Keys to Success in Securing NIDA/NIH Funding

1. Keys to Success in Securing NIDA/NIH Funding Shakeh Kaftarian.Ph.D. Division of Epidemiology, Services and Prevention Research November 10, 2005 Vanderbilt University

2. Steps to NIH Grant-Writing • Have an idea • Match your idea with an NIH Institute • Match your idea to a current initiative • Find a Project Officer to help you • Complete your application • Wait (for scientific and programmatic reviews) Wait some more Start revising (for administrative processing of the award) If project is strong as-is If project needs revisions

3. Where can I get one of these “ideas”? • GET CURRENT! • Review the literature to see what’s been done before http://nihlibrary.nih.gov/Elecres/databases.htm • Find out if other researchers are interested in similar ideas • Check CRISP to see if there is any Federally-funded work being done currently in this area http://crisp.cit.nih.gov/crisp/crisp_query.generate_screen

4. Casting a critical eye over new data

5. Match your idea with an Institute • Many NIH Institutes may have relevance to your area of interest: • NIDA (Drug Abuse) • NIAAA (Alcohol Abuse & Alcoholism) • NIMH (Mental Health) • NICHD (Child Health & Human Development) • See: http://www.nih.gov/icd/ for a list of NIH Institutes and their missions

6. Find yourself a Project Officer(“Cruise Director”) • Project Officer (or Program Official or PO) is a scientist with expertise in particular areas of research • The PO can help you navigate the grants system (research priorities, current initiatives, application process) • The PO can also help identify potential consultants and collaborators, instruments, etc.

7. How do I find one of these Project Officers? • Search the Institute’s website NIDA: http://www.drugabuse.gov/about/organization/Organization.html • Call the Institute’s main number • Call someone you know

8. Match your idea to a current initiative • NIH guide: http://grants1.nih.gov/grants/guide/index.html • You can join a free listserve that will automatically email a list of all NIH initiatives that are announced each week: http://grants1.nih.gov/grants/guide/listserv.htm • NIDA’s website: http://www.drugabuse.gov/funding/

9. Types of Initiatives • Program Announcement (PA) • Request for Applications (RFA)

10. Program Announcement (PA) Standing calls for applications in general areas No set-aside funds Rolling deadlines (Competes with all other grants in the Division)

11. Requests for Application (RFA) One-time calls for applications in targeted areas Funds set-aside for meritorious applications Single deadline (Competes only with other applications in the same RFA)

12. Mechanisms: • Fellowship Programs (F Series) • Research Career Awards (K Series) • Research Projects and Research Program Projects (R….., P01) • Centers (P30, P50, P60) • Training Programs (T Series) • Cooperative Agreements (U Series)

13. Fellowship programs: • F31 Postdoctoral Fellowship (Minority or disabled) • Up to 5 years • F32 Postdoctoral Individual Award • 3 years total support • F33 Senior Fellow • 2 years support

14. Research Career Awards: • K01 Mentored Research Scientist • K02 Independent Scientist Award • K07 Academic Career Award • K08 Mentored Clinical Scientist • K12 Mentored Clinical Scientist • K23 Mentored Patient-Oriented Research • K24 Mid-Career Investigator • K25 Mentored quantitative Research

15. NOTE: Amounts and times may be exceeded with prior NIDA approval – contact program official minimum 6 weeks before deadline with full budget and justification. Research Projects and Research Program Projects: • R01 Research Project (Traditional – $500K/year/5 yrs) • R03 Small Grant ($50K/year/2 yrs) • R03 B/START Small grant ($50K / pilot study) • R13 Conference Grants ($25K / Conferences) • R15 Academic Enhancement Research ($150K start-up for new faculty) • R21 Exploratory/Developmental Grant (2 yrs/ collect data leading to R01; $275K) • R37 Merit Award (Nominated by PO/ exceptional grant and PI – extends original R01 to twice duration) • U01 Research Project (Cooperative Agreement)

16. Research Projects and Research Program Projects: • R41 (STTR) Phase 1 • R42 (STTR) Phase 2 • R43 (SBIR) Phase 1 • R44 (SBIR) Phase 2

17. Centers: • P20 Exploratory Centers • P30 Core Center Grants • P50 Specialized Centers • P60 Comprehensive Centers

18. Roadmap Themes • New pathways to discovery • Research teams of the future • Re-engineering the clinical research enterprise

19. Application Forms • Applications have use PHS 398 forms (but read the announcement carefully for exceptions) • New forms will be used • Electronic forms are on the website in Word or PDF format: http://grants1.nih.gov/grants/funding/phs398/phs398.html

20. Scientific Decisions • Study design • Population • Recruitment strategies • Measures used • Data collected • Analyses needed • Research team (PIs, consultants, clinicians) • Budget • Human Subjects Protections/IRB approvals • HIPAA compliance

21. Scientific Review Criteria(listed in the grant announcement) • Significance • scientific contributions, public health impact • Approach • theoretical justification, methods, data analytic plan • Innovation • creativity, charting new waters • Investigator • experience, publication record, strength of team • Environment • research-supportiveness of institution of agency • Gender/Minority/Children Inclusion • Human Subjects Protection

22. Priority Scores • Scientific merit judgments are quantified • In theory, Priority Scores range from 100 – 500, where 100 = best possible score • In practice, Priority Scores rarely exceed 300 because of “triaging” or “unscoring” • In general, although there is wide variability, a Priority Score of 150 or lower has a good likelihood of funding

23. Triaging or Unscoring • Review committees are encouraged to identify the bottom half of applications as “unscored” • “Unscored” does not mean that the project had no scientific merit; only that it had little chance of funding during that round of review

24. Percentile Scores • Because funding decisions are made based on Priority Scores assigned by different review committees, percentile scores are usually calculated as a way of trying to standardize the Priority Scores • Percentile Scores are not calculated for grants reviewed in ad hoc RFA committees, or for training grants reviewed in the training (i.e., “K”) committee • In general, although there is great variability, a Percentile Score of 15% or lower has a good likelihood of funding

25. Summary Statements(“Pink Sheets”) • Priority Score • Percentile Score • Significance • Approach • Innovation • Investigator • Environment • Gender/Minority/Children • Human Subjects • Budget

26. The Process ofScientific Peer Review

28. Review Process for a Research Grant National Institutes of Health Center for Scientific Review Submits Application Assign to IC & IRG/Study Section University or Agency Initiates Research Idea Study Section Review for Scientific Merit Institute Evaluate for Relevance Allocates Funds Advisory Councils and Boards Conducts Research Recommend Action Institute Director Takes Final Action

29. Applications Submitted to NIH • Approximately 40,000 grant applications are submitted to NIH each year, of which 15-20% are funded • Competing grant applications are received for three review cycles per year

30. Typical Timeline for a New Individual Research Project Grant Application (R01) • There are three overlapping cycles per year: • Submit in February(June,October) • - Review in June (October,February) • -Council in September (January,May) • -Earliest award in December (April,July) Cycle 1 ---- Cycle 2 ---- Cycle 3 ----

31. Your application is here.

32. RFA-DA-06-001Enhancing Practice Improvement in Community-Based Care for Prevention & Treatment of Drug Abuse or Co-occurring Disorders

33. RFA Philosophy • Research-to-services AND Services-to-Research • Research and service improvement: • Adoption, implementation, and sustained use of science-based approaches • Understanding factors that hinder adoption, implementation, and sustained use of science-based approaches • Testing effectiveness of existing promising but unproven policies and practices • Foundation for future research to facilitate continuous practice improvement

34. Community-based Service Providers Are Primary Investigators (PI) in This RFA

35. Eligibility Requirement – Provider Organization A. Community-based Provider Organization (1) An organization, an agency, or an association of organizations/agencies (National, State, or Regional) that deliver(s) services to prevent or treat (2) Must demonstrate sufficient patient load, N of sites, site size and diversity to study system-wide assessment of existing or newly adopted therapeutic and/or business policies and practices.

36. Eligibility Requirement – Provider Organization (3) Applications are encouraged from a community-based organization with one or more of the following characteristics: - For-profit organizations - Non-profit organizations - Domestic Institutions - Faith-based or community-based organizations - Units of Local/State Tribal government

37. What does sufficient patient load, number of sites, site size, & diversity mean? • Do you have enough statistical power to answer your research question? • Will your results generalize to your whole organization? • Will your results generalize to other provider organizations?

38. When Thinking about an NIH Research Mechanism CONSIDER!!! PI experience <-> Project complexity <-> Project budget

39. Study Design Study design should: • Match your research question(s) • Be as rigorous as possible • Be feasible – Don’t plan to do too much! Study design can be: • Qualitative, quantitative, or a combination • Experimental, quasi-experimental

40. What Are Some “Researchable” Questions?

41. Readiness and Capacity for Practice Improvement Purpose: Examine implementation of science-based practice X and its effects on treatment retention and abstinence. • Did we implement practice X? • Did the practice have the intended effect? • How if at all did the intended effect contribute to patient outcomes?

42. Readiness and Capacity for Practice Improvement • Purpose: Examine the implementation of evidence-based practice. • Did you implement the service intervention proposed? • Did the service intervention have the intended effect? • How if at all did the intended effect contribute to patient outcomes?

43. Systems-level Factors that Facilitate/Impede Continuous Practice Improvement Purpose: Refine data management system to improve performance monitoring. • How can we best monitor our performance, and what systemic data do we need to do it? • What are our current data collection demands? What more do we need? • How feasible are new data collection requirements, and how useful are the new performance measures?

44. Systems-level Factors that Facilitate/Impede Continuous Practice Improvement Purpose: Identify person centered, program specific and other contextual factors that enhance or impede engagement and retention in evidence based practice. • What are the individual and group differences (religious and spiritual beliefs, traditions, and value systems) to engagement and retention of care? • How can culturally appropriate interventions improve accessibility, usability, and sustainability of services in diverse populations? • What are the contextual factors (family beliefs) that impact accessibility and sustainability of care?

45. Costs and Cost-Effectiveness of Practice Improvement Purpose: Determine the best use of staff training budget. • What are our current staff training needs? • What are two training options for meeting those needs? • Which of the two training options will yield the greatest benefit for the dollars spent?

46. Don’t Go It Alone! • Science • Project Management & Staffing • Business Component • Pulling the Proposal Together

47. Questions