How do I suggest and make a research plan?

How to Develop a Research Plan

Begin by formulating a focused research question using the PICO framework (Population, Intervention/Exposure, Comparator, Outcome) and ensure it meets FINER criteria (Feasible, Interesting, Novel, Ethical, Relevant) before proceeding with any other planning steps. 1, 2

Step 1: Formulate Your Research Question

• Identify gaps in current evidence through systematic literature review, focusing on areas where existing studies are insufficient or contradictory 3, 1
• Use the PICO format to structure your question: define the specific population, intervention or exposure of interest, appropriate comparator group, and measurable outcomes 1, 2
• Apply FINER criteria to evaluate whether your question is feasible given available resources and time, interesting to the scientific community, novel enough to contribute new knowledge, ethically sound, and clinically or scientifically relevant 1, 2
• Convert the broad research topic into a testable hypothesis, then translate this into a null hypothesis with specific aims that outline the steps to refute or accept it 4

Step 2: Assemble Your Research Team

• Recruit a diverse team from the outset that includes individuals with different backgrounds (age, gender, race/ethnicity, geographic location, disability status, sexual orientation) to strengthen trust and increase participation rates, particularly when working with under-represented populations 5
• Incorporate community members authentically as active collaborators who identify important study areas, suggest interventions, and build trust—following the principle "no research about us, without us" 5
• Consider community-based participatory research (CBPR) approaches that involve community members in all research steps to create equitable partnerships 5
• Obtain mandatory training on inclusive community engagement approaches with minoritized groups before applying for funding and designing your study 5

Step 3: Select Your Theoretical Framework and Study Design

• Identify a theoretical framework that will inform your research question, hypotheses, study design, and interpretation 5
• Consider multilevel, intersectional frameworks that account for how multiple social identities and determinants interact to affect health outcomes 5
• Choose the most appropriate study design: prospective inception cohort studies provide the strongest evidence for evaluating outcomes over time 3
• Use qualitative or mixed methods when appropriate to capture nuanced experiences and perspectives that quantitative methods alone cannot address 5
• Clearly identify and describe your study design to directly address your research question 3

Step 4: Define Study Parameters

Eligibility Criteria

• Detail inclusion and exclusion criteria for participant selection, ensuring they align with your research question and target population 3
• Plan for consecutive enrollment beginning at study onset to avoid selection bias 3

Sample Size and Power

• Specify pre-planned sample size requirements with power calculations to ensure adequate statistical power to detect meaningful effects 3
• Document recruitment strategies to understand potential biases in your target sample 3

Variables and Measurements

• Provide a complete list of core variables grouped as baseline characteristics, exposures, and outcomes 3
• Choose reliable and valid measures that consider equity and social determinants of health based on your research question and framework 5
• Describe variables in detail, including timing of collection and methods of assessment 3

Step 5: Plan Data Collection and Management

Participant Characteristics to Record

• Collect standard demographic data: disease/condition under investigation, sex and gender, age, ethnic group, and detailed geography (postcodes rather than broad regions) 5
• Include additional characteristics: sexual orientation, gender identity, disabilities, and religious affiliation 5
• Transparently explain to participants why these data are collected and how they will be handled under data protection regulations (aggregation, anonymization, restricted access) 5
• Provide multiple-choice format options where possible so participants feel less exposed, and always inform them of their right not to answer 5

Data Management Infrastructure

• Establish secure data storage systems with unambiguous, accurate, maintained, and secure internal records 5
• Plan for sensitive personal data by using secure managed-access repositories (such as European Genome-Phenome Archive or NIH-NCBI database) with data access committees and data access agreements 5
• Ensure GDPR compliance and other jurisdiction-specific data protection requirements from the outset 5

Step 6: Develop Your Statistical Analysis Plan

• Summarize the main aspects of your statistical analysis plan before beginning data collection 3
• Include pre-planned strategies to identify and mitigate main sources of bias 3
• Pay attention to appropriate quantitative and qualitative approaches, assess intersectionality, and disaggregate data whenever possible 5
• Predefine experimental groups, outcome measures, and stopping points to maintain methodological rigor 6

Step 7: Address Ethical Considerations

• Obtain appropriate ethical approval before beginning any data collection 3
• Register your study protocol in an appropriate registry before data collection begins 3
• Review donor consent to ensure suitability for your specific research use, including any requirements for use in animals where relevant 5
• Create a communication and support plan for participants who may receive concerning findings, including how/when to communicate results and arrange further testing, referrals, and counseling 5

Step 8: Plan for Sustainability and Dissemination

Long-term Planning

• Address three key questions at project start: where will materials/data be stored after funding ends, who will maintain and distribute them, and how will datasets be stored and linked 5
• Use publicly available tools like hPSCreg or similar registries to track details and ensure research outputs remain findable and accessible after project completion 5

Results Dissemination

• Plan and budget for sharing updates with participants in appropriate formats and languages, with deadlines extending beyond grant end dates 5
• Communicate clearly from the outset exactly when and how results will be shared with participants 5
• Disseminate via multiple formats and channels, including factual information, health implications, and general research information 5
• Relay results as soon as possible (participants desire results within 6-10 weeks), and if results will take longer, explain this upfront and offer interim question-and-answer sessions 5
• Consider equity-informed dissemination strategies including low-cost or free Open Access publications 5
• Budget for community-specific, accessible dissemination including translations and interpretation for live events 5

Step 9: Create Your Research Protocol Document

Your final protocol should include:

• Abstract and study description with clear research question and rationale 4
• Review of previous studies on the subject to justify your approach 4
• Objectives, hypotheses, and aims developed systematically from your research question 4
• Design and methods describing study type, population, sample size, subject selection, data collection methods, and data management plan 4
• Project management structure including timeline and milestones 4
• Strengths and limitations of your proposed approach 4
• Budget with detailed justification for all expenses 4
• Description of investigators and their qualifications 4
• Ethical considerations and approval documentation 4

Common Pitfalls to Avoid

• Avoid projects without clear research questions or methodological rigor, as these waste resources and cannot produce meaningful results 6
• Do not proceed without appropriate controls or blinding procedures where applicable 6
• Recognize limitations of small sample sizes and potential biases in data collection from the planning stage 6
• Never begin without considering ethical implications, particularly when working with vulnerable populations 6
• Do not wait until project end to consider data storage, ownership, and accessibility—plan these from the beginning 5
• Avoid lack of planning for broad shareability of tools and data, as this leads to extensive delays and wasted resources 5