1. Tips on Writing Basic Research Grants John S. Adams, M.D. Burns and Allen Research Institute & General Clinical Research Center (GCRC) Cedars-Sinai Medical UCLA David Geffen School of Medicine

2. Experience 1987-91V.A. Career Development Study Section 1994-96NIH Orthopedic Study Section, ad hoc 1997-01NIH Orthopedic Study Section 1997-01NIH, OBM Study Section, special emphasis panels 1992-presGCRC grant author and reviewer K30 curriculum developer K23 and T32 program director

3. Agenda tips for success –know the process and players –get and use a grant-writing mentor resubmission process –“pink sheet” analysis –crafting and effective Introduction

4. Timeline of Events Months 0154328769 OCT NOVMAR FEB JANDEC JUNMAYAPR JUL submission IRG (study section) assignment study section review supplementary material to SRA scoreresubmission Council revision “pink sheets”

5. Imperatives Recognize your strengths and weaknesses. Know your audience; all study section members vote on your proposal. key concepts –significance –innovation –hypothesis-driven Start from scratch; no “cutting & pasting allowed.

6. Composition Tips “trip to the zoo” approach –tell the reader a story –directed –connected use pictures for concept expression “model” human experiments –in animals –in vitro

7. Timeline of Events Months 0154328769 OCT NOVMAR FEB JANDEC JUNMAYAPR JUL submission IRG (study section) assignment study section review supplementary material to SRA scoreresubmission Council revision “pink sheets”

8. Study Section Assignment Comes from the DRG (Division of Research Grants) Arrives within 2-4 weeks of submission deadline Provides study section (initial review group; IRG) assignment Assigns an IRG contact person; usually the SRA (senior review administrator) of the study section Provides Institute assignment Could be assigned to 2 or even more institutes

9. Study Section Assignment

10. Timeline of Events Months 0154328769 OCT NOVMAR FEB JANDEC JUNMAYAPR JUL submission IRG (study section) assignment study section review supplementary material to SRA scoreresubmission Council revision “pink sheets”

11. Date:04/23/02 To:Dr. Adams: From:Office of Extramural Research Subj:Application Number: 2R01AR/AG46231-03 Program Code 6 B Application 2R01AR/AG46231-03 entitled: OSTEOINDUCTIVE GENE EXPRESSION -ARTERIAL CALCIFICATION completed the first phase of peer review and received a priority score of 350 and a percentile of 63.9. A Summary Statement, containing evaluative comments andbudget recommendations, will be sent to you in approximately eight weeks. After receiving your Summary Statement, you may call the program administrator listed below to discuss the contents. Should a revised application be indicated, follow the instructions in thePHS 398 instructions (http://grantsl.nih.gov/grants/funding/phs398/phs398.html). Current NIH policy limits the number of amended versions of an application to two, and that these must be submitted within two years of the date of the original version of the application. Contact: JOAN A. MCGOWAN,PH.D. DIR. BONE DISEASES PROG. & CHIEF, MUSC. DIS. BR. (MDB) NATCHER BLDG, RM 5AS-43E 594-5055 MCGOWANJ@MAIL.NIH.GOV CC: Program Administrator, JOAN A. MCGOWAN,PH.D.

12. Notice of Score Comes from the Institute to which grant assigned Arrives within 2-3 weeks of study section (initial review group; IRG) meeting Provides score and percentile rank Assigns the Institute contact person, usually a Program Administrator cannot contact this person until after receipt of the summary statement Provides approximate time for arrival of the summary statement of “pink sheets”

13. Face sheet Resume and Summary of Discussion Description (applicant’s own words) Critiques Human subjects utilization Animal utilization Budget recommendations Study Section roster Summary Statement or “Pink Sheets”

15. Resume and Summary of Discussion Composed by the Scientific Review Administrator (SRA) of the study section Summarizes –Hypothesis of the proposal –Strengths –Weaknesses –Sentiment of the study section

16. Critiques In order; primary, secondary, tertiary reviewer comments –Can contain a minority opinion Each addresses five issues –Significance –Approach Most extensive, critical review of the science –Innovation –Investigators –Environment Critically important for ‘K’ grantees

17. Adams Method for “Pink Sheet” Analysis Tabulate strengths (black) and weaknesses (red). –Be comprehensive, but –Don’t count the same criticism twice –black to red ratios >1:1; score ≤150 ~1:2; score ≤200 ~1:3; score ≤250 <1:4; score ≤300 <1:5; unscored Most important criticisms are those levied by more than a single reviewer.

18. Black and Red Critique Identification

19. Timeline of Events Months 0154328769 OCT NOVMAR FEB JANDEC JUNMAYAPR JUL submission IRG (study section) assignment study section review supplementary material to SRA scoreresubmission Council revision “pink sheets”

20. Resubmission Due in March, July, or November Uses the 398 format –Contains clearly marked revisions to the original submission Introduction precedes Section A –Limited to two pages –Delineates substance and sites of revisions

21. Your Resubmission Do: Follow 398 instructions precisely. Assume all of the initial study section comments were correct. Respond to all criticisms. Assume the same reviewer(s) will be seeing your revised application. –try to identify “your reviewer(s)” from the summary statement roster –write the resubmission with your reviewers’ research/expertise in mind

22. assume you’re smarter than your reviewers argue with the reviewers in your response Leave out a consideration of any criticism, regardless of how “minor” it might seem to you fail to have your colleague and/or mentor review your revision before resubmission fight with your: –grants and contract officer –IRB office –IACUC representative Your Resubmission Don’t:

23. Writing the Introduction Thank the IRG for their work Begin on a positive note –“Recount” the strengths noted by the IRG “Recount” the weaknesses –Start with most frequently noted and substantial –Move to least common and serious –Identify the site of revisions in response to stated weaknesses End on a positive note

24. Your Resubmission Fatal Flaws Not marking points of revision in your resubmission Writing a “non-responsive” Introduction Writing an antagonistic (i.e. condescending) Introduction Resubmitting before you have the additional preliminary data requested