Clothes pins on red wire outsideIn the Research Approach section, you need to describe the study design and indicate, in general terms, how the design will fulfill the intent of the study. General design issues include: primary and secondary objective(s) and how they relate to choice of primary and secondary measures most appropriate for the study design.  The validity and reliability of the primary and secondary measures should be explained explicitly in this section, including details of why certain design features were chosen.

  • Four questions your Research Approach should answer:
    • Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?
    • Are potential problems, alternative strategies, and benchmarks for success presented?
    • Will the strategy establish feasibility and will particularly risky aspects be managed?
    • If the project involves clinical research, are the plans for
      • protection of human subjects from research risks, and
      • inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
  • Design the approach based on your proposed objectives and the availability of the resources. In this section you should consider approach and methods to be used, and demonstrate the study’s technical merit. The principal investigator will need to explain the study duration/study timeline, including the stages of the study such as: review of medical records, data collection and data analysis, and presentation and publication.
  • Include a description of the research strategy in the study design or approach, and demonstrate the study’s technical merit.
  • Answer these questions for each of your specific aims until you have a complete outline of how you will complete your research.
    • The following approach and methods will be used….
    • The number of subjects…
    • The statistical analysis needed…
    • The detailed expectations include…
    • The results will be interpreted…
    • The potential problems alternative strategies, and benchmarks for success anticipated…
  • Back up your methods. If you are a young research, or your team has limited experience, you need to convince the reviewers that you understand the methods you are proposing and that they are evidence-based and proven methods. You can do this in many ways:
    • Cite a publication that used a similar method that provides background and support.
    • Focus on the experiments which highlight your expertise.
    • Lay out a backup plan with alternative methods if you should get negative results.
  • Discuss quantitative baseline data and initial metrics (patient-level data describing problem) in the target area. Describe the collection source/method and how data was analyzed to determine your gap or area of need. Also, describe your primary audience(s) targeted for this project and who will directly benefit.
  • Keep in mind your project deliverable(s) as you complete your research approach and reinforce your key points about the project’s significance, the potential impact on your field and your long-term goals as an investigator.