Dr. William Parks_Tactical Approach Parks.pptx

Dr. William Parks: A Tactical Approach to Writing Your Grant Application.

1. William Parks, PhD Department of Medicine Cedars-Sinai Medical Center A Tactical Approach to Preparing Your Grant Application

2. Topics Emphasis on an NIH R01 Submission Preparation and Timelines Reviewers and Review Criteria Investigator Criterion, ESI Presentation Tips Institute Assignment Study Section Assignment You ➜ ➜ ➜ NIH ➜ ➜ Reviewers ➜ Back to You OCGA ORA Grant Admin

3. My Central Recommendations Read other grant proposals – both successful and unsuccessful Become familiar with the grant-submission process, rules, and deadlines Both NIH and Your Institution’s Rules Give yourself plenty of time Get as much admin stuff – letters, budget, forms etc. – done early Get feedback from your mentor, mentoring committee, other faculty, your peers, and this and other workshops

4. Preparation and Timelines Institute Assignment Study Section Assignment You ➜ ➜ ➜ CSR ➜ ➜ Reviewers ➜ Back to You OCGA ORA Grant Admin

5. How to Submit your Application Be familiar with NIH rules, forms, etc. Identify your group’s grant administrator Tell this person that you plan to submit an R01 for Feb 2025 Do this 2-3 months – if not longer – ahead of the due date Important: You are not the only one submitting a grant Email your documents to your grant admin person Grant admin uploads components and builds application Institution uploads to grants.gov

6. Grant Preparation: NIH Things to do Well in Advance Familiarize yourself with NIH grants, forms, instructions, and due dates Grants & Funding: https://www.nih.gov/grants-funding PAs for All Grants: https://grants.nih.gov/grants/guide/parent_announcements.htm NIH Forms: http://grants.nih.gov/grants/forms.htm Page Limits: https://grants.nih.gov/grants-process/write-application/how-to-apply-application-guide/page-limits Due Dates: https://grants.nih.gov/grants-process/submit/submission-policies/standard-due-dates Instructions and more: https://grants.nih.gov/grants/how-to-apply-application-guide.html Lots more here: https://grants.nih.gov/grants-process Know what Institute to target and what they are in interested in RFA, Program announcements, etc.: https://grants.nih.gov/funding/searchguide/index.html#/ By Institutes: http://www.nih.gov/icd/ Know your competition RePORT (Research Portfolio Online Reporting Tools): http://report.nih.gov/ Database of all NIH grants, success rates, and much more Good video on some grant preparation tips: http://www.youtube.com/watch?v=lAOGtr0pM6Q

7. Get the NIH Instructions Download Research Instructions Go here: https://grants.nih.gov/grants/how-to-apply-application-guide.html

8. Instructions

9. Instructions Research Plan

10. Parent Announcements – A Very Useful Site https://grants.nih.gov/grants/guide/parent_announcements.htm All Grants:

11. NIH Dates for New (A0) R01s in 2025 Feb 5 Jan 29 June Sept Dec June 5 May 29 Oct Jan Apr Oct 5(6) Sept 29 Feb May July • OCGA* (UCLA) or ORA** (CS) submits your application to Grants.gov • Your submission deadline to them is 5 (UCLA) or 3 (CS) business days before the NIH due date . *Office of Contract and Grant Administration **Office of Research Administration  NIH Due Dates NIH Submission Due Date UCLA Due Date # Study Section Review Council Review Funding Begins UCLA Due Dates #Estimates; actual dates are posted quarterly

12. Timeline for a Feb 5, 2025, Submission Dec 2025 Funded! Good Score Submit Reviewed Think Plan Data Write Feedback Re-write Admin Stuff Feb (Jan) 2025 Summer/Fall 2024 Oct to Jan 2024/25 Jun 2025

13. Timeline for a Feb 5, 2025, Submission Oct 2025 Feb 2026 Jul 2026 Funded! Fair Score Resubmit Re- reviewed Realistically a 2-year + Process Good Score Submit Think Plan Data Write Feedback Re-write Admin Stuff Critique 2-3 weeks later Reviewed Feb (Jan) 2025 Summer/Fall 2024 Oct to Jan 2024/25 Jun 2025

14. Grant Preparation - Things to do Well in Advance Give yourself plenty of time Form a mentoring committee 3-5 members who have grants Present your ideas and aims to your colleagues Do this more than once Do not ask them to review your aims, proposal 3 days before the due date! Formulate your ideas and think Testable hypothesis that advances a field Know the literature & be critical Issues and controversies What gaps will your work fill Generate preliminary data Support all hypotheses Confirms feasibility Publish Read successful applications Enlist collaborators, consultants Special reagents, techniques, advice Obtain letters Take care of the administrative stuff Budgets Human subjects, animals, biohazards, etc.

15. R01 Grant Sections Face Page Table of Contents Performance Site Project Description: Abstract Project Narrative: 2 sentences References Cited Facilities and Other Resources Equipment Key Personnel Biosketches Budget (all years) Budget Justification Introduction (resubmission only) Specific Aims Research Strategy Significance Innovation Approach Protection of Human Subjects Women & Minorities Planned Enrollment Table Children Vertebrate Animals Select Agents Multiple PI Plan Letters of Support Data Management & Sharing Authentication of Key Biological and/or Chemical Resources PHS Assignment Form

16. R01 Grant Sections You Prepare or Obtain Face Page Table of Contents Performance Site Project Description: Abstract Project Narrative: 2 sentences References Cited Facilities and Other Resources Equipment Key Personnel Biosketches Budget (all years) Budget Justification Introduction (resubmission only) Specific Aims Research Strategy Significance Innovation Approach Protection of Human Subjects Women & Minorities Planned Enrollment Table Children Vertebrate Animals Select Agents Multiple PI Plan Letters of Support Data Management & Sharing Authentication of Key Biological and/or Chemical Resources PHS Assignment Form

17. R01 Grant Sections That are Easy Face Page Table of Contents Performance Site Project Description: Abstract Project Narrative: 2 sentences References Cited Facilities and Other Resources Equipment Key Personnel Biosketches Budget (all years) Budget Justification Introduction (resubmission only) Specific Aims Research Strategy Significance Innovation Approach Protection of Human Subjects Women & Minorities Planned Enrollment Table Children Vertebrate Animals Select Agents Multiple PI Plan Letters of Support Data Management & Sharing Authentication of Key Biological and/or Chemical Resources PHS Assignment Form

18. R01 Sections That Do/May Not Differ Much Among Applications Face Page Table of Contents Performance Site Project Description: Abstract Project Narrative: 2 sentences References Cited Facilities and Other Resources Equipment Key Personnel Biosketches Budget (all years) Budget Justification Introduction (resubmission only) Specific Aims Research Strategy Significance Innovation Approach Protection of Human Subjects Women & Minorities Planned Enrollment Table Children Vertebrate Animals Select Agents Multiple PI Plan Letters of Support Data Management & Sharing Authentication of Key Biological and/or Chemical Resources PHS Assignment Form

19. R01 Grant Sections That Require the Most Effort Face Page Table of Contents Performance Site Project Description: Abstract Project Narrative: 2 sentences References Cited Facilities and Other Resources Equipment Key Personnel Biosketches Budget (all years) Budget Justification Introduction (resubmission only) Specific Aims Research Strategy Significance Innovation Approach Protection of Human Subjects Women & Minorities Planned Enrollment Table Children Vertebrate Animals Select Agents Multiple PI Plan Letters of Support Data Management & Sharing Authentication of Key Biological and/or Chemical Resources PHS Assignment Form

20. NIH Grant Review Process How Your Application is Evaluated What Matters to the Reviewers Institute Assignment Study Section Assignment You ➜ ➜ ➜ NIH ➜ ➜ Reviewers ➜ Back to You OCGA ORA Grant Admin

21. National Institutes of Health

22. NIH Institutes and Year Established http://www.nih.gov/icd/ Office of the Director AIDS Research Women’s Health National Institute on Alcohol Abuse and Alcoholism 1970 National Inst of Arthritis, Musculo- skeletal & Skin Dis 1986 National Cancer Institute 1937 National Institute of Diabetes and Digestive and Kidney Diseases 1950 National Institute of Dental and Craniofacial Research 1948 National Institute on Drug Abuse 1974 National Institute of Environmental Health Sciences 1969 National Institute on Aging 1974 National Institute of Child Health and Human Development 1962 National Institute on Deafness and Other Communi - cation Disorders 1988 National Eye Institute 1968 National Human Genome Research Institute 1989 National Heart, Lung, and Blood Institute 1948 National Institute of Mental Health 1949 National Institute of Neurological Disorders and Stroke 1950 National Institute of General Medical Sciences 1962 National Institute of Nursing Research 1986 National Library of Medicine 1956 Center for Information Technology 1964 Center for Scientific Review 1946 National Center for Complementary & Integrative Health 1999 National Institute of Allergy and Infectious Diseases 1948 Fogarty International Center 1968 National Center for Advancing Translational Sciences 2011 Clinical Center 1953 National Institute of Biomedical Imaging & Bioengineering 2000 National Center on Minority Health and Health Disparities 2010

23. Who’s Responsible for Review of Your Application? All use the same mechanism and structure Peer-review at a Study Section Training/Career Grants Institute Specific Councils $$

24. The Fate and Evaluation of Your Proposal Pretty dull and needlessly long video of this topic http://www.youtube.com/watch?v=DuuAGROm_1Q&feature=relmfu Your can influence this process Institute Assignment Study Section Assignment You ➜ ➜ ➜ CSR ➜ ➜ Reviewers ➜ Back to You Suggest Institute assignment Suggest Study Section Identify conflicts Identify areas of needed expertise Do not recommend specific reviewers PHS Assignment Form OCGA ORA Grant Admin

25. Who Do You Call? Institute based Before submission After initial (study section) review Has influence on funding Tracks progress Program Officer (PO) Scientific Review Officer (SRO) CSR (mostly) or institute based Manages the study section and review During initial review stage Has no influence on funding PO SRO Submit to NIH Grant Preparation Resubmit to NIH 2 nd Review Funded 1 st Review PO

26. Study Sections CSR: Center for Scientific Review ~50,000 applications per year (77% of all applications) Study Sections (>200) Organ or disease focused ~24 members per study section essentially all from academia 40-90 applications per Study Section meeting 3 reviewers per applications 10-12 applications per member (>240 pages/reviewer) Information at the CSR web site Study section scope and policies Roster of reviewers Schedules Study sections are advisory - they do not fund applications. More videos: https://public.csr.nih.gov/NewsAndPolicy/PeerReviewVideos

27. Review Criteria and Scoring

28. How Your Application is Scored and Ranked Criterion Scores Overall Impact Score – this is the one that matters Two Components

29. Scored Review Criteria Individual Training F-series Grants Candidate Career development plan Career goals and objectives Plan to provide mentoring Research Plan Mentor(s), consultants, collaborators Environment & Institutional commitment Career Development K-series Grants Investigator Initiated R-series Grants Significance* Investigator* Approach* Innovation Environment Focus on training potential Focus on the science and you *Most important Candidate Training Potential Research Plan Mentor(s), consultants, collaborators Environment & Institutional commitment

30. Scored Review Criteria – R Proposals Criterion Score Whole numbers: 1-9 1 (exceptional); 9 (um, well let ’ s just hope you never get a 9) Significance Investigator Approach Innovation Environment

31. Scored Review Criteria – R Proposals Overall Impact Criterion Score Whole numbers: 1-9 1 (exceptional); 9 (um, well let ’ s just hope you never get a 9) Overall Impact Score Not the mean of the criteria scores – but within their range Different criteria are weighted by each reviewer Significance Investigator Approach Innovation Environment

32. Scored Review Criteria – R Proposals Overall Impact Criterion Score Whole numbers: 1-9 1 (exceptional); 9 (um, well let ’ s just hope you never get a 9) Overall Impact Score Not the mean of the criteria scores – but within their range Different criteria are weighted by each reviewer Significance Investigator Approach Innovation Environment 4 2 4 6 2 2-6

33. Scored Review Criteria – R Proposals Overall Impact Criterion Score Whole numbers: 1-9 1 (exceptional); 9 (um, well let ’ s just hope you never get a 9) Overall Impact Score Not the mean of the criteria scores – but within their range Different criteria are weighted by each reviewer Final Impact Score, Percentile All Study Section members provide a score Mean of all scores x 10 ➤ 10 – 90 Ranked among all applications across 3 meetings Institute paylines are based on percentile Significance Investigator Approach Innovation Environment

34. Review Process

35. Review Process - Before the Meeting Applications available to all Study Section members about 6 weeks before meeting Except conflicts Scores and critiques are uploaded 1 week before study section Each criterion is given a score These are not discussed at the Study Section But they are included in the Summary Statement you will get Each reviewer gives each application an overall Impact Score Impact Score is the only score that is discussed Initial scores and critiques become available to all committee members Based on the mean of the initial impact scores by the 3 reviewers, lower 50% are not discussed

36. The Review Process - at the Meeting Good video of a mock Study Section https://www.youtube.com/watch?v=fBDxI6l4dOA Review Grants - random order Assigned reviewers state their initial impact scores: 1, 2, 3…9 1˚ reviewer, 2˚, 3˚, then open for discussion Human subj, vertebrate animals, etc. All members vote (score) Budget, others 15-20 min per application Begin at 8 am EST (i.e., 5 am PST) Cramped room full of laptops and several jet-lagged reviewers

37. Review Criteria

38. Review Criteria – Useful Links https://grants.nih.gov/policy/peer/reviewer-guidelines.htm https://grants.nih.gov/grants/guide/parent_announcements.htm All Grants Rigor & Reproducibility https://grants.nih.gov/policy/reproducibility/index.htm https://grants.nih.gov/grants/peer/guidelines_general/Reviewer_Guidance_on_Rigor_and_Transparency.pdf Documents and Instructions for Reviewers

39. Review Criteria https://grants.nih.gov/grants/guide/parent_announcements.htm All Grants: Read these sections R01

40. R01 Grant Sections Face Page Table of Contents Performance Site Project Description: Abstract Project Narrative: 2 sentences References Cited Facilities and Other Resources Equipment Key Personnel Biosketches Budget (all years) Budget Justification Introduction (resubmission only) Specific Aims Research Strategy Significance Innovation Approach Protection of Human Subjects Women & Minorities Planned Enrollment Table Children Vertebrate Animals Select Agents Multiple PI Plan Letters of Support Data Management & Sharing Authentication of Key Biological and/or Chemical Resources PHS Assignment Form

41. R01 Grant Sections Reviewers Care About Face Page Table of Contents Performance Site Project Description: Abstract Project Narrative: 2 sentences References Cited Facilities and Other Resources Equipment Key Personnel Biosketches Budget (all years) Budget Justification Introduction (resubmission only) Specific Aims Research Strategy Significance Innovation Approach Protection of Human Subjects Women & Minorities Planned Enrollment Table Children Vertebrate Animals Select Agents Multiple PI Plan Letters of Support Data Management & Sharin g Authentication of Key Biological and/or Chemical Resources PHS Assignment Form

42. R01 Grant Sections Reviewers Really Care About Face Page Table of Contents Performance Site Project Description: Abstract Project Narrative: 2 sentences References Cited Facilities and Other Resources Equipment Key Personnel Biosketches Budget (all years) Budget Justification Introduction (resubmission only) Specific Aims Research Strategy Significance Innovation Approach Protection of Human Subjects Women & Minorities Planned Enrollment Table Children Vertebrate Animals Select Agents Multiple PI Plan Letters of Support Data Management & Sharin g Authentication of Key Biological and/or Chemical Resources PHS Assignment Form

43. Review Criteria - Investigator Early Stage Investigators (ESI) Within 10 years of terminal training PhD: clocks starts on the day you defended MD: last day of fellowship ESIs get a bit of break with productivity – but just a bit Quality and relevance of publications are important criteria Reality : Numbers and quality do matter. Your competition may have more. Pay line handicap varies by institute https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-101.html https://grants.nih.gov/policy/early-investigators/index.htm https://grants.nih.gov/grants/esi-status.pdf

44. ESI Success Rates = Established PI Success Rates New (First Time) Established NIH Data Book No Difference by Gender

45. Review Criteria - Investigator Not a review criterion Does not affect scoring Cannot even be discussed NIH/CSR Rules Independence Reality However, it is in the reviewer’s mind If you remain associated with your mentor, include a letter from him/her confirming your independence My Advice: Do not include your mentor as key personnel Do not say your lab space is in their lab space Get a letter from your chair indicating commitment to you

46. Presentation

47. Formatting For sections you prepare MS Word.docx 0.5-in margins 11 pt Arial No header or footer Submit to grant admin as PDFs Guide: https://grants.nih.gov/grants/how-to-apply-application-guide.html#format Fonts: https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/format-attachments.htm Page Limits: https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/page-limits.htm Facilities and Other Resources Equipment Budget Justification Introduction (resubmission only) Specific Aims Research Strategy Human Subjects pages Vertebrate Animals References Cited Multiple PI Plan Data Management & Sharing Authentication of Key Biological and/or Chemical Resources

48. Presentation and Style Zero tolerance for tpyos Avoid excessive use of abbreviations Avoid vague terms: e.g., ‘ affects ’ , ‘ influences ’ Avoid pleonasms: “ … has been shown to … ” Clean, concise English Active voice is better than the passive voice Simple, clear language

49. Presentation and Style Paragraphs and spaces Don ’ t make it look dense or cluttered Zero tolerance for tpyos Avoid excessive use of abbreviations Avoid vague terms: e.g., ‘ affects ’ , ‘ influences ’ Avoid pleonasms: “ … has been shown to … ” Clean, concise English Active voice is better than the passive voice

50. Which Would You Rather Read?

51. Presentation and Style Paragraphs and spaces Don ’ t make it look dense or cluttered Flow Logical transitions from sentence to sentence, paragraph to paragraph Do the work for your reader Again, read & look at successful applications Zero tolerance for tpyos Avoid excessive use of abbreviations Avoid vague terms: e.g., ‘ affects ’ , ‘ influences ’ Avoid pleonasms: “ … has been shown to … ” Clean, concise English Active voice is better than the passive voice

52. Good Luck! [email protected]