form which lists all the documents).
- Site documents required by the HRA.
- A signed CI declaration form or internal CI agreement (if you are a UoB researcher) should be submitted to us.
- If you are collecting or using human samples: certificate from the MRC online Human Tissue Act training.
Once you have submitted a complete document set and an IRAS authorisation request, the Research Governance team will review the application and validate it within 5 working days. This involves ensuring that the document set contains the correct forms and is complete prior to issuing it to a governance officer for review. Once the application is validated and allocated to a governance officer for review, in 95% of the cases you should receive our initial feedback within 10 working days. If for some reason review times are longer than that, you should be informed at the time of application.
To show an example of a list of documents required for a valid study please see below (please note that this is an example and may vary depending on the nature of the study).
Example of Sponsor application validation checklist
Qualitative studies (e.g. involving questionnaires or interviews):
- Research proposal/protocol
- Participant Information sheets
- Consent form
- Any other patient facing documents such as posters
- Chief Investigator CV (for student project the student's CV as well as that of the supervisor's)
- Chief Investigator declaration form
- For studies involving the NHS/NHS sites: An Organisation Information Document and Scheule of Events are needed. Both templates can be found on the IRAS website.
Once your project is approved for Sponsorship, the Research Governance Team will electronically authorise your IRAS form. They will also send you a ‘Sponsor Pack’ consisting an Essential Documents Checklist for your information, a letter concerning insurance of the project and, if applicable, an insurance certificate (if the project falls under the University’s standard insurance, then you can download the certificate from here).
Please note that for Clinical Trials, University of Birmingham Sponsorship is conditional on trials being run according to the University's quality management systems. Information on these and the University's Standard Operating Procedure for the management of clinical trials can be found here.
Clinical Trials of Investigatory Medicinal Products (CTIMPs) must be run in accordance with the university's Standard Operating Procedure and are subject to substantial oversight.
Please also note the Statement on use of University of Birmingham as a site in regulated clinical trials. The University of Birmingham would not normally act as a ‘site’ for regulated clinical trials or surgery trials (i.e. Clinical Trials of Investigatory Medicinal Products (CTIMPs) or of medical devices).