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/http://crisp.cit.nih.gov/ –ICHP: www.ichp.eduwww.ichp.edu

3. Research Background Research Experience PhD in Epidemiology, 1994, University of Minnesota PhD in Epidemiology, 1994, University of Minnesota Associate Professor, EHPR and Associate Director, ICHP Associate Professor, EHPR and Associate Director, ICHP $29M in grant funding, mostly NIH $29M in grant funding, mostly NIH Child & adolescent health; community-wide preventive interventions; group-randomized trials Child & adolescent health; community-wide preventive interventions; group-randomized trials Mentor graduate students and junior faculty Mentor graduate students and junior faculty Grant Review Experience NIH grant reviews NIH grant reviews UK’s Medical Research Council 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 Administration for Children and Families (ACF) Administration for Children and Families (ACF) Food and Drug Administration (FDA) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Health Resources and Services Administration (HRSA) The Secretary Deputy Secretary The Secretary Deputy Secretary Administration on Aging (AoA) Administration on Aging (AoA) Centers for Medicare and Medicaid Services (CMS) Centers for Medicare and Medicaid Services (CMS) Indian Health Services (IHS) Indian Health Services (IHS) Centers for Disease Control and Prevention (CDC) Centers for Disease Control and Prevention (CDC) Substance Abuse and Mental Health Services Administration (SAMHSA) Substance Abuse and Mental Health Services Administration (SAMHSA) Program Support Center (PSC) Program Support Center (PSC) Agency for Toxic Substances and Disease Registry (ATSDR) Agency for Toxic Substances and Disease Registry (ATSDR) Agency for Health Care Policy and Research (AHCPR) Agency for Health Care Policy and Research (AHCPR) National Institutes of Health (NIH) National Institutes of Health (NIH)

6. 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. National Institutes of Health

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

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.aspxhttp://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 Development ARRA 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. Career Development Plan Yes Do I have pilot data?No No Apply for R03/ B/START Do I need more training or changing career emphasis? Institutional Pre-Doctoral Fellowship-T32 Pre-Doctoral Fellowship-F31 Post-Doctoral Fellowship-F32 Institutional Post-Doctoral Fellowship-T32 R01Yes Apply for Mentored K

20. 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. Applications for NIH Research Grants Grants are normally submitted to NIH in three ways:

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

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

26. 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 ReviewCouncil Cycle 1 Receipt Referral Award Review Council Cycle 3 Receipt Referral Award Review Council Cycle 2 Receipt Award Referral

27. NIH’s Electronic Submission 1.Require electronic submission through Grants.gov for all NIH grant applications. 2.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 + Science 2 + 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. 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! Grant Writing Tips Summary

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, Director Kelli A. Komro, MPH, PhD, Associate Director Jill Boylston Herndon, PhD Damon Clark, PhD I-Chan Huang, PhD Caprice Knapp, PhD Mildred M. Maldonado-Molina, PhD June Nogle, PhD John Reiss, PhD Joseph V. Terza, PhD Alexander C. Wagenaar, PhD

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

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