One of the initial steps to get your project into motion is to discuss your idea with the Research Advisor who will help identify whether or not your study falls under the category of research, service evaluation or clinical audit. The Research Advisor will also provide guidance on the sponsorship process, protocol development and advice on applying for funding, right through to support on regulatory approvals.
As part of the initial process, an appropriate individual or organisation (or group of individuals or organisations) will be identified to take on responsibility and act as sponsor to confirm that there are proper arrangements to initiate, manage and monitor, and finance a study.
You will also need to write and develop a research protocol to highlight the necessity and feasibility of the study and to provide a detailed plan of the investigation. This should include;
- The Research Question
- Information Regarding Funding
- Key Trial Contacts
- Information Regarding Sponsorship
- Background and rationale
- Objectives and outcomes
- Patient and Public Involvement
- Statistics and data analysis
- Data management
The protocol can then be used as a reference to apply to the Health Research Authority (HRA) and NHS Research Ethics Committee through the IRAS (Integrated Research Application System) application form. More information on applying to the HRA and Research Ethics Committee can be found through the above links or on our REC application page.
For more information and guidance regarding protocol development don’t hesitate to contact the Trust Research Advisor or access the protocol templates