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Grant Writing

Grant Writing. John Chae, MD Case Western Reserve University MetroHealth Medical Center 2007 Annual Meeting of the AAP. Disclaimer. I’ve never taken a “class” on grantsmanship I’ve only written 5 unique NIH grants in my career (R29, three R01s and K24)

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Grant Writing

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  1. Grant Writing John Chae, MD Case Western Reserve University MetroHealth Medical Center 2007 Annual Meeting of the AAP

  2. Disclaimer • I’ve never taken a “class” on grantsmanship • I’ve only written 5 unique NIH grants in my career (R29, three R01s and K24) • However, each, except one, was funded the first time • “School of hard knocks”

  3. Overview • NIH • People • Types of Grants • K and R award Structure • Review criteria • Comments on other mechanisms • Review Process • What’s really important…

  4. NIH • Part of the Department of Health and Human Services • Consists of 20 Institutes and 7 Centers: Each are allocated a budget • Institutes: -Each institute has an identified domain and receives funding to support research in these domains -Each institute make final funding decisions -Intramural and Extramural research • Centers -Several function similar to an Institute -Several provide infrastructure predominantly -Several do both

  5. Institutes of Interest National Institute on Aging (NIA) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Institute of Biomedical Imaging and Bioengineering (NIBIB) National Institute of Child Health and Human Development (NICHD) National Institute of Neurological Disorders and Stroke (NINDS) Centers of Interest Center for Scientific Review (CSR) National Center for Complementary and Alternative Medicine (NCCAM) National Center for Research Resource (NCRR) NIH Clinical Center (CC) Comment: National Center for Medical Rehabilitation Research (NCMRR) NIH

  6. People • Scientific Review Administrator (SRA)-Review group specific • Program Officers-Institute specific • Grants manager-Institute specific

  7. Types of Grants “Mechanisms” • R: Field or investigator initiated research grants -R03: Small grants (2-yrs, $100K, 10 p research plan) -R21: Exploratory grants (2-yrs, $350K, 15 p research plan) -R01: Traditional research grants (3 to 5-yrs, no $ limit, 25 page research plan) • K: Career awards (5-yrs, salary + $25-50K/yr, 50 p) • T: Training grants • F: Fellowships • P: Program Project or Center grants

  8. K-Award (K23) Section I: Administrative Data • Face page • Description, performance sites, key personnel • Table of contents • Budget • Biographical sketches • Other support (for mentors) • Resources

  9. K-Award (K23) Section II: Specialized Information 1. The candidate (25 pages) A. Candidate background B. Career goals and objectives: Scientific biography C. Career development/training activity during award period D. Training in the responsible conduct of research

  10. K-Award (K23) 2. Statement by Sponsor, Co-Sponsor(s), Consultants and Contributors 3. Environment and Institutional Commitment to Candidate A. Description of Institutional Environment B. Institutional commitment to candidate’s research career development: 75% protected research time

  11. K-award (K23) 4. Research Plan A. Specific Aims B. Background and Significance C. Preliminary studies/progress report D. Research design and methods E. Human Subjects Research F. Vertebrate Animals G. Select Agent Research H. Literature Cited I. Consortium/contractual arrangements J. Resource Sharing A-D: 25 pages

  12. K23 Review Criteria • Candidate: -Quality of the candidate’s academic and clinical record -Potential to develop as an independent clinical researcher focusing on patient oriented research (POR) -Commitment to a career in POR • Career Development Plan: -Likelihood that the plan will contribute substantially to the scientific development of the candidate -Appropriateness of the content and duration of the proposed didactic and research phases of the award -Consistency of the career development plan with the candidate’s career goals and prior research experience -Quality of the proposed training in responsible conduct of research

  13. K23 Review Criteria (cont’) • Research Plan: “Reviewers recognize that an individual with limited research experience is less likely to be able to prepare a research plan with the breadth and depth of that submitted by a more experienced investigator. Although it is understood that K23 applications do not require the level of detail necessary in regular research grant applications, a fundamentally sound research plan must be provided. In general, less detail is expected with regard to research planned for the later years of the award, but the application should outline the general goals of these years.”

  14. K23 Review Criteria (cont’) • Research Plan (cont’) -Appropriateness of the plan to the stage of research development and as a vehicle for developing the research skills as described in the career development plan -Scientific and technical merit of the research question, design and methodology -Relevance of the proposed research to the candidate’s career objectives -Adequacy of the plan’s attention to including both genders and minority subjects in projects involving human subjects -Adequacy of plans for including children as appropriate for scientific goals of the research, or justification for exclusion

  15. K23 Review Criteria (cont’) • Mentor -Appropriateness of mentor’s research qualifications in the area of application -Quality and extent of mentor’s proposed role in providing guidance and advice to the candidate -Previous experience in fostering the development of researchers -History of research productivity and support • Environment and Institutional Support -Institution’s commitment to the scientific development of the candidate -Adequacy of facilities and the availability of appropriate educational opportunities -Quality and relevance of the environment for scientific and professional development -Institution’s commitment to an appropriate balance of research and clinical responsibilities

  16. K23 Review Criteria (cont’) • Budget: Evaluate the justification of the requested budget in relation to career development goals and research aims • Human Subjects: Assess risks and benefits and data and safety monitoring plan • Gender/Minority/Children inclusion

  17. R Awards • Same as K-award but without the Candidate section • Primary focus in the research plan: A. Specific Aims B. Background and Significance C. Preliminary studies/progress report D. Research design and methods E. Human Subjects Research F. Vertebrate Animals G. Select Agent Research H. Literature Cited I. Consortium/contractual arrangements J. Resource Sharing A-D: 25 pages

  18. R-award Criteria • Significance: -Does this study address an important problem? -If the aims are achieved, how will scientific knowledge or clinical practice be advanced? -What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventive interventions that drive the field?

  19. R-award Criteria (cont’) • Approach: -Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-reasoned and appropriate to the aims of the project? -Does the applicant acknowledge potential problem areas and consider alternative tactics?

  20. R-award Criteria (cont’) • Innovation: -Is the project original and innovative? -Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? -Does the project develop or employ a novel concept, approaches, methodologies, tools, or technologies for this area?

  21. Other Mechanisms • R03: Small grant -$50K/yr, 2 yrs -Pilot studies, 10 page Research Plan -Preliminary study not needed • R21: Exploratory grant -$350K over 2 yrs -High risk, potential high yield -Preliminary study not needed -15 page Research Plan

  22. Review Process Dual level process • Scientific Review -Received by the Center for Scientific Review(CSR) -CSR assigns the grant to a Scientific Review Groups (SRG), AKA “Study Section” *Musculoskeletal Rehabilitation *Function, Integration, Rehabilitation Sciences Subcommittee -Each SRG managed by a Scientific Review Administrator (SRA) -Most SRG are not aligned with an Institute, but some are -Peers, independent investigators for the most part • Council Review -Institute specific -Peers, program officers

  23. Review Process • 1-5 (1=outstanding) -No specific instructions on how to weigh each criterion -Reviewer’s overall impression • Priority score: Rating of intrinsic scientific merit of the proposed research (100-500) • Percentile: the relative rank of each priority score (along a 100.0 percentile band) among the scores assigned by a particular study section • Streamlining: Up to half of proposals are unscored (bottom half of applicants, ~priority score 3.0 or higher)

  24. What really matters… I will assume that you have a great • idea • mentor • institution

  25. Communicate! Write in English Learn to write! Use correct grammar Use correct spelling Keep it simple and clear Don’t try to impress Write to a scientists who is not in your field Remember, the reviewers are: Spending 6-10 hrs per K-award application Fatigued Grumpy and irritable Not easily impressed Poorly paid Working above and beyond their regular work What really matters…

  26. What really matters… Format • Remember, reviewers are spending hrs reviewing grants, their eyes are red and glassy and they are fatigued • They need to see! • Follow instructions • Watch margins • Arial 11 or larger • Include pictures and diagrams; a sea of letters tend to merge into a blur

  27. What really matters… Read other people’s grants: • Knutson R21: 153, 11% • Chae single site R01 -Initial submission: 273, 49.4% -A1: 170, 16.7% -A2: 130, 1.0% • Chae multi-site R01: 135, 3.1%

  28. What really matters… Start early • Give yourself at least 4-mo to write a R-award (~2 hrs/day) • For a K-award, start earlier to identify a mentor, establish a training plan, research plan etc • Get it done early

  29. What really matters… Have others read your application • Independent investigators with a track record of success • Members of study sections • Remember, it takes approximately 8 hrs to review a K-award • Don’t give it to your colleague last minute; give them at least 2-wks • Have a thick skin; they are trying to help you, not humiliate you • Take their feedback seriously

  30. What really matters… After you receive your score… • Review your summary statement with your mentor • Follow up with your program officer • Determine whether you’re in the fundable range • Determine whether the grant has merit for resubmission • Try, try again…

  31. Summary • NIH structure • People to know • Types of Grants • K and R Award Structure • Review criteria • Comments on other mechanisms • Review Process • How to write…

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