Writing a research proposal or a protocol What do I need to do? What is a research proposal? A research proposal is a concise summary of your research – try to limit it to 1500 words. It is an initial set of ideas for a research study which are supported by a literature review and /or a pilot study or a feasibility study. Proposals should be concise and must address what you plan to achieve, why you want to research this and how you are going to do this. To begin you should think about your research question – what do you really want to know more about? Your research question should lead to the creation of new knowledge and understanding. What is a research protocol? A research protocol is a detailed set of activities for the project you are proposing. Activities in your protocol are supported by evidence from previous research but also show how the fill existing gaps in knowledge. The protocol is a time a timetable and guide to your research and shows what you are planning to achieve and how. Above all protocols demonstrate evidence of planning, including anticipation of potential problems and how you plan to deal with these. How do I tell if my research idea is sound? Does your proposal make a strong argument and show the importance of the research from a health, societal and economic viewpoint? Have you shown where there are gaps in the existing knowledge and how your research will address these? Does the proposal frame the issues in a way that makes them amenable to research using the methodologies and design proposed? Does the research address key questions in the field? Are your aims and objectives clearly defined? How will you tell if your research findings are significant? Are my methods sound and appropriate? Is my study practical and feasible? Are the study design and methods fully described, explained and justified? Will the design and methods of the study deliver the aims and objectives? Have you describe the study in enough detail for an external person to be able to determine the feasibility of it? Have you shows that the design and methods of the proposed research are the most efficient what to deliver the aims and objectives? Is it possible to complete the study to the timescale given? Is it possible to complete the study with the resources described in the proposal? Does the proposed study design take into account issues of representativeness? Are recruitment realistic? Have you shown how you will address bias? Are travelling realistic? Does your study meet relevant and legislative requirements? Do you or does your study team have all the relevant knowledge and expertise to complete the project? Has your proposal addressed the benefits of the study? rates estimates How do I write a Research Proposal or a Research Protocol? The following guide outlines a common structure of a protocol/proposal. Title The title should be concise and descriptive, many research studies develop an acronym that can be used for easy identification, this is included as part of the study title. Investigators Details Typically a research proposal will be made up of a team that may include: Chief Investigator (CI) – the overall person in charge of the research. Primary Investigators (PI) – individuals responsible for a study centre (in multicentred studies). On single centre studies the CI and PI are often the same person. Co-Investigators (Co-I) - these people make up the research team providing different expertise such as statistics input. Research Assistants (RAs) or Trial Co-ordinators that you have in place for your proposed research (optional). All investigators should be named and contact details given, you may wish to include the CVs of each of your investigators as an appendix. Background and Rationale Explain the background and context of your proposed research. Here you will include details of the literature review you carried out, showing where the gaps in current research are and making a case to show how your proposed research will provide the knowledge to bridge these gaps. Research Questions Your research questions should be formulated clearly and be answerable. You should be able to answer your research question through carrying out the study you describe. You may wish to bring in a hypothesis at this stage. Aims and Objectives Outline concise and precise objectives that should follow on from the hypothesis. Study Design and Methods Study Design What study design is most appropriate to answer your particular research question? Setting Where will the research take place? Will your research take place over multiple sites? Will your research take place in a clinical, care or home setting? Participants/Patients Detailed information regarding your participants should be given, this can include the population from which your participants will be drawn – why did you decide to recruit these people? How will you identify participants and how will you recruit them? What are you inclusion and exclusion criteria for the study? How many people do you need to recruit onto your study – have you used a sample size calculation to ascertain this – if not why not? You may also wish to describe the criteria for participation or completion of the study, whether you have any participant retention strategies in place. If you have already developed consent forms and participant information leaflets for your study, reference these here and attach these as appendices. Randomisation Methods Some research studies require a random allocation of patients to the different experimental groups or interventions. You will need to explain what randomisations methods you will use. Methods of Assessment or Measurement How will you collect data, what instruments will be used to collect data – why are these suitable? Outcome Measures/Objectives The measurement outcomes used to support or reject the hypotheses can be stated and separated into primary and secondary outcomes. Interventions (If applicable) A description of the study intervention should be provided. If you are giving a treatment or investigation, the dose, timing, method of providing, administering and receiving the treatment should be detailed. All necessary safeguards and potential risks should be made clear, including the methods by which intervention will be monitored. Ethical Considerations You should familiarise yourself with all of NSFTs governance and ethical approvals necessary for conducting research within the Trust when you begin to design your study. Obtaining the correct approvals can be time consuming and this should be taken into account when developing the timescales of the study. All ethical concerns should be outlined here. You should explain the methods by which the participant’s interests will be safeguarded. Examples of this include the process of risk limitation, how you will maintain confidentiality or anonymise patient’s data and how you will monitor any adverse side effects. Timescales You need to draw up a timeline for your research that takes into account all processes from planning to dissemination. This timeline will also serve as a monitoring tool, allowing you (and external monitors) to see whether the research is progressing in line with what was expected. Remember here to take into account the fact that things may go wrong, be realistic with time frames for recruitment, make sure you factor in travel time (if necessary) – if you are carrying out research across two counties you will spend a significant amount of time on the move! If you are carrying out interviews you will want to factor in transcription time, if you are carrying out questionnaires don’t forget that data entry may be required. It may be helpful here to develop a Gantt Chart, this helps you to visually see what your research timeline will look like. Dissemination Are you planning to hold a dissemination event, whereby you inform people about the research and what you have found out? Who might be key to include in such an event – would this be an opportunity to involve wider stakeholders/commissioners in the field? Are you planning to develop any publicity to disseminate your findings? What are you hoping to do with your research findings? Could this lead to a potential publication and if so where? If you are planning to publish – think about who can review your work and feedback on it. What might the findings of your research lead to in the future? For more information and advice please contact NSFT Research we have people who can advise on research development as well as on ethics and research governance approvals. We also have people here who work on live research studies within the Trust, they can advise on the practicalities of research. We are here to help! Tel: 01603 421152 Email: rdofficemailbox@nsft.nhs.uk Or pop in and see us in NSFT Research within the Knowledge Centre, Hellesdon Hospital, Norwich NR6 5BE