There are a number of issues you need to consider before you start filling in applications forms.
Contacting the Research and Innovation team in the first instance will ensure you have the relevant support through the key stages of planning your research. If you have not carried out key steps such as getting correct approvals to carry out your study, you will not be able to proceed. Research will not be approved retrospectively.
Our Study Support Officers are able to advise and help with your initial planning and make sure that all requirements are in place before you submit your project for a governance review. In this initial stage they can help you address the following areas:
Is your project research and what type is it?
The Health Research Authority (HRA) Decision Tool will help you establish whether your project is research, an audit or a service evaluation. These categories determine the approvals required to undertake your project in the Trust. The Research and Innovation team will clarify this with you and tell you who to contact if it is an audit or a service evaluation.
Once you have established your project is research, your Research Facilitator will also assist you in classifying the type to determine the national approvals required. This will clarify the steps required especially for drug studies (Clinical Trial for Investigational Medicinal Product – CTIMP) or studies of devices.
Developing a protocol
A protocol acts as an instruction manual for your particular study. It describes the approach that will be taken and how it will address a specific research question, in a rigorous and consistent manner. It will help ensure results are of high quality, and that data is reproducible. Contact the Research and Innovation team for specific templates to develop the protocol for your type of study.
All protocols must be peer reviewed. If you are applying for a grant then this may be part of the application process.
More key stages for initial planning
Prior to conducting your study, you also have a responsibility to follow and carry out tasks at these stages:
Sponsorship: All research projects require a sponsor. Sponsorship is separate from funding and relates to indemnity. The sponsor confirms the project has been adequately peer reviewed and the organisation agrees to indemnify the methodology and conduct of the study.
Funding: Before sending applications for grants, research conducted within the Trust should be reviewed for feasibility to ensure the study is fully costed with clear agreements as to how the expenditures are to be covered.
Feasibility: A feasibility review considers the tasks and activities outlined in a clinical research protocol, which describes the patient population, recruitment, trial timeline, study procedures and involvement of human subjects.
Approvals: You are required to get permission from national organisations and from local organisation where you are conducting your study. For example, studies involving NHS patients will need to be reviewed and approved by a research ethics committee, which are managed by National Research Ethics Service.
In addition to the protocol, all projects will require other documentation, such as patient information sheets, consent forms and questionnaires. The guidance and templates section of the HRA website clarifies the specific documentation and format required for your project.
The Research and Innovation team will tell you which ones are relevant to your research and will review the content to ensure regulations and requirements are met.