THE PHS 398 APPLICATION FORM

In this handbook, there is a great deal of emphasis placed on seeking grants from the The National Institutes of Health (NIH). The reason is simple -- NIH is by far the richest source of funding for health related research in the world. The rest of this section details some of the finer points of writing your grant application for the NIH.

The PHS 398 Form is the standard application form for National Institutes of Health grant applications, as well as for some research proposals to other agencies of the Department of Health and Human Services. Like most federal forms, it can be daunting at first glance. Any investigator hoping to do federally-sponsored research, however, would do well to get acquainted with the PHS 398 in advance of needing it. Both hard and disk copies (in Wordperfect or Word/Excel) are available from the Office of Research Development; these electronic versions can also be downloaded here. Various digitally-formatted versions can also be downloaded from other Web sites (See "How to Apply")

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PHS 398 TABLE OF CONTENTS

To get an overview of your task in completing the PHS 398, look at the Table of Contents page from the application packet. It lists the required forms and sections in the order in which they should appear in your application. Many entries in the Table of Contents provide context and identifying information, convey assurances or show that the financial plan for the project is appropriate and feasible (See Constructing a Grant Budget). The "science" part of the 398 is presented in the central sections, set off under the heading, "Research Plan".

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THE RESEARCH PLAN

Part a: Specific Aims

NIH reviewers are not sympathetic toward waffling. Vague promises and purple prose are totally useless in a 398 application. For every section of the narrative, you must provide detailed, specific information on WHAT you plan to do, HOW you plan to do it, and WHY it is important to do it.

In Part a, you will present the skeleton of your proposal as succinctly as possible. Generally, this section should follow this outline:

* One or two sentences summarizing your research question. This is the general problem to be solved by your proposed work.

* A brief summary of the context for this work: The current state of knowledge in the field; gaps or ambiguities that need resolution; linkage to larger goals (i.e., health care).

* Enumerate the specific aims of your proposal. These can be in the form of hypotheses (you will test whether...) or in the form of objectives (will demonstrate that...), or both. Your specific aim may be to develop a methodology, rather than to test an hypothesis.

Write out your aims so that a reviewer can easily imagine what kind of activity each would entail. Number them in the text. Reviewers may refer back to your aims when they read the methodology section, to see how well your methods fit your aims.

* Briefly summarize the design and methods to be used to accomplish your aims.

Part a should be no longer than one page, single-spaced. If yours is longer: 1) edit out all unnecessary verbiage; 2) check to see if you have put in more detail than necessary on the context or the design and methods (you will have an opportunity to present the detail in later sections); and 3) check to see if any of your aims overlap (reorganize them if they do).

If after this editing your specific aims section still runs over a page, consider whether your project as conceived might be too complex or ambitious for one proposal. If so, simplify your plan.

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Part b: Background and Significance

In this section, you will demonstrate that you know your field well, and that you understand the significance of the research problem.

Start with a review of the relevant literature. Your literature review should be thorough, up-to-date, and selective. Read and cite every important publication on your topic. Omit any marginal ones. Discuss the theoretical framework for this project. Even in the most empirically-oriented field, there is an implicit theoretical ground which determines what questions to ask. State this theoretical ground as succinctly as you can.

DO NOT ASSUME THAT YOUR REVIEWERS WILL BE FAMILIAR WITH THE THEORY IN YOUR FIELD!

If you come down on one side of a theoretical fence, say so. Cite the previous work (yours and others) that convinces you. Show your reviewers that you also understand the other side of the fence.

Discuss the significance of your project: What is the significance of your proposal to the body of scientific knowledge? What is its significance to the funding agency?

If you do the proposed research, what gaps in the knowledge of your field will be filled? What ambiguities will be cleared up? What further research will be made possible? This discussion should follow easily from the review of literature and theory.

If you do the proposed research, what larger goals of the agency will be met? Assuming that the agency is one of the National Institutes of Health, these goals will be health-related. Will diagnostic techniques be improved? Will more effective treatments become feasible? Will health care be made more cost-effective?

This section should not exceed 3 pages, single-spaced.

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Part c: Preliminary Studies/Progress Report

In Part c, you will demonstrate that the research tasks you propose are possible, feasible, and informative.

To get funding for any major grant, it is absolutely essential to have done pilot work first. For the experienced investigator with a well-equipped facility, this is no problem. For a new investigator, however, it presents a chicken-and-egg problem: How do I get funding to do research if I have to do research before I get funding?

There are several ways around this problem. First, you can apply for grants that are reserved for new investigators: clinical investigator awards (K series), pilot/seed money grants or small grants (RO3). Some foundations and professional societies also make small grants available for pilot work. When applying for pilot project money, be sure show that you have the training and expertise to carry out the project. Let your professional development to date be your pilot work.

Another way to deal with the piloting problem is to do some preliminary work that partially pilots your project: the initial development of a measurement technique, for instance, or analysis of a few cases. The more of this preliminary work you can complete and report the better. In general, the larger the award you seek, the more extensive your piloting will have to be.

Your report on preliminary work is a miniature research article: describe your hypotheses, methods, subjects, experimental protocol, measurement techniques, data analysis,and your interpretation of the results. Describe what you will do differently in the proposed research based on this preliminary work. Emphasize what you have shown to be feasible by this preliminary work.

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Part d: Research Design and Methods

This is the actual work you propose to do. This section must be very well organized. Use separate headings for each topic (Design, Subjects, Data Analysis, etc.); use subheadings if they make the overall plan clearer.

* Start by stating your hypotheses, as you did in the introductory section.

* Give an overview of the design ("Two groups of 40 subjects each will be randomly assigned to experimental and control groups, each of which will be tested on four separate days...")

* Describe your subject population in detail: include population demographics, how subjects will be recruited, inclusion and exclusion criteria, method of sampling and assignment to groups, and expected attrition rate. Show that you have access to enough qualified subjects to complete the research. If you are limiting your sample to subjects of one sex or ethnic group, you must give the rationale for this (and it better be good). If you do not intend to include children in a clinical research sample, this must also be justified.

* Describe any experimental manipulations in detail.

* Describe all measurements to be taken. Include brief descriptions of any specialized equipment or facilities to be used. If you are using a standard test, or published questionnaire or survey instrument, report on its reliability and validity. Describe how data will be coded, reduced and stored. If experimental blinds are used, describe how they will be maintained.

* Give a summary of all procedures to be used for each group. A table may be the most concise way to summarize your protocol, especially if you have multiple groups.

* Describe the statistical analyses to be carried out. Be sure they are appropriate to the kind of data you are analyzing. Don't try to bluff your reviewers on statistics. If you don't know what is appropriate, ask a statistical consultant. It actually counts in your favor to show you are willing to find expert consultants and include them in your plan and in your budget. If appropriate, do a power analysis to show that you will include enough cases to detect meaningful results.

* Anticipate the potential criticisms of this design, and answer them. (Why did you choose a case control rather than a randomized design?) Show that you understand there are alternate ways to approach the problem, and give your rationale for the one you have chosen.

* Give an overall timetable for the entire project period, including all funded activities, from recruiting and hiring staff to write up the results. Be realistic here. It will count against you if you promise to do too much too soon.

At this point your narrative (Parts a through d) will be 25 pages, single spaced. DO NOT EXCEED THIS LIMIT. To meet the limit, edit as tightly as you can. Use simple sentences. Remove any vague wording. Move tables, figures and charts to the appendix if they are not essential in the narrative.

Resist the temptation to shrink the font size, margins or line spacing. Even when a font smaller than 12 point is allowed -- as it is in the 398 -- the second cardinal rule of grant writing is: Thou shalt not commit eyestrain. Don't make your reviewer struggle to read your application; the bad feeling that results is not worth the extra text you can squeeze in this way. (The first cardinal rule of grant writing can be found here)

Finally, give the draft of the narrative to a knowledgeable friend or colleague to read. Ask that person to mark the parts that are not clear, and to comment on the overall manuscript. A prior review can save a lot of grief during the real review, so pay close attention to your friendly reviewer's comments.

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This chapter covers only the narrative research plan in the application. As you can see from the Table of Contents, you will also have to provide a detailed budget and budget justification, an abstract of the proposal, biographical sketches for all key personnel, descriptions of the resources and environment (available facilities, etc.), the use of human or other vertebrate subjects, a list of literature cited and descriptions of any collaborative arrangements. You also will need letters of support, copies of any paper forms, charts, questionnaires, etc., to be used, and copies of your own relevant publications. Most of this material needs only to be gathered and put in acceptable form.

The major exception is the budget. Preparing a grant budget is discussed in another chapter of this Handbook. Many prospective researchers who write otherwise great proposals get bogged down here.

NIH has made budget preparation for the PHS 398 somewhat easier by allowing "modular applications" for most projects. Still, you will need a budget of your own to insure that your project costs can be met by the award. If you are ready to prepare your first research project budget, find someone who is experienced in budgeting to lead you through it. You are welcome to call the Office of Research Development, and we will work one-on-one with you.

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A Final Word

In the PHS 398 Application Packet, you will find this message: "PHS estimates that it will take approximately 50 hours to complete this application for a regular research project grant."

This some sadistic bureaucrat's idea of a little joke. Start preparing your proposal at least two months before its due date.

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See also:
PHS 398 Form & Instructions (in PDF Format)
Download the PHS 398 in Wordperfect or Word/Excel Format
Two-Minute Tip Sheet on Grant Applications
Constructing a Grant Budget
Life After the Deadline: NIH Grant Reviews
How to Apply for Funding