This approach uses a Sponsorship Committee to approve requests for institutional sponsorship of investigator-initiated trials. If the host institution/organisation conducts high risk trials, it may be appropriate that the institution’s sponsorship approval process include a sponsorship committee to provide an appropriate level of assurance and adequate risk assessment.
Committee members may include representatives from the grants team, legal department, and research governance office with options to include other experts as required according to the type of trial being submitted (based on level of risk, patient population, indication etc).
The sponsorship and ethics review process may occur in parallel or, ethics review may commence following sponsorship approval. Once sponsorship is approved, the Sponsor-Investigator will be required to inform the sponsorship committee of any change to the identified risks throughout the course of the trial.
