I am working on an NIH grant looking at various Bayesian models for accrual. NIH changed the grant proposal format last year to a much shorter proposal. Good for them, I say. Here are some of the details that I’m reviewing prior to writing my grant proposal.
A brief summary of page limits at the NIH website shows one page for specific aims, six pages for the research strategy (this is for R03 and R21, but R01 grants get twelve pages here), and four pages for the biographical sketch. The italicized material comes from here with additional material taken from the video presentation.
The specific aims provides a broad overview of the goals of your research. You need to include a discussion of the overall impact of the proposed research.
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 exert 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.
The research strategy should address these peer review criteria:
Overall impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach. 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? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) 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?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
The research approach replaces the “Background and Significance” “Preliminary Studies” and “Research Design and Methods” of the earlier grant application formats. The research approach has three major sections.
Significance
- Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses.
- 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.
Innovation
- Explain how the application challenges and seeks to shift current research or clinical practice paradigms.
- Describe any novel theoretical concepts, approaches or methodologies, instrumentation or intervention(s) to be developed or used, and any advantage over existing methodologies, instrumentation or intervention(s).
- Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation or interventions.
Approach
- Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Unless addressed separately in Item 5.5.15, include how the data will be collected, analyzed, and interpreted as well as any resource sharing plans as appropriate.
- 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.
- 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 5.5.11 below.
The biographical sketch now has an additional section, the personal statement.
Personal statement. Briefly describe why your experience and qualifications make you particularly well-suited for your role (e.g., PD/PI, mentor) in the project that is the subject of the application.
This is the “meat” of the grant application, but there are other pages, described here.
These additional pages are:
- Form Page 1. Face page
- Additional page for multiple PD/PIs.
- Form Page 2. Summary, Relevance, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells
- Form Page 3. Research Grant Table of Contents
- Form Page 4. Detailed Budget for Initial Budget Period
- Form Page 5. Budget for Entire Proposed Project Period
- Resources Format Page
- Checklist Form Page
- Targeted/Planned Enrollment Table Format Page
- Inclusion Enrollment Report Format Page
- Mailing Address vAll Personnel Report Format Page
Another source lists the following additional pages:
- Inclusion Enrollment Report
- Bibliography and References Cited
- Protection of Human Subjects
- Inclusion of Women and Minorities
- Targeted Enrollment Table
- Inclusion of Children
- Vertebrate Animals
- Select Agent Research
- Multiple PI/PD Leadership
- Consortium/Contractual Agreements
- Letters of Support
- Resource Sharing Plan
The Resources and Facilities section should provide a description of how the scientific environment will contribute to the probability of success of the project.
You can find an earlier version of this page on my original website.