Grantsmanship and Navigating through the NIH

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Lucy Whitehead
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1 Grantsmanship and Navigating through the NIH Bill Parks Center for Lung Biology Data on grants and federal budget Demographics and funding trends Grant preparation And after lunch, the review process

What s the Big Deal with NIH Grants? The major source of research dollars in US 2003: $27.1 billion 2004: $28.0 billion (+3.1%) 2.7% 2005: $28.6 billion (+2.2%) 3.4% 2006: $28.6 billion (-0.2%) 3.2% 2007: $29.

2 What s the Big Deal with NIH Grants? The major source of research dollars in US 2003: $27.1 billion 2004: $28.0 billion (+3.1%) 2.7% 2005: $28.6 billion (+2.2%) 3.4% 2006: $28.6 billion (-0.2%) 3.2% 2007: $29.2 billion (+2.1%) 2.9% 2008: $29.2 billion (0%) 4.0% 2009: $30.4 billion (+4.1%) -1.3% 2010: $31.0 billion (+2%; +6.2%) The gold standard of extramural funding Essential for advancement and promotion Your salary support Inflation Rate Most important: Indirect Costs: $1 = $0.52

3 Top Recipients of Taxpayers Largesse * 2816 institutions/companies/organizations ranked #2814 ($1): New York City Technical College Stillman College, AL South Bank University, London *~2,000 Submitted

4 Top Recipients 2007

5 NIH Funds at UW 50% of Research Funds at UW Come from the NIH 2008 $1,037 - Total grants and contracts $ Federal funding $ Non-federal funding

6 Most Research Funds Go to the SOM Desperate for more information on UW research funding? Go here:

7 Funds from NIH at UW - Tracks with NIH Budget

8 With Inflation, Funding Value at UW has Decreased

9 National Institutes of Health US Department of Health and Human Services Kathleen Sabelius - H&HS The Boss Francis Collins, MD PhD a former Darwinist and atheist

10 The Bulk (~85%) of the NIH Budget Supports Extramural Research & Training FY2009 President s Budget Request Total NIH Budget Authority $29.2 Billion* Research Mgmt. & Support 3.9% Training 2.7% All Other 5.5% Other Research (Including K Awards) 5.9% Research Centers 9.9% Research Project Grants 52.9% $15.5 Billion R&D Contracts 9.6% Intramural Research 9.7% *~3 days in Iraq

11 NIH Structure Office of the Director National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Institute of General Medical Sciences National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Library of Medicine National Institute of Biomedical Imaging and Bioengineering National Center on Minority Health and Health Disparities NIH Institutes Clinical Center Center for Information Technology Center for Scientific Review No funding authority

12 Appropriations Cancer Heart, Lung & Blood Diabetes, Digestive, Kidney Neurol. Disorders & Stroke Allergy & Infectious Dis. General Med. Sci. Child Hlth. & Human Dev. Deafness & Communication Disorders Research Resources Office of the Director

13 Bye-bye Growth Change in NIH Appropriations, FY % 16% 25 14% 20 12% Appropriations Billions $ 15 10% Percent Change 8% 10 6% 4% 5 2% Pre-Doubling Period of Doubling Post Doubling * 0% Fiscal Year

Growth Wasn t That Great Anyway $30 $25 Billions $20 $15 Current Dollars Constant Dollars $10 $5 $0 2007 2006 2005 2004 2003

14 Growth Wasn t That Great Anyway $30 $25 Billions $20 $15 Current Dollars Constant Dollars $10 $5 $

15 More Applications + Flat Budget = Reduced Paylines

16 NIH Award Mechanisms

17 Award Mechanisms for You Training Awards (Apr 8, Aug 8, Dec 8) F32 (NRSA): 0-7 yrs post MD or PhD Salary support + ~$5K (which UW keeps) Several others 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 75% effort ($75K cap on salary) + $25K supplies K99/R00: Pathway to Independence K: 2 yr, $90K/yr R: 3 yr, $249K/yr Info: Several others Institute-specific rules Loan Repayment:

18 Success Rate of F32 (NRSA) Applications Similar for MDs and PhDs

19 Percent of Fellowships by Institutes % 8% Percent of Awards 6% 4% 2% 0% NIGMS NINR NIEHS NIDCR NIMH NIDCD NICHD NIDDK NHLBI NIBIB NIAMS NCCAM NIAAA NIDA NIA NINDS NCI NIAID NEI NHGRI NCRR Par/cipa/ng NIH Ins/tutes and Centers

20 Success Rates - K08s

K08 Applications and Awards by NIH Institute - 2007 Number of

21 K08 Applications and Awards by NIH Institute Number of Applica/ons/Awards Applica/ons Awards Par/cipa/ng NIH Ins/tutes and Centers

22 More Entry Level Career Awards K08: Mentored Clinical Scientist K23: Mentored Patient-Oriented Research K01: Mentored Research Scientist K25: Mentored Quantitative Research Developmen K99: Pathway to Independence

Grant Preparation Read other applications Seek advice and input Be scholarly Be fastidious Guide your readers by the hand Useful sites for planning: Lots of info and links: http://grants1.nih.

23 Grant Preparation Read other applications Seek advice and input Be scholarly Be fastidious Guide your readers by the hand Useful sites for planning: Lots of info and links: Find and apply: Really good site Detailed, multilevel checklist: Electronic submission: Due Dates: CRISP (Computer Retrieval of Information on Scientific Projects) Database of all NIH grants Know your competition

24 Grant Preparation Formulate your ideas Testable hypothesis that advances a field Generate preliminary data Supports all hypotheses Confirms feasibility Not so critical for F32 (typically comes from the mentor) Publish a paper The importance of this cannot be stressed enough Read successful applications!

25 Grant Preparation (cont) Training potential New directions and technology Develop relationships outside of your immediate lab Mentoring Advisory committee Seek advice Enlist collaborators, consultants Special reagents, techniques, advice Obtain letters Evidence of enhanced training potential Courses and Compliance (if and as needed) Research ethics Biostatistics Animal training & regulation, HIPAA, etc. Specialized courses

26 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 Grant Preparation (cont) Know what Institute to target and what they are in interested in RFA, Program announcements, etc. By Institutes: Total NIH search and more:

27 Grant Preparation (cont) Take care of the administrative stuff Budget and budget justification Human, animal, biohazards approvals (Just in Time) Resources Your statement, experience, transcripts Mentor s statement Experience as a mentor Funding Training plan and career development Co-mentor? Supporting letters (at least 3) Biosketch Separate abstracts/reviews from peer-reviewed, original papers, please. Complete references

28 Grant Preparation (cont) Be aware of the review criteria Candidate (i.e., you) Scholastic performance Research and/or clinical experience Career goals Publications Recommendations Sponsor (mentor) and Training Environment Mentor s track record and funding Make up of the lab (other postdocs, students, etc.) Classes, seminars, journal clubs Collaborators and other labs Tools Research Training Proposal Training Potential Grant sections - Pages: 10 [F32], 15 [K], 25 [R01] Specific Aims Background and Significance Preliminary Data Experimental Plan References, Human subjects, Animals, Letters, etc. Appendix Each section a separate PDF

29 Specific Aims: 1 page Introductory paragraphs State purpose and importance Concise summary of key findings A clearly stated hypothesis: My 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) and advance the field List of aims (3-4) Importance for Reviewers Many say this is the most important section

30 Background and Significance: 2-5 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 are the gaps in our knowledge? What new information will your work provide? Don t be shy Use first-person pronouns (I, we) Show your enthusiasm Know your audience CSR database (see review section below)

31 Preliminary Data: 1-8 pages Summarize relevant experience and contributions OK to use data from mentor s - but give appropriate credit 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 reviewers to make your conclusions! Make figures clear Number the figures Embed figures near text Include legends (but not overly detailed) Do not rely on materials in the appendix

Experimental Plan: 5+ pages This is the meat More narrative than technical For each aim, provide: Rationale Approach Experiments Expected results and interpretation Potential pitfalls and alternative

32 Experimental Plan: 5+ 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 1B 2A 2B 2C 3A 3B 3C 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 Role of matrilysin in ischemia-reperfusion repair Neutrophil activation in vivo Neutrophil binding to KC/syndecan-1 complexes Requirement of syndecan-1 shedding Syndecan-1 association with integrins Binding sites of KC:syndecan-1 interaction Neutrophil activation with disrupted KC/syndecan-1. Inhibit KC/syndecan-1 interaction in vivo

Day, How to Write and Publish a Scientific Paper Paragraphs and spaces Don t make it look overly dense or cluttered Fonts,

33 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 Fonts, margins, etc. Use some system (bold, underline, numbers) to indicate sections and subsections Flow Logical transitions from sentence to sentence, paragraph to paragraph Do the work for your reader

35 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

36 A February 12 Deadline - K08 Jan-Dec: Nov-Jan: Dec: Jan: Feb-Mar: Mar: Apr: Apr: June: May-Jun: Jun: Jul: Sep 1: Think, advice, preliminary data, manuscripts Download forms, write, seek advice, get feedback, rewrite Admin stuff: Budgets, letters, etc. Submit near-completed draft for routing/approval Send to UW Office of Research Sorted by CSR Assigned an unique number: K08-HL Assigned to a Study Section Reviewers picked and assigned by SRA Applications sent to reviewers Supplementary data Study section meets Scores uploaded to era Commons Summary statement uploaded/ ed Institute Council $$$$ or resubmit (now: K08-HL A1)

37 UW - Office of Sponsored Programs UW OSP, with lots of links to grant writing sites:

38 Life after a K08 - Award Mechanisms for Grown-ups 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 yr, renewable, variable budgets Multi-PI Grants Center Grants & Roadmap Initiatives Other mechanisms

39 New and Early Stage Investigators Not previously a PI on any PHS-supported research project other than on Small R-series (R03, R15, R21) Development career awards (K01, K08, and K12). Non-mentored career awards (K02, K04) Details at: Early Stage Investigators Within 10 yrs of terminal degree or completion of medical residency Extensions: injury, birth Breaks for New and Early Stage Investigators Separate payline 5 points higher Fund all years requested Expedited review if missed elevated payline by 5 points or less (i.e., >5-10) Shortened turn-around time for revision: 1 st renewal: payline 5 points higher

40 Number of R-series Awards - New & Established PIs

41 Grant Preparation for R01s Establish your independence Letter from mentor and/or chief/chair confirming this More emphasis on preliminary data and productivity Everything else is about the same

42 Whose Getting the Grants? Middle-age to Old PhDs in Basic Science Departments

43 NIH Applications and Success Rate by Degree

44 NIH Research Awards by Age of PI FY2001

45 A Country for Old Men (and Women) R-series Grants by Age of PI

46 Gender Data

47 Success Rates by Gender

48 Average Age of R-series Awardees

49 Average Age at Time of Appointment to Assistant Professor at US Medical Schools MD/PhD PhD MD

Get a Grant and Retire 1980 2006 Total NIH PIs Number Average Age New NIH PIs Number Average Age Number of Medical School Faculty Positions Average Age of Medical School Faculty

50 Get a Grant and Retire Total NIH PIs Number Average Age New NIH PIs Number Average Age Number of Medical School Faculty Positions Average Age of Medical School Faculty Average Age of First time Assistant Prof , , , , , , ,552 73, ,

Stay in the School of Medicine NIH Success Rate by Departments - 2007 Want

51 Stay in the School of Medicine NIH Success Rate by Departments Want more information on NIH Award stati Go here:

52 How are Grants Reviewed and Evaluated

53 CSR: Center for Scientific Review Receives, assigns and reviews ~80,000/yr 200 SRA (Scientific Review Administrators) ~18,000 reviewers per year >220 Study Sections/Special Emphasis panels 1,800 grant review meetings/yr CSR has no funding authority

54 Study Sections Organized into IRGs (Integrative Review Groups) members, essentially all from academia Plus about another 12+ ad hoc reviewers applications per meeting ~10-14 per member 3 reviewers per applications Information from CSR web site: Study section scope Roster of reviewers Policies Schedules Study sections are advisory - they do not fund applications.

Review Process Applications sent to reviewer 6-8 weeks 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 uploaded up to 2 days beforehand Riveting video of a mock Study Section: http://cms.

55 Review Process Applications sent to reviewer 6-8 weeks 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 uploaded up to 2 days beforehand Riveting video of a mock Study Section:

56 8 am Lower half stream-lined Reviewers state scores 1-9 Adjectives: Exceptional (1) Outstanding (2) Excellent (3) Very Good (4) Good (5) Acceptable (6-7) Find another job (8-9) Discussion min per application Restate scores Budgets and administrative issues Next application 6-7 pm Bar, eat, bar, sleep, repeat next day Review Process

57 Review Criteria Training/Career Development F and K Grants Candidate Sponsor and training environment Training proposal Training potential Investigator Initiated Grants R01s etc. Significance Is the work important, relevant? Will it have an impact? Approach Meat of the critique Design, methods, plans, etc. Innovation Novel concepts and/or approaches Investigator Training and experience Productivity Productivity Environment Institution, facilities

59 Criterion Score New Scoring System Whole numbers: (exception); 9 (um, well let s just hope you never get a 9) Given by reviewers but not discussed at study section Provided in summary statement of all applications (discussed and not discussed) Overall Impact Score Whole numbers: 1-9 Not the mean of the criteria scores Different criteria are weighted by each reviewer Each review recommends a score All committee members score within the range Can vote outside the range, but must state that you are doing so Final Score Mean of all scores x Percentiled against similar applications across 3 meetings Payline Varies among institutes

60 Criteria Scores Score Descriptor Additional Guidance on Strengths/Weaknesses 1 Exceptional Exceptionally strong with essentially no weaknesses 2 Outstanding Extremely strong with negligible weaknesses 3 Excellent Very strong with only some minor weaknesses 4 Very Good Strong but with numerous minor weaknesses 5 Good Strong but with at least one moderate weakness 6 Satisfactory Some strengths but also some moderate weaknesses 7 Fair Some strengths but with at least one major weakness 8 Marginal A few strengths and a few major weaknesses 9 Poor Very few strengths and numerous major weaknesses Minor Weakness: An easily addressable weakness that does not substantially lessen impact Moderate Weakness: A weakness that lessens impact Major Weakness: A weakness that severely limits impact

61 Overall (Impact) Score Impact Score Descriptor Strengths/Weaknesse 1 Exceptional High Impact 2 Outstanding 3 Excellent 4 Very Good Moderate Impact 5 Good 6 Satisfactory 7 Fair Low Impact 8 Marginal 9 Poor Weaknesses

62 Summary Statement

63 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 methodologie 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. Poor training potential

64 Didn t Make It Revised Application One chance only A1, 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 Seek advice

2017 NIH Update. Presented by Stephanie Smith and Stacey Wade

2017 NIH Update. Presented by Stephanie Smith and Stacey Wade 2017 NIH Update Presented by Stephanie Smith and Stacey Wade PRESENTERS Stephanie Smith Post-Award Office of Sponsored Programs Stacey Wade Pre-Award Office of Sponsored Programs NIH INSTITUTES National