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TABLE OF CONTENTS
INTRODUCTION
This information is based very closely on NIH Publication No. 93-3606, "Quick Guide for the Preparation of Grant Applications", written and distributed by the Hispanic Cancer Control Research Network (HCCRN), Hispanic Cancer Control Program, Special Populations Studies Branch, National Cancer Institute, NIH. The original publication was the result of a grant-writing workshop sponsored by HCCRN in 1991 and a follow-up activity in 1992. It contains information and suggestions especially pertinent to cancer control research, along with more generic information. This document has been modified to more specifically meet the needs of investigators preparing applications for laboratory-based research projects.
The guide is organized according to the major sections of the PHS-398 Grant Application Instructions. Each section is described, and a checklist is provided detailing what that section should cover. In addition, suggestions are included to enhance an application;s success. The checklists are not exhaustive, but rather are designed to job ther application writer's memory and ensure completeness. This document in no way obviates the need for an inexperienced applicant to seek further advice from experienced colleagues or from appropriate program personnel at NIH.
PLANNING YOUR APPLICATION
Several key issues should be considered before, during, and after your application is written.
- The usual deadlines for new NIH grant applications are:
February 1, June 1, and October 1;
- The usual deadlines for amended applications and competing renewal applications are:
March 1, July 1, and November 1;
- Please note: The deadlines for investigator-initiated applications related to AIDS and in response to RFAs may differ.
- The review and selection process for applications takes 8 to 10 months. Submit your very
best application because reviewers expect you to have taken the time needed to think it through
before submitting.
- Before you begin writing your grant application, read the PHS 398 instructions carefully and become familiar with all the requirements and certifications necessary. If you are submitting, in response to a published initiative such as Program Announcements (PA) or Request for Applications (RFA), read the PA or RFA in detail. If at all possible, find someone in your institution who can assist you in understanding and completing the application. Ask your colleagues for copies of successful NIH grant applications to get a more concrete idea of what each section should include. Incomplete applications are returned without review.
- Establish deadlines for the preparation of the grant application, particularly when collaborating investigators are involved. Be aware of institutional deadlines that could delay your application. Allow time for equipment failures, personnel shortages, etc.
- Reread your application. Have someone else read it. Proofread it again.
- If several people are contributing to the writing, decide who will do the final editing.
- If possible, have objective experts (e.g., successful grantees, an institutional panel) review
your proposal. Friends or close associates are rarely as critical as the reviewers on an NIH study
section.
- Do not feel inhibited about requesting technical assistance from the funding agency or your, institution. Talk to the program representative who will manage the grant for advice on scientific and technical issues and to the grants management specialist for advice on administrative issues. Your institutional grants office can also be of assistance. Talk to them and find out how they can help you.
- Investigate any special research priorities of funding agencies, and ascertain from the program representative whether your project falls within the scope of an existing initiative (RFA or PA) or an area of special emphasis.
- When submitting a revised application, answer all reviewer concerns mentioned in the earlier Summary Statement. Changes you make in the revised application must be described and illustrated, e.g., bracketing, underlining, etc. Regardless of how you feel, don't insult the reviewers. If you differ in your opinion try to courteously convince the reviewers of your point -of views. In addition to responding to specific reviewer concerns, review all other aspects of the application to determine whether updating, or improvement is called for or possible. Just because it was not criticized before is no guarantee it will not be criticized in the review of the revised application..
- First Award Applicants: letters of reference and institutional commitment are very important, particularly the wording or phrasing of these letters. You should emphasize this to those who will write your letters. The institutional commitment letter, in particular, should clearly state that the applicant has independent lab space and adequate equipment. Any other tangible expression of institutional commitment that might exist (start-up funds, support for a technician, etc.) should be mentioned. This indicates to Study Section members that you are not merely a "pair of hands" but have independence and institutional support.
ABSTRACT
Purpose: The purpose of the abstract is to describe succinctly every major aspect of the proposed project except the budget. The abstract is an important part of your application. It is used in the grant referral process,. along with a few other parts of the application, to dete@ne what study section is appropriate to review the application and to what institute at NHi it is most relevant. Members of the Study Section who are not primary reviewers may rely heavily on the abstract to understand your proposal.
Recommended Length: The recommended length of the abstract will vary among different funding agencies, but the NIH abstract is a half-page, and confined to the designated space provided in the application.
Content
The abstract should include:
- a brief background of the project;
- specific aims or hypotheses;
- the unique features of the project;
- the methodology (action steps) to be used;
- expected results;
- evaluation methods; and
- description of how your results will effect other research areas.
- the significance of the proposed research
Suggestions
- Be complete, but brief.
- Use all the space allotted.
- View the abstract as your one-page advertisement.
- Write the abstract last so that it reflects the entire proposal. Spend time reviewing it.
- Remember that the abstract will have a longer shelf life than the rest of the proposal and may be used for purposes other than the review, such as to provide a brief description of the grant in annual reports, presentations, or in response to requests from top management at NIH.
RESEARCH PLAN (Overview)
Purpose:The purpose of the research plan is to describe the what, why, and how of the proposal. This is the core of the proposal and will be reviewed with particular care. The what will be Part A: Specific Aims; the why, Part B: Background and Significance; and the how, Part C: Preliminary Results contributes to both the why and how. Part D: Research Design and Methods. The assessment of this research plan will largely determine whether or not the proposal is favorably recommended for funding.
Recommended Length: The maximum length of the research plan is 25 pages.
Content: The research plan should answer the following questions:
- What do you intend to do?
- Why is this worth doing? How is it innovative?
- What has already been done in general, and what have other researchers done in this field? Use appropriate references. What will this new work add to the field of knowledge?
- What have you (and your collaborators) done to establish the feasibility of what you are proposing to do?
- How will the research be accomplished? Who? What? When? Where? Why?
Suggestions
- Make sure that all sections (A, B, C, and D--the what, why, and how of the proposal) are intemally consistent and that they dovetail with each other. Use a numbering system, and make sections easy to find. Lead the reviewers through your research plan. One person should revise and edit the final draft.
- Show knowledge of recent literature and explain how the proposed research will further what is already known.
- Emphasize how some combination of a novel hypothesis, important preliminary data, a new experimental system and/or a new experimental approach will enable important progress to be made.
- Establish credibility of the proposed principal investigator and the collaborating researchers.
RESEARCH PLAN PART A:
Specific Aims
Purpose: The purpose of the specific aims is to describe concisely and realistically what the proposed research is intended to accomplish.
Recommended Length: The recommended length of the specific aims is one page.
Content: The specific aims should cover:
- broad, long-term goals;
- the hypothesis or hypotheses to be tested, and
- specific time-phased research objectives.
Suggestions:
- Generally, the Specific Aims section should begin with a brief narrative describing the long-term goals of the project and the hypothesis guiding the research. This is followed by a numbered list of the Aims.
- State the hypothesis clearly. Make sure it is understandable, testable and adequately supported by citations in the Background and by data in the Preliminary Results Sections. Be sure to explain how the results to be obtained will be used to test the hypothesis.
- Show that the objectives are attainable within the stated time frame.
- Be as brief and specific as possible. For clarity. each aim should consist of only one sentence. Use a brief paracraph under each aim if detail is needed. Most successful applications have 2-4 specific aims.
- Don't bite off more than you can chew. A small, focused project is generally better received than a difftise, multifaceted project.
- Be certain that all aims are related. Have someone read them for clarity and cohesiveness.
- Focus on aims where you have good supporting preliminary data and scientific expertise.
RESEARCH PLAN PART B:
Background and Significance
Purpose: The purpose of the background and significance section is to state the problem to be investigated, the rationale for the proposed research, the current state of knowledge relevant to the proposal and the potential contribution of this research to the problem(s) addressed.
Recommended Length: Approximately 3 pages
Content: The background and significance section should cover:
- the rationale for the proposed project;
- the state of existing knowledge, including literature citations and highlights of relevant data;
- gaps that the project is intended to fill
Suggestions
- Make a compelling case for your proposed research project. Why is the topic important? Why are the specific research questions important? How are the researchers qualified to address these?
- Establish familiarity with recent research findings. Avoid outdated research. Use citations not only as support for specific statements but also to establish familiarity with all of the relevant publications and points of view. Your application may well be reviewed by someone worlcing in your field. If their contributions and their point of view are not mentioned, they are not iikely to review your application sympathetically.
- Make sure the citations are specifically related to the proposed research. Cite and paraphrase correctly and constructively.
- Highlight why research findings are important beyond the confines of a specific project i.e., how can the results be applied to further research in this field or related areas.
- Stress any innovations in-,experimental methods (e.g., new strategies,- research methods used, interventions proposed).
RESEARCH PLAN PART C:
Preliminary Results/Progress Report
Purpose: The purpose of the preliminary results section is to describe prior work by the investigators relevant to the proposed project. In a new application, the preliminary results are important to establish the experience and capabilities of the applicant investigators in the area of proposed research and to provide experimental support for the. hypothesis and the research design. This section is not mandatory for new applications, but it is virtually impossible to obtain a favorable review without strong preliminary data. In a competing renewal application, . this section becomes a progress report describing studies performed during the last grant period.
Recommended Length: The recommended length of the preliminary results/progress report section is 6-8 pages.
Content: The preliminary results section should include the following:
- most importantly, a description of recent studies by the applicant investigators that establish the feasibility and importance of the proposed project;
- a brief description of older published studies by the applicant that provide important background information relevant to the proposed project;
- results of previous studies by the applicant not directly relevant to the proposed project if they are needed to establish the applicant's competence and experience with the experimental techniques to be used in the proposed project.
Suggestions
- All Tables and Figures necessary for the presentation of preliminary results must be included in this section of the application. Full-size glossy photographs of materials such as electron micrographs, gels, etc. may be included in the appendix, but only if a photocopy (reduced in size, as appropriate) is included in the body of the Research Plan.
- Figures and Figure legends must be legible. There are specific limits on type size given in the application instructions, but beyond these rules, the critical factor is whether the data are legible and convincing to the reviewers.
- Do not dwell on results already published. Summarize the critical findings in the text and include reprints of the full article in the appendix. Up to 10 publications can be included with the appendix material.
RESEARCH PLAN PART D:
Research Design and Methods
Purpose: The purpose of the research design and methods section is to describe how the research will be carried out. This section is crucial to how favorably an application is reviewed.
Recommended Length: The maximum recommended length of the research design and methods section is 20 pages.
Content: The research design and methods section should include the following:
- an overview of the experimental design;
- a detailed description of specific methods to be employed to accomplish the specific aims;
- a detailed discussion of the way in which the results will be collected, analyzed, and interpreted;
- a projected sequence or timetable (work plan);
- a description of any new methodology used and why it represents an improvement over the existing ones;
- 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;
- precautions to be exercised with respect to any procedures, situations, or materials that may be hazardous to personnel or human subjects.
Suggestions
Number the sections in this part of the application to correspond to the numbers of the Specific Aims.
- Give sufficient detail. Do not assume that the reviewers will know how you intend to proceed.
- Avoid excessive experimental detail by referring to publications that describe the methods to be employed. Publications cited should be by the applicants, if at all possible. Citing someone else's publication establishes that you know what method to use, but citing your own (or that of a collaborator) establishes that the applicant personnel are experienced with the necessary techniques.
- If relevant, explain why one approach or method will be used in preference to others. This establishes that the alternatives were not simply overlooked. Give not only the "how" but the "why."
- If employing a complex technology for the fast time, take extra care to demonstrate familiarity with the experimental details and potential pitfalls. Add a coinvestigator or consultant experienced with the technology, if necessary.
- Document proposed collaborations and offers of materials or reagents of restricted availability with letters from the individuals involved.
BUDGET AND JUSTIFICATION
Purpose: The purpose of the budget and justification is to present and justify all expenses required to achieve project aims and objectives. For multi-institutional applications, there must be a separate budget for each subcontractor or consortium member.
Recommended Length: Special forms are provided for the budget and justitication. Read the instructions carefully. If there is a coinvestigator at another institution, for whom funds are requested, be sure to include their budget.
Content: The budget and justification should cover the following:
- personnel;
- consultants;
- equipment;
- supplies;
- travel; and
- other expenses, e.g., animal maintenance.
Suggestions:
- Be realistic. Both "padding" and deliberately underbudgeting reflect naivete, which will be recognized by reviewers.
- Provide brief descriptions of duties for all positions listed in the budget, with the percentage of effort requested each year and any anticipated flucations. Special skills or accomplishments of a designated person may be included if not discussed elsewhere.
- If possible, try to identify specific individuals for each position requested. "To be named" personnel are very often deleted by reviewers.
- Justify all equipment purchases. The proposed acquisition of major pieces of equipment is likely to be scrutinized very carefully. Details are important, especially for non-project specific equipment e.g., FAX machine and computers.
- Break out supply costs into major categories (reagents, disposables, etc.). Provide special justification for any unusual expenses requested.
- Detail and justify travel costs. Make sure they reflect cuffent fares and lodging costs and that proposed travel is project related.
- Explain any year-to-year fluctuations in the budget, including the level of effort of personnel, especially if they can not be attributed to routine salary increases. Changes should parallel the research plan and project aims.
- Check indirect costs. Some institutions have on-campus and off-campus rates.
- Be complete but concise. There are no page limits in this section.
- Provide adequate justification for the need to use outside consultants, if applicable.
- The budget must be approved by the grantee institution business office before they can sign the application.
- If applicable, provide documentation of institutional rates for animal maintenance and
acquisition. Exceptionally large numbers of animals will need detailed justification.
- Prorate service contracts to percentage of time equipment is used for this project.
ASSURANCES
Purpose: The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines.
Recommended Length: A special form must be completed for the assurances section. See page B of the PHS 398 application.
Content: The assurances cover:
- human subjects;
- vertebrate animals;
- inventions and patents;
- debarment and suspension;
- drug-free workplace;
- lobbying;
- delinquent Federal debt;
- misconduct in science;
- civil rights;
- handicapped individuals:
- sex discrimination; and
- age discrimination.
Suggestions
- Be familiar with assurances, certifications and requirements for complying with these
regulations.
- Begin to obtain assurances early, since they tend to require the cooperation of different institutions.
- Check your institution's grants management office for additional requirements. Different institutions follow different procedures and timelines.
HUMAN SUBJECTS
Purpose: The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects.
Recommended Length: There is no specified length, but be succinct.
Content: Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section. If an exemption has been designated in item 4a on the face page, enough detail still must be provided to allow the determination of the appropriateness of the exemption. If no exemption is claimed, there are six points which must be addressed in this section. A full description of these points can be found on page 22 of the PHS 398 application package. Be thorough in addressing these six areas.
All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population. A justification is required if there is limited representation of women and minorities. Peer review and NIH program staff will consider this justification in their evaluation of your application. Failure to address this issue will impose a bar, making any award until all the concems raised by the IRG have been resolved.
The assurance of compliance number from the NIH Office of Protection from Research Risks
(OPRR) must be provided in item 4b of the face page, as must the IRB approval date.
Suggestions
- Most institutions have a multiple project assurance from OPRR. If your institution does not, contact OPRR as soon as possible to obtain a single project assurance.
- All research involving human subjects requires a current review by your Institutional
Review Board (IRB). Be sure to provide the most recent review date for your project.
- You must provide information on the inclusion of women and minorities in the study population.
VERTEBRATE ANIMALS
Purpose: The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals .. involved in the proposed research.
Recommended Length: There is no specified length, but be succinct.
Content: Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section. There are five points which must be addressed in this section. A full description of these points can be found on page 23 of the PHS 398 application package. Be thorough in addressing these five areas. Failure to address any of these areas will delay any award until these issues have been resolved.
The animal welfare assurance number from the NIH Office of Protection from Research Risks
(OPRR) must be provided in item 5b of the face page, as must the IACUC approval date.
Suggestions
- Most institutions have a multiple project assurance from OPRR. If your institution does not, contact OPRR as soon as possible to obtain a single project assurance.
- All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC). Be sure to provide the most recent review date for your project.
- Be sure the number of animals proposed is realistic.
- Justify all animal expenses.
RESOURCES AND ENVIRONMENT
Purpose: The purpose of the resources and environment section is to describe the resources, facilities, and support available to the researcher.
Recommended Length: A special form is provided for the resources and environment section.
Suggestions
- Make sure the resources and environment section addresses all requirements of the proposed research plan.
- Justify any reliance on resources external to the research.
- Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem.
- Make certain your resources and budget requests are consistent.
OVERALL CONSIDERATIONS
- Observe application guidelines strictly.
- Use basic English and avoid jargon.
- Make sure all acronyms are spelled out when used initially.
- Type single-spaced and stay within the margins.
- Observe the type size and page limitations strictly; do not use a small font.
- Do not use photo reductions on a copy machine, particularly gels, etc. because they may
become unreadable.
- Draw or print all graphs, diagrams, charts, and tables in black ink (be consistent with
formats). Label these items carefully.
- Include only those graphs, tables, etc., that are essential to the narrative; these should
complement the text and be appropriately inserted.
- List all citations (six pages maximum) at the end of the research plan.
- Make sure all citations are complete: title, authors, book or jounal, volume number, inclusive pages, year of publication.
- Have an outside reader review the proposal for clarity and consistency.
- Proofread carefully by reading aloud. Do not rely on computer "spell check" to point out mistakes.
- Be consistent with terms, references, and forrn writing style.
- Supplement the text material by including additional information in the appendices. However, appendices should contain supportive or supplemental, rather than essential material. Essential data should be included within the body of the application. Provide a table of contents of the appendices for easy reference by the reviewers.
- Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official.
- Make sure all the "check-box" items on page II of the PHS 398 application are completed.
- Be sure that your application is received at the Division of Research Grants by the appropriate deadline.
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