Writing Your R01

The guidance below follows an R01 format (including instructions), but all grant proposals should have these components – establishing (1) the importance of the problem, (2) the critical barrier and how YOU can overcome it, and (3) the expected outcome. A storytelling approach engages the reader (reviewer) and brings them on board to your way of thinking.

R01 proposals have two sections – a Specific Aims (1 page, similar to ERC B1, 5 pages) and a Research Strategy (12 pages, similar to ERC B2, 15 pages).

1) SPECIFIC AIMS (1 page):

NIH Instructions:

  • State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will have on the research field(s) involved.
  • List succinctly the specific objectives of the research proposed (e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology).

LSE Outline:

  • Brief background:
  • Problem:
  • Why is this still a Problem:
  • Consequence of not solving the Problem:
  • Overall Objective(s):
  • Central Hypothesis:
  • Why can you meet the challenge:
  • Specific Aims:
  • Outcomes:

…

2) RESEARCH STRATEGY (12 pages):

The three sections of the Research Strategy – Significance, Innovation and Approach – are each scored from 1 (best) to 9 (Investigator and Environment are also scored). The Approach section should be 60-70% of your proposal.

For new applications, include information on preliminary studies within the following three sections of the research strategy. Discuss the PD/PI’s preliminary studies, data, and or experience pertinent to this application.

…

A. SIGNIFICANCE:

NIH Instructions:

  • Explain the importance of the problem or critical barrier to progress that the proposed project addresses.
  • Describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project.
  • Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.
  • Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.

LSE Outline: Elaborate on Specific Aims with details from the literature – “rigor of prior research”. Break up the text with subheadings.

  • Brief background:
  • Problem:
  • Why is this still a Problem: likely has to do with what the literature leaves unresolved (rigor)
  • Consequence of not solving the Problem:
  • Overall Objective(s):
  • Central Hypothesis:
  • Why can you meet the challenge (& summarize aims): your expertise, collaborations, tools, resources, environment etc. Directly overcomes “Why this is still a problem”. Likely includes Preliminary Data.
  • Outcomes: We expect to achieve…. These findings would be significant because…

…

B. INNOVATION:

NIH Instructions:

  • Explain how the application challenges current research or clinical practice paradigms.
  • Describe any novel theoretical concepts, approaches or methodologies, instrumentation or interventions to be developed or used, and any advantage over existing methodologies, instrumentation, or interventions.

LSE Outline: These can be individual subheadings.

  • Technical Innovations
  • Conceptual Innovations
  • Novel Expertise

…

C. APPROACH:

NIH Instructions:

  • Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project.
  • Describe plans to address weaknesses in the rigor of the prior research that serves as the key support for the proposed project.
  • Describe the experimental design and methods proposed and how they will achieve robust and unbiased results.
  • Unless addressed separately in the Resource Sharing Plan section, include how the data will be collected, analyzed, and interpreted, as well as any resource sharing plans as appropriate. Resources and tools for rigorous experimental design can be found at the Enhancing Reproducibility through Rigor and Transparency website.
  • For trials that randomize groups or deliver interventions to groups, describe how your methods for analysis and sample size are appropriate for your plans for participant assignment and intervention delivery. These methods can include a group- or cluster-randomized trial or an individually randomized group-treatment trial. Additional information is available at the Research Methods Resources webpage.
  • Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims.
  • If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high-risk aspects of the proposed work.
  • Explain how relevant biological variables, such as sex, are factored into research designs and analyses for studies in vertebrate animals and humans. For example, strong justification from the scientific literature, preliminary data, or other relevant considerations, must be provided for applications proposing to study only one sex. Refer to NIH Guide Notice on Sex as a Biological Variable in NIH-funded Research for additional information.
  • Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised. A full discussion on the use of select agents should appear in the Select Agent Research section below.
  • If research on Human Embryonic Stem Cells (hESCs) is proposed but an approved cell line from the NIH hESC Registry cannot be chosen, provide a strong justification for why an appropriate cell line cannot be chosen from the registry at this time.
  • If you are proposing to gain clinical trial research experience (i.e., you will not be leading an independent clinical trial), briefly describe your role on the clinical trial.)

LSE Outline: These should be individual subheadings in your approach.

  • Aim (plan on 2-3 Aims, and each Aim should have a separate subheading)
    • Introduction/Rationale
    • Preliminary Data & Methods
    • Expected Outcomes
    • Potential Pitfalls & Alternatives
  • Rigor & Reproducibility
  • Timeline (Gantt chart)
  • Future Work/Trajectory/Long-term goal

.

REFERENCES

Books:
TED Talks:
Online Course: Sentence Structure