week 6

NIH OVERVIEW

· This is provided only as an overview. Please refer to the RFA and SF424 Application Guide for further details. http://grants.nih.gov/grants/funding/424/

FORMAT

· Font: Arial, Helvetica, Palatino Linotype or Georgia – 11 points or larger

· Margins: at least one-half inch margins

· No information in headers/footers or margins

· A header with PI’s name, page number and table of contents is automatically generated.

· Limit of 6 pages for Research strategy (Significance, innovation, approach including preliminary studies for new applicants)

· NIH and other PHS agencies limit title character length to 81 characters, including the spaces between words and punctuation.

R&R OTHER PROJECT INFORMATION

Project Summary/Abstract

· No longer than 30 lines of text

· Should contain a statement of objectives and methods to be employed.

Project Narrative

· In two to three sentences describe the relevance of this research to your field.

RESEARCH PLAN

1. Introduction (Only for Renewals and Revisions) (NOT NEEDED FOR 8118)

2. Specific Aims: 1 page

( State concisely the goals of the proposed research and summarize the expected outcomes, including the impact that the results of the proposed research will exert on the field involved.

( List succinctly the specific aims 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).

A strong proposal is driven by a strong hypothesis(es) that leads to clear research objectives. The Specific Aims section should encapsulate these concepts. It typically begins with a brief narrative paragraph or two that concisely states the issue or problem to be addressed, describes the long-term goals or objectives of the project and clearly states the hypothesis to be tested. This is followed by a numbered list of the Specific Aims. The aims test different aspects of the hypotheses, operationalize the objectives and provide a rationale for the experimental approach to be described later. For clarity, each aim should consist of only one sentence. Use a brief paragraph under each aim if detail is needed. Most successful applications have 2-4 specific aims. Make sure the aims are logical, achievable, and clearly relate back to the hypothesis.

Depending on the goals of the application, the Specific Aims section may take on a somewhat different form if, rather than testing a specific hypothesis, the goal is to 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.

In crafting the Specific Aims section, you should consider the following questions. Do your specific aims address the research goals and objectives? Did you state your hypotheses and link them appropriately to your specific aims? Are the specific aims clearly related to each other? Do the specific aims represent an achievable amount of work? An unrealistic and overly ambitious set of specific aims is a common pitfall of many applications.

3. Research Strategy: 6 pages

( The research strategy is organized into three sections: Significance, Innovation, and Approach The assessment of this research plan will largely determine whether or not the application is favorably recommended for funding. For an application with multiple Specific Aims, the applicant may address Significance, Innovation and Approach for each Specific Aim individually, or address Significance, Innovation and Approach for all of the Specific Aims collectively. The R01 application allows for a maximum of 6 pages, which include the three strategy components: Significance, Innovation, and Approach. Other types of applications may have different length limits. Images, graphs, and charts should be included within this section, not in a separate attachment. They count against the page limit. Investigators must use image compression such as JPEG or PNG. Do not include figures or photographs as separate attachments either in the Appendix or elsewhere in the application. Applicants are discouraged from submitting proprietary information unless it is essential to the evaluation of the proposed project.

( Start each section with the appropriate section heading – Significance, Innovation, Approach.

( Cite published experimental details in the Research Strategy section and provide the full reference in the Bibliography and References Cited section.

a. Significance – 1-2 pages

· In this section, state the research problem, current state of knowledge, and potential contributions of the research to the field. 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. The background leading to the present application should be brief. It should include a critical evaluation of the literature and identify the gap that this project will fill. The literature review should provide only that information that directly pertains to the scientific need for your project and should reflect up-to-date knowledge of the field.

· Consider the following questions. Does this study address an important problem? Will it resolve an important controversy in the field? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventive measures that drive this field?

· Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses

· Explain how project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields

· Describe how concepts, methods, technologies, etc. that drive this field will be changed if aims are achieved

b. Innovation – 1 page

· In this section, 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 interventions to be developed or used, and any advantage over existing methodologies, instrumentation, or interventions. Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation, or interventions.

· Consider the following questions. Is the project original and innovative? For example, does the project challenge existing paradigms or clinical practice? Does it address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

· Explain how application challenges and seeks to change current research

· Describe novel concepts, approaches, methodologies, instrumentation or interventions to be developed or used

· Explain refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation, or interventions

c. Approach (Include Preliminary Studies for New Applications) – 3-4 pages

· In this section, describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Describe how you plan to carry out the research. Include details related to specific methodology, and explain why the proposed methods are the best to accomplish study goals. Describe any novel concepts, approaches, tools, or techniques. Your research methods should relate directly to the specific aims. This section is critical for demonstrating that you have developed a clear, organized, and thoughtful study design that tests the central hypothesis. State how the data will be collected, analyzed, and interpreted. Describe statistical techniques that will be used. Include a proposed timeline for completing the work. 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.

· Consider the following questions when drafting this section. Does the background provide a clear statement of the general problem being addressed? Have you compared, contrasted, and critiqued what others have done? Have you shown how existing work lays the ground work for the research you propose? Have you cited the literature appropriately? Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Did you provide an overview of the experimental design before giving details of the methods? Did you relate the design and methods back to each specific aim? Did you use diagrams or flow charts to explain complex protocols? Did you give enough detail to show that you know what you’re talking about? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PIs, is the leadership approach, including the designated roles and responsibilities, governance and organizational structure consistent with and justified by the aims of the project and the expertise of each of the PIs?

· Include information on Preliminary Studies as part of the Approach section. Discuss your preliminary studies, data, and or experience pertinent to this application. Except for Exploratory/Developmental Grants (R21/R33), Small Research Grants (R03), and Academic Research Enhancement Award (AREA) Grants (R15), preliminary data can be an essential part of a research grant application and help to establish the likelihood of success of the proposed project. It can also provide support for feasibility of the proposed research and for experience and competence of applicant. Discuss how the previous work leads to the current proposal.

· Emphasize how previous work demonstrates feasibility of proposed methods. Accuracy is critical in figures, tables, and graphs.

· New or early stage Investigators should include preliminary data if they have any. However, for R01 applications, reviewers will place less emphasis on the preliminary data in applications from new or early stage Investigators than on the preliminary data in applications from more established investigators.

· In brief, the content of the Approach section should include:

· the overview of the experimental design;

· a description of methods and analyses to be used to accomplish the specific aims of the project;

· a discussion of potential difficulties and limitations and how these will be overcome or mitigated;

· expected results, and alternative approaches that will be used if unexpected results are found;

· a projected sequence or timetable (work plan);

· if the project is in the early stages of development, describe any strategy to establish feasibility, and address management of any high risk aspects of the proposed work;

· a detailed discussion of the way in which the results will be collected, analyzed, and interpreted;

· a description of any new methodology used and why it is an improvement over the existing ones.

d. New applications - include Preliminary Studies as part of Approach (NOT NEEDED FOR 8118)

For new applications, include information on Preliminary Studies as part of the Approach section. Discuss the PD/PI’s preliminary studies, data, and or experience pertinent to this application. Except for Exploratory/Developmental Grants (R21/R33), Small Research Grants (R03), and Academic Research Enhancement Award (AREA) Grants (R15), preliminary data can be an essential part of a research grant application and help to establish the likelihood of success of the proposed project. Early Stage Investigators should include preliminary data (however, for R01 applications, reviewers will be instructed to place less emphasis on the preliminary data in application from Early Stage Investigators than on the preliminary data in applications from more established investigators).

Bibliography and References

· Provide bibliography of any references cited Provide a bibliography of any references cited in the project narrative and any other parts of your application. This sections shows your breadth of knowledge in your field. There is no page limit for this section. Each reference must include the names of all authors (in the same sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication.When citing articles that fall under the Public Access Policy (i.e., arose from NIH support), provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the Pubmed Central (PMC) reference number (e.g., PMCID234567) for each article. If the PMCID is not yet available because the journal submits articles directly to PMC on behalf of their authors, indicate “PMC Journal – In Process.” Citations that are not covered by the Public Access Policy, but are publicly available in a free, online format may include URLs or PMCID numbers along with the full reference. The following is an example of an appropriate citation in the bibliography: Pillai SK, Good B, Pond SK, Wong JK, Strain MC, Richman DD, Smith DM. Semen-specific genetic characteristics of human immunodeficiency virus type 1 env. J Virol. 2005 79(3):1734-1742. PMCID: PMC544119. Copies of publicly available publications are not accepted as appendix material. The references should be limited to relevant and current literature.

BIOSKETCHES

· Required for all senior key personnel and other significant contributors HOWEVER, you should only do one for yourself for this project

· Limit of 4 pages

· Format is required including personal statement

· A. Personal Statement, B. Position and Honors, C. Selected Peer Review Pubs D. Research Support

Budget and Budget Justification

· The amount of money requested should reflect the scope of the science proposed. The budget includes such items as investigator time, equipment, supplies, travel expenses, and the like. Salaries generally account for 60% to 80% of direct costs. Begin to work with one of the MMC research accountants early (see timeline).

· Each of them are experienced with NIH budget development and financial rules. All costs must be allowable, reasonable, and necessary. If you ask for too little money given the work proposed, reviewers will see the application as naïve. If you ask for too much, reviewers will cut the budget. The budget also includes a narrative section called the Budget Justification. There are two types of budgets: 1) a modular budget, which must not be over $250,000 per year in direct costs (for an R01) and only requires personnel justification, and

· 2) SF424 budget, for requests over $250,000 or specific RFAs, which require detailed line items and detailed justifications for all items. You cannot go above $500,000 per year in direct costs without NIH Institute approval. The FOA and your own budgetary needs will determine the budget you decide to use. Plan to spend time thinking through the budget and justification. If the budget is getting too high for the grant mechanism or your stage of career development, consider cutting back the specific aims or experiments. There are no page limits for this section.

Facilities & Other Resources (NOT NEEDED FOR 8118)

4. Identify the facilities to be used. If appropriate, indicate their capacities, pertinent capabilities, relative proximity and extent of availability to the project. Describe only those resources that are directly applicable to proposed project. (Required)

5. NEW: Describe how scientific environment in which the research will be done contributes to probability of success.

6. If multiple sites, describe resources at each site

7. If any biohazards, describe any special facilities.

Equipment (NOT NEEDED FOR 8118)

Only if applicable, list major items of equipment already available for this project.

Protection of Human Subjects (IF yes and no exemption – sections 6-9 required) (NOT NEEDED FOR 8118)

a. Refer to PHS 398 Application Guide pages II-1 – II-16

Inclusion of Women and Children(NOT NEEDED FOR 8118)

Targeted/Planned Enrollment Table(NOT NEEDED FOR 8118)

Inclusion of Children(NOT NEEDED FOR 8118)

Vertebrate Animals (If applicable) (NOT NEEDED FOR 8118)

Select Agent Research (If applicable) (NOT NEEDED FOR 8118)

Multiple PD/PI Leadership Plan (If applicable) (NOT NEEDED FOR 8118)

Consortium/Contractual Arrangements (If applicable, explain the programmatic, fiscal and administrative arrangements to be made between UNLV and consortium organization) (NOT NEEDED FOR 8118)

Letters of Support (if applicable) (NOT NEEDED FOR 8118)

SENIOR KEY PERSONNEL (NOT NEEDED FOR 8118)

· List all senior key personnel and other significant contributors (consultants)

· Required fields are: name, address, phone, email, organization, title, role, biosketch

· Degree Type and Degree Year are optional fields.

· Current and Pending – not applicable to NIH

APPENDIX (NOT NEEDED FOR 8118)

· Up to 10 PDF attachments allowed

· Must follow instructions in SF424 Application Guide (pages I-113 & I-114)