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P REPARING AND S UBMITTING A S UCCESSFUL G RANT A PPLICATION

P REPARING AND S UBMITTING A S UCCESSFUL G RANT A PPLICATION. Priti Mehrotra, Ph.D. Chief, Immunology Clinical Review Branch National Institute of Allergy and Infectious Diseases National Institutes of Health. July 22, 2007. To Build or Maintain a Sustainable Research Career.

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P REPARING AND S UBMITTING A S UCCESSFUL G RANT A PPLICATION

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  1. PREPARING ANDSUBMITTINGASUCCESSFUL GRANT APPLICATION Priti Mehrotra, Ph.D. Chief, Immunology Clinical Review Branch National Institute of Allergy and Infectious Diseases National Institutes of Health July 22, 2007

  2. To Build or Maintain a Sustainable Research Career • It is important to • Choose the right mechanism • Focus on institute's mission • Understand the programmatic needs of the IC • Know NIH peer review policies

  3. Today’s Discussion • Application Preparation • Application Submission • NIH Peer Review Process • Additional Resources • Grantsmanship Tips • Electronic Submission • Review Criteria • Internet Resources

  4. APPLICATION PREPARATION

  5. Overview • Preparing a competitive grant application • Is challenging • Is time-sensitive and time-consuming • Involves • Planning • Writing • Submitting Note: Mastery of grantsmanship is critical for research success

  6. Choosing the Right Mechanism • Unsolicited Investigator Initiated Applications • Capitalize on your strengths • Find great ideas and concentrate on your expertise • Funding mechanism opportunities • Research Project Grants (R01) • Small Grants (R03) • NIH Exploratory Research (R21) • Other Funding Opportunities Announcements (including multi-project applications)

  7. Choosing the Right Mechanism (cont.) • Solicited Initiatives • Are first approved as concepts and these concepts are listed in the • NIAID Funding Opportunities • NIAID Newsletter • Are published in the NIH Guide for Grants and Contracts • Allow time to establish collaboration and accumulate data

  8. Strategies for Success • Future impact • New, original ideas • Innovative and significant • Brainstorm with colleagues and mentors • Focused research • Solid hypothesis-driven approach • Supported by preliminary data • Achievable specific aims • Precise, focused and related to hypothesis

  9. Strategies for Success (cont.) • Future directions and contingency plans • Appropriate plans for data analysis • Adequate staff with experience/training in essential methodology • Complement expertise with collaborators and consultants • Appropriate resources and facilities • Knowledge of relevant published scientific literature • Administrative plans for communication and interaction

  10. Strategies for Success (cont.) • Prepared according to NIH standard review criteria • Significance • Innovation • Approach • Investigator • Environment • Initiative specific review criteria, if applicable • Proof read

  11. Elements of Unsuccessful Applications • Project not likely to produce useful information • Failure to describe significance of the proposed work • Lack of focused hypothesis or specific aims • Insufficient preliminary data and experimental detail • Lack of scientific basis and rationale • Failure to address experimental pitfalls and alternative approaches

  12. Elements of Unsuccessful Applications (cont.) • Over-ambitious research plan • Inappropriate or insufficient expertise of the Principal Investigator (PI) and/or key personnel • Over-commitment of the PI • Insufficient knowledge of relevant literature and research area(s) • Lack of administrative plan(s): communication, interaction, and collaboration

  13. Elements of Unsuccessful Applications (cont.) • Lack of attention to details • Lack of institutional support • Inadequate attention to the submission requirements

  14. Advice for New Investigators • Check eligibility, if no previous R01 funding has been received • Utilize available resources • NIH Office of Extramural Research New Investigator Program • http://grants.nih.gov/grants/new_investigators/ • NIAID Advice for New Investigators • http://www.niaid.nih.gov/ncn/grants/plan/plan_i1.htm

  15. Why Include Multiple Principal Investigators? • To promote multi-disciplinary team science • Complement expertise • To recognize collaborators • To define responsibility and accountability of each PI

  16. APPLICATION SUBMISSION

  17. Electronic Submission is Happening! IMPORTANT CHANGES TO THE APPLICATION SUBMISSION PROCESS ARE IN PROGRESS! http://era.nih.gov/ElectronicReceipt/

  18. Key Elements of Electronic Submission • Most types of NIH grant applications are submitted electronically via Grants.Gov using SF-424 forms • 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 commons accounts to track review progress and to retrieve scores and summary statements Note: See ‘Additional Resources’ section for electronic submission details

  19. Avoid Having Your Application Returned • Follow formatting instructions • Submit correct forms (PHS 398 or SF-424) • Know the Deadlines • Standard Submission dates • Special Submission dates for AIDS • Receipt dates for solicited applications • Contact the Scientific Review Administrator and Program Officer, if you have any questions

  20. Receipt and Referral • All applications submitted to NIH go to the Center for Scientific Review (CSR) • Referral officers at CSR assign applications to a Scientific Review Group (SRG) or institute for the review • Applications may be assigned to one or more NIH institutes for funding consideration • A cover letter can help direct application toward appropriate SRG and institute assignments based on scientific area

  21. NIHPEER REVIEW PROCESS

  22. Overview • Competitive process • Managed by Scientific Review Administrator(s) • Follows NIH/NIAID policies and procedures • Follows Office of Extramural Research for Peer Review policy

  23. The Two Step Process • Scientific and Technical Evaluation • SRGs evaluate scientific merit and assign priority scores • CSR reviews the majority of applications • Review divisions of funding institutes review the rest • Advisory Councils at funding institutes • May concur with priority score and recommend funding • Provide special consideration of applications that address high program priorities

  24. NIH Staff Roles • Scientists administering the research grant process • Scientific Review Administrators (SRA) • Program Officers (PO) • Grants Management Specialists (GMS) Note: NIH staff can not influence the evaluation of applications

  25. NIH Staff Roles (cont.) • Scientific Review Administrator (doctoral scientist) • Is an expert on peer-review policy, procedures and compliance • Protects the confidentiality of the applications • Recruits reviewers, insures scientific expertise on the panel, and selects chairperson to moderate discussions • Serves as a point of contact for review related issues

  26. NIH Staff Roles (cont.) • Scientific Review Administrator (cont.) • Manages the review meeting as a Federal Official • Provides scientific, administrative, and logistical oversight of the “peer-review” • Writes resume of discussion at the review meeting and generates final summary statements

  27. NIH Staff Roles (cont.) • Program Officer • Provides scientific stewardship and administer grants • Identifies areas of scientific priorities • Serves as advocate for investigators • Provides guidance on resources for research and collaboration • Tip! Contact the PO to discuss science • Grants Management Specialist • Is the Government official on fiscal policy • Negotiates, approves and awards all grants

  28. What Happens Prior to the Review Meeting? • Assigned Reviewers provide preliminary scores on internet assisted review (eRA commons) website • Provide a Priority Score to the application • Outstanding (1.0 - 1.5) in 0.1 increments • Excellent (1.5 - 2.0) “ • Very Good (2.0 - 2.5) “ • Good (2.5 - 3.5) “ • Acceptable (3.5 - 5.0) “ • NRFC (Not Recommended for Further Consideration)

  29. What Happens During a Review Meeting? • Streamlining • Non-competitive among pool of the applications • Unscored and not discussed • Receive reviewers critiques • Competitive Applications • Discuss and receive a priority score by all non-conflicted reviewers

  30. What Happens During a Review Meeting? (cont.) • Review of Applications based on • Review Criteria • Significance • Approach • Innovation • Investigator • Environment  Also initiative specific review criteria, when applicable

  31. Post-Meeting • Summary statements • Description provided by applicant • Resume of discussion written by SRA • Written critiques from assigned reviewers • Scores and critiques are made available to the investigators (eRA Commons) and to the assigned institutes for funding consideration (30 days)

  32. QUESTIONS?

  33. Contact Information Priti Mehrotra, Ph.D. Chief, Immunology Clinical Review Branch Division of Extramural Activities NIAID, NIH, DHHS 6700-B Rockledge Drive, Room 3138, MS 7616 Bethesda, MD 20892-7616 Phone: 301-435-9369 / Fax: 301-480-2310 pmehrotra@niaid.nih.gov

  34. ADDITIONAL RESOURCES

  35. Grantsmanship Tips

  36. “THE RULES”for Navigating the NIH Peer Review System

  37. Application Must Be Complete • Write the application section by section • Address ALL the review criteria • Address Special Requirements of award type or solicitation • Include all documents necessary for review • ONLY the information in the application is reviewed • Applications are NOT compared

  38. Application Must Be Complete (cont.) • Make the Description (Abstract) understandable and complete • Helps to orient reviewers • Needs to be written carefully • Will be in CRISP, if funded • Write it last to make it comprehensive • Describe a clear, concise, and factual synopsis of the application • Do not cut and paste • Define acronyms • Fit it in the space

  39. Make It Easy for the Reviewers • Present clear overall organization • Be concise • Make your application visually appealing: charts, tables, diagrams, figure legends, and flow-charts • Use appendices well • Cross-reference biosketches of key personnel, label, and number relevant items • Organize according to the Review Criteria

  40. Be Straightforward • Lay out strengths and weaknesses of experimental approaches and techniques • Identify potential limitations and problems • Show how you propose to address them • Don't over- or under-estimate the budget • Do not assume reviewers will know what you mean • Do not assume reviewers will ignore review criteria • Don't indulge in blatant self-promotion • Don't add irrelevant information to biosketches

  41. Don’t Work Alone • Seek collaborators and consultants • Network widely • Find available resources • Read a successful application and its summary statement • Allow enough time for writing • Seek advice from senior investigators • Allow enough time for feedback

  42. Be Aware of Changes in Science and Policies • Periodically check NIH and NIAID web page • Keep abreast of change in policies • Know NIAID high priority area(s) • Communicate with Program Officers, Scientific Review Administrators, and Grants Management Specialist • Stay in touch with your University / Institution Office of Sponsored Programs

  43. Be Aware of Changes in Science and Policies (cont.) • NIH Manual Chapters • http://www1.od.nih.gov/oma/manualchapters/scripts/mcs/browse.asp • NIAID Standard Operating Procedures • http://www.niaid.nih.gov/ncn/sop/default.htm • NIAID Research Funding • http://www3.niaid.nih.gov/researchFunding/

  44. Don’t Give Up! Initial failure is common: learn from it and succeed – the majority do! • Read criticisms in the summary statement • Decide if problems are repairable • Attend diligently to each criticism • Keep a positive tone and attitude • Revise and resubmit • When resubmitting: address reviewers’ comments

  45. Electronic Submission Process

  46. Electronic Submission is Happening! • The NIH is transitioning from paper submission of grant applications to electronic submission • A phase out from the Form PHS 398 grant application is in progress • Form 398 is being replaced with the SF 424 Research and Research-related (R&R) application form • The transition is in progress and may end in 2008-2009 for all mechanisms

  47. Must be Done for Electronic Submission • Register on Grants.gov • Non-US institution or organization • One-time registration • To obtain EIN (Employer Identification Number) from the Internal revenue Service (IRS) • Request DUNS (Dunn and Bradstreet) number • Register with the US government’s “Central Contractor Registry” CCR • Identify the Point of Contact

  48. Must be Done for Electronic Submission (cont.) • Register the Authorized Organization Representatives (AORs) • Individual who can submit the application NOTE: This process may take 4-8 weeks. Non-US institutions may require additional registration with a North Atlantic Treaty Organization Commercial and Government Entity (NCAGE)

  49. Must be Done for Electronic Submission (cont.) • ERA Commons (NIH Electronic Research Administration System) • For applicants and grantee • To receive and transmit information or application electronically • Both applicant and organization must register • Organization • One-time registration • If registered, see institution on the list http://era.nih.gov/commons/index.cfm • If not listed, check the following site https://commons.era.nih.gov/commons/registration/registrationinstructions.jsp

  50. Must be Done for Electronic Submission (cont.) • ERA Commons and Grants.gov registration can be done simultaneously • Allow 2-4 weeks to complete

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