NIH Grant Writing Tips

1. NIH Grant Writing Tips Kelli A. Komro, MPH, PhD Associate Professor, Department of Epidemiology and Health Policy Research, COM Associate Director, Institute for Child Health Policy www.ehpr.ufl.edu www.ichp.ufl.edu komro@ufl.edu

2. Outline • My background • NIH structure and budget • Types of awards • Peer review process • Grant writing tips • UF NIH investigators & grant writing course • CRISP: http://crisp.cit.nih.gov/ • ICHP: www.ichp.edu

3. Research Background • Research Experience • PhD in Epidemiology, 1994, University of Minnesota • Associate Professor, EHPR and Associate Director, ICHP • $29M in grant funding, mostly NIH • Child & adolescent health; community-wide preventive interventions; group-randomized trials • Mentor graduate students and junior faculty • Grant Review Experience • NIH grant reviews • UK’s Medical Research Council

4. Goal: To adapt, implement and evaluate an alcohol preventive intervention for urban young adolescents

5. U.S. Department of Health and Human Services The Secretary Deputy Secretary Administration for Children and Families (ACF) Administration on Aging (AoA) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Centers for Medicare and Medicaid Services (CMS) Agency for Health Care Policy and Research (AHCPR) Indian Health Services (IHS) National Institutes of Health (NIH) Centers for Disease Control and Prevention (CDC) Agency for Toxic Substances and Disease Registry (ATSDR) Substance Abuse and Mental Health Services Administration (SAMHSA) Program Support Center (PSC)

6. National Institutes of Health Mission NIH conducts and supports basic, applied, clinical and health services research to understand the processes underlying human health and to acquire new knowledge to help prevent, diagnose, and treat human diseases and disabilities.

7. NIH Funding • Increase in applications & applicants • Flat budget & inflation • Success rates per application • 2008: 19% • 1999: 27% • Strategies to encourage and support junior scientists • 2009 payline: 25%

9. National Institutes of Health Fogarty International Center National Institutes of Health National Institutes of Health Office of the Director Office of the Director Office of the Director Office of the Director National Institute National Institute National Institute National Institute National Institute National Institute National Institute National Institute National Institute National Institute National Institute National Institute National Institute National Institute National Institute National Institute National Institute National Institute of Arthritis and of Arthritis and National Cancer National Cancer of Child Health of Child Health National Institute National Institute of Arthritis and of Arthritis and National Cancer National Cancer of Child Health of Child Health of Allergy and of Allergy and on Alcohol Abuse on Alcohol Abuse of Allergy and of Allergy and on Alcohol Abuse on Alcohol Abuse on Aging on Aging Musculoskeletal Musculoskeletal Institute Institute and Human and Human on Aging on Aging Musculoskeletal Musculoskeletal Institute Institute and Human and Human Infectious Diseases Infectious Diseases and Alcoholism and Alcoholism Infectious Diseases Infectious Diseases and Alcoholism and Alcoholism and Skin Diseases and Skin Diseases Development Development and Skin Diseases and Skin Diseases Development Development National Institute on National Institute on National Institute National Institute National Institute National Institute National Institute on National Institute on National Institute National Institute National Institute National Institute National Institute National Institute National Institute National Institute Deafness and Other Deafness and Other of Dental and of Dental and of Diabetes and of Diabetes and National Institute National Institute National Eye National Eye Deafness and Other Deafness and Other of Dental and of Dental and of Diabetes and of Diabetes and National Institute National Institute National Eye National Eye of Environmental of Environmental of Environmental of Environmental Communication Communication Craniofacial Craniofacial Digestive and Digestive and on Drug Abuse on Drug Abuse Institute Institute Communication Communication Craniofacial Craniofacial Digestive and Digestive and on Drug Abuse on Drug Abuse Institute Institute Health Sciences Health Sciences Health Sciences Health Sciences Disorders Disorders Research Research Kidney Diseases Kidney Diseases Disorders Disorders Research Research Kidney Diseases Kidney Diseases National Institute National Institute National Institute National Institute National Institute National Institute National Heart, National Heart, National Human National Human National Institute National Institute National Heart, National Heart, National Human National Human National Institute National Institute of Neurological of Neurological National Institute National Institute National Institute National Institute of Neurological of Neurological National Institute National Institute of General of General Lung, and Blood Lung, and Blood Genome Research Genome Research of General of General Lung, and Blood Lung, and Blood Genome Research Genome Research of Mental Health of Mental Health Disorders and Disorders and of Nursing Research of Nursing Research of Mental Health of Mental Health Disorders and Disorders and of Nursing Research of Nursing Research Medical Sciences Medical Sciences Institute Institute Institute Institute Medical Sciences Medical Sciences Institute Institute Institute Institute Stroke Stroke Stroke Stroke National Center National Center National Center National Center National Institute of National Institute of National Center on National Center on National Center National Center National Institute of National Institute of National Center on National Center on National Center National Center for Complementary for Complementary National Library National Library for Complementary for Complementary National Library National Library Biomedical Imaging Biomedical Imaging Minority Health and Minority Health and for Research for Research Biomedical Imaging Biomedical Imaging Minority Health and Minority Health and for Research for Research and Alternative and Alternative of Medicine of Medicine and Alternative and Alternative of Medicine of Medicine and Bioengineering and Bioengineering Health Disparities Health Disparities Resources Resources and Bioengineering and Bioengineering Health Disparities Health Disparities Resources Resources Medicine Medicine Medicine Medicine Center for Center for Center for Center for Center for Center for Center for Center for Clinical Center Clinical Center Information Information Clinical Center Clinical Center Information Information Scientific Review Scientific Review Scientific Review Scientific Review Technology Technology Technology Technology

11. Institute/Center Program Officers • A scientist and administrator • Manages grants, contracts, cooperative agreements • Identifies needs in scientific areas • Identifies scientific areas of special interest and communicates interest • Monitors research progress • Advocates for the best science

12. Institute/Center Strategic Plans • Institute/Center web sites • Strategic plans • http://report.nih.gov/strategicplans/index.aspx • Priority areas • Program Announcements (PAs) • Request for Applications (RFAs) • American Recovery and Reinvestment Act • $10.4 B in support of scientific research priorities, available for two years

13. National Institute for Child Health and Human DevelopmentARRA Priorities • GO Grants, due May 27, 2009 • Developmental Biology and Perinatal Medicine • Maternal and Child Health • Contraception, Reproduction and Population Research • Medical Rehabilitation Research • Challenge Grants, due April 27, 2009 • Behavioral interventions • Clinical research • Comparative effectiveness research • Health disparities • Etc. • Supplements to existing NIH grants, various dates

14. Most Common NIH Grant Types • Small Grants Program (R03) • 2 years • Up to $50,000 per year • 10 page proposal • Regular Research Awards (R01) • Up to 5 years • Research costs not limited, but need permission to submit budget of over $500,000 in direct costs in any year • 25 page proposal

15. Mentored Career Development Awards • Mentored Research Scientist Development Award (K01) • Mentored Clinical Scientist Development Award (K08) • Career Transition Award (K22) • Mentored Patient-Oriented Research Career Development Award (K23) • Mentored Quantitative Research Career Development Award (K25)

16. Features of the Mentored Career Awards • Purpose: • Provide applicant with professional degree three-five years of additional supervised research • Training must be in an area new to the applicant and/or one in which additional supervised research experience will substantially add to the research capabilities of the applicant • Focus on progression to independence: The candidate must provide a plan for achieving independent research support by the end of the award period • Allowable Costs: • Annual Salary $48,000-90,000 • Research Development Support up to $50,000 per year

17. Review Criteria for Mentored Career Development Awards • Candidate: • Quality of the candidate's research, academic and/ or clinical record • Potential to develop as an independent researcher; and commitment to a research career • Career Development Plan: • The content, phasing, and duration of the plan • Consistency with the candidate's career goals • Likelihood the plan will contribute to achieving of scientific independence • Research Plan: • Methodology • Relevance to the candidate's career objectives • Appropriateness of the plan to the stage of research development • As a vehicle for developing research skills for career development

18. Review Criteria for Mentored Career Development Awards • Mentor/Co-Mentor: • Research qualifications • Quality and extent of mentor(s) role in providing guidance • Previous experience in fostering the development of researchers • History of research productivity • Adequacy of support for the proposed research project • Environment and Institutional Commitment: • Adequacy of research facilities and training opportunities • Quality of the environment for scientific and professional development • Institution's commitment to candidate—assurances that the institution intends the candidate to be an integral part of its research program • Institution's commitment to an appropriate balance of research and other responsibilities including 75% effort proposed by the candidate

19. Pre-Doctoral Fellowship-F31 Institutional Pre-Doctoral Fellowship-T32 Post-Doctoral Fellowship-F32 Institutional Post-Doctoral Fellowship-T32 Do I need more training or changing career emphasis? Yes No Apply for Mentored K Do I have pilot data? No Yes Apply for R03/ B/START Career Development Plan R01

20. Applications for NIH Research Grants Grants are normally submitted to NIH in three ways: • Unsolicited Grant Application • Program Announcement (PA) - Institute or Center is inviting grant applications in a general scientific area of research. There are generally no funds set aside for these projects. • A Request for Applications (RFA) - one or more NIH Institutes and Centers invite applications in a well-defined scientific research area. Specific funds are set aside for the projects.

21. NIH Guide for Grants and Contracts How do I find out about NIH PAs and RFAs? The NIH Guide Announces NIH Scientific Initiatives provides NIH Policy and Administrative Information. See: http://www.nih.gov/grants/guide/index.html

22. ScientificReview Group (SRG) • Provides Initial Scientific Merit Review of Grant Applications • Rates Applications and makes Recommendations for Appropriate Level of Support and Duration of Award Second Level of Review: Institute or Center Council • Assesses Quality of SRG Review of Grant Applications • Makes Recommendation to Institute Staff on Funding • Evaluates Program Priorities and Relevance • Advises on Policy Dual Review System for NIH Grant Applications

23. NIH Peer Review Process The reviewers study each application individually before the meeting; and for each application, some reviewers are assigned to prepare written critiques. Those projects deemed most competitive, approximately the upper third, are fully discussed and given a priority score based on the scientific merits of the project.

24. Review Criteria • SIGNIFICANCE • APPROACH • INNOVATION • INVESTIGATOR • ENVIRONMENT

25. National Institutes of Health Research Grant Application School or Other Research Center Center for Scientific Review Assigns to IRG/Study Section & IC Study Section Initiates Research Idea Submits Application Evaluates for Scientific Merit Institute Evaluates for Program Relevance Advisory Councils and Boards Allocates Funds Conducts Research Recommends Action Institute Director Takes final action for NIH Director Review Process for A Grant Application Submitted to CSR, NIH

26. Cycle 2 Receipt Council Review Award Referral Cycle 3 Receipt Council Review Award Referral Normal Timeframe from Submission to Award for 398 Unsolicited Grants (PAs & RFAs may be different) • There are normally three overlapping cycles per year : JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC JAN FEB MAR APR MAY JUN JUL Cycle1 Receipt Review Council Award Referral

27. NIH’s Electronic Submission • Require electronic submission through Grants.gov for all NIH grant applications. • Transition from the PHS 398 application form to SF424 family of forms data set.

28. Grant Writing Tips • First Steps: • Broaden your vision • Seek mentoring and research experience • Discuss your ideas with successful senior investigators • Institutional support for pilot projects? • Start early. Do not rush!

29. A Good Idea + Science2 + Marketing Art x (pilot data + good idea) =Grantsmanship Your end product must: be clearly written and well structured be important be unique contribute significantly to the field!

30. Review Criteria • SIGNIFICANCE: address important problem? Will scientific knowledge be advanced? • APPROACH: design and methods appropriate to research questions? Are potential problem areas addressed? • INNOVATION: is the project original and innovative? • INVESTIGATOR: are investigators appropriately trained and well suited to carry out this work? Does the team bring complementary and integrated experience to the project? • ENVIRONMENT: does the scientific environment contribute to the probability of success? Is there evidence of institutional support?

31. Proposal Sections • Abstract • Specific Aims • Background and Significance • Preliminary Studies • Research Design and Methods

32. Abstract • Summarize: • Nature of the problem • Long-term objectives • Need for research • Specific aims • Research design and methods • Must grab the reviewers interest immediately

33. Specific Aims • Clear statement of the problem or question • Background material to provide context • Why proposal is innovative, needs to be done • Public health significance • What you plan to do (basics of design and outcomes) • Specific aims or hypotheses

34. Background and Significance • Problem study will address • Why a public health concern • What others have done and why that wasn’t sufficient • What you plan to do is different • How your research will have an impact on PH • Why your plan is novel • Overview of methods and hypotheses

35. Preliminary Studies • Description of the team, including prior collaborations and relevant experience • Studies conducted by the PI and key personnel that are relevant • Pilot data

36. Research Design and Methods • Overview of methods • Hypotheses • Study design, including strengths and advantages, and a discussion of possible alternatives and reasons for not choosing them • Subjects (population characteristics, inclusion/exclusion criteria) • Informed consent procedures • Recruitment and attrition information, including a flow chart

37. Research Design and Methods continued • Sample size and power calculations • Description of intervention, independent variables, and control variables • Description of outcomes • Procedures, including quality control • Randomization method • Study timeline • Data management and missing values • Statistical analyses • Dissemination of results • Potential limitations and solutions

38. NIH website: www.nih.gov For More Information NIH Office of Extramural Research:http://grants1.nih.gov/grants/oer.htm

39. Grant Writing Tips Summary • • Seek mentoring and research experience • • Discuss your ideas with colleagues • • Know NIH and its priorities • Discuss your ideas with NIH Program Staff • • Write clearly and concisely with excellent organization. Strictly follow guidelines. • • Avoid unnecessary complexity • • Have senior colleagues critically read your application • • Be open to helpful criticism • • Be persistent!

40. Grant Writing Course • GMS 6811: Granting Writing Skills in Epidemiology and Clinical Research Instructor: Dr. Shenkman Fall Semester Wednesdays, 3-6 PM 1329 Building

41. Elizabeth A. Shenkman, PhD, DirectorKelli A. Komro, MPH, PhD, Associate DirectorJill Boylston Herndon, PhDDamon Clark, PhDI-Chan Huang, PhDCaprice Knapp, PhDMildred M. Maldonado-Molina, PhDJune Nogle, PhDJohn Reiss, PhDJoseph V. Terza, PhDAlexander C. Wagenaar, PhD

42. National, state and community policies and practices Community orgs and schools Quality of health care & quality of life Access to health care Palliative care Families Public Health Policies Health Care Policies Continuum of Policy Research

43. UF Research Mentors • CRISP: http://crisp.cit.nih.gov/ • ICHP: www.ichp.edu