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NIH Grant Writing Workshop

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  1. NIHGrant Writing Workshop Susan McHale Professor of Human Development; Director, SSRI Douglas M. Teti Professor of Human Development, Psychology, and Pediatrics; Associate Director, SSRI Rhonda BeLue Associate Professor of Health Policy and AdministrationKristin Buss Professor of Psychology, College of the Liberal Arts Michelle Frisco Associate Professor of Sociology and Demography, College of the Liberal Arts

  2. Workshop Outline • NIH Organization • NIH Funding Mechanisms • The Grant Writing Process • Focus on the R01 • The NIH Review Process • Overview of Review Meeting • The Scoring Process • A Penn State example • Workshop Evaluation

  3. Thanks to: • Lori Francis, Associate Professor of Biobehavioral Health and Center for Family Research in Diverse Contexts, PSU • Donna Panasiti, Social Science Research Institute

  4. I. The NIH • Department of Health and Human Services • National Institutes of Health • 25 Awarding Institutes/Centers aka ICs (e.g., NICHD, NIMH, NIDA, NIA) • Center for Scientific Review • Office of the Director

  5. The NIH Extramural Team A. Program B. Grants Management C. Review

  6. A. The Program/Institute StaffProgram Administrator • Maintains knowledge of scientific area • Attends study section meetings • Makes funding recommendations • Monitors scientific progress • Identifies scientific area of importance • Reports to senior staff • Development of programs and initiatives

  7. B. Grants Management • Interprets Federal regulations and policies • Assures compliance with Federal regulations and policies • Monitors financial aspects of projects • Interprets regulations and policy

  8. Center for Scientific Review (CSR) or NIH Institute & Center (IC) Scientific Review Group (SRG) Non-federal scientists with relevant expertise Led by a Scientific Review Officer (SRO) http://www.csr.nih.gov/Roster_proto/sectionI.asp C. Review:Scientific Review Group (1st Level)

  9. C. Review:Advisory Council or Board (2nd Level) The potential awarding IC performs the second level of review. Comprised of scientists from the extramural community and public representatives. NIH program staff examine applications for impact (formerly “priority”) scores, percentile rankings, & summary statements against the IC’s needs. Program staff provide grant funding plan to Advisory Council or Board. Advisory Council or Board advises the IC director. Director makes final decision.

  10. NIH Grant Application Cycle Investigator Institution NIH InitiatesResearch Peer Review Submits Application Council Review Allocates Funds Funding Decision ConductsResearch

  11. Grant Application: It’s a process, not an event • Communicate with Program Officer • Introducing ideas, getting feedback, pre-review 2. Get your proposal to the right review committee • Review the rosters and talk to colleagues • Effectively wording the abstract • Make a written request 3. Seek feedback from colleagues and consultants on drafts of the grant (prepare ahead!) 4. Consider who is likely to review your grant (review the rosters) and make sure to know and cite their work when relevant 5. Recognize that funding on first submission is rare

  12. II. NIH Grant Mechanisms • Ks: NIH Career Development Awards (K01, K02, K05, K07, K08, K22) • P01: Research Program Project Grant • P30: Center Core Grants • R01: NIH Research Project Grant Program • R03: NIH Small Grant Program • R13: NIH Support for Conferences and Scientific Meetings (R13, U13) • R15: NIH Academic Research Enhancement Award (AREA)

  13. NIH Grant Mechanisms (continued) • R21: NIH Exploratory/Developmental Research Grant Award • R34: NIH Clinical Trial Planning Grant • T series: NRSA Training Grants (T32, T34, T35, T90, etc.) • U series: Research Project Cooperative Agreement • Diversity Supplements: Research Supplements to Promote Diversity in Health-related Research • Roadmap: NIH Roadmap Initiatives (Director’s Pioneer Award; Director’s New Innovative Program

  14. Pre-doctoral and Post-doctoral Training Awards (F-series) • Focuses on the training environment, research training plan, and the candidate’s strengths • Research strategy is 6 pages • F31 covers doctoral study tuition and living stipend (levels set by NIH). Up to 60 months of support. • F32 covers living stipend and funds for research/professional development

  15. Career Awards (K-series) • Nine different Career Development (K) Awards • Body of application is 12 pages for most • Support individuals after they have completed clinical training and have accepted a faculty position • Provide for release time for research and monies for research/faculty development

  16. R03 • Small research grant • Research strategy is 6 pages • Can be used to collect pilot data, conduct feasibility studies • Often analysis of an existing dataset • May be used to develop new research technology • $50K per year for 2 years

  17. R21 • Exploratory or Developmental Grant • Research strategy is 6 pages • Often little or no pilot data • Feasibility study • 2 years of funding (Total of $275K) • Not necessarily the first step for new investigators

  18. R34 • Supports the development of Phase III clinical trials • Establishment of the research team • Development data management tools • Definition of recruitment strategies • Finalization of the protocol • Research strategy is 6 pages • The planning grant is designed to lead to an application for support of a full-scale trial

  19. R15 Area Award • Used to stimulate research in educational institutions that have not been major recipients of NIH support • Research strategy is 12 pages • Opportunity to conduct research; strengthen the research environment of the institution; and benefit the student through exposure to and participation in research • Limited to up to three years of funding for total of $150,000 • Preliminary data generally not required

  20. R01 (primary focus today) • Used to support a discrete, specified, circumscribed research project • NIH’s most commonly used grant program • Research Strategy is 12 pages • Advance permission required for $500,000 or more (direct costs) in any year • Generally awarded for 3 to 5 years

  21. Research Center Grants (P-series) • Established by ICs to meet special needs • May support research and/or core facilities • Usually initiated by the IC • Request for Applications (RFA) • P30, P50, P60, U54 • P01 Center grants are investigator-initiated, linked R01s with an additional core of funding

  22. Research Supplements to Promote Diversity in Health-Related Research • Administrative supplement to R01 grants and many other types • Need to have at least 2 years of funding left on the grant • Contact project officer for permission to submit • Can be used for students, doctoral students, junior investigators

  23. New and Early Stage Investigators:A Competitive Edge • New Investigator has not previously served as a PI for an R01; may have been an investigator or received other smaller, developmental or research training awards • Early Stage Investigator (ESI) is within 10 years of completing his/her terminal research degree, or is within 10 years of completing medical residency

  24. III. The Grant Writing Process • Grant writing is: • A skill like any other… • But not the same skill as article writing • Instead, more of a problem-based writing activity (theory and practice problem)

  25. A few preliminary tips • Start early, make a timeline and STICK TO IT • Should allow time for serious pre-submission review & subsequent revision • Develop a relationship with project officers • It is not possible to overdo clarity • Let your passion come through in your proposal • Take advantage of early stage and new investigator opportunities

  26. Getting ready to write • Know what has been done • Know what has been funded • NIH website • Decide on the problem • Important enough to get funded but simple enough to explain as clean design in 12 pp (for the R01; less for other mechanisms) • Mediators and moderators, mechanisms of change • Assemble team--CAREFULLY • Preliminary research (R01)

  27. Getting ready to write • Communicate with program officer • Establish a relationship and trust (funding decision) • Acquire information on mechanism and priorities • Obtain input on aims/proposal

  28. Main Sections of the NIH Application(see Francis et al. for example) • Face Page • Table of Contents • Performance Sites • Other information • Project Summary/Abstract (Description) • Public Health Relevance Statement • Facilities & Resources

  29. More Sections • Key Personnel • Biosketches --with personal statements • Budgets (for each study year) • Budget Justification • Clinical Trial and Human Embryonic Stem Cell (HESC) • List of Research Plan Attachments

  30. Main Sections of the R01: Specific Research Plan • [Introduction – revisions only] • Specific Aims: The basis for the proposal’s organization • Research Strategy • Significance and Innovation • Approach • Preliminary studies • Design • Sample/recruitment/power analyses • Procedures & measures • Analyses

  31. Page Limit Guide: Plan your proposal with these limits in mind Page limits may vary for other funding mechanisms. Check Funding Opportunity Announcement: http://grants.nih.gov/grants/guide/search_results.htm?scope=pa&year=active

  32. And More Sections • Protection of Human Subjects • Women and Minorities • Planned Enrollment Table • Children • References Cited • Letters of Support • Resource Sharing Plan • Checklist SO START EARLY!

  33. Keys to R01 Success • Impact and Significance • Practice (2-3 sentences) • Prevalence of problem in population • Important social concern • Theory (model) • Building, testing, using • Innovation • New directions, value added • Importance of Preliminary Research

  34. Keys to Success - Methods • Methods are very important • Overall -- clarity and detail • May include a table that traces aims to hypotheses to constructs to measures (table/s) • Is the design feasible? • Are there gaps in the methods (e.g., fidelity for interventions) • Stats are very, very important (methodologist team member) • Include a detailed timeline

  35. More Methods - Issues • Community-based participatory research -- very strict about how this is done. • Lab versus field • Focus groups, interviews, analyses

  36. And More Methods: The Sample • Preference for representative samples • Students only if relevant to age/situation (e.g., college drinking) • Generalizability from a single entity (university, clinic, state) • Unit of assignment is unit of analysis

  37. Budgets • Direct Costs • Senior Personnel (PI, co-Is, project director) (PSU fringe at 36.5%) • Other Personnel (full time staff, RAs, part time wages) (PSU fringe 36.5% for full time staff, 13.2% for Grad Assts AY; 7.9% for part time wages and summer) • Equipment • Travel • Participant/Trainee Support Costs

  38. Budgets.2 • Other • Materials and supplies • Publication costs • Consultant services • Subawards/Consortium/Contractual Fees • Other • Indirect Costs (> 45% at PSU, but does not include all expenses) • Budget justification

  39. Receiving the Summary Statements: The Hardest Part! • Reviews critical, even harsh • Reviewers usually find grant’s weaknesses, while recognizing strengths • Summary statements spend much more time on critique than praise • Many investigators experience a mixture of rage and depression when they read their summary statements and easily lose perspective • Take a day or two (or more!) and then read again with a cooler head

  40. Receiving the Summary Statements: Bouncing Back! • Ask experienced colleagues to read reviews • Don’t interpret criticism as hopeless • Program Officer may be helpful in clarifying critique • If “discussed” (rather than triaged), you have a chance of funding in next round • The lower the initial score, the fewer problems and more likely to be successful after revision

  41. Resubmission:Resilience and Flexibility! • Persistence pays off in the grant process!! • Second submission must respond to the critiques through revision or clearly defending reasoning • Same reviewers may or may not review resubmission, but will see critique

  42. Most Common Reasons for a Poor Score (in priority order) • Lack of impact or significance • Lack of new or original ideas – show your passion! • Hypotheses ill-defined, superficial, lacking, unfocused, or unsupported by preliminary data • Methods unsuitable, not feasible, not rigorous or not likely to yield results; methods don’t clearly link to aims • Design not logical, inappropriate instrumentation, poor timing or conditions; doesn’t link well to aims • Data management and analysis vague, not rigorous; analyses don’t clearly link to aims • Inadequate expertise or knowledge of field for PI; too little time to devote to the work • Poor resources or facilities; limited access to appropriate population

  43. When to Revise • Basic idea was significant and innovative or these can be bolstered • Design/measurement/analysis problems can be clarified (more information) or fixed • Need preliminary data • Problem is poor writing

  44. IV. The NIH Review Process • A. The Review Meeting • B. Review Discussion • C. The Scoring Process • D. A Penn State Example

  45. A. The Review Meeting: The SRO’s Role Prior to Meeting • Point of contact until review group meets (then project officer) • Analyze submissions for completeness and conflicts • Recruit ad hoc reviewers as needed • Schedule 1-2 day meeting • Assign applications to reviewers (at least 3) • Primary, secondary, discussant • Create review order based on preliminary impact scores from best to worst within categories

  46. Reviewers’ Role Prior to Meeting • Familiarize self with criteria, mechanisms, and scoring • Review assigned applications • Assign scores to each criteria and other areas • Write bulleted strengths and weaknesses for each criteria • Reviews are advice to institutes for funding decisions, not advice to PI • Post scores and comments on NIH Commons • Read other reviews of assigned applications • Prepare presentation of reviews • Skim/read non-assigned applications

  47. Format of the Review Meeting • SRO opening remarks • Chair orientation • New investigator R01 grants • Other R01 grants • Other grant types (R03, R15, R21, R34) • Applications discussed in order of Impact Score; bottom 50% are not discussed

  48. SRO Opening Remarks • Confidentiality • Review order • Proposals below median within each category may not be discussed

  49. Chair Orientation • Start with reviewer impact scores • May differ from posted scores • Goal of discussion is to clarify not reach agreement • If scores are similar, shorter discussion • If scores are dissimilar, longer discussion • Recommended time • Primary – 5 minutes • Secondary – 3 minutes • Discussant – 2 minutes

  50. B. Review Discussion • Identify proposal • Members in conflict leave • Reviewers provide preliminary impact scores • Reviews • Impact, Significance, Investigators, Innovation, Approach, Environment • Stress main points, do not repeat previous points • Non-reviewers typically ask questions to clarify • Human Subjects issues affecting scoring • Open discussion to entire committee