Grantsmanship and Navigating through the NIH

William C. ParksCenter for Lung Biology

University of Washington School of Medicine

What’s the Big Deal with NIH Grants?

• The major (though now stagnant) source ofresearch dollars in US• Extramural budget. 2003: $27.173 billion

2004: $28.028 billion (3.1%)2005: $28.644 billion (2.2%)2006: $28.587 billion (-0.2%)2007: $28.587 billion (0%)

• The gold standard of extramural funding

• Essential for advancement and promotion

• Most important: Indirect Costs: $1 = $0.52

Top Recipients of Taxpayers Largesse

• JHU• UW• Penn• UCSF• Science Applications

International Corp.*• Wash U• U Mich• UCLA• Pitt• Duke *1 contract, ~$300 mil

Top 102005

• 2816 institutions/companies/organizations ranked• #2814 ($1): New York City Technical College

Stillman College, ALSouth Bank University, London

*

*~2,000 Submitted

NIH Funds at UW50% of Research Funds at UW Come from the NIH

$989,699,618 - Total grants and contracts$769,677,223 - Federal funding$220,022,394 - Non-federal funding

2006

Desperate for more information onUW Research Funding data?Go here:www.washington.edu/research/statistics.html

The Bulk (>80%) of NIH FundsGo to Extramural Research

IntramuralResearch

9.7%

R&D Contracts9.6%

Research Centers9.9%

Other Research(Including K Awards)

5.9%

All Other 5.5%

Research Mgmt. &Support 3.9%

Training 2.7%

Research ProjectGrants 52.9%

$15.122 Billion

FY2007 President’s Budget RequestTotal NIH Budget Authority

$28.578 Billion

Appropriations

NIH Instituteshttp://www.nih.gov/icd/

Elias A. Zerhouni, M.D

CancerHeart, Lung & Blood

Diabetes, Digestive, Kidney

Allergy & Infectious Dis.Neurol. Disorders & Stroke

Research Resources

General Med. Sci.Child Hlth. & Human Dev.

Deafness & Communication Disorders

Michael Leavitt - H&HS

The Decider

Bye-bye GrowthChange in NIH Appropriations, FY 1995 - 2007

0

5

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15

20

25

30

1995Pre-Doubling

1996 1997 1998Period ofDoubling

1999 2000 2001 2002 2003 2004Post

Doubling

2005 2006 2007*

Fiscal Year

AppropriationsBillions $

0%

2%

4%

6%

8%

10%

12%

14%

16%

18%

PercentChange

Growth Wasn’t That Great Anyway

$30

$25

$20

$15

$10

$5

$0 197719781979

1980

19811982

19831984198519861987

198819891990

19911992

199319941995

1996199719981999

2000200120022003200420052006

2007

Current Dollars

Constant DollarsBillions

More Applications are Being Submitted

New Applications

Revised New Applications

Renewals

Revised Renewals

…and So Success Rates are Dropping…

25.9%27.2%

30.1% 30.9%32.0% 32.0% 31.7%

30.6% 30.2%

25.5%

22.7%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

SuccessRate

… and Pay Lines Sink

Pay Lines at NIGMS

Whose Getting the Grants?

Middle-age to Old PhDs inBasic Science Departments

NIH Applications and Success Rate by Degree

NIH Research Awards by Age of PIFY2001

NIH R-series Grants by Age of PI

Average Age of R-series Awardees

Average Age at Time of Appointment toAssistant Professor at US Medical Schools

32

33

34

35

36

37

38

39

40

41

42

1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004

MDPhD

MD/PhD

Want more information on NIH Award statistics?Go here: http://grants.nih.gov/grants/award/award.htm

NIH Success Rate by Department

Award Mechanisms

• Training Awards (Apr 8, Aug 8, Dec 8)• F32 (NRSA): 0-7 yrs post MD or PhD

• Career Development Awards (K’s) (Feb 12, Jun 12, Oct 12)• K01: Mentored Research Scientist (Ph.D.)• K08: Mentored Clinical Scientist (M.D., M.D./Ph.D.)• K23: Mentored Patient-Oriented Research• K99/R00: Pathway to Independence

• K: 2 yr, $90K/yr• R: 3 yr, $249K/yr• Info: http://grants1.nih.gov/grants/guide/pa-files/PA-06-133.html

• Others• Institute-specific rules.

• Loan Repayment: http://www.lrp.nih.gov/

Award Mechanisms

• Investigator Initiated Awards (Feb 5, Jun 5, Oct 5)• R03: Small Research Grants - innovative, high-risk ($50K/yr, 2 yr)• R21/R23: Exploratory and Development Grants• R01: Independent Research Grants - 3-5 yr, renewable, variable budgets• Multi-PI Grants

• Center Grants & Roadmap Initiatives

• Useful site: http://grants1.nih.gov/grants/oer.htm

• Submission deadlines:http://grants1.nih.gov/grants/funding/submissionschedule.htm

New Investigators

• Not previously a PI on any PHS-supported researchproject other than on a• Small R-series (R03, R15, R21)• Development career awards (K01, K08, and K12).• Non-mentored career awards (K02, K04)• Details at: http://grants.nih.gov/grants/new_investigators/• Also: http://grants.nih.gov/grants/new_investigators/resources.htm

• Breaks for Young Investigators• Separate payline 5 points higher• Fund all 5 years• Expedited review if missed payline by 5 points or less• Shortened turn-around time for revision:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-013.html

NIH Support of 1st Time Investigators

NIH Competing R01/R29 awards to individuals without prior research grant support

1 3 53 1 28 414 07 1 43 9 15 1 1 1 5 32 15 4 3 1 5 59 1 64 3

14 92 1 49 2

0

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1400

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200019

95Pr

e-do

ublin

g

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1997

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Perio

d of

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blin

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2004

Post

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2005

Fiscal Year

Number ofAwards

Grant Preparation

• Read other applications• Seek advice and input• Be scholarly• Be fastidious• Guide your readers by the hand

Grant Preparation

• Formulate your ideas: testable hypothesis that advances a field• Establish your independence (R series)

• Letter from mentor and/or chief/chair confirming this

• Generate preliminary data• Supports all hypotheses• Confirms feasibility

• Seek mentoring and advice• Advisory committee• Read successful applications!• Seek advice

• Enlist collaborators, consultants• Special reagents, techniques, advice• Obtain letters

Grant Preparation (cont)

• Think

• Know the literature & be critical• Issues• Controversies• Unfounded dogma• What gaps will your work fill?

• Give yourself plenty of time

• Don’t submit until ready

• Know what Institute to target and what they are in interested in• RFA, Program announcements, etc.• By Institutes: http://www.nih.gov/icd/

• Total NIH search and more: http://www.grants.gov/

• CRISP (Computer Retrieval of Information on Scientific Projects)• Know the competition• http://crisp.cit.nih.gov/crisp/crisp_query.generate_screen

Really good site

Grant Preparation (cont)

• Start writing• Take care of the administrative stuff

• Budgets and justification• Human, animal, biohazards approvals (Just in Time)• Resources• Supporting letters• Biosketch

• Separate abstracts/reviews from papers, please.

• Grant sections (15 [K] - 25 [R01] pages)• Specific Aims• Background and Significance• Preliminary Data• Experimental Plan• References cites, Human subjects, Animals, etc.

• Grants.gov• http://www.grants.gov/• http://era.nih.gov/ElectronicReceipt/

Each section aseparate PDF

Specific Aims: 1 page

• Introductory paragraphs• State purpose and importance• Concise summary of key findings• A clearly stated hypothesis: “Our hypothesis is…”

• Be clear and mechanistic• Don’t be obvious or tautological: “…the cytoskeleton is important for cell structure.”

• Relate how aims will address the big picture (long-term goals) andadvance the field

• List of aims (3-4)

• Importance for Reviewers• Many say this is the most important section

Background and Significance: 3-5 pages

• Critically review the literature• No limit on number of citations• Original papers over reviews• Do not be afraid to say you disagree with something (but explain why and how

you will correct this travesty)• Question dogma• Limit discussion to things (pathways, diseases, molecules, etc.) you will study• Justify your overall experimental approaches and models• Provide graphics (cartoon, model, pathways, etc.)

• What new information will your work provide?

• Don’t be shy• Use first-person pronouns (I, we)

• Show your enthusiasm

• Know your audience• CSR databases (below)

Preliminary Data: 4-8 pages

• Summarize relevant experience and contributions

• Provide interesting data

• Demonstrate your ability to do things

• Demonstrate feasibility of doing new things

• Critically interpret your own data - say what it means• Thus, these data indicate…• Do not expect your review to make your conclusions!

• Make figures clear

• Number the figures

• Embed figures near text

• Include legends (but not overly detailed)

Experimental Plan: 10+ pages

• This is the meat• More narrative than technical• For each aim, provide:

• Rationale• Approach• Experiments• Expected Results and interpretation• Potential pitfalls and alternative strategies• Future directions (short)

• Quantification and statistics• Methods

• Justify selection of techniques• Detailed methods are boring, but…• Give priority to new or difficult methods• Kit Rule

Aim Description YR 1 YR 2 YR 3 YR 4 YR 5

1A Role of matrilysin in ischemia-reperfusion repair

1B Neutrophil activation in vivo

2A Neutrophil binding to KC/syndecan-1 complexes

2B Requirement of syndecan-1 shedding

2C Syndecan-1 association with integrins

3A Binding sites of KC:syndecan-1 interaction

3B Neutrophil activation with disrupted KC/syndecan-1.

3C Inhibit KC/syndecan-1 interaction in vivo

• Priorities• Time line at the end of this section

• Logical flow from aim to aim• Caution: do not make an aim

dependent on a preceding aim

Presentation and Style

• Clean, concise English• Grammar and syntax• Active vs. passive voice• Avoid pleonasms: “…has been shown to…”• Read: Strunk and White, The Elements of Style• Read: Robert A. Day,

How to Write and Publish a Scientific Paper

• Paragraphs and spaces• Don’t make it look overly dense or cluttered

• Flow• Logical transitions from sentence to sentence, from

paragraph to paragraph• Do the work for your reader

Presentation and Style

• Zero tolerance for typos• Figures should be self explanatory

• Legends• Label the X and Y axes• Point to or demarcate key features

• Avoid excessive abbreviations• Avoid vague terms: e.g., ‘affects’, ‘influences’• Cite complete references• Take the reviewer by the hand

• Don’t make them think• Don’t require them to look elsewhere for information

• Look at successful applications

A February 12 Deadline - K08• Jan - Dec: Think, advice, preliminary data, manuscripts• Nov - Jan: Download forms, write, seek advice, get feedback• Late Dec, Early Jan: Admin stuff: Budgets, letters, etc.

Submit near-completed draft for routing/approval• Late Jan: Send to UW Office of Research• Feb - Mar: Sorted by CSR

• Assigned an unique number: K08-HL077765-01• Assigned to a Study Section

• Feb-Mar: Reviewers picked and assigned by SRA• Early Apr: Applications sent to reviewers• Late Apr: Supplementary data• May: Study section meets• May-June: Scores sent to applicant• June: Summary statement sent to applicant• July: Institute Council• Sept 1: $$$$ or resubmit (now: K08-HL077765-01A1)

UW - Office of Sponsored Programs

UW OSP: http://www.washington.edu/research/osp/index.php

CSR: Center for Scientific Review

• Receives, assigns and reviews• 64,178 in FY2003 (70% of total)• 200 SRA (Scientific Review

Administrators)• ~11,000 reviewers per year• ~220 Study Sections/Special

Emphasis panels

Study Sections

• Organized into IRGs (Integrative Review Groups)• 12-24 members, essentially all from academia

• Plus about another 12+ ad hoc reviewers

• 60-100+ applications per meeting• ~10-14 per member• 3-4 or 5 reviewers per applications

• Information from CSR web site: http://cms.csr.nih.gov/• Study section scope• Roster of reviewers• Policies• Schedules

Why Join a Study Section?

Review Process

• Applications sent to reviewer 6-8weeks before the meeting

• Streamlining• 1-2 weeks before, grants in the “lower

half” are identified• Streamlined grants are triaged, i.e., not

discussed

• Written critiques/scores uploadedup to 2 days beforehand

• Riveting video of a mock Study Section:http://cms.csr.nih.gov/ResourcesforApplicants/InsidetheNIHGrantReviewProcessVideo.htm

Review Criteria

• Significance• Is the work important, relevant?• Will it have an impact?

• Approach• Meat of the critique• Design, methods, plans, etc.

• Innovation• Novel concepts, methods, and/or approaches

• Investigator• Training and experience• Productivity• Productivity

• Environment• Institution, facilities

Review Process

• 8 am• Done alphabetically or by institute• Lower half stream-lined• Reviewers state scores

• 1.0 - 5.0• Adjectives:

• Outstanding (1.0 - 1.5)• Excellent (1.5 - 2.0)• Very Good (2.0 - 2.5)• Good (2.5 - 3.0)• Acceptable (3 - 4)• Find another job (4 -5)

• Discussion• 15-20 min per application

• Restate scores• Budgets and administrative issues• Next application• 6-7 pm• Bar, eat, bar, sleep, repeat next day

Scores and Summary Statement

• Priority score: mean of all scores• Percentile

• Relative rank within a Study Section• Averaged over 3 meetings.

• Pay line• Varies among institutes• ~14% at NHLBI (19% for new invest.)• http://www.aecom.yu.edu/ogs/NIHInfo/paylines.htm

0

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Priority Score

Top Reasons Why Grants Don’t Get Funded

1. Lack of new or original ideas.

2. Diffuse, superficial, or unfocused research plan.

3. Lack of knowledge of published, relevant work.

4. Lack of preliminary data and/or experience with essential methodologies.

5. Uncertainty concerning future directions (where will it lead?).

6. Questionable reasoning in experimental approach.

7. Absence of an acceptable scientific rationale.

8. Unrealistically large amount of work.

9. Lack of sufficient experimental detail.

Didn’t Make It

• Revised Application• A1, A2, then new proposal

• Consider the critique (without emotion)• Address concerns in an Introduction

• 1-2 pages before Specific Aims• Be agreeable but not obsequious• Be firm but not confrontational

• Do not re-submit until all is in order• Avoid the A2 Curse• How long is too long?

• Seek advice