THE NIH GRANT WRITING AND PEER REVIEW TOOLBOX

1. THE NIH GRANT WRITING AND PEER REVIEW TOOLBOX Adolphus Toliver, Ph.D. Division of Minority Opportunities in Research, National Institute of General Medical Sciences

2. Contents of the Toolbox The toolbox contains tips and tools about: • Research Grants • Peer Review • People • Resources • Databases

3. National Institutes of Health The pursuit of science to uncover new knowledge that will lead to better health for everyone. • NIH works toward this mission by: • Conducting research in our own labs (1K PIs) • Supporting research at various institutions (212K PIs) • Fostering communication of medical & health info • Training research investigators

4. NIH FY2009 Budget Other 6% Intramural Research 10% Total ~$30 Billion Extramural Awards ~84% www.nih.gov 50,000 grants; 212,000 researchers; 2,800 institutions. 27 Institutes and Centers, including NIGMS

5. Review Process for a Research Grant Application Center for Scientific Review Initiates Research Idea Assign to IRG/ Study Section Submits Application to NIH Study Section Review for Scientific Merit Institute Evaluate for Relevance Advisory Councils and Boards Allocates Funds Recommends Action Institute Director

6. LIFE CYCLE OF A RESEARCH GRANT • Develop a critical idea for a research proposal • Respond to: • Program Announcement (PA) • Request for Applications (RFA) • Investigator Initiated Grant

7. LIFE CYCLE OF A RESEARCH GRANT Submit the grant application to the funding agency • Submission dates: October 1, February 1, June 1 • Reviewed in Feb/March, June/July, Oct/Nov • Goes to Institute advisory Council May/June, Sept/Oct, Jan/Feb • Earliest award: July, December, April

8. PREPARING AN APPLICATION • read the instructions • Read the Instructions • READ THE INSTRUCTIONS • Read the CORRECT instructions, i.e., those pertaining to the grant for which you are applying • Read all of the instructions and follow the most current instructions

9. THE WRITTEN PRESENTATION • Information is interpreted more easily if it is placed where most readers expect to find it. • For clarity, use simple declarative sentences. • Avoid complicated words, unusual abbreviations, and poor syntax • The application should be easy to read and comprehensible

10. TYPICAL PROPOSAL SEQUENCE FOR READING • Title page and abstract • Introduction and the problem (need) • Specific aims or measurable objectives • Significance (literature review and background) • Progress report • Research plans (research design and methodology • Budget and Biographic sketch

11. CONCEPTUAL STRUCTURE OF A GRANT APPLICATION • IDEA • SUPPORTING IDEAS • DETAILS OF THE PLAN • APPENDICDES

12. TYPICAL SEQUENCE FOR PROPOSAL DEVELOPMENT • The problem or need • Significance • Specific aims • Research plan • Budget • Biographical sketch • Abstract

13. REQUIREMENTS FOR A COMPETITIVE RESEARCH APPLICATION • Brief introduction including the long range goal of the project • Background to establish a solid foundation on which to build your proposal • The goal of this particular application • The central hypothesis to be examined • Rationale for the project • Specific Aims • Anticipated results

14. BRIEF INTRODUCTION • Underscores the importance of the proposed studies • Should convey the important findings in the field of study • Should highlight the problem that proposed studies will address

15. LONG-RANGE GOAL • It is the goal of the overall program of which the current application is a part. • It is NOT the goal of the current application.

16. CENTRAL HYPOTHESIS • If possible,the proposed research should be hypothesis driven! • The hypothesis must be testable and should select an experimental outcome from among various possiblities. • The hypothesis should NOTpresent a predetermined conclusion.

17. RATIONALE • This is the underlying reason for the studies proposed • The rationale must be relevant to the problem that has been presented in the introduction.

18. SPECIFIC AIMS • They should be brief, focused, and limited in scope. • Each aim should logically flow into the next aim. • Each aim should be briefly expanded upon. • Be realistic: do not overestimate your abilities or capabilities for completing the work proposed in your application in the time requested.

19. BACKGROUND The purpose of the Background : • To establish a solid foundation on which to build your proposal. • Is NOT to impress reviewers with your comprehensive knowledge of the field.

20. PREPARATION OF THE APPLICATION

21. What Exists Now What Is Present level of knowledge What Should Be What Ought to Be Desired State of Knowledge PROBLEM OR NEEDS STATEMENT

22. PROBLEM OR NEEDS STATEMENT The problem or needs statement is the disparity between what is and what should be, that created the GAP which your proposed project will attempt to close of make smaller.

23. PRELIMINARY STUDIES • Describe published studies in limited detail and include the most important figures and/or tables. • Describe unpublished studies in more complete detail, including newer data. • Do not duplicate the preliminary studies with the proposed studies.

24. PRELIMINARY STUDIES • Include the results of your recent work that have direct relevance to the studies proposed in your grant application. • Exclude any studies in which the relationship to your proposed study is not relevant.

25. EDITORIAL CONSIDERATIONS FOR PRELIMINARY STUDIES • All figures/graphs and tables should be clearly legible. • Provide original photographs of gels; xerox copies are not easily interpreted. • Methodology should be placed in the figure/table legends, not in the text.

26. TECHNICAL CONSIDERATIONS FOR PRELIMINARY STUDIES • Graphs should be uncomplicated; the simpler, the better. • Each table or figure should be designed to convey a single point or idea. • Extraneous or irrelevant data should be avoided.

27. THE RESEARCH DESIGN This is the “heart and soul’ of the application. In this section, state precisely • What you propose to do • How you plan to do it • What the results will mean in terms of the overall project • What pitfalls you might consider • Alternative approaches to cope with the anticipated problems or pitfalls

28. RESEARCH DESIGN continued Restate each Specific Aim and for each, provide: • Introduction • A methods of approach • Anticipated findings or results • Potential pitfalls/alternative approaches

29. RESEARCH DESIGN continued INTRODUCTION Each section of the research design should restate the hypothesis to be tested, the rationale for the study, overall approaches to be taken, and the anticipated results.

30. RESEARCH DESIGN, continued METHODS OF APPROACH • Separate sections on the specific aims should be used to develop each of the planned studies. • This section is not intended to be a materials and methods manual; therefore avoid emphasis on routine methods. • Use detailed methods only for unfamiliar technology

31. RESEARCH DESIGN, continued ANTICIPATED RESULTS • Summarize your results. • Emphasize only the most important results. • Do not over-inflate or under-inflate the results. • If limitations exist, they should not be ignored, but should be discussed in a positive manner.

32. RESEARCH DESIGN, continued POTENTIAL PROBLEMS • Anticipate potential problems, and discuss them, but do not overemphasize them. • Offer alternative strategies. • Reconcile the results of differing approaches.

33. SOME COMMON REASONS FOR FAILURE • Lack of an innovative or good original idea • Unimportant or unresponsive problem • Inadequately developed methodology • Unacceptable rationale • Lack of expertise, experience or resources • Superficial or unfocused approach • Unrealistic amount of work proposed • Uncertain outcomes and/or lack of future directions.

34. BIOGRAPHICAL SKETCH • Document your credentials accurately • Provide aspects of your training and expertise that are relevant to the application. • Do not misrepresent your publication record • Do not include unimportant or non-relevant entries

35. THE BUDGET The budget should never drive the proposal. • Justify all personnel with respect to effort and expertise. • The equipment request must be congruent with the resource statement and stem from the proposed methodology • Don’t ask for a Mercedes when a Saturn will do. • Strongly justify all equipment requested • Supply request should match your research design, and be strongly justified.

36. THE ABSTRACT • It should be written after the project has been completed because the writer will have a clear idea of exactly what information is to be distilled and summarized. • It should be succinct and motivating because is the most often read section of a grant application. • It is a summary of the proposal; it does not list objectives, it summarizes them.

37. TIPS FOR WRITING PROPOSALS • Write with reader in mind because readers do not simply read, they interpret. • Most readers may make his/her most interpretative decisions about the substance or prose based on the clues they receive from the structure of the presentation. • Remember that information is interpreted more easily and uniformly if it is placed where most readers expect to find it.

38. REVIEW PROCESS FOR RESEARCH GRANT APPLICATIONS • Application is submitted to CSR • Assigned to an Initial Review Group (IRG) • IRG reviews application for scientific merit • Advisory Council for Institutes/Centers (IC) recommends action • IC’s take final action and allocates funds

39. CENTER FOR SCIENTIFIC REVIEW (CSR) • Serves as central receipt point for NIH grant applications • Assigns applications to CSR IRGs or IC IRGs for review • Assigns applications to NIH ICs as potential funding components • Conducts initial scientific review o grant applications submitted to NIH

40. PEER REVIEW in CSR • CSR IRGs are managed by a Scientific Review Administrator (SRA) who is a Ph.D. professional with a scientific background close to the expertise of the IRG. • Each CSR standing IRG has 12-24 members who are primarily from academia • As many as 60-100 applications are reviewed at each IRG meeting

41. RESPONSIBILITIES OF THE SRA • Performs administrative and technical review of applications • Selects the reviewers for an application • Manages the IRG • Prepares the Summary Statement • Provides requested information about IRG recommendations to the IC’s National Advisory Councils/Boards

42. CRITERIA for SELECTION OF REVIEWERS • Demonstrated scientific expertise • Doctoral degree or equivalent • Mature judgment • Work effectively in a group context • Breadth of perspective • Impartiality • Interested in serving • Adequate representation of women and individuals from groups underrepresented in the biomedical research arena of the nation.

43. REVIEW CRITERIA • Significance • Approach • Innovation • Investigator • Environment

44. SCORING OF APPLICATIONS 1= Exceptional 2= Outstanding 3 = Excellent 4 = Very Good 5 = Good 6 = Satisfactory 7 = Fair 8 = Marginal 9 = Poor NFRC = Not recommended for further consideration UN = Unscored

45. Scoring Descriptions

46. RESEARCH GRANT APPLICATIONS People To Know and Why You Need To Know Them • Institute and Center Directors • Institute Division Directors • Institute Branch Chiefs and Program Directors (Administrators) • Scientific Review Administrators

47. RESEARCH GRANT APPLICATIONS Responsibilities of Branch Chiefs and Program Directors • Primary contact and information link • Post-review discussions • Pre-award discussions

48. BRANCH CHIEFS AND PROGRAM DIRECTORS Primary Contact and Information Link • Program Announcements (PAs) • Requests for Applications (RFAs) • Requests for Proposals (RFPs) • Upcoming initiatives • Opportunities for new initiatives • Information about NIH Program Policies

49. BRANCH CHIEFS AND PROGRAM DIRECTORS Post-review Discussions • Responding to summary statements • No action needed • Informational letters • Appeal letters • Resubmission • Deferrals

50. COMPUTERIZED DATABASES A tool for knowing what NIH has funded http://www-commons.cit.nih.gov/crisp A tool for knowing what NIH is funding and the latest requests for applications (RFA) or Program Announcements (PA) http://www.nih.gov/grants/guide/index.html