Early research considerations
Thinking about the practical aspects and challenges of research will help you formulate your research question and design a safe and successful study to answer this.
The following considerations can help you decide how to conduct your research:
- Feasibility and staffing support
- Protocol and peer review
- Service user and carer involvement
- NIHR Clinical Research Network Portfolio
A key step before launching your study is to assess whether the research is feasible at the Trust. It's important to consider whether you will be able to recruit enough people with the health condition that you are hoping to study. You will also need support from the key clinical teams working in this area, and may need access to other services such as pharmacy, radiography or a laboratory with specialist equipment and technicians.
Anyone starting a research project at the Trust must assess whether they have appropriate funding in place.
All research studies need to be funded to cover the costs of the research procedures and related expenses. If you are applying to the NIHR or one of their partner funding bodies, you can get further advice on your grant application from the Research Design Service for the East of England. If you need help working out costs, please contact email@example.com.
If your study involves other organisations or services, legal agreements may be required to state each party’s roles and responsibilities. These contracts could include:
- A site agreement between the sponsor and participating site. This contract typically covers indemnity, intellectual property, confidentiality, financial and termination issues as well as roles and responsibilities.
- A service level agreement between a sponsor/site and a provider contracting services for a study.
- A tissue or data transfer agreement if tissue or data from participants is to be sent to another organisation for research.
Identifying what is required early on will avoid possible delays, and there are nationally approved model agreements to enable this process. Please contact the R&D office for advice.
All research studies need a protocol describing how the research will be conducted. The protocol describes the research question: hypothesis, objectives, primary outcome and - if applicable - secondary outcomes, justifies the importance, and the methodology of how it will be answered. Protocols should have appropriate peer review before submission to research ethics committees and other relevant regulatory bodies.
For further guidance about writing your protocol please contact the R&D office
Service users and carers have a right to be involved in the design of research, and they can help improve the acceptability and effectiveness of a project.
CPFT's User and Carer R&D Manager Iliana Rokkou can provide advice and support to researchers who want to work in partnership with service users and carers in their research project. Get in touch to seek advice on how to involve people with experience of different health issues in your project. You can also link in with service users and carers who would like to get involved in research projects and share their knowledge and expertise to make research studies more relevant and realistic.
Service users and carers need to be involved in our research in a way that is meaningful and effective. In order to achieve this, involvement should be arranged at an early stage, when research topics are identified, grant applications are developed and decisions are being made. This is when service user and carer involvement can have the greatest impact.
Please contact Iliana to discuss how you can involve service users and carers in the design and implementation of your project.
In general, research taking place in the NHS will be covered by the NHS Indemnity Scheme. If the Chief/Principal Investigator is employed by an academic institution, separate arrangements will need to take made to insure the design of the study’s protocol. For more local information, please contact the Cambridge University Insurance Office.
The NIHR Clinical Research Network can provide a range of services for research studies taking place at the Trust, including:
- Financial support for studies: If adopted to the portfolio, your study may be eligible for financial support.
- Access to research nurses and clinical studies officers employed by the NHS to help implement the research
- Assistance with recruitment in terms of practical suggestions and support
Check the benefits of NIHR CRN portfolio adoption below: