Successful Grant Writing for NIH

1. Successful Grant Writing for NIH Michael A. Sesma, Ph.D. Program Official Research Training and Career Development Program Division of Developmental Translational Research NIMH/NIH Bethesda, MD. 20892 ms265g@nih.gov Milton J. Hernández, Ph.D. Director Division of Loan Repayment OEP, OER, OD National Institutes of Health Bethesda, MD 20892 mh35c@nih.gov

2. CSR Referral and Review “Anatomy” of Grant Process Researcher Idea Institution Program Announcement or RFA Program Staff Collaborators Grant Application (R01, R03, R21, K01, K08, etc.) Revision $ National Advisory Council Program Staff

3. Grant Writing for Success Writing the Application • Start early • Seek advice from colleagues • Start with a good idea • Talk to your NIH Program Official(s) • Use the NIH webpage (www.nih.gov) • Remember review criteria • Follow instructions carefully Transition to Electronic Submission (http://era.nih.gov/ElectronicReceipt/)

4. What Determines Which Grants Are Funded? Scientific merit - Priority Score Program considerations Availability of funds

5. NIH Award Mechanisms • Grants • Numerous grant mechanisms • R01s, R21s, R03s, K99’s, etc. • Multi-project grants- Ps • Investigator initiated (PA) or solicited (RFA) • Cooperative agreements • “U” grants, used for complex studies, most clinical trial networks • Substantial NIH staff involvement • Solicited (RFA) • Contracts • N01s • Solicited (RFP)

6. Three Ways to Work with an IC • Submit an application for a grant or contract • Apply for your own funding for a research project grant at any time • Apply to a specific competition for grant set-asides (RFA) or a specific contract competition (RFP, BAA) • Indirectly through someone who has funding from the IC • Collaborate with an extramural awardee as a sub-recipient • Collaborate with our Intramural Research Program through material transfer agreements, etc. • Gain access to IC sponsored resources • Get help and in-kind materials from our specimen resources, etc.

7. Applying for Grants (e-Submission)

8. Grant Submission Dateshttp://grants.nih.gov/grants/funding/submissionschedule.htm#elec

9. Electronic Submission • Most types of NIH grant applications are submitted electronically via Grants.Gov • eRA Commons is a web-based system for secure information exchange with applicants and applicant organizations (http://commons.era.nih.gov/) • Applicants must establish personal eRA Commons accounts to track review progress and to retrieve scores and summary statements

10. You must register for e-submission • Register on Grants.gov • Register with US CCR • Obtain DUNS number • Obtain Grants.gov credentials • Assign an AOR to submit grants • Non-US institution or organization may require additional registration with a North Atlantic Treaty Organization Commercial and Government Entity (NCAGE) • Register on eRA Commons • Both applicant and organization must register • One-time registration • Enables you to receive and transmit information or application electronically • This process may take 4-8 weeks

11. Applying for an NIH Grant

12. “I don’t really care about that administrative stuff!”But it isIMPORTANT: • To understand how NIH works! • Easy to disengage and only focus on the lab • Network with NIH staff • Talk to us at meetings, on the phone, by email • The squeaky wheel gets the oil • If I don’t know you, how can I help you? • Understand how NIH peer review works • Learn what works and what doesn’t in peer review AND funding

13. Are You a “New Investigator”? NIH fosters research independence of early career investigators Definition: Has not previously served as PI on any PHS grant Except for R03, R15, R21 or mentored K awards Get special considerations during peer review and IC funding decisions Resource web site with further information grants1.nih.gov/grants/new_investigators

14. Are you an Early Stage Investigator (ESI)? • NIH fosters research independence of early career investigators • Definition:Has completed his or her terminal research degree or medical residency—whichever date is later—within the past 10 years and has not yet been awarded a substantial, competing NIH research grant • Get special considerations during peer review and IC funding decisions

15. Where are applications reviewed? • CSR • Study Sections • Research Project Grants (R01s) • AREA Grants (R15s) • Fellowships (F32s & F31s) • SBIRs • Shared Instrumentation Grants • Small Grants (R03s) • Exploratory/Developmental Grant (R21s) • INSTITUTES • Scientific Review Groups • Contract Review Ctees. • Program Project Grants (P01s) • Center Grants (P30s) • Training Grants (T32s) • K Grants • RFAs (some of which will be for R01s) • Contracts

16. Who are the Peer Reviewers? • Established Investigators - few assistant professors • Demonstrated scientific expertise • Mature judgment • Breadth of perspective • Impartiality • Adequate representation of women and minority scientists • Diversity of expertises represented

17. Peer Review: Evaluation Criteria • Review of applications based on NIH standard review criteria • Significance • Approach • Innovation • Investigator • Environment • Also initiative specific review criteria, when applicable • Different criteria for training related applications

18. Peer Review: New NIH Scoring System

19. Peer Review: Process • The SRO prepares an order of review that clustersNew Investigator (NI)applications, Early Stage Investigator applications (ESIs) and clinical applications if feasible. • NI and ESI applications are identified for reviewers so there can be appropriate review in context of career stage. • Expectations of preliminary data and publication track recordless than for established investigators.

20. MOST IMPORTANT SLIDE!Most common reasons for not receiving funds: • Lack of new or original ideas • Diffuse, superficial or unfocused research plan • Lack of knowledge of published relevant work • Lack of experience in the essential methodology • Uncertainty concerning the future directions • Questionable reasoning in experimental approach • Absence of acceptable scientific rationale • Unrealistically large amount of work • Lack of sufficient experimental detail • Uncritical approach

21. Formula for Successful Applications

22. Start with a Good Idea • Does it address an important problem? • Will scientific knowledge be advanced? • Does it build upon or expand current knowledge? • Is it feasible … • to implement? • to investigate?

23. Good Grantsmanship • Contact NIH program staff early • Assess IC interest & “goodness of fit” • Are there related FOAs? • Searching web sites is good start … but follow up with personal contact • Send a 2 – 3 page concept paper to a program contact

24. Good Grantsmanship What’s a Concept Paper? Facilitates productive discussion with Program Official • Study Goals • You want support from which IC to do what? • Problem/Background • Why does this topic need study? • Significance • Why this is important to the field? • Research Question • What hypotheses will you test? • Design/Analysis • What study design and statistical approach do you propose? • Team • Who will be the key participants and collaborators?

25. Collaborate with other investigators Fill gaps in your expertise and training Add critical skills to your team “Team Science” is the new direction Support for multidisciplinary research projects Consider the Multiple-PI Model Talk to NIH program contact if the project involves multiple PIs Good Grantsmanship grants1.nih.gov/grants/multi_pi

26. Good Grantsmanship • Ask a colleague to review your draft • Ask a colleague who does not already know what you intend to do • Ask a colleague who is not your best friend • Your draft reviewers need to understand • What you intend to do • Why you believe it is important to do • Exactly how you are going to do it • Leave enough time to make revisions

27. Good Presentation • Read the application instructions carefully • Read the application instructions carefully • Don’t forget … ... read the application instructions carefully http://enhancing-peer-review.nih.gov/restructured_applications.html 3 Simple Steps:

28. Alignment of Application Format with Review Criteria Core Review Criteria Application

29. Application Changes Changes to three parts of application: • Biographical sketch • Research Plan • Resources Changes in page limits and format

30. Application Changes: Biographical Sketch (4 pages) • Personal Statement – why experience and qualifications make the applicant particularly well-suited for role in the project • Publications limited to 15 • 5 most recent • 5 best • 5 most relevant to the application

31. Restructured Research Plan:Significance, Innovation, Approach Review Criteria now aligned with Application Format

32. Application Changes: Resources Facilities and Other Resources (in 424 part of the R&R Other Project Information; in 398 the Resources Format Page) Environment - New instruction to address how scientific environment will contribute to probability of success, unique features of environment, etc. For ESIs, provide description of institutional investment in success of the investigator.

33. Good Presentation • Title • Captures the essence of goals and objectives • Abstract • Concise presentation of the project • Statement of significance • Hypotheses and research questions • Methods and analyses • Some reviewers may see only these

34. Good Presentation Organize the Research Strategy to answer 4 essential questions: • What do you intend to do? • Why is the work important? • What has already been done? • How are you going to do the work?

35. Good Presentation Address the Core review criteria • Significance: Does the study address an important problem? How will scientific knowledge be advanced? • Approach: Are design and methods well-developed and appropriate? Are problem areas addressed? • Innovation: Are there novel concepts or approaches? Are the aims original and innovative? • Investigator: Is the investigator appropriately trained? • Environment: Does the scientific environment contribute to the probability of success? Are there unique features of the scientific environment?

36. Good Presentation • Provide well-focused research plan • Keep specific aims simple … and specific • Link hypotheses to specific aims • Explain method chosen to test every hypothesis • Don’t wander from the main theme • A conceptual model can clarify ideas

37. Good Presentation • Be realistic … not overly ambitious • Discuss potential problem areas • Discuss possible solutions • Explain rationale for your decisions • Be explicit • Reviewers cannot read your mind … Don’t assume they know what you intend

38. Good Presentation Prepare a reviewer-friendly application • Be well organized and clear • Use logical transitions between sections • Add section headings -- major and minor • Make tables and figures easy to view • Eliminate all mispeelings and type-O’s

39. Good Presentation Prepare a reviewer-friendly application • Be well organized and clear • Use logical transitions between sections • Add section headings -- major and minor • Make tables and figures easy to view • Eliminate all misspellings and typo’s

40. Good Review Get to the right review group • Make sure your application goes to the right review group* • Title, abstract, specific aims all point to the main goals of your project • Include a Cover Letter • suggest IC and review group assignment* • Outline key expertise needed for appropriate review • do not name specific reviewers * Consult with Program Officer

41. Good Review Good Presentation will keep your reviewers happy • Reviewers often work late at night • Help them stay alert and interested • Make your application easy to read and easy to understand • Convince reviewers to advocate for your idea • Get reviewers on your side!

42. Good Luck Results from: • Good Ideas • Good Grantsmanship • Good Presentation • Good Review

44. Elements of an Outstanding Grant Application • New or original ideas • Pilot data (essential for R01/ less critical for Fs and Ks) • Focused, incisive research plan • Knowledge of published relevant work • Experience in the essential methodology • Future directions and contingency plans

45. Writing an R01 (Regular Research Grant)Directly from a senior reviewer • Write Specific Aims section and discuss with mentor or an NIH grantee • Give yourself four weeks to write first draft • Full draft to mentor one month before submission date • Read and follow the instructions (electronic 424) • Prepare budget with budget person • Write for a general scientific audience • Simple is better • Repetition is good

46. Writing an R01 (cont’d) • You must have simple testable hypothesis that is supported by preliminary data • Study Sections are conservative • No preliminary data = No award • Demonstrate medical significance • Rationale, limitations of methods, controls, and back-up plans are critical • Details of methods are unimportant (boring) but make sure the reviewers know you know the methods and say so • Get collaborators and consultants- strong letters

47. R01 Common Errors • Not discussing literature that is contrary to your ideas • Not discussing strengths and limitations of your data- don’t let reviewer do it for you! • Proposing too much for 3 or 5 years • Common criticisms: • “This Specific Aim could serve as an entire grant in and of itself” • “Research is unfocused” • “Study is overambitious” • “Not clear investigator has needed experience”

48. R01 Common Errors (cont’d) • Lack of relationship to disease • Methodology over Biology is not good • Descriptive vs Hypothesis-driven • “Looking at” (bad) vs “testing” (good) • “Fishing expedition” (bad) • No biostatistical support • Sample size (power) calculations for animal or human studies • Inadequate control group

49. Specific Aims • The most critical page in the application • It is a one page summary of the application • Why is this problem significant? • What is the exciting preliminary data? • What are the hypothesis supported by the data? • Simple list of your Aims is good • Be general • Avoid long (laundry) list of things you are going to do • 2-3 Specific Aims is sufficient

50. Research Strategy • Assume you are not writing for an expert • Emphasize general medical importance and then specific importance of your topic • Avoid jargon • Discuss controversies in the area • Avoid selective citation of the literature • Make your story interesting- make the reviewer want to read more! • Correct English, grammar, and attention to typographical errors is important. • Reviewers like a “pretty” application.