Clinical Trials Set Up Fund

BHF allows applicants to apply for a small amount of funding (up to £50,000) as part of an awarded Clinical Study Grant before the grant is formally activated. This funding is intended to support the work required to obtain the necessary approvals and permissions for clinical trials research.

This can include seeking clinical trials authorisation, ethical approval and other preparatory work for the start of the study. Please note that we usually expect ethical approval to be obtained within 6 months.

• You can request funding of up to £50,000 as a separate ‘Clinical Trials Set Up Fund’ budget item in the Overall Costs table on the Funding/Support Requested page of the Clinical Study Grant application form. You will also be asked to provide a breakdown of the activities that will be performed using this funding, and a justification for the costs requested. 
• As noted above, there is a separate section for requesting the Clinical Trials Set up fund costs in the application form, and activities supported by the fund should therefore not be incorporated into salary requests or consumable costs in the yearly costs for the trial.  
• Any activities proposed to be supported by the ‘Clinical Trials Set Up Fund’ should be marked as taking place prior to grant activation in the study timetable and Gantt chart (included in the Clinical Study Grant Case for Support), and the time taken to complete these preparatory activities should not contribute to the grant duration.
• The proposed grant start date in the application form should be scheduled after the Clinical Trials Set up Fund activities are completed. 
• If your application is awarded, you will need to submit a formal request to BHF for release of the Clinical Trials Set Up Fund, stating the proposed date to activate the fund and the anticipated time required for obtaining approvals and performing preparatory activities.
• Costs awarded through the Clinical Trials Set Up Fund can be claimed prior to formal activation of the grant and may be used flexibly to support study set up activities. No further funding can be claimed from the grant, and the grant cannot be formally activated, until BHF has received copies of all required regulatory and research governance approvals and any other grant conditions specified in the award letter have been met.
• If part of the fund is used to support salaries of staff on the grant who are required to perform set up activities, BHF will not provide any further salary support for such posts until the grant is activated and the post(s) on the grant formally begin.
• Applicants may only request Clinical Trial Set-Up Funds for costs incurred after the BHF has formally approved the release of the funding.