The RGEA Sponsorship group will need to review your documentation alongside ethics review by the RGEA ethics group, who facilitate the MS IDREC subcommittee, if the study involves healthy volunteers and recruitment of NHS staff as participants, or use of NHS facilities, premises or identifiable NHS data. This is because such studies require HRA approval.
If submitting through the MS IDREC because your research involves the above, then the MS IDREC will accept the IRAS full dataset and site-specific information forms for review. The application should be submitted via the online ethics application system (Worktribe). A Sponsorship and ethics checklist needs to be followed to ensure all supporting documents are provided, and this completed checklist uploaded to Worktribe. Documents will be shared with the Sponsorship group for joint review.
The Sponsorship process requires that you write a study-specific protocol for review. This protocol must describe in detail the objectives, design, methodology, statistical considerations and organisation of the research and will act as a ‘manual’ for the research team to ensure adherence to planned methods. As the research gets underway, it can be used to monitor progress and evaluate study outcomes.
The protocol should go into as much detail about the research project as possible, to enable all bodies to which you are submitting for approval to understand what you intend to do. The protocol is essential to ascertain that appropriate insurance cover can be provided for the study.
