Step 3. Defining the research question and writing a protocol
Now that you have identified collaborators and engaged with the public, it is time to define your research question and how you will go about investigating it.
It is important that your question is specific and concise, and most of all, answerable. For example, is there a hypothesis that you think you can test?
Writing a protocol
A protocol is a full description of the research study, the rationale, aims, and methods used. It will also include details of the defined research team, resources and budget, with clear work programme for delivery and be used to help monitor the progress of the research study and evaluate the outcomes.
Things to consider when writing your protocol:
1. Is the research a good idea?
- Does the proposal make a convincing and coherent argument for the need for the research to fill gaps in current knowledge?
- Does the research proposed address the key questions in the field?
- Are the aims and objectives of the study clearly described and explained?
2. Are the methods sound and appropriate?
- Are the design and methods for the proposed study fully described, explained and justified?
- Will the results be generalisable or transferable beyond the immediate research setting?
- Does the proposal describe and explain the approach the study will take to avoid potential sources of bias*?
- Can the proposed study meet the relevant legislative and regulatory requirements?
3. Is the study practical and feasible?
- Is it possible to complete the study to the timescale described in the protocol?
- Is it possible to complete the study with the resources described in the protocol?
- Is the proposed recruitment and follow up rate realistic? Has a pilot study been conducted to determine likely recruitment rates from eligible populations?
- Do the study investigators have the experience required to carry out the research project?
- Does the proposal identify the benefits and limitations of the study?
A clear and concise protocol will help ensure the scientific quality of the project can be assessed, and provide clarity on the role of individuals involved.
Useful templates and guidance on protocol development and a generic template protocol are available. Public Health Wales has its internal Research Protocol Template for research involving staff or resources linked to the organisation.
Other reference materials to support you in writing your proposal include the MRC’s guidance on developing and evaluating complex interventions, and the Economic and Social Research Council (ESRC) resources.
Specific funding organisations may have their own research proposal requirements (see step 4).