1. GRANT WRITING FOR SUCCESS Grant Writing for Success LeShawndra N. Price, Ph.D., NIMH, NIH Henry Khachaturian, Ph.D., OEP/NIH

2. Take Home Messages Become a well-informed consumer Learn about NIH Institutes’ and Centers’ missions, programs, and specific uses of funding mechanisms Contact appropriate program staff early and often Develop a plan for your research and career Talk with potential mentors, collaborators, & peers Take advantage of many available resources

3. Grant Writing for Success Writing the Application  Start Planning EARLY  Develop your good idea  Use the NIH webpage  Talk to your NIH Program Official(s)  Provide a good presentation  Align the application with the review criteria  Identify collaborators  Seek advice and feedback from colleagues  Understand the peer review process and how grants are funded

4. START PLANNING YOUR APPLICATION EARLY  GRANT WRITING IS A LEARNED SKILL  Writing grant applications, standard operating protocols and manuals of procedures that get approved are learned skills  Writing manuscripts that get published in peer reviewed journals is a learned skill  GRANTSMANSHIP IS A FULL TIME JOB  Learn about the grant application process Grantsmanship Tips 101

5. Principles of Success Understand the peer review process Understand the agency mission  Every IC is different! Learn and practice the skills of writing applications for grant funds Secure collaborators (mentors) to complement your expertise and experience  Don’t compete … collaborate!

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

7. 7 Assess Your Readiness…Then, Determine Your Goals You are here Success is Relative… andLocal

8. Pre-Submission Planning Timeline call NIH

9. Assess Your Readiness Research Experience  Previous supported research/Principal Investigator  Research administration experience  Publications in proposed/related research areas Time Commitment Knowledge

10. Assess Your Capacity Research support available to you Institution (e.g., Office of Sponsored Research, office space, lab space, clerical assistance)  Graduate students/research staff support  Colleagues with research experience Know who can help you at your institution and at the NIH

11. 11 Make a Plan…Plan to Work…Work Your Plan Make a Plan Plan to Work Use Your Time Effectively Work Your Plan Be Flexible Enough for Course Corrections

12. FURTHER DEVELOPING YOUR GOOD IDEA UNDERSTAND THE MISSION OF THE NIH Grantsmanship Tips 101

13. Understanding the Mission Mission of each NIH IC is based and defined in law  Authorizations (create/continue an agency – periodic)  Appropriations ($ for the agency – annual) ICs establish specific research emphases  Legislative mission  Current state of science Use the Web!

14. www.nih.gov

15. Look for the IC Website of Interest

16. 16 GRANTS.NIH.GOV

17. grants1.nih.gov/grants/grant_tips.htm NIH Regional Seminars June 2013

18. Identifying NIH Initiatives Most NIH Institutes establish specific research Initiatives and Priorities  Become knowledgeable about research and researcher development activities at NIH and ICs related to your research interests  Read the IC web pages regularly  Read the IC’s strategic plan  Participate in IC workshops and programs (e.g., technical assistance workshops, webinars) Funding Opportunity Announcements (FOAs)  Must respond to a FOA via Grants.gov

19. grants1.nih.gov/grants/oer.htm

20. NIH Guide for Grants and Contracts Official publication listing NIH funding opportunities and policy notices  Request for Applications (RFA)  Program Announcements (PA, PAR, PAS)  Request for Proposals (RFP)  Notices (NOT) Published daily, distributed weekly

21. NIH Guide for Grants and Contracts http://grants.nih.gov/grants/guide/index.html

22. Research Portfolio Online Reporting Tool (RePORT) http://report.nih.gov A searchable database of federally supported biomedical research Access reports, data, analyses, expenditures, results of NIH supported research activities Identify, analyze IC research portfolios, funding patterns, funded investigators: Identify areas with many or few funded projects Identify NIH-funded investigators and their research Identify potential mentors/collaborators

23. Identify NIH Funded Grants See what research projects the NIH or any Institute has funded Get to know projects that are ongoing in your research area Find potential collaborators for your project and/or competition in the field Determine if there are any potential projects eligible for supplement opportunities

24. http://projectreporter.nih.gov/reporter.cfm NIH RePORTer

25. Search Results

26. SEARCHING NIH WEBSITES IS A GOOD START BUT FOLLOW UP WITH PERSONAL CONTACT  Contact NIH program staff EARLY  Ask what information would help them advise you about IC interest & “goodness of fit”  Are there related FOAs? Grantsmanship Tips 101

27. What does a Program Official Do? Scientist and Administrator Manages grants, contracts, & cooperative agreements Identifies needs in scientific areas Identifies areas of special interest & communicates program priorities Reports on scientific progress and program accomplishments Government’s technical representative for funded projects a.k.a. Program Director/Chief, Health Scientist Administrator

28. What should I talk about with a Program Official? Give us a thumb nail sketch of what you have in mind Does the idea fit the Institute’s interests? Get information from us on FOAs What kinds of grant mechanisms can be used and are there any priorities for those mechanisms? Will the PO read a concept paper? Send one. Email to set up a time to discuss—remember, this is advice, not obligation 28

29. What is a Concept Paper? A short summary of a project that serves as a “calling card” for the investigator Components ■ Initiative to which you are applying ■ Study Goals ■ Problem/Significance ■ Research Question ■ Hypotheses ■ Design/Analysis ■ Participants/Collaborators 29

30. COLLABORATE WITH OTHER INVESTIGATORS Fill gaps in your expertise and training Add critical skills to your team “TEAM SCIENCE” CAN BE POWERFUL Grantsmanship Tips 101 IDENTIFY COLLABORATORS

31. Collaborate with others  In your department  In other departments Network at Meetings Stay connected to past colleagues and mentors Use technology (social networking sites) Cultivate a strong network that understands the funding process Collaborate with Others

32. Ask Collaborators to Review Your Application Show your draft application to:  Your collaborators  A colleague that does not know what you intend to do  Someone who is not your best friend Draft “reviewers” must understand:  What you intend to do  Why you believe it is important to do  Exactly how you’re going to do it. If they don’t get it, you must revise your application!

33. Multiple Principal Investigators Single PI model does not always work well for multi-disciplinary, collaborative research Recognizes contributions of full team In place for most submissions to Grants.gov Implications for “New Investigator” status A complex issue – Talk to NIH program staff if you are considering multiple PIs ! grants.nih.gov/grants/multi_pi

34. ARE YOU READY TO WRITE? DEVELOPING YOUR GOOD IDEA INTO:  STRONG SCIENCE  A COMPETITIVE APPLICATION Grantsmanship Tips 101

35. Remember … Before you start Talk to Program Staff at appropriate IC Read instructions for application form Are you a New or Early Stage Investigator?  http://grants.nih.gov/grants/new_investigators/index.htm Know your audience  Which Integrated Review Group (IRG) is most likely to get your application? Propose research about which you are passionate and totally committed to doing

36. 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?  in my hands/lab? Good Idea

37. PRESENTING GOOD IDEAS CLEARLY IS PARAMOUNT! DEVELOPING YOUR IDEA Grantsmanship Tips 101

38. Application Preparation Start early READ THE INSTRUCTIONS READ THE INSTRUCTIONS Review the literature thoroughly Make sure that you have a good idea about how to answer an important question Align YOUR goals with the funding agency goals Make sure that reviewers can understand WHAT you want to do, WHY it is important, that you CAN do it

39. Application Preparation cont. Don’t assume reviewers ‘know what you mean’ Use space (including biosketch, resources) wisely Obtain pre-review from faculty mentors early and often (i.e., don’t go it alone) State rationale of proposed investigation clearly Include well-designed tables and figures Present an organized plan of research

40. PROVIDE A GOOD PRESENTATION TO ACHIEVE A GOOD REVIEW Grantsmanship Tips 101

41. Keys to Good Presentation Be realistic … not overly ambitious Discuss potential problem areas and possible solutions Be explicit  Reviewers cannot read your mind!  Don’t expect reviewers to read between the lines  Don’t assume they know what you intend!

42. Good Review Understand the dynamics of peer review: Reviewers will review many applications Make your application easy to read and easy to understand The impact and significance should be clear throughout the application Convince them to be your advocate  Get them on your side!

43. Develop a Strong Research Plan Grab the reader immediately State long-term objectives AND expected impact Explicitly state hypotheses and research question Specific Aims

44. Develop a Strong Research Plan Why is this research important? Expands on the specific aims Identifies key themes of the literature and links to specific aims Critically analyzes existing literature Documents a solid theoretical basis for your study Background/Significance

45. Develop a Strong Research Plan How previous work -- by you, your team, and others -- leads to this study Demonstrate your experience, competence and likelihood of continued success Must flow logically from literature review and major themes of the problem area Preliminary Studies/ Progress Report

46. Develop a Strong Research Plan Does your plan flow logically from the literature review and prior studies? How will each hypothesis be tested? Do your measures capture the variables needed to test hypotheses? Why did you choose those measures? Methods and analyses must match Approach

47. Develop a Strong Research Plan For clinical studies be explicit and thorough in discussing  intervention or system to be studied  target population  inclusion and exclusion criteria  independent and dependent variables  all measures and instruments  power analyses Approach- Clinical Studies

48. Align your application with the Review Criteria 1. Overall Impact 2. Core Review Criteria  Significance  Investigator  Innovation  Approach  Environment http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-025.html http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-024.html

49. Impact OVERALL IMPACT The likelihood for the project to exert a sustained, powerful influence on the research field(s) involved:  in consideration of the following five core review criteria, and  additional review criteria (as applicable for the project proposed) Address this on your Specific Aims page!

50. Align with Review Criteria

51. 1 Core Review Criterion #1 SIGNIFICANCE Does this study address an important problem? If the aims are achieved, how will scientific knowledge be advanced? What will be the effect on concepts or methods that drive this field?

52. Core Review Criterion #2 INVESTIGATOR Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

53. Core Review Criterion #3 INNOVATION Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?

54. Core Review Criterion #4 APPROACH Are the conceptual framework, design, methods, and analyses adequately developed, well- integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternatives?

55. Core Review Criterion #5 ENVIRONMENT Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?

56. Other Review Considerations Human subjects Animal care and use Select agents Model organism sharing plan Data sharing plan The FOA will list the review criteria and any additional issues that reviewers will be asked to evaluate.

57. Good Review Get to the right review group Title, abstract, specific aims all point to the main goals of your project Attach a cover letter for the Center for Scientific Review Division of Receipt and Referral  suggest IC and review group assignment*  outline areas of key expertise needed for appropriate review  Do NOT name specific reviewers * Consult with Program Official

58. GUIDANCE FOR A COMPETITIVE GRANT APPLICATION Grantsmanship Tips 101

59. How to assure that your application is competitive? Good ideas, well presented always win Think clearly Write clearly Be complete but not verbose Never lose sight of the significance Point to the impact Pay attention to details

60.  Strong significance to an important problem in public health: IMPACT is high  High degree of novelty and innovation  Strong track record by a well qualified applicant  Clear rationale  Relevant and supportive preliminary data  Clear and focused approach that provides unambiguous results  Careful attention to details — Spelling, punctuation, grammar, fonts, clarity of data, error bars, spelling, etc Hallmarks of an Outstanding Grant Application

61.  Lack of or weak impact  Significance not obvious or weak  Too ambitious, lacking focus  Unclear or flawed hypothesis or rationale  Applicant track record weak or lacking appropriate expertise  Feasibility unsupported  Approach flawed  Poor writing and lots of errors Common Reasons Cited for a Weak Application

62. Common Errors Conceptual Problems  Lack of new or original ideas  Absence of an acceptable scientific rationale  Failure to document why the problem is important  Lack of connection of aims & methods  Superficial, diffuse, and/or unfocused description of research plan/insufficient detail  Empirical findings not distinguished from speculation Weak Progress Report/Background  Failure to analyze key themes in the literature  No consideration of alternate perspectives  Crucial studies are not cited

63. Common Errors Lack of Expertise in the essential methodology  Inadequate demonstration of expertise or publication in approaches  Outdated methodology  Low productivity (e.g., few recent papers) for position/academic rank without justification  No collaborators recruited/no letters of support from collaborators and/or research sites  Letters should be detailed and specific  Little demonstration of institutional support Unrealistically large amount of proposed work (“overly ambitious” Uncertainty concerning future directions

64. AFTER PEER REVIEW Grantsmanship Tips 101

65. After the Review Read the summary statement (Don’t take it personal) Reread the summary statement Contact your program officer and be prepared to discuss: what the reviewers said about your application (after you have summary statement) Scores and percentiles the likelihood of funding the prospects of a revised application Wait for the AWARD, or Listen to advice from Program Officer about options

66. If Not Funded, Try Again! NIH Regional Seminars June 2013 You are in good company Know your options Get advice, Regroup Contact your Program Officer

67. Revise and Resubmit Properly Revised applications can receive fundable scores and subsequent $$  Score can inform degree of revision necessary Update Preliminary Results Maintain communications with Program Official Notice NOT-OD-14-074: NIH and AHRQ Announce Updated Policy for Application Submission

68. Revising and Resubmitting Write A Clear Introduction Section Address All Criticisms Thoroughly Respond Constructively Acknowledge and Accept the Help of Reviewer Comments Don ’ t Be Argumentative! Don ’ t be Abrasive or Sarcastic! Resubmission is an opportunity to improve the entire application

69. Q: What if you know that you are “ Right ” and the reviewers are “ Wrong, ” is it appropriate to argue your position in your resubmission? A: NO! Remember An application for funding is not about the facts of your completed research. It is about ideas and potential research Responding to reviewer comments

70. Revise and Resubmit Prepare a REVISION COVER LETTER For Revisions, Indicate Review History Request Same Or Different Study Section Provide Justification for your request

71. Three Simple Rules to remember when planning, writing and submitting your application

72. #1 DO NOT write the application for yourself Unless you are going to fund it yourself You MUST convince the entire review committee and the funding agency the proposed research will be of high impact and feasible

73. #2 Reviewers are never wrong, Reviewers are never right: they simply provide an assessment of material that you provided in your application Don’t Take the Criticism Personally!

74. If you are revising the application the comments in the summary statement only list some of the weaknesses …. not all of the weaknesses. When you revise your application use the time as an opportunity to improve the entire application. #3

75. FUNDING DECISIONS Grantsmanship Tips 101

76. What Determines which applications become grants? Funding Decisions are based on: scientific merit and impact program considerations available funds Funding Decisions are made by the Institute Director

77. Writing a Successful Career (K) Application What is Different about K awards? Strategy Planning Application Requirement Review Criteria

78. Timeline for K Applications Review:  Jun/July  Oct/Nov  Feb/Mar Council:  October  January  May Award Date:  December  April  July Receipt Date:  Feb 12 (Mar 12)  Jun 12 (Jul 12)  Oct 12 (Nov 12)

79. Develop a Strategy (1 of 2)  Assess your career situation and needs. Find an experienced mentor(s) and collaborators.  Asses the field and the competition. See what is being funded by NIH: Research Portfolio Online Reporting Tools (RePORT).  What are your strengths and weaknesses? Can you fill in any gaps with collaborators or consultants?  Find out what resources and support your organization has and what additional support you will need.

80. Develop a Strategy (2 of 2)  Is there an added value to your receiving a K award? Why not another funding mechanisms?  Give yourself plenty of time to write the application, probably three to six months.  Know your organization's key contacts and internal procedures for electronic application.  Call an NIH Program Officer to discuss you research training needs and career development plans.

81. Plan Your Application  Coordinate the application with your mentor’s schedule. Remember that a K application is a collaboration between you and your mentor.  Make sure your planning and feedback are adequate by putting together your own review committee.  After you've settled on a project, draft a short description of your specific aims and discuss these with the committee.

82. Application Requirements  Candidate Qualifications, Career Goals and Objectives  Mentor (s), Collaborators, and Consultants  Institution Environment and Commitment to the Candidate  Specific Aims  Research Strategy

83. Candidate’s Qualifications Biographical Sketch:  Personal Statement: Your research experience and other qualifications for this K award.  Research Support: Your/colleagues accomplishments attesting to qualifications of the research team. Candidate’s Background:  Coordinate with information in the Biographical Sketch, e.g., research and/or clinical training experience that has prepared you for the K award.

84. Career Goals and Objectives Explain any new or enhanced research skills you will gain as a result of the K award. Stress other activities that will enhance your research career, e.g., courses, techniques. If you have changed research direction, discuss reasons for the change, and justify how it will help you to develop your research career. Always provide a career development timeline, including plans to apply for subsequent grant support.

85. Mentor(s), Collaborators, Consultants Each mentor must explain how he/she will contribute to the development of the candidate. Discuss the research and also other activities, e.g., seminars, scientific meetings, presentations. Document the sources and amounts of anticipated support for the candidate’s research project. Discuss plans for transitioning the candidate to the independent investigator stage by the end of the K award. Provide details for any previous experience as a mentor.

86. Institution’s Environment & Commitment Document a strong, well-established research program related to the candidate's interests. Experienced faculty, facilities and resources available for the candidate. Opportunities for intellectual interactions, e.g., journal clubs, seminars, and presentations. Commitment to the candidate’s career development independent of the K award. Agree to provide adequate office and lab space, time and support to the candidate for the period of K award.

87. Specific Aims of the Project Provide a clear statement of each aim’s objectives, for example:  To test a stated hypothesis  To create a novel design  To solve a specific problem  To challenge an existing paradigm  To address a critical barrier to progress in the field  To develop new technology

88. Research Strategy Significance:  Provide an explanation of the importance of the problem you are trying to study.  Explain how your proposed study will improve scientific knowledge, technical capability, or clinical practice in one or more fields.  Discuss how existing concepts, methods, technologies, treatments, or interventions may be impacted if the proposed aims are achieved.

89. Research Strategy Innovation:  Provide an explanation on how your proposed research project may challenge current research or clinical practice paradigms.  Describe and fully discuss any novel theoretical concepts, approaches, methodologies, or interventions that may be developed or used.  Describe any advantage over existing approaches, methodologies, instrumentation, or interventions.

90. Research Strategy Approach:  Describe the methodology and analyses to be used to accomplish the specific aims of the project.  Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims.  For early stages of development, describe strategies to establish feasibility and manage high-risk aspects of the proposed work.

91. Responsible Conduct of Research  Discuss the five components outlined in the NIH Policy: Format, Subject Matter, Faculty Participation, Duration, and Frequency.  Is the plan appropriate for your career stage, and will it enhance your understanding of ethical issues related to research?  Document any prior participation in RCR training and/or propose plans to receive additional instruction.

92. Career Award Review Criteria Scored Review Criteria:  Candidate  Career Development Plan, Goals and Objectives  Research Plan  Mentor(s), Consultants(s), Collaborator(s)  Environment and Institutional Commitment to the Candidate

93. Career Award Review Criteria Candidate:  Research, academic and/or clinical record  Commitment and potential to develop as an independent and productive researcher  Quality of the letters of reference Career Development Plan, Goals and Objectives:  Contribute substantially to the scientific development of candidate  Content, scope, phasing, and duration of the plan in the context of prior experience

94. Career Award Review Criteria Research Plan:  Scientific and technical merit of the research question, design and methodology career objectives  Relevance of the proposed research to the candidate‘s career objectives  Appropriateness of the research plan to the stage of research development and as a vehicle for developing the research skills described in the career development plan

95. Career Award Review Criteria Mentor(s), Consultants(s), Collaborator(s):  Qualifications, funding, and statement by Mentor(s), collaborators, and/or Consultants Environment and Institutional Commitment to the Candidate:  Assurance that minimum 75% effort will be devoted to research and related activities  Capable faculty and research facilities  Assurance that institution intends for the candidate to be an integral part of its research program

96. Career Award Review Criteria Additional Review Criteria:  Protection of Human Subjects  Inclusion of Women, Minorities, and Children  Care and Use of Vertebrate Animals  Biohazards Additional Review Considerations:  Responsible Conduct of Research  Select Agents  Resource Sharing Plans  Budget and Period of Support

97. … AND WE HOPE YOU FIND SUCCESS WITH NIH FUNDING ! Use all your NIH Resources