The purpose of research is to discover answers to questions through the application of scientific procedure. The main aim of research is to find out the truth which is hidden and which has not been discovered yet.
This section will include information pertaining to the process used in Medway NHS Foundation Trust’s Research and Innovation Department, general research processes, types of research, research design, logical fallacies, and other useful links to information sources and forms.
Medway Research and innovation home grown project process
This section outlines the general process for completing a home grown research project. All forms discussed in this section can be obtained at the bottom of this page.
1. Register project with Research and Innovation Department.
At this stage there are 3 forms that need to be completed and submitted.
a. The Research and innovation project registration form.
i. Can be obtained from the R&I department via email
ii. Should be submitted to email@example.com
b. The Originality check (Horizon scan request).
i. Can be obtained from the MFT Library
ii. Should be submitted to firstname.lastname@example.org
c. Literature search form (Library registration e-form)
i. Can be obtained from the MFT Library
ii. Should be submitted to email@example.com
Upon receipt of the project registration form, the Research and Innovation Department will convene a meeting to discuss the projects merits and category (research/quality improvement/audit). Based on the outcome of the meeting the project will either be:
Rejected. In this eventuality the Research and Innovation Department will either request more information or signpost the project lead to the appropriate department.
Accepted. The project leads will be invited to attend a meeting with a project facilitator to discuss the project and Research and Innovation process.
2. Research and Innovation Department meeting with project team
Once the project has been accepted, the project team will be invited to meet with the Research and Innovation team that will oversee the project.
a. Project team can provide an overview of the project aims, objectives and methods
b. Clarification of any points of concern
c. Discussion of process, training needs and protocol requirements
Once the project team has agreed to the Research and Innovation Department processes, the project will be registered with the Research and Innovation Department.
3. Protocol development
This will build a detailed description of the methodology to be used during the study based off the initial study registration form, using the Research and Innovation protocol template.
a. The protocol development may require a collaborative effort from both the lead investigator and the project facilitator, with each suggesting and making amendments until both teams are happy with the document.
b. This should include:
- Background and literature review. Using the information gathered during the library literature search
- Aims and objectives
- Primary & secondary measures
- Duration of study
- Participants inclusion and exclusion criteria
- Sample size & how it was calculated
- Details of planned statistical analysis
- Risks and benefits of the study
4. Early-stage review
Once the Research and Innovation and project teams have developed a protocol it will be sent out for early stage peer review. This is intended to provide expert, patient and, public feedback on the planned study.
In order for this stage to be completed it is important to ensure that the lay overview of the project aspect of the Protocol template is fully completed.
5. Finalise protocol
Once feedback has been received from the early-stage review process, amendments can be made to produce a final version of the protocol.
Upon receiving the finalised Protocol the Research and Innovation team will issue Sponsorship in Principle. Sponsorship in principle indicates the Research and Innovation Department’s commitment to support the project.
6. Capacity and Capability
At this stage checks will be performed to ensure that Hospital/s, Department/s, Ward/s and, staff planned to be involved in the project are able to fulfil their project obligations without hindrance to standard duties.
7. Ethics and Funding Applications
During this stage ethical approval and funding will be sort, if required.
Ethics ensures projects are conducted in a safe, scientifically sound way. It is important to adhere to ethical principles in order to protect the dignity, rights and welfare of research participants. As such, all research involving human beings should be reviewed by an ethics committee to ensure that the appropriate ethical standards are being upheld.
- The Research and Innovation team will assess what approvals are required based on the protocol and begin the application via the IRAS system.
- The Research and Innovation team will work with the project team to complete the IRAS application form.
- The IRAS application process will take approximately 60 days from submission of the application to a decision.
- For more information and decisions tool visit https://www.hra.nhs.uk/approvals-amendments/what-approvals-do-i-need/
This stage is only applicable to projects which require monetary support. This support may be obtained from companies and funding providers by submitting a bid that outlines what the project involves and how the funds will be spent. Research and Innovation can help find and apply for funding if needed.
8. Submit Research and Innovation forms
At this point the Research and Innovation Department will ensure that all study documents are complete and will request any outstanding documents.
Once all required project documents are complete and received the Research and Innovation Department will issue project authorisation. At this point the project is ready to begin.
9. Conduct study
After receiving project authorisation from the Research and Innovation Department, the project can begin.
10. Research and Innovation project completion forms
After completing the project a Project completion form should be completed.
This form contains information regarding the outcome of your project and how you found the process.
Medway Research and Innovation home grown project documents
Research and Innovation Project registration form
The Project Registration Form is a document that should be completed when you wish to undertake a research project on your idea at Medway NHS Foundation Trust. The form will provide contact and project details to the Research and Innovation Governance Team so we can best support your project. In addition, this document gives the Research and Innovation Team information about what you wish to do in your research project.
When completing the form, fill in as many aspects of it as thoroughly as possible. Though a full research protocol is not expected at this stage, providing as much detail as possible will help the Research and Innovation Team to support you.
Literature search form
This form will assist in gathering the relevant literature for your research topic. Once complete, the library will be able to search through the literature and provide you with some targeted material for your project.
Providing as much detail throughout this form will help the library team return the literature most relevant to your chosen research topic. This form should be returned to the Medway NHS Foundation Trust library at firstname.lastname@example.org.
Horizon scan e-form
This form allows the library service to search to see if current studies are taking place that are the same as your proposed study. This will ensure no doubling of effort when completing a research project. It will also allow you to see how novel your work is and make the changes necessary to keep it novel.
Please fill in this form with as much information as you have. This will focus the search and ensure the novelty of your work.
A study protocol is one of the most important documents in a research study as it provides details on the design of a study. A protocol will describe all aspects of the study, including ethical approval, study objectives, the methodology to be employed and the overall organisation of the study. It is a vital document required for research and is used to standardise the methods for those conducting research.
The study protocol can be an important document that will provide detailed descriptions of how the research study will be conducted. The Template for the Study Protocol will direct you through each step. The R&I Team can assist with the writing and editing of this document.
Informed consent is a founding principle of research ethics. Consent is intended to ensure that those participating in research projects are doing so of their own free will and is done knowing fully what is involved in the project. In order to provide informed consent participants must fully understand what they are signing up for and they retain the right to withdraw from participation at any time.
Participant information Sheet
The participant information sheet (PIS) provides potential participants with all the information they need to make an informed decision if they want to participate in the project. This document should contain a brief overview of the project and its aims. The PIS should contain information regarding what participation in the project means in practice how long participation takes, where the project takes place and what it involves. This document should be written in an accessible way for the target audience and thus, it may be necessary to write several version if it needs to be understood by different groups i.e. parents and children, teachers and pupils etc.
The following list is not exhaustive but gives an idea of the main topics to be covered:
- Explain that participation is always voluntary and that participants can withdraw at any time;
- Outline the nature and aims of the research;
- Explain exactly what participation means in practice (when, where, who, what);
- Outline clearly the inclusion and exclusion criteria for the study;
- Outline any risks, inconvenience or discomfort that could reasonably be expected to result from the study;
- Describe the benefits for participants (if relevant, as there might not be any direct benefits for the participant);
- Explain how privacy and confidentiality would be maintained.
A project budget is a detailed breakdown of the costs involved in setting up and delivering a specific project. This document should include staff time, resources, equipment, consumables and all other cost associated with the project. This documents is essential if you plan to apply for funding.
The researcher CV is used to demonstrate that you are qualified by education, training and experience to conduct the research.
A standard template for an investigator CV is set out below. This template would be suitable for submission of CVs by:
- Chief Investigators (for submission with main REC application)
- Local Principal Investigators (for submission with the Site-Specific Information Form to RECs and NHS R&D offices)
- Academic supervisors (for submission with student applications).
The template is issued as guidance and is not intended to be prescriptive. Use of the template is not a requirement for a valid application.
The National Research Ethics Service (NRES) Standard Operating Procedures state that CVs should be a maximum of 2 pages. This is also guidance and is not an absolute requirement.
Experience relevant to the specific research project must be fully summarised, but the overall document should be kept concise. It is not necessary to provide a complete record of the applicant’s professional and academic background. In particular, CVs should not include lengthy lists of publications.
This template is recommended by NRES and the NHS R&D Forum for applications both for ethical review and R&D approval.
A risk assessment is a process of identifying what hazards that are currently present, or may appear over the course of the project. This document uses potential hazards and the likelihood of this hazard occurring to calculate the risk. This document ensures that the project team has properly considered all possible risks associated with the project and steps have been taken to ensure the project is as safe as possible for both participants and the project team.
Project completion form
The project completion form is completed once a project has finished. This form is intended to indicate the definitive end point of a project. This form collects data regarding the project and enable the Research and Innovation Department to keep track of the research being conducted at the hospital.