Grantsmanship:The Good, the Bad and the Ugly!

or How to Swim with the Sharks and Survive!

Jerry Heindel, Ph.DJerry Heindel, Ph.D..

Scientific Program AdministratorScientific Program Administrator

Division of Extramural Research and Training, NIEHSDivision of Extramural Research and Training, NIEHS

heindelj@niehs.nih.govheindelj@niehs.nih.gov

..

NIH/DHHS/NIEHSNIH/DHHS/NIEHS

I am from the Government

and I am here to help you!

NIH

Overview

Problems first time (and other) applicants Problems first time (and other) applicants make…..make…..

What to do about it!What to do about it!

Principles of grantsmanship-Principles of grantsmanship-

Grants.gov and electronic submissionsGrants.gov and electronic submissions

Start With the End in Mind!Start With the End in Mind!

Elements of Grant Success

Good Ideas

Good Timing

Good Reviewers

Good Luck

Good Grantsmanship

Formula for Grant Success

NIH GRANT$

Good LuckThe consequence of:

• Good Ideas

• Good Presentation

• Good Timing

• Good Reviewers

• Good Grantsmanship

Formula for Grant Success

NIH GRANT$

Grant writing is a learned skill

Writing manuscripts that get published in Writing manuscripts that get published in peer reviewed journals is a learned skill.peer reviewed journals is a learned skill.

Writing grant applications, is also a Writing grant applications, is also a learned skills.learned skills.

Grantsmanship is a full time job….Knowing the Science is not enough!

Common Problems with Applications Overly ambitiousOverly ambitious Lack of innovationLack of innovation Lack of linkage to human health problemLack of linkage to human health problem Lack of focused/mechanistic hypothesisLack of focused/mechanistic hypothesis Lack of focused aims that will prove and only prove the Lack of focused aims that will prove and only prove the

hypothesishypothesis Unfocused research plan that does not test feasibilityUnfocused research plan that does not test feasibility Questionable reasoning in approachQuestionable reasoning in approach Lack of experimental detailLack of experimental detail Lack of experience with methodsLack of experience with methods

What to do….. Start early!Start early! Learn to move from lab experiments to the big picture. Learn to move from lab experiments to the big picture. Learn to think in terms of hypotheses to test and how to test Learn to think in terms of hypotheses to test and how to test

them….even in everyday lab work.them….even in everyday lab work. Develop a specific niche research area of your own…you Develop a specific niche research area of your own…you

need to be known as an expert in a specific area…think long need to be known as an expert in a specific area…think long term not just one application.term not just one application.

Focus on specific aims page.Focus on specific aims page. Think salesmanship/grantsmanship.Think salesmanship/grantsmanship. Get help reviewing drafts and working through the Get help reviewing drafts and working through the entireentire

process ( Mentor and Granting Organization).process ( Mentor and Granting Organization).

Start Planning Early!!!!!Planning Schedule…..Planning Schedule…..

NIHApplying for Funding

THE NIEHS EXTRAMURAL TEAM !

PROGRAMADMINISTRATOR

GRANTSMANAGEMENT

SPECIALIST

SCIENTIFICREVIEW

ADMINISTRATOR

Scientific Program Administrator

Develop program initiativesDevelop program initiatives Provide guidance and assistance to applicantsProvide guidance and assistance to applicants Attend Scientific review group (SRG) meetings as Attend Scientific review group (SRG) meetings as

program resource person(s)program resource person(s) Communicate results of review to applicantsCommunicate results of review to applicants Make funding recommendationsMake funding recommendations Monitor progress during the award periodMonitor progress during the award period

Scientific Review Administrator

Review administrators Review administrators setup and conduct setup and conduct scientific and technical reviewsscientific and technical reviews of grant of grant applications to identify those of highest scientific applications to identify those of highest scientific and technical merit in their respective discipline and technical merit in their respective discipline and disease areas.and disease areas.

Grants Management Specialist

Grants Management Officials ensure that Grants Management Officials ensure that business business management actionsmanagement actions for NIH programs and awards are for NIH programs and awards are performed correctly, efficiently, and in accordance with performed correctly, efficiently, and in accordance with pertinent grant policies and good business practices, pertinent grant policies and good business practices, including responsibility for maintaining official grant including responsibility for maintaining official grant files.files.

When to Interact with Various Staff Members

Scientific Program AdministratorScientific Program Administrator: :

Prior to submissionPrior to submission After the review is completeAfter the review is complete Prior to the awardPrior to the award During the progress of the researchDuring the progress of the research

Grants Management OfficialGrants Management Official::

Fiscal or Administrative questions prior to submission or Fiscal or Administrative questions prior to submission or award and throughout awardaward and throughout award

Scientific Review AdministratorScientific Review Administrator::

After SubmissionAfter Submission Prior to Summary StatementPrior to Summary Statement

Assistance (Grant) Mechanisms Regular Research Grant-R01Regular Research Grant-R01 OthersOthers

Small grants - R03Small grants - R03http://grants.nih.gov/grants/funding/r03.htmhttp://grants.nih.gov/grants/funding/r03.htm

New Investigator-K99/00New Investigator-K99/00http://grants.nih.gov/grants/guide/pa-files/PA-06-133.htmlhttp://grants.nih.gov/grants/guide/pa-files/PA-06-133.html

Exploratory – R21Exploratory – R21http://grants.nih.gov/grants/funding/r21.htmhttp://grants.nih.gov/grants/funding/r21.htm

Academic Research Enhancement AwardAcademic Research Enhancement Award(AREA) - R15(AREA) - R15http://grants.nih.gov/grants/funding/area.htmhttp://grants.nih.gov/grants/funding/area.htm

Principles of Grantsmanship Preparing an R01(R03, R21) Application

TitleTitle Abstract (200 words)Abstract (200 words) Research Plan Research Plan

Specific Aims ( 1 page)Specific Aims ( 1 page) Significance ( bkg) (2-3 pages)Significance ( bkg) (2-3 pages) Preliminary StudiesPreliminary Studies Experimental Methods/ApproachExperimental Methods/Approach

Budget/TimelineBudget/Timeline ReferencesReferences

It is not the will to win that’s important. Everyone wants to win! It is the will to prepare to win that makes the difference. Bobby Knight

Important Point to Remember

There is an art to writing applications!There is an art to writing applications!

TIP: MELD SCIENCE, SALESMANSHIP TIP: MELD SCIENCE, SALESMANSHIP

AND COMMUNICATION SKILLSAND COMMUNICATION SKILLS

Grantsmanship : General Preparation

Assess the field….know state of field and Assess the field….know state of field and opportunities.opportunities.

Check out the “competition”.Check out the “competition”. Brainstorm ideas….match them to NIH.Brainstorm ideas….match them to NIH.

Novel, innovative, impactNovel, innovative, impact Check with NIH program directors.Check with NIH program directors. Give yourself plenty of time….3-6 mo!Give yourself plenty of time….3-6 mo! Start with the end in mind !Start with the end in mind !

Grantsmanship Start With the End in Mind!Start With the End in Mind!

Receipt and Referral ( Institute and Study Section)Receipt and Referral ( Institute and Study Section) Review SystemReview System

Study SectionsStudy SectionsReviewersReviewers

Review CriteriaReview Criteria

Overall goal: To make everyone involved in the Overall goal: To make everyone involved in the process happy…to make their job easier.process happy…to make their job easier.

The key to success in grant writing is to engender enthusiasm in the reviewer---who then becomes an advocate for the proposal!

Grantsmanship:Start With The End in Mind 1. Know your Audience!

The ReviewersThe Reviewers

Accomplished, dedicated, fairAccomplished, dedicated, fair

Overly committed, tired, inherently Overly committed, tired, inherently skeptical, overly criticalskeptical, overly critical

General understanding onlyGeneral understanding only

Used to reviewing R01 applicationsUsed to reviewing R01 applications

Start with the End in Mind!2. Review Criteria

SIGNIFICANCE:SIGNIFICANCE:

Does this study address and important Does this study address and important problem? problem?

If the aims are achieved, how will scientific If the aims are achieved, how will scientific knowledge or clinical practice be knowledge or clinical practice be advanced?advanced?

What will be the effect of these studies on What will be the effect of these studies on the concepts, methods, technologies, the concepts, methods, technologies, treatments, services or preventative treatments, services or preventative interventions that drive the field?interventions that drive the field?

Start with the End in Mind!2. Review Criteria

INNOVATION:INNOVATION: Is the project original and innovative?Is the project original and innovative?

Does the project challenge existing Does the project challenge existing paradigms or clinical practice: address paradigms or clinical practice: address an innovative hypothesis or critical an innovative hypothesis or critical barrier to progress in the field?barrier to progress in the field?

Does the project develop or employ Does the project develop or employ novel concepts, approaches, novel concepts, approaches, methodologies, tools or technologies methodologies, tools or technologies for this area of research?for this area of research?

APPROACHAPPROACH Are the conceptual or clinical framework, Are the conceptual or clinical framework,

design, methods, and analyses design, methods, and analyses adequately developed, well integrated, adequately developed, well integrated, and appropriate to the aims of the and appropriate to the aims of the project?project?

Does the applicant acknowledge Does the applicant acknowledge potential problem areas and consider potential problem areas and consider alternative strategies?alternative strategies?

Start with the End in Mind!2. Review Criteria

INVESTIGATOR:INVESTIGATOR: Is the Principal Investigator capable of Is the Principal Investigator capable of

coordinating and managing the proposed coordinating and managing the proposed work ? work ?

Is the work proposed appropriate to the Is the work proposed appropriate to the experience level of the Principal Investigator experience level of the Principal Investigator and other researchers, including consultants and other researchers, including consultants and subcontractors (if any)?and subcontractors (if any)?

Are the relationships of the key personnel to Are the relationships of the key personnel to the University and to other institutions the University and to other institutions appropriate for the work proposed?”appropriate for the work proposed?”

Start with the End in Mind!2. Review Criteria

Start with the End in Mind!2. Review Criteria

ENVIRONMENT:ENVIRONMENT:

Is there sufficient access to resources (e.g., Is there sufficient access to resources (e.g., equipment, facilities)? equipment, facilities)?

Does the scientific and technological Does the scientific and technological environment in which the work will be done environment in which the work will be done contribute to the probability of success?contribute to the probability of success?

Do the proposed experiments take advantage Do the proposed experiments take advantage of unique features of the scientific of unique features of the scientific environment or employ useful collaborative environment or employ useful collaborative arrangements?arrangements?

Start with the End in Mind!3.Selling Yourself and Your Ideas!

Knowing the Science is not enough.Knowing the Science is not enough. ScientistScientist SpokespersonSpokesperson

Communicator ( writer & speaker)Communicator ( writer & speaker) SalespersonSalesperson

Grantsmanship : A Research Focus

The Scientist as a SalespersonThe Scientist as a Salesperson : :

You are a Business : Big BusinessYou are a Business : Big Business

CEO ; Scientific Director ; Sales RepresentativeCEO ; Scientific Director ; Sales Representative

Sell yourself and your ideasSell yourself and your ideas

Use Your CommunicationUse Your Communication skillsskills

Written and OralWritten and Oral

Grantsmanship: Sell yourself and your ideas!

WhatWhat are you selling? are you selling? WhyWhy is it important? is it important? ImpactImpact (who will benefit) (who will benefit) HowHow will you do it? will you do it? AdvantagesAdvantages/strengths/limitations/strengths/limitations Track record Track record (can you do it?)(can you do it?)

And put it in the proper form !And put it in the proper form !

Principle of Successful Selling

Make people like you…develop rapportMake people like you…develop rapport Find out what they need or wantFind out what they need or want Get the other person point of viewGet the other person point of view Know your productKnow your product Show advantages of your productShow advantages of your product Develop a desire for your product Develop a desire for your product GetGet people saying YESpeople saying YES

Principles of Grantsmanship Preparing an R01(R03, R21) Application

TitleTitle Abstract (200 words)Abstract (200 words) Research Plan Research Plan

Specific Aims ( 1 page)Specific Aims ( 1 page) Significance ( bkg) (2-3 pages)Significance ( bkg) (2-3 pages) Preliminary StudiesPreliminary Studies Experimental Methods/ApproachExperimental Methods/Approach

Budget/TimelineBudget/Timeline ReferencesReferences

ABSTRACT:Stated Guidelines State the application’s broad, long term objectives and State the application’s broad, long term objectives and

specific aims.specific aims. Make reference to the health-relatedness of the project.Make reference to the health-relatedness of the project. Describe concisely the research design and methods for Describe concisely the research design and methods for

achieving goals.achieving goals. Discuss potential for innovation.Discuss potential for innovation. Avoid summaries of past accomplishments and the use Avoid summaries of past accomplishments and the use

of first person.of first person. Do not exceed 200 words.Do not exceed 200 words.

Grantsmanship: ABSTRACT IDENTIFY PROBLEM:IDENTIFY PROBLEM:

What is the problem addressed? ( Must be public health What is the problem addressed? ( Must be public health problem!!)problem!!)

Who caresWho cares SOLUTION: SOLUTION:

Hypothesis/goal/productHypothesis/goal/product PLAN: PLAN:

ApproachApproach Specific aims/milestonesSpecific aims/milestones Techniques/methodologies usedTechniques/methodologies used

BENEFITS: BENEFITS: Expected resultsExpected results Application/benefitApplication/benefit

Grantsmanship : The Heart of The Application

Specific AimsSpecific Aims

Background and SignificanceBackground and Significance

Preliminary StudiesPreliminary Studies

Research Design/MethodsResearch Design/Methods

Literature CitedLiterature Cited Abstract

Research Plan

Hypothesis

Specific Aims

DO NOT write the application for the “Specialist”

You MUST convince the entire review committee

Jargon: Be careful what you say…..

One reason some branches of government have One reason some branches of government have trouble operating jointly is that they don’t speak trouble operating jointly is that they don’t speak the same language. the same language.

Goal: “Secure a Building”Goal: “Secure a Building” Air ForceAir Force ArmyArmy MarinesMarines NavyNavy

Grantsmanship: Specific Aims Section (One Page)

Introductory ParagraphIntroductory Paragraph Statement of long term health-related goalStatement of long term health-related goal (1 sentence) (1 sentence) Background/significance of problemBackground/significance of problem (1-2 sentences) (1-2 sentences) Preliminary data/state of the artPreliminary data/state of the art (2-3 sentences) (2-3 sentences) Data gaps/controversyData gaps/controversy (1-2 sentences) (1-2 sentences) Clearly defined hypothesis/specific goalClearly defined hypothesis/specific goal

( 1-2 sentences)( 1-2 sentences)

The flow of logic must be compelling!!!The flow of logic must be compelling!!!

Specific Aims (Cont’d) Specific Aims/MilestonesSpecific Aims/Milestones

2-5 aims2-5 aims ( One sentence each) ( One sentence each)

Specifically focused to prove hypothesis/develop Specifically focused to prove hypothesis/develop productproduct

Logical order with no dead endsLogical order with no dead ends To characterize, To determine the, To relate...To characterize, To determine the, To relate... Focus on scientific goal not technologyFocus on scientific goal not technology

Summary StatementSummary Statement Emphasize novel product and innovative approach Emphasize novel product and innovative approach

and impact on fieldand impact on field ( 2-3 sentences) ( 2-3 sentences)

The aims should be endpoints…so it can be easily determined if they have been met!!

Aim 1. To determine if……

or

Aim 1. To characterize

Idea and Hypothesis. NOVEL!!!

New, innovative and novel ideas…paradigm New, innovative and novel ideas…paradigm shifters.shifters.

You need to be first….we don’t fund followers!You need to be first….we don’t fund followers! We don’t fund gap filling.We don’t fund gap filling. We don’t fund verification/repetition.We don’t fund verification/repetition.

Why is this application special….what singles out Why is this application special….what singles out this application?this application?

Hypothesis

We hypothesize that calcium causes We hypothesize that calcium causes reproductive dysfunction by interfering reproductive dysfunction by interfering with pituitary gonadotropin secretion, with pituitary gonadotropin secretion, testosterone synthesis and secretion, testosterone synthesis and secretion, androgen metabolism in target organs androgen metabolism in target organs and sex steroid hormone receptor and sex steroid hormone receptor binding in the neuroendocrine system binding in the neuroendocrine system and in the reproductive organs.and in the reproductive organs.

Hypothesis

We hypothesize that estrogen-like We hypothesize that estrogen-like endocrine disruptors alter uterine growth by endocrine disruptors alter uterine growth by altering HOX gene expression via altering HOX gene expression via disruption of estrogen stimulation of HOX disruption of estrogen stimulation of HOX gene cis regulatory DNA elements.gene cis regulatory DNA elements.

Our overall hypothesis is that TCDD exerts Our overall hypothesis is that TCDD exerts its effects on ovarian steroidogenesis by its effects on ovarian steroidogenesis by binding to the AhR and specifically binding to the AhR and specifically inhibiting P450 aromatase gene expression.inhibiting P450 aromatase gene expression.

Background and Significance

Goal: To convince the reviewers that you are familiar with the Goal: To convince the reviewers that you are familiar with the field and to justify need for proposed study.field and to justify need for proposed study.

Logical development of background information that forms basis of Logical development of background information that forms basis of proposal.proposal.

Critical evaluation of current knowledge. …show how proposed work Critical evaluation of current knowledge. …show how proposed work builds on previous work.builds on previous work.

Identification of data gaps, conflicts, needs, what’s new and novel and Identification of data gaps, conflicts, needs, what’s new and novel and innovative.innovative.

Importance of research and how it will fill need. Importance of research and how it will fill need. Thus these studies demonstrate the importance of this area….Thus these studies demonstrate the importance of this area…. These studies provide important background for this study in….These studies provide important background for this study in…. The proposed project will build on this previous work….by….The proposed project will build on this previous work….by….

Public health benefit….significance paragraph to frame current status of Public health benefit….significance paragraph to frame current status of work in the field and explain how the proposed project will make a work in the field and explain how the proposed project will make a contribution.contribution.

Preliminary Data

Goal: To establish your experience and competence in the Goal: To establish your experience and competence in the area of application.area of application. Convince reviewers you are familiar with and have done all Convince reviewers you are familiar with and have done all

the techniques proposed including data analysis and the techniques proposed including data analysis and interpretation…interpretation…

that the work is feasible…that the work is feasible… that suitable groundwork has been done (preliminary data). that suitable groundwork has been done (preliminary data). Simple graphs and tables with descriptive legends.Simple graphs and tables with descriptive legends. No extraneous or irrelevant data.No extraneous or irrelevant data. Black and white.Black and white.

Experimental Methods/Research Plan

For Each Aim/MilestoneFor Each Aim/Milestone:: Rationale for approachRationale for approach Experimental Design in detail including data Experimental Design in detail including data

analysis and interpretationanalysis and interpretation Potential Difficulties/LimitationsPotential Difficulties/Limitations Alternative approachesAlternative approaches

Justify everythingJustify everything including number of animals, including number of animals, assays, statistical analysis, timetable and that you assays, statistical analysis, timetable and that you have experience and expertise needed.have experience and expertise needed.

General Issues

Attention to detailsAttention to details

Layout and formatLayout and format

NIH Support of New Investigators ImplementationImplementation

Review groups received orientation during the Review groups received orientation during the 1998 review round . They are reminded each 1998 review round . They are reminded each review round.review round.

Reviewers are informed of the “New” Reviewers are informed of the “New” investigator “ definition and honor the investigator “ definition and honor the guidelines.guidelines.

Review groups are provided with a list of first-Review groups are provided with a list of first-time applicants with review assignments and at time applicants with review assignments and at review.review.

Common Problems with Applications Overly ambitiousOverly ambitious Lack of innovationLack of innovation Lack of linkage to human health problemLack of linkage to human health problem Lack of focused/mechanistic hypothesisLack of focused/mechanistic hypothesis Lack of focused aims that will prove and only prove the Lack of focused aims that will prove and only prove the

hypothesishypothesis Unfocused research plan that does not test feasibilityUnfocused research plan that does not test feasibility Questionable reasoning in approachQuestionable reasoning in approach Lack of experimental detailLack of experimental detail Lack of experience with methodsLack of experience with methods

Grantsmanship Guidance at NIH

http://http://www.niaid.nih.gov/ncn/grants/default.htmwww.niaid.nih.gov/ncn/grants/default.htm

http://grants1.nih.gov/grants/funding/sbir_policy.htmhttp://grants1.nih.gov/grants/funding/sbir_policy.htm

http://grants1.nih.gov/grants/funding/sbirgrantsmanship.pdfhttp://grants1.nih.gov/grants/funding/sbirgrantsmanship.pdf

http://niaid.nih.gov/ncn/sbir/advice/advice.pdfhttp://niaid.nih.gov/ncn/sbir/advice/advice.pdf

What is Grants.gov?

The Federal government’s single, online portal for any person, business, or State, Local and Tribal government to to electronically:electronically:Find Grant OpportunitiesApply for Grants

A cross-agency initiative involving

900 grant programs

26 grant-making agencies

Over $350 billion in annual awards

Posting Funding Opportunity Announcements on Grants.gov

Funding opportunities will continue to be Funding opportunities will continue to be posted in the NIH Guide and Contracts as usual.posted in the NIH Guide and Contracts as usual.

NIH will continue to use RFAs and PAs, but NIH will continue to use RFAs and PAs, but all solicitations will be referred to as all solicitations will be referred to as funding opportunity announcementsfunding opportunity announcements in in Grants.gov.Grants.gov.

They will simultaneously be posted to They will simultaneously be posted to Grants.gov by OER staff along with the Grants.gov by OER staff along with the appropriate application package.appropriate application package.

NIH’s Electronic Receipt Goal

By the end of May 2007, NIH plans to:

1. Require electronic submission through Grants.gov for all NIH grant applications

2. Transition from the PHS 398 application form to SF424 family of forms data set SF424 Research and Research-Related (SF424

(R&R))

Announced in the NIH Guide, Aug. 19, 2005:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-067.html

Electronic Receipt: How it works

ApplyingApplying for Grants at Grants.gov: for Grants at Grants.gov:

After finding the grant opportunity on Grants.gov:After finding the grant opportunity on Grants.gov:

Step 1: Download the grant application package. Step 1: Download the grant application package. (PureEdge Software required to view.)(PureEdge Software required to view.)

Step 2: Complete the application.Step 2: Complete the application.

Step 3: Submit the application to Grants.gov. Step 3: Submit the application to Grants.gov. (Processed through Authorized Organizational (Processed through Authorized Organizational Representative (AOR)).Representative (AOR)).

Step 4: Track the status of the submitted application Step 4: Track the status of the submitted application package you are notified it has been retrieved by NIH.package you are notified it has been retrieved by NIH.

Electronic Receipt: How it works

Step 5: eRA software checks the application against NIH Step 5: eRA software checks the application against NIH business rules.business rules.

Step 6: NIH notifies PI and Signing Official via email to Step 6: NIH notifies PI and Signing Official via email to check the eRA Commons for results of NIH rule checking.check the eRA Commons for results of NIH rule checking.

Step 7: If the application passes NIH rules, SF424 (R&R)-Step 7: If the application passes NIH rules, SF424 (R&R)-based grant image appears.based grant image appears. Principal Investigator (PI) and Signing Official (SO) Principal Investigator (PI) and Signing Official (SO)

review application.review application.If acceptable, the application is accepted in 24 hrs in

Commons.If not, the PI or SO rejects the application in

Commons, makes changes and resubmits via Grants.gov

Electronic Receipt: How it works

ApplyApply for Grants (cont.): for Grants (cont.):

Step 8: If application does not pass NIH Step 8: If application does not pass NIH rules, errors and warnings are listed.rules, errors and warnings are listed.

Fix errors and resubmit to Grants.govFix errors and resubmit to Grants.gov

Step 9: After verification, data and grant Step 9: After verification, data and grant image are saved and application begins image are saved and application begins getting processed by NIH staff.getting processed by NIH staff.

71

2006

NIH Timeline:Submission of Grant Applications through Grants.gov

Using SF424 Family of Grant Application Forms

Submit R01 via Grants.gov (2/1/07)

Submit R03, R21 & R33 via Grants.gov (6/1/06)

APR FEB MARMAY JUN JUL AUG SEP OCT NOV APRDEC JAN MAY JUN JUL AUG SEP

2007

APPLICATION, REVIEW, and AWARD

University Researcher

National Institutes of Health

Applicant InitiatesResearch Idea

Conducts Research

AllocatesFunds $$

Institute Director

Center for Scientific Review

Assign to IC and IRG

Scientific Review Group

Review for Scientific Merit

Institute

Evaluate for Relevance

Advisory Council or Board

Recommends Action

Takes final action for NIH Director

SubmitsGrant

Application

~2-3 monthsafter submission

~2-3 months

after review