Elizabeth A. Holly, PhD, MPH, UCSF1 NIH Grant Applications Part II, Abstract, writing tips 8 August 2007 (with some slides from Part I) Elizabeth A. Holly,

Elizabeth A. Holly, PhD, MPH, UCSF 1

NIH Grant ApplicationsPart II, Abstract, writing tips

8 August 2007(with some slides from Part I)

Elizabeth A. Holly, PhD, MPH

Professor, University of California San Francisco

(415) 476-3355

[email protected]


Course Schedule All lectures held in Room N217

• Primarily a course in Clinical & Epidemiologic research with principles in grant writing that apply to most “grant applications”

• July 18--N217--K-Awards

• July 25--N217--K-Awards, continued

• Aug 1--N217--NIH definitions, people & relationships, application types,

how assignments/awards are made, study section & grant application processing www.grants.nih.gov

• Aug 8--N217--Abstract, Specific Aims, Writing tips• http://grants.nih.gov/grants/award/awardtr.htm Funding Trends

• Aug 15--N217--Background, Preliminary Studies, Budgets

http://grants.nih.gov/grants/award/awardtr.htm


What determines which awards are made?

• Scientific Merit

• Program Considerations

• Availability of Funds

Award Process:


Dual Review for Grant Applications (part 1 of the review)

Scientific Review Group (SRG) This is the Study Section (part 1 of the review) under the SRA (Scientific Review Administrator or NIH leader of the Study Section)

• SRG provides initial scientific review of grant applications. Then AFTER the science review. . .

• SRG makes recommendations for appropriate level of support and the duration of award


Dual Review for Grant Applications (cont.)

Board of Scientific Advisors (BSA) (part 2 of the review)

• Assesses the quality of the Study Section review of each grant application (quickly done--nearly always takes the recommendation of the Study Section)

• Makes recommendation to the Institute staff on funding (e.g. NCI)

• Evaluates program priorities and relevance

• Advises on policy


Criteria for Rating of NIH Grant Applications• Significance

Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field?

• ApproachAre the conceptual framework, design, methods, and analyses adequately developed, well integrated and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

• InnovationDoes the project use novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms, develop new methods or technologies?

• InvestigatorIs the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers on the research team?

• EnvironmentDoes the scientific environment where the work will be done contribute to the probability of success? Do the proposed study design and/or experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?


Review of New Investigator R01sGuidelines for Reviewers

Implementation:When reviewing these grant applications, reviewers should keep in mind the experience of and the resources available to the new investigator. When considering an application from a new investigator the five review criteria [prior slide] must be evaluated appropriately based on the expectations for and problems likely to be faced by a new investigator. Specifically, when considering 3 of the 5 criteria:

Approach: more emphasis should be placed on demonstrating that the techniques and approaches are feasible than on preliminary results

Investigators: more emphasis should be placed on their training and their research potential than on their track record and number of publications--emphasis should be placed on their independent status

Environment: there should be some evidence of institutional space commitment and time to perform the research


Preparing an NIH Abstract using PHS 398 Forms

Things to keep in mind re your abstract:

• Clarity and conciseness are important---most Study Section members only read the Abstract and Specific Aims. It sets the stage for the primary reviewers thoughts about your grant application.

• Avoid use of the first person and summaries of past accomplishments. Use the space wisely.



Things to keep in mind:

• Consider the abstract as your one-page advertisement. It is meant to serve as a succinct and accurate description of the proposed work when separated from the application.

• Remember that if the application is funded the abstract will become public information. Therefore, don't include proprietary or confidential information. OK to put in the application.



Things to keep in mind about your abstract: (1)

The title is to be 81 or fewer characters including spaces

•The abstract and title will be used to assign your application to a peer-review panel (i.e. a Study Section and Institute (e.g.NCI).

Abstract--a critical 200+ words that is used for NIH officials, websites for the public and for multiple other uses if your disease is of particular interest. Examples are:



Remember that. . .

The abstract also may be used to provide a brief description of the grant in annual reports (of the NIH

Institute where it is funded), presentations to the Board of Scientific Advisors or in response to requests from high-level NIH personnel, including the director of NIH. Congress also may use these abstracts when interested in funding specific diseases.

• Be proud of it--make it exceptional--strive for excellence. Be thorough.


NIH Abstract for Grant Application PHS 398 form

Contents and style of abstract--overview:

ClarityAbstract size 30 lines of text, font size 11 Arial, Helvetica. . . othersNo use of first personVery brief background--or no background--1 sentence is goodWHAT will you study? Succinctly state your Specific AimsWHO will you study and the number of study participantsHOW will you select and study these participants? Study design

should be defined & described What interview data & biologic specimens will be collected?

How are specimens processed and stored?HOW will you analyze the data?List the strengths of your application if you have space

If all necessary parts are included, reviewers will have a snapshot of entire application



What to include and describe in your abstract:

•Background--state the problem or rationale in one brief sentence

WHAT will you study? Include your Aims.

•State the broad long-term objectives and specific aims, making reference to the health relatedness of the project

•Aim 1…"study polymorphisms at the CYP2D6 gene locus to investigate the possible role of genetic factors in the metabolism of cigarette-derived carcinogens in pancreatic cancer” •Then immediately state your hypothesis for Aim 1.



• Describe the study design concisely

• e.g. “A population-based case-control study will be conducted among 1000 cases and 1500 controls to examine the relationship between cigarette smoking and pancreatic cancer.”



•Concisely describe methods to achieve study goals:

WHO is being studied?

•“Rapid case ascertainment (RCA) will be used to obtain cases. All newly diagnosed patients with adenocarcinoma of the exocrine pancreas who are between the ages of 21 and 85, speak English, are alive and lived in the San Francisco Bay Area at the time of diagnosis are eligible.”


•Concisely describe the methods to achieve study goals: (continued)

HOW will you obtain controls?

•“Random digit dial (RDD) and the Health Care Financing Administration (HCFA) will be used to obtain control participants. Controls will be frequency-matched to cases by sex and 5-year age-group.”



Methods for the abstract (continued)

HOW will you study the participants?

• “In-person interviews will be conducted at the participant’s home by a trained interviewer. Interview topics will include detailed information on job history and chemical exposures, diet, personal medical history and family history of pancreatic cancer and related conditions.”



Preparing an NIH Abstract Using PHS 398 Forms

Methods for the abstract (continued)

WHAT specimens will be collected?

•“Blood and specimen collection will be performed by the study phlebotomist in the person’s home.”

•Specimen storage, e.g. “Serum will be stored in 1cc aliquots at -80ºC and cell samples will be stored frozen with liquid nitrogen.”


HOW will you analyze your data?

Statistical analysis, e.g. “Analyses will be conducted using univariate and multivariable statistics with careful consideration of potential confounders.”




WHAT makes your research special? End abstract with:

Strengths--Emphasize the importance of the research

and how it will contribute to research in other medical/

scientific fields. Stress the innovative and unique

components of the grant application that will enable you

to contribute significantly to the understanding of the

disease (such as P.I.’s work in this area, preliminary

data, facilities, expert collaborators, accessible study

population, cutting-edge methods and technologies).


Writing a Successful Grant Application-- (1)

• Instead of: Write:

in order to to

for the purpose of to

have a preference for prefer

with the exception of except

in excess of more than

in the near future soon

in the not too distant future soon

in addition to also

as well as and or also

at this point in time now

in the context of transformation in transformation


Writing a Successful Grant Application-- (2)

Instead of: Write:at the present time now (currently)

up until now currently

in the event that if

in the course of while (during)

(Note: While and Since refer to time)

in a number of cases some (several)

in the majority of instances usually (most of)

in all probability probably

in the nature of like (similar to)

in view of because

in view of the fact that because

taking into consideration the fact that whereas

(Don't use the word fact unless it IS a fact)

Documents

Elizabeth A. Holly, PhD, MPH, UCSF1 NIH Grant Applications Part II, Abstract, writing tips 8 August 2007 (with some slides from Part I) Elizabeth A. Holly,