Chapter 7. writing the application III: the PHS 398 FORMS PACKET
This chapter covers a lot of ground, as much ground as the form pages themselves cover. I’ll teach you how to develop a budget, what should go into your project title, how to describe your institution’s resources, and so on. NIH provides you with a comprehensive set of instructions, and I am not going to repeat these if I can avoid it, except when I want to elaborate or explain. Read these, though; you should know them so well that you practically have them memorized by the time you get done. C’mon, its only 74 pages. The URL can be found at http://grants1.nih.gov/grants/funding/phs398/phs398.html
I’m going to use the structure that NIH provides in the PHS 398 – the form pages and the order in which they come – as a guiding principle for this chapter. Thus, a relatively small point (I don’t say “trivial” – nothing here is trivial) may sit right next to a large and very important section. You can use this chapter as reference, with your own form pages sitting open on your computer as you fill them out. The PHS 398 form pages comprise the main form of submission that you will be using. If you are submitting a K award, you will still use the PHS 398, although some of the pages will not be used, and others may be substituted (the substitute pages are included right there in the form package, and I show them at the end of this chapter). I am going to focus on the standard PHS 398 package. The other “major” package, by the way, is the PHS 2590, which is used for noncompeting renewals, i.e., progress reports, and we’re not going to cover those. The forms are similar to those in the PHS 398, and differences are self-explanatory.
7.1 The Face Page
The cover page contains a good deal of the administrative data that NIH requires. Many institutions have a web page that provides this specific information; it can be called by any number of names. At Columbia University, where I work, the page is called “Proposal Submission Procedures”, and contains information such as, how long before the grant submission date must signatures must be obtained (we’ll discuss this) and which offices must see the proposal prior to submission. It also contains a section called “Important Information for Proposal Processing” (elegant language, right?). Get on your institution’s home page and look around. If you don’t find it, ask someone in your Grants and Contracts office.
On the next page, you will see a copy of the face page, that has been filled in (with fallacious data, pertaining to the example I have been using). There is more than one set of PHS 398 form pages available on the web as of this writing, an older set, which may still be used until sometime in 2005 (although by the time you read this, the older set may not even appear on the website); and a newer set. I have used the newer set in this example. An easy way to ensure that you are using the correct set of forms is to look at Section 1 on the cover page (“Title of Project”: It should say “Do not exceed 81 characters, including spaces and punctuation”. The previous version allowed only 56 characters.
Face Page example: see following page.
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Form Approved Through 09/30/2007 OMB No. 0925-0001Department of Health and Human Services
Public Health Services
Grant Application
Do not exceed character length restrictions indicated. / LEAVE BLANK—FOR PHS USE ONLY.
Type / Activity / Number
Review Group / Formerly
Council/Board (Month, Year) / Date Received
1. TITLE OF PROJECT (Do not exceed 81 characters, including spaces and punctuation.)
RCT: Effect of Guided Breathing Intervention on Ambulatory BP in Hypertensives
gG
2. RESPONSE TO SPECIFIC REQUEST FOR APPLICATIONS OR PROGRAM ANNOUNCEMENT OR SOLICITATION NO YES
(If “Yes,” state number and title)
Number: / T Title:
3. PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR / New Investigator No Yes
3a. NAME (Last, first, middle) / 3b. DEGREE(S) / 3h. eRA Commons User Name
Kaoru Okata / M.D. / kokata
3c. POSITION TITLE
Assistant Professor of Medicine / 3d. MAILING ADDRESS (Street, city, state, zip code)
New York Medical Center
Dept. of General Medicine, Box 383
890 125th Street
New York, NY 10027
3e. DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT
General Medicine
3f. MAJOR SUBDIVISION
Medicine
3g. TELEPHONE AND FAX (Area code, number and extension) / E-MAIL ADDRESS:
TEL: Tel: / (212) 555-1234 / FAX: FAX: / (212) 555-1235 /
4. HUMAN SUBJECTS
RESEARCH
No Yes / 4b. Human Subjects Assurance No.
FWA99991234 / 5. VERTEBRATE ANIMALS No Yes
4c. Clinical Trial
No Yes / 4d. NIH-defined Phase III
Clinical Trial No Yes / 5a. If “Yes,” IACUC approval
Date / 5b. Animal welfare assurance no.
4a. Research Exempt
No Yes / If “Yes,” Exemption No. / A9999-01
6. DATES OF PROPOSED PERIOD OF
SUPPORT (month, day, year—MM/DD/YY) / 7. COSTS REQUESTED FOR INITIAL
BUDGET PERIOD / 8. COSTS REQUESTED FOR PROPOSED
PERIOD OF SUPPORT
From / Through / 7a. Direct Costs ($) / 7b. Total Costs ($) / 8a. Direct Costs ($) / 8b. Total Costs ($)
12/1/2003 / 11/30/2008 / 280,938 / 425,772 / 1,509,813 / 2,247,066
9. APPLICANT ORGANIZATION / 10. TYPE OF ORGANIZATION
Name / The Trustees of New York Medical Center / Public: ® Federal State Local
Address / 900 125th Street
New York, NY 10027 / Private: ® Private Nonprofit
For-profit: ® General Small Business
Woman-owned Socially and Economically Disadvantaged
11. ENTITY IDENTIFICATION NUMBER
13-1234567A8
DUNS NO. / 123456789 / Cong. District / 14
12. ADMINISTRATIVE OFFICIAL TO BE NOTIFIED IF AWARD IS MADE / 13. OFFICIAL SIGNING FOR APPLICANT ORGANIZATION
Name / Mr. Allen Birdwell / Name / Ms. Paula Omale
Title / Associate Director for Finance / Title / Associate Dean for Sponsored Programs
Address / 900 125th Street
New York, NY 10027 / Address / 900 125th Street
New York, NY 10027
Tel: Tel: / 212-555-1236 / FAX: FAX: / 212-555-1237 / Tel: / 212-555-1238 / FAX: FAX: / 212-555-1239
E-Mail: / / E-Mail: /
14. PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR ASSURANCE: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. / SIGNATURE OF PI/PD NAMED IN 3a.
(In ink. “Per” signature not acceptable.) / DATE
15. APPLICANT ORGANIZATION CERTIFICATION AND ACCEPTANCE: I certify that the statements herein are true, complete and accurate to the best of my knowledge, and accept the obligation to comply with Public Health Services terms and conditions if a grant is awarded as a result of this application. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. / SIGNATURE OF OFFICIAL NAMED IN 13.
(In ink. “Per” signature not acceptable.) / DATE
PHS 398 (Rev. 09/04) Face Page Form Page 1
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Face Page Notes
Usually, I’ll put references numbers on the form page, but the cover page, as you can see, is divided into numbered sections already, and I’ll just use these. If I don’t mention a number (e.g., I don’t mention “Section 2”) it is because there is nothing tricky about it, and you can get what you need from the instructions.
Section 1. Don’t just dash off a title; it is the first detail that will be noted about your proposal, and in 81 characters (including spaces; absolutely no more than that!) you want to provide a great deal of information about your proposal. In this title, we have included:
· The major independent and dependent variables (Guided Breathing intervention, ambulatory blood pressure)
· The study population (Hypertensives)
· The design (a randomized controlled trial, or RCT)
An RCT is an extremely powerful research method, and we want to note that we are using that design in the title; this will also help to make sure that the proposal goes to the study section that you prefer (see Chapter 9 for details on how this works). Why prefer one study section over another? It comes down to the question of what sort of experts do you want reviewing your proposal? If this proposal went to a study section composed mainly of laboratory experimentalists, say, they may not be able to appreciate why you will have made some choices, and what the problems are in conducting an RCT (these are very different than those that come up in laboratory studies).
Also, ambulatory blood pressure is accepted in the research community as a superior method of assessment, compared to clinic measurements; it is a better predictor of target organ damage, for example. Thus, it is important to mention it in the title as well.
A couple of other things. Should you use an abbreviation such as “RCT” or “BP” in the title? In this case, I would say yes. Everyone on the relevant study section will know what it means, and it tells a great deal about what you intend. Make sure to mention your main independent and dependent variables.
New Investigator: To ensure fair reviews for new investigators, the NIH has issued instructions to reviewers that all applicants should be evaluated in a manner appropriate for the present stage in their careers. So, if you are eligible to mark yourself as a New Investigator, do so. A new investigator is one who has not previously served as such on any PHS-supported research project other than a small grant (R03), an Academic Research Enhancement Award (R15), an exploratory/developmental grant (R21), or certain research career awards directed principally to physicians, dentists, or veterinarians at the beginning of their research career (K01, K08, K22, and K23). Current or past recipients of Independent Scientist and other nonmentored career awards (K02 and K04) are not considered new investigators.
Section 3h. This is new. Log onto the ERA Commons page (URL: https://commons.era.nih.gov/commons/), open an account, and note your user name. (Sections 4 and 5. See chapter 6 for a detailed discussion of this section. Also, the Human Subjects Assurance Number is one of those bits of information you will find on your institution’s grants information page, or, by asking someone in your Grants and Contracts Office.
5b. Include this number even if you are not studying animals (and include the Human Subjects Assurance Number, box 4b, even if you are not studying humans).
Section 6. Chapter 9 will give you an approximate schedule of when things will happen, including, if you are funded, when you will get your money. I tend to assume about a year from the submission date. For example, if I submit for June, 2005, I will note in this section that the money will begin on June 1, 2006. It should end one day earlier than it began (if it begins on June 1, it ends on May 31) in the appropriate year (depending on how many years support you requested, and receive).
Sections 7 and 8. We’re going to discuss this in detail later in this chapter; you can’t complete these boxes, however, until you complete the budgets (Section 7.4) and the Checklist (Section 7.6).
Sections 9-13. Find all this out from your institution’s grants information page, or, by asking someone in your Grants and Contracts Office.
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7.2 Abstract, Performance Sites, Key Personnel, Human Embryonic Stem Cells
For those of you who have done this before, you will notice changes from the previous form pages (these are provided at the beginning of the PHS 398 instructions. The second form page underwent one of the most radical makeovers, as it went from one to two pages. The first page covers the abstract and performance sites; the second page covers Key Personnel and human embryonic stem cells. An example follows:
Principal Investigator/Program Director (Last, First, Middle): / Okata, K.DESCRIPTION: See instructions. State the application’s broad, long-term objectives and specific aims, making reference to the health relatedness of the project (i.e., relevance to the mission of the agency). Describe concisely the research design and methods for achieving these goals. Describe the rationale and techniques you will use to pursue these goals.
In addition, in two or three sentences, describe in plain, lay language the relevance of this research to public health. If the application is funded, this description, as is, will become public information. Therefore, do not include proprietary/confidential information. DO NOT EXCEED THE SPACE PROVIDED.
Although drug therapies have improved blood pressure (BP) control, 50% of hypertensives on drug treatment have inadequately controlled BP. Device-Guided breathing trains patients to slow their breathing to a rate of 5-6 breaths/minute (0.1 Hz) range. It is this range at which respiratory sinus arrhythmia (RSA) has its greatest amplitude, and is associated with maximal heart rate variability (HRV). Several published studies have shown that the intervention has had substantial effects on BP reduction, ranging from reductions in systolic/diastolic BP (SBP/DBP) of 5.5/3.6 to 15.2/10.0 mm Hg. These effects are surprisingly large, considering the relatively brief practice sessions (daily 15-minute sessions for 8 weeks), and may represent an effective, accessible, cost-efficient way to help control BP in hypertensives. However, there are 3 limitations which must be addressed before the Guided Breathing technique can be recommended for widespread use. (1) To what extent are the observed BP changes sustained throughout the day and night? The FDA requires that effective antihypertensive treatment lower the BP over a full 24 hours. So far, only one small study (N=13) has examined the effects on ambulatory BP (ABP), and only daytime BP was measured. (2) Is there anything special about breathing at 6-10 breaths/minute, or is it a non-specific relaxation effect? (3) What is the effect duration? Only one study (6-month duration) has examined the effects of guided breathing on BP for more than 8 weeks. It is possible that the intervention causes some resetting of BP-regulating mechanisms that persists after the intervention is discontinued, or it is possible that the BP will return to the pretreatment level. For example, one would not give anti-HTN medication for 8 weeks and stop, and expect an effect on BP a year later. The development of behavioral interventions needs to take into account methods to sustain long-term effects. The aim of this proposal is to conduct a blinded, randomized controlled trial (RCT) to test the efficacy of a Guided Breathing Intervention in uncontrolled hypertensives to address these issues. (1) We will use 24-hour ABP to examine BP changes. (2) We will include 2 control groups, Usual Care (UC), and a Placebo Condition (using a device that is identical to the guided breathing device, except that it does not slow the breathing rate). (3) We will study the effects of the intervention at both 8 weeks (the duration of the training, and again at 12 months, in both the intervention and placebo arms. {2}
PERFORMANCE SITE(S) (organization, city, state)
New York Medical Center, New York, NY
Bronx Hospital, The Bronx, NY
PHS 398 (Rev. 09/04) Page 2 Form Page 2