Successful Grant Writing for NIH

1. Successful Grant Writing for NIH Cheryl Anne Boyce, Ph.D. Chief, Behavioral and Brain Development Branch Associate Director, Child and Adolescent Research Division of Clinical Neuroscience and Behavioral Research National Institute on Drug Abuse Houston Baker, Ph.D. Program Director Imaging Technology Development Branch Cancer Imaging Program National Cancer Institute

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? Impact Score—Scientific merit Program considerations Availability of funds

5. NIH Award Mechanisms • Grants • Numerous grant mechanisms • R01s, R21s, R03s, K99’s, etc. • Multi-project grants- P01, P30, P41, P50, etc. • Investigator initiated (PA or PAR) or solicited (RFA) • Cooperative agreements • “U” grants, used for most clinical trial and other networks • Substantial NIH staff involvement • Solicited—Request for Applications (RFA) • Contracts • N01s • Solicited—Request for Proposals (RFP)

6. Three Ways to Work with an IC • Submit an application for a grant or contract • Apply for grant funding for your research project grant at any time or for specific opportunities (PA, PAR, PAS) • 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 subcontractor • 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 NIH grant applications require electronic submission via http://Grants.Gov • eRA Commons: secure web-based information exchange between NIH and applicant organization (PI and Business Official) http://commons.era.nih.gov • Applicant business office and PI 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 (may take 4-8 weeks) • Register with US CCR (Central Contractor Registration) • Obtain DUNS number (Data Universal Numbering System) • Obtain Grants.gov credentials • Assign an AOR to submit grants (Authorized Organizational Representative); SO (Signing Official) • Non-US organization: may require registration with 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 application or information electronically

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 new investigators Definition: Has not previously served as PI on any NIH grant Except R03, R15, R21, R42, R43 or mentored K awards Gets special consideration during peer review and IC funding decisions See web site for details: 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 consideration 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 • Investigators • Innovation • Approach • 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 Scored Review Criteria Scored 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 • Capture essence of goals and objectives • Abstract • Present your project Concisely • State significance Clearly • State Hypotheses, Research Problem, Solution • Methods and Rationale • Write direct, active text: Read aloud. • Snooze? Fix!

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 Scored Review Criteria • Significance: Does the study address an important problem? How will scientific knowledge be advanced? • Investigator: Is the investigator appropriately trained? • Innovation: Are there novel concepts or approaches? Are the aims original and innovative? • Approach: Are design and methods well-developed and appropriate? Are problem areas addressed? • 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

43. 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

44. 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

45. 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

46. 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”

47. 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

48. Specific Aims • The most critical page in the application • It is a one page summary of the application • Describe Overall Impact expected • Why is this problem significant? • What are the exciting preliminary data? • What hypotheses do the data support? • 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 (Focus: must fit together)

49. 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.

50. Preliminary Data • Show primary data for critical methods • Make figures or tables readable • Progress Report- for renewals • Restate Aims (avoid laundry list) • Publication list MUST be very strong. No productivity- no grant • Convince reviewer that you can do what you propose