Federal Funding 201: Crafting a Successful PHS Grant Application

1. Federal Funding 201: Crafting a Successful PHS Grant Application James Alan Neff, Ph.D., MPH Professor and Director Substance Abuse Research Development Program University of Texas at Austin School of Social Work

2. Welcome! • First in a series of monthly ‘First Friday’ workshop/seminars • Part of newly funded Substance Abuse Research Development Program for Underserved Populations • NIDA initiative to stimulate substance abuse research in social work • Social workers are in the trenches dealing with substance abuse issues in their clients, but are not the ones doing the federally funded research • UT-Austin is the 3rd school of social work in the country to be funded

3. Substance Abuse Research Development Program involves: • 5 years of funding; 2 million dollars • Designed to provide infrastructure to develop federally funded research on substance abuse in underserved populations • Two ‘arms’ of the program • Workshop/seminar series • Funding of faculty Pilot projects and dissertation stipends to encourage PhD students to incorporate substance abuse in their dissertations

4. Research Development Program Personnel: • Dr. Jim Neff: Director • Dr. Diana DiNitto: Co-Director • Nadine Schulte: Assistant Director • 10+ years at University of Washington, Seattle with the Center for Health Education Research working with faculty research development activities

5. Overview of Workshop • Part I: Introduction to the Federal Grant Process • Designed to be a Grants 201, not 101 • Review of general process may overlap with 101 • Changes in 2001 in forms and process are new • Highlight online and local resources to help • Web-based instructions and forms at NIH.GOV • Local templates for grant and budget • Part II: Case study of Dr. Dick Spence’s recently funded NIDA grants • Show you how it is done in practice

6. Introduction: Crafting a Successful PHS Grant Application? • What is PHS? • Public Health Service • Group of Institutes focusing on specific health and other issues • NIMH • NIAAA • NIA • And, of course, NIDA • What is a PHS form 398? • Standard research grant application form

7. Overview of the Process Proposal Preparation Proposal Submission Study Section Review “Pink Sheets’ Review Summary And Priority Score “Council Review’ And ‘Payline’ Funding? 9 +/- Months

8. Why bother with a complicated frustrating funding process when there are other ‘easier’ sources of funds to do my research? • The glory of scientific endeavor….. • Changes in the Nature of Social Work Research…. • “Status” of having a federal grant: (professionally for PI as well as increasing status of Department or School in University) • Bottom line……$$$$$$$$$$$$$ • Federal Grants (R01) allow larger budgets than many foundations • University federal indirect cost rates negotiated in the range of ~ 50% • Some percentage of indirect trickles down to School • Having federal grants increasingly looks good in terms of promotion and tenure • Schools increasingly interested in finding new faculty mentored in federal grant application process

9. Preparing the Proposal • Neff’s Four T Theory: • Topic: (Of course, you need an idea…) • Novel and innovative • Extends scientific knowledge • Capitalizes upon unique elements of institution, community, study populations, expertise, culture • Theory based, but practically relevant • Build upon existing track record • PI, Co-Investigators, Consultants, Institution, Environment

10. Timing: • Be at the right place at the right time • Keep up with existing and new Program Announcements (PA’s) and Request for Proposals (RFP’s) • NIH Guide: Get on the NIH Weekly LISTSERV Service • Go to: http://grants.nih.gov/grants/guide/listserv.htm • To subscribe to the Guide TOC Notifcation LISTSERV service, please send us email and in the first line of the email message itself - not the "Subject" line - provide the following information: • subscribe NIHTOC-L your name • where your name is the name you wish to use. Your email address will be automatically obtained from the email message you send to the LISTSERV. • Examples: • My NIAAA study of Ethnicity, Drinking Patterns, and HIV Risk Behaviors • Current NIH interest in Compliance with Antiretroviral Therapy

11. Team: • Interdisciplinary • Co-investigators and consultants should have track record of federal funding • Have strongest team in terms of publications and funding as possible • Ethnic and Gender Diversity Essential! • Emphasize linkage to agency or community collaborators • Have a ‘real’ statistician • Serious power calculations and analysis plan • Study Sections are multidisciplinary and often have biomedical types • Claiming that a social scientist is statistician is often dismissed

12. Track Record: • “Preliminary Studies” Crucial • Section of proposal dealing with track record • Two Goals: • Show how track record of Principal Investigator and Co-investigators lead naturally to proposed project, theoretically and methodologically • Cite your team’s publications • Highlight previous contributions to literature, noting how proposed project extends that work • Show how the ‘team’ ties together • Present pilot data showing feasibility of proposed project • Show collaboration with proposed recruitment site agencies or populations • Show that study populations can be accessed • Provide data on psychometrics of instruments, etc • Provide data to support need for study; ie., pilot findings to support substantive hypotheses

13. Funding Mechanisms Designed to fit Investigator’s Career Stage • F Series: Fellowship Program • F 31: Pre-doctoral Individual National Research Service Award • F 32: Post-doctoral Individual National Research Service Award • K Series: Research Career Program • K 01 : Mentored Research Scientist Development Award (New Investigator) • http://grants.nih.gov/grants/guide/pa-files/PA-00-019.html • Research Supplements for existing Grants • Minority Supplement • http://grants.nih.gov/grants/guide/pa-files/PA-01-079.html • Disability Supplement • http://grants.nih.gov/grants/guide/pa-files/PA-01-080.html

14. R Series: Research Projects • R01: Investigator Initiated Research • Requires significant track record and pilot work • Up to 5 years in duration • Budgets can be large • R03: Small Grant Mechanism • Designed for new investigators or new research areas • Up to 2 years • Budget up to $50,000/year direct costs http://grants.nih.gov/grants/guide/pa-files/PAR-97-038.html • R21: Exploratory Research Grant • Designed for new areas or established investigators changing their research areas • Up to 3 years • Budget up to $100,000 per year

15. Online Resources: • Basic Entry into NIH is: nih.gov • Grants information: http://grants.nih.gov/grants/index.cfm • Searching the NIH Guide for Relevant PA’s and RFA’s: http://grants.nih.gov/grants/guide/index.html#search • Different Funding Initiatives (R01, R03, R21, K01): http://grants.nih.gov/grants/funding/funding_program.htm • Information on Study Sections and Membership: http://www.drg.nih.gov/Committees/rosterindex.asp • Database of Currently Funded Grants: https://www-commons.cit.nih.gov/crisp/ • New PHS Grant Application Instructions available online at: ftp://grants.nih.gov/forms/phs398.pdf • Grant Application Forms (fillable) available online at: http://grants.nih.gov/grants/funding/phs398/phs398.html#forms

16. Getting Started • Have a Great Idea! • Get Team Together • Interests/Expertise should coalesce • Track records should be credible • Make sure that you are connected with community or agency sites for data collection

17. Do Your Homework, Research-wise • Homework Step #1: • Updated Literature Review: • Publications and Professional Meetings • Always one publication that you miss (you find it after you submit your proposal)

18. Homework Step #2: • Find out what Target Agency is Currently Funding: • CRISP: Online Database

19. CRISP: What is Currently Funded in a Research Area • CRISP: ‘Computer Retrieval of Information on Scientific Projects’ • Online at: https://www-commons.cit.nih.gov/crisp/ • Searchable database: by Investigator, Institution, Institute, or Subject Area • Searches yield abstracts, funding dates, investigator information, and Study Section

21. crispprd 1.0 Abstract Abstract: The Center for Social WorkResearch (CSWR) in the School of Social Work (SSW) at The University of Texas at Austin (UT) proposes a Social Work Research Development Program (SWRDP) focusing on ethnicity and psychosocial factors as they relate to strategies for improving drug abuse prevention and treatment (including treatment readiness/engagement, utilization, retention, and outcomes) for African Americans and Mexican Americans. The CSWR at UT proposes to build an infrastructure for drug abuse research in the SSW and to increase participation of UT social work faculty in interdisciplinary drug abuse research to improve the quality of interventions aimed at reducing drug abuse and addiction in the US, especially among African American and Mexican American children, adults, and families. The proposed SWRDP will consist of an administrative core designed to facilitate federally funded research and a research core designed to focus on ethnic and psychosocial factors that increase treatment utilization, retention, and outcomes. Two pilot projects on these topics are proposed to begin during year 1. Strategies to leverage current strengths of the CSWR and fill gaps in infrastructure for an enduring program of interdisciplinary drug abuse research include establishing a Multi-disciplinary Research Advisory Board, a Multi-disciplinary Steering Committee, and a Community/Consumer Liaison Committee……….. Thesaurus Terms:behavior prediction, comorbidity, drug abuse, drug abuse therapy, health care service utilization, psychosocial service, therapy compliance behavioral /social science research tag, health services research tag

22. Homework Step #3: • Check out who is on ‘Study Section’ that may review your proposal • Check out Study Section Roster • Look at Member’s grants and publications • Make certain that you cite their work (positively)

23. Information on Study Sections Available Online • http://www.drg.nih.gov/Committees/rosterindex.asp • Lists Study Sections: • Descriptions of Section Focus • Lists Name and Contact Information on Section SRA (Scientific Review Administrator) • Provides listing of Study Section Members

24. Example:Risk, Prevention and Health Behavior 1 Study Section [RPHB-1][RPHB-1 Roster] • The Risk, Prevention and Health Behavior [RPHB] IRG considers applications covering a wide range of biological, psychological, cultural and social conditions and traits that affect the manifestation, prevention, treatment or management of physical and mental diseases and disorders. Emphasis may be placed on individual behavior, interpersonal relations, or group contexts. Populations studied may include clinic, community-diagnosed, symptomatic and high-risk groups, and research may be concentrated on specific age groups or address questions of change or transition across the life course. Interventions may be purely behavioral, or may involve non-behavioral elements such as pharmacological treatments and devices. Specific areas of interest include (but are not limited to): cognitive and affective processes and markers of disease and illness, genetics and other biobehavioral factors, behavioral and pharmacologic interventions; risk and protective processes and models, intra- and inter-personal interventions, social development and interpersonal processes, aggressive behavior and violence, and prevention and intervention methodology; intervention and risk factor modification studies, interactions between psychological processes and disease management, psychological and biobehavioral responses to disease screening and management, rehabilitation of conditions associated with psychological, physical, communicative, and social disability; and social, cognitive, and affective conditions and processes that influence disease and disorder across the lifespan. The following study sections are included within the RPHB IRG: • Detailed Listing of Interest Areas Follows……

25. PREVENTION AND HEALTH BEHAVIOR 1RISK, PREVENTION AND HEALTH BEHAVIOR INTEGRATED REVIEW GROUPCENTER FOR SCIENTIFIC REVIEW(Terms end 6/30 of the designated year)ROSTER • CHAIRPERSON ALLEN,   JOSEPH   P. ,  PHD   (02)PROFESSORDEPARTMENT OF PSYCHOLOGYCOLLEGE OF ARTS AND SCIENCESUNIVERSITY OF VIRGINIACHARLOTTESVILLE,  VA 22904 • AMMERMAN,  ROBERT   T. ,  PHD   (04)PROFESSORDEPARTMENT OF PEDIATRICSCOLLEGE OF MEDICINEUNIVERSITY OF CINCINNATICINCINNATI,  OH 45229 • BROMAN,  CLIFFORD   L. ,  PHD   (05)PROFESSORDEPARTMENT OF SOCIOLOGYCOLLEGE OF SOCIAL SCIENCEMICHIGAN STATE UNIVERSITYEAST LANSING,  MI 48824 SCIENTIFIC REVIEW ADMINISTRATORLEVIN,  VICTORIA   S. ,  MSWCENTER FOR SCIENTIFIC REVIEWNATIONAL INSTITUTES OF HEALTHBETHESDA,  MD 20892 Note: Use this to check out potential reviewers

26. Homework Step #4: • Establish a relationship with Institute Program Officer • Contact person listed in back of PA or RFA • Role: Responsible for encouraging grant submissions • Will generally be encouraging • Goal: to increase their ‘portfolio’ and show to congress that they need more money to fund more good research

27. Call and Introduce Yourself • Lay out Project Idea and Ask for Feedback • Who is doing work in that area • Who is funded in Institute portfolio • What Study Section likely to review • Specific funding initiative most appropriate (ie., specific RFA that fits) • What funding mechanism most appropriate given your career stage • Remember: It is a selective club that you want to join! • Project Officer should know key players on committee and who to cite (gatekeeping role) • Types of methodologies, theories, etc that are likely to fly • Eg., Approaching project officer regarding intervention study with at risk kids---told to avoid ‘Risk and Resilience’ Models • “It’s been done”? • Look out for personal opinions that may not be shared

28. The Concept Paper • Get preliminary feedback from Project Officer regarding idea • 2 – 5 page summary overview • Be succinct and clear • I like to show that I am thinking in terms of the grant process (use PHS grant outline format) • Specific Aims • Background and Significance • Preliminary Studies • Methods/Design • Briefly present Rationale, Conceptual Model, and Design, and Analysis • Shows you are familiar with process • Forces you to think in proposal terms (clarity) • Shows that you have thought project out and are not a flake

29. Preparing the Actual Proposal

30. Overview of PHS 398 Forms(Available online in fillable RTF and PDF formats) • Form Page 1:  Face Page • Form Page 2:  Description (abstract), Performance Sites, and Key Personnel • Form Page 3:  Research Grant Table of Contents • Form Page 4:  Detailed Budget for Initial Budget Period • Form Page 5:  Budget for Entire Proposed Period of Support • Continuation Page (blank page in which you fit your technical proposal) • Modular Budget Format Page • Biographical Sketch Format Page (4 pages per investigator) • Resources Format Page (institutional resources available) • Checklist Form Page • Personal Data Form Page • Other Support Format Page: (Other ongoing federal funding) • Personnel Report Format Page • Targeted/Planned Enrollment Format Page • Enrollment Report Format Page • Mailing Address and RFA Labels

31. Sections of the Technical Proposal and Page Limitations • Proposal (Research Plan) must be 25 pages Maximum • The height of the letters must not be smaller than 10 point; Helvetica or Arial 12-point is the NIH-suggested font. (I like Arial Narrow—saves space) • Type density, including characters and spaces, must be no more than 15 characters per inch (cpi). For proportional spacing, the average for any representative section of text must not exceed 15 cpi;  • No more  than 6 lines of type within a vertical inch; • Margins, in all directions, must be at least ½ inch.  • Note: Margins are not standard 1”! Source: http://grants.nih.gov/grants/funding/phs398/section_1.html#format_specifications

32. Sections • A. Specific Aims (1 page)* • B. Background and Significance (2 -3 pages)* • C. Preliminary Studies (6 – 8 pages)* • D. Research Design (remaining Pages)* • E. Human Subjects • F. Vertebrate Animals • G. Literature Cited (no limit) • H. Consortium and Contractual Arrangements • I. Consultants (Insert Letters of support here—NOT IN APPENDICES) • Appendices: 5 sets, up to 10 publications; NO unpublished manuscripts or in press. * Only these sections count toward page limits

33. Contents of Each Section • Specific Aims: Be succinct in 1 page (+/-) • Brief statement of problem • Statement of need for research • Brief statement of Aims to be addressed • Keep the list short • If you can organize Aims around conceptual issues, etc, do it • Want to use these Aims to organize and integrate methods, analysis, etc, so be clear • Suggest method, design to be used, and project duration • Indicate ‘ultimate goal’ and significance

34. Background and Significance: • Not a ‘dissertation style’ literature review • Strategic, not detailed review of ‘Smith and Wesson (1998)’, etc (unless seminal articles that guide conceptual model or design) • Use literature to support your model; show gaps in literature • Show knowledge of state of the art literature in field • Have a Conceptual Model or Framework; • Graphic or Path-type model is good to give reviewers an explicit sense of theory (25 pages of single spaced verbiage is mind-numbing) • Use this model to guide methodology (ie., conceptual domains to be measured) • Use model to guide analyses (statistical modeling strategy should ‘fit’ conceptual model • Ie., Proposal suggesting elaborate causal models should not propose simplistic bivariate analysis techniques • End with Sales Pitch Regarding Significance: • What is novel theoretically, methodologically? • What study will contribute to scientific literature? • How study capitalizes upon unique factors of institution, investigators, setting, agency collaboration, study population, prior or ongoing research? • How study results will influence practice? • Be Blatant: “The proposed research is significant in several respects…..”

35. Preliminary Studies: Highlight ‘team’ • Show how your track record and the ‘team’ leads inexorably to the present study • Review track record of each investigator, highlighting funding record and citing publications shamelessly (show off your expertise and prior collaboration) • Present preliminary data to show that study is feasible • Highlight collaborative relationships with study agencies or populations (beyond letter of support) • Show that you can access study populations (participation and refusal rates) • Show that instruments work (reliability) • Show preliminary data regarding hypotheses • Do variables predict? • Does it look like intervention may work?

36. Research Design and Methodology: • This is more standard ‘research’ section • Describe study populations (gender and ethnic are critical; show expected distributions) • Describe recruitment and follow-up (attrition, if longitudinal and how minimized; references) • Detailed descriptions of measures (psychometrics and utility in proposed study population) • Data management and quality control • Data Analysis: • Follow Specific Aims (#1, #2…) and Conceptual Model • Have section written by REAL STATISTICIAN • Show that statistical consultant is on board • Make sure write up is thorough and addresses issues • Present Power/Sample Size Calculations appropriate to SPECIFIC HYPOTHESES—NOT GENERAL • Usepilot data on variability or effect sizes to show that it works • If meta-analytic studies are available to suggest expected effect sizes, use them!

37. Human Subjects: • New Policy: Do not need to have IRB approval prior to Study Section Review • Used to have to submit proposal as ‘Pending’ if not approved and submit evidence of IRB approval within 90 days • Study Section reviewers will review for Human Subjects • Need approval prior to release of funds

38. Application Submission Schedule: 3 Review Cycles During Year Note that AIDS Grants have different cycle and shorter turn around time

40. The Peer Review Process • Initial Screening: • Reviewers decide if proposal falls in upper 50% of proposals • Lower 50%: Returned only with reviews (can be resubmitted)* Some people throw together proposals and submit to get feedback Getting a proposal returned ‘unscored’ labels you (urinates of the reviewers) Proposal goes back to same review group (minor changes) • Upper 50%: Sent on for Study Section review and scoring • Scientific Review Group (SRG) Review: • Study Section reviews applications and scores them • 100 (best possible) to 500 (worst possible) • ‘Pink Sheet’ Review Comments: 6 – 8 weeks later • Advisory Council Review (pro forma) • Program Staff determine ‘Payline’: ~ 36% at NIDA • Funding cutoff variable: < 150 or so? • NIDA funding up 16% this year • Unfunded Applications can be resubmitted only 2 more times within 2 years of date of original submission

41. Study Section Review Criteria http://grants.nih.gov/grants/guide/notice-files/not97-010.html • Significance: • Importance of problem • Scientific advance • Approach: • Conceptual framework, design, methods, and analysis well developed, integrated, and appropriate • Acknowledge problem areas and alternatives • Innovation: • Novel approaches or methods • Aims original and innovative • Challenge existing paradigms or develop new methods • Investigator: • Suitable training and qualifications (track record) • Investigator and team experienced • Environment: • Track record and resources of environment • Research capitalizes upon unique features of environment • Collaborative relationships • Institutional support Plus: Inclusion of women and minorities, reasonableness of budget, And Human Subjects appropriate.

42. Recent Review Changes to Discourage Lousy Proposals • Initial Screening to weed out lower 50% of proposals • Reduce Study Section Workload • Implicitly punish sloppy proposal submissions • Limitations on Re-submissions • 2 re-submissions • 2 year limit from date of initial submission • 9+ month turn-around for review limits resubmissions by definitions • Bottom Line: A hastily thrown-together proposal may get you ‘feedback’, but hurts you in the long run • Get colleagues (with funding history) to review • Over-write (over 25 pages) and judiciously edit • Make sure you have a team and preliminary studies