Applying for Sponsorship

If your research falls within the Research Governance Framework you will require a sponsor.

A comprehensive sponsor review will need to be undertaken by the Research Governance Manager and for this you will need to submit the following documentation by e-mail to uolsponsor@le.ac.uk:

Sponsor Application Form  IRAS Form  Study Protocol 

Participant Documentation Peer Review Form  LUCRE Costing

Feasibility Form  Schedule of Events HRA Submission

 

Sponsor Review Green Light processOnce the initial sponsor review is complete you will be contacted and may be asked to provide further information or clarification if necessary. Once the process is complete, and all requested documentation has been received and checked, you will receive authorisation from the Research Governance Manager to book your study in for review by an Ethics Committee which, depending on the study, will be either an NHS Ethics Committee or a University Ethics Committee.

At this point you will receive an “in principle” agreement to sponsor letter and a University reference number for your study. Agreement in principle is subject to the research receiving all relevant regulatory permissions, including but not limited to University Insurance confirmation, NHS Trust Approval, Research Ethics Committee Favourable Opinion, and where relevant the Medicines & Healthcare products Authority (MHRA) approval.

Please do not book your study in for ethical review prior to receiving your “in principle” sponsor agreement as this will delay your application.

Indemnity must be provided to cover the Protocol of the research study by the Sponsor of the research.  Adequate indemnity will be confirmed as part of the sponsor review process.

An indemnity letter will be requested, by the research governance officer, from the University insurance office, evidence of this will be required if your research is being submitted for ethical review by a National Research Ethics Committee. This will be sent to you by e-mail.

From the point of “in principle” sponsorship agreement you will be required to copy the sponsor into all correspondence with and from funders, ethics committees and host organisations.

If your study will be adopted onto the Clinical Research Network portfolio, can you please contact their Study Support Service for further information. CRN Study Support Leaflet.

Once all R & D approvals have been received you will receive a signed Agreed Responsibilities Form, Contract between Host & Sponsor and Sponsor confirmation letter to start your study.

 

 

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