Writing the Research Plan Section: Research Design and Methods

Research Design and Methods

• Length: +10 pages (or approximately one-half the length of the research plan).
• Organization and common subsections
• Overview of study design
  • Describe the experimental design and procedures in detail and give a rationale for their use, if needed.
• In many instances, you may have struggled with a crucial design question and arrived at a satisfactory solution.
  • Don’t just present your solution.
  • The reviewers may wonder why you chose a particular route.
  • Therefore, you should provide a rationale for your decision and discuss the rejected alternatives.

Research Design and Methods(cont’d)

• Study population
  • Eligibility criteria
    • Provide rationales for inclusion and exclusion criteria
    • Provide rationales for control groups.
• Subject recruitment, enrollment, and retention.
  • Describe sources of eligible subjects.
  • Describe methods for identifying; contacting; and enrolling subjects, including obtaining informed consent.
• Study procedures: provide an overview of the following:
  • Number of study visits
  • Where study visits will take place
  • Types of data that will be collected
  • Who will collect data or perform procedures
  • Where specimens will be stored/analyzed

Research Design and Methods(cont’d)

• Study measurements
  • Organize and categorize them by
    • Specific Aim, or
    • How they will be used analytically:
      • predictor variables
      • outcome variables
      • confounding variables
  • Provide rationales for your choice if several options are available.
  • Limit the amount of technical detail.
• Data quality and management
  • Issues that could be included:
    • Staff training
    • Quality audits
    • Missing data
• Data analysis
  • Hypothesis testing
  • Sample size calculations
  • Expected findings
  • Data interpretation

Research Design and Methods (cont’d)

• Potential problems and alternative approaches
  • Openly recognizing any inherent holes or pitfalls in your research plan can “show maturity.”
  • It is entirely appropriate to acknowledge weaknesses and to present alternative plans.
  • It is a common and costly mistake to leave this kind of information out of your research plan.
• Timeline: Indicate when each specific aim will be implemented and completed.
  • Emphasize feasibility of accomplishing all specific aims within timeframe and resources requested.

Abstract: Project Summary and Relevance

• Provide an abstract of the whole application (candidate, environment, and research).
  • Include the candidate’s immediate and long-term career goals, research career development plan, and a description of the research project.
• Using no more than 2 or 3 sentences, describe the relevance of this research to public health.
  • Be succinct and use plain language that can be understood by a general, lay audience.

Human Subjects Research

• A part of the peer review process will include careful consideration of protections from research risks for study participants, as well as the appropriate inclusion of women, minorities, and children.
• The study section will assess the adequacy of the safeguards of the rights and welfare of research participants and the appropriate inclusion of women, minorities, and children.
  • Evaluation of the inclusion plans will be factored into the overall score for scientific and technical merit.

Budget Issues

• Mentored K awards provide salary support for the candidate (usually $75,000/year) plus $25,000 to $50,000/year to cover the costs of the proposed training and research.
  • The amount of salary support and funds for research/training may differ by institute.
• You may not receive salary support from federally funded sources in Years 1 – 3 of the K award, although you may be a principal investigator on your own R01, R03, or R21 in Years 4 and 5.
• A detailed, itemized budget is not required by NIH, although you do have to provide a justification if you are requesting more than $25,000/year for research/training expenses.
• However, an itemized, detailed budget is required for internal review by UCSF, although it is not included in the grant application submitted to NIH .

Biosketches

• This section must include the biographical sketches of all Key Personnel and Other Significant Contributors.
• For the candidate only, the section on Publications must be divided into the following categories:
  • Original research
  • Non-experimental articles (e.g., literature reviews, book chapters)
  • Books, pamphlets, etc.

Resources

• Describe the facilities used to conduct the research (see Examples 11 and 12).
• Indicate performance sites and describe capacities, pertinent capabilities, relative proximity, and extent of availability to the project.
• If research involving “Special Agents” will occur, the biocontainment resources available at each site should be described.

Task List

• Develop a list of all components of your grant application package, including those required by the UCSF Office of Sponsored Research (OSR).
• Indicate who is responsible for completing each component.
• Develop this list in collaboration with your RSA (research support analyst), who will help you compile the grant application for submission to the OSR and NIH.