NIH 101: What You Need to Know! Daniel Sklare, PhD & Lana Shekim, PhD, NIDCD Peggy McCardle, PhD, NICHD ASHA LfS ’08

1. NIH 101: What You Need to Know!Daniel Sklare, PhD & Lana Shekim, PhD, NIDCDPeggy McCardle, PhD, NICHDASHA LfS ’08 Conference

2. Outline • Introduction to NIH 101 (Sklare) • Recent Research Training/Career Development Initiatives: K99/R00; LRP; NIDCD Outreach to the Health Professions (Sklare) • NIDCD Mission in Research on Human Communication; Brief Orientation to NIH Research Project Grant Programs (R03, R21, R01) & the People Behind Them (Program, Review, Grants Management)(Shekim) • NICHD Mission in Research on Human Communication; NIH Two-Tiered Review Operations: Who are your reviewers and what transpires at study section? The Funding Decision: How Does it Happen?(McCardle): • Q&As

3. Introduction to NIH 101

4. Environment of the Research Scientist Competing for NIH Funding

5. The Facts of Life for Academic Researchers • Increasingly keen competition for grant support • Resources constant or diminishing; NIH FY08 Budget ($29.2 billion; 1% over FY07 funding) will have net effect of decreasing our “research purchasing power” from FY07 • Extramural research funding is an increasingly important litmus test for academic recruitment, promotion & tenure • Grantwriting skills & thorough understanding of the review & funding process essential for an academic research career • Like Navy pilots, best prepared applicants will compete successfully, even in the toughest times

6. A Darwinian Approach to Casting an Academic Research Career • Survival of the fittest for research • Situate the individual in a supportive environment with just enough pressures for success….

7. Your Keys to Success • Your research idea/proposal • Your ability to stay focused on short-term & long-term research & career goals • If at the training stage, your training & mentorship plan • Your commitment to/passion with research & tenacity • Your grant writing skills

8. Winning the Big Prize- Your First NIH GrantWhat the instructions won’t tell you, but the sages will… • Grants are won or lost on the first page- ENGENDER ENTHUSIASM! • Make your message significant & memorable; keep it focused, yet simple • Leave visual space throughout the application • On the first page, present a significant problem that you attack with a directional, main hypothesis, sub-hypotheses testing the main, & supported by your novel observations • Introduce a conceptual model, followed with your more formal model, each grounded in evidence; identify the component you now address

9. Winning the Big Prize- Your First NIH GrantWhat the instructions won’t tell you, but the sages will… (cont.) • Constitute a research team high on: commitment, targeted expertise, & (ideally) track record with NIH • Alternative explanations for expected/possible findings are intriguing opportunities • Your program officer is your friend, but respect the “tight-rope” s/he walks • While locking-in focus on your research program, regularly rethink your scientific journey

10. What is the National Institutes of Health (NIH)? • The steward of biomedical and behavioral research for the Nation • Composed of 27 Institutes and Centers (24 awarding components) • NIH Mission: Promote & support fundamental and clinical/applied research on the nature and behavior of living systems & the application of that knowledge to extend healthy life & reduce the burdens of illness & disability.

11. Where is this research conducted? • Extramural Research • Conducted by nonFederal scientists in ~2000 academic & nonacademic research institutions in the USA & abroad • ~90% of NIH funds are extramural • Intramural Research • Conducted mainly in NIH laboratories

12. NIH Extramural Staff Program Grants Management Review

13. Find the Funding Agency/Component (i.e., NIH Institute) Whose Scientific Mission & Funding Priorities Fit Your Proposal • Consult relevant program officerbefore crafting an application (missions & funding priorities evolve over time) • Frame research plan to help funding agency achieve its mission • Know the right grant program or mechanism & how your funding source uses it (e.g., Institute-specific provisions) • Stay informed on Federal Funding Opportunities Announcements [(FOAs) (PA, RFA, RFP)] & Notices (NIH GUIDE, grants.gov)

14. Recent Research Training/Career Development Initiatives

15. NIH Research Training & Career Development Awards: Goals & Expectations • Identify & support those candidates from a diverse pool with highest potential to advance Nation’s health • Support research training, not clinical training(except for med students in integrated MD/PhD dual-track) • Facilitate the transition of such individuals from research training stage to independent investigator stage • Underlying expectation from this support, if fruitful, is a fundable full-scale research grant, typically, a New Investigator R01

16. NIH Research Training and Career Development Awards • Ruth L. Kirschstein National Research Service Awards (NRSAs) • Individual Fellowships (F30, F31, F32, F33) • Traineeships on Institutional Training Grants (T32, T35) • Career Development (K-)Awards • Mentored Junior Clinician-Investigator Awards (K08, K23) • Early-Stage Career Transition Awards (K99/R00) • Junior-Midcareer Mentored Research Scientist Development Award (K01)

17. NIH Pathway to Independence Award (K99/R00) • Nurture highly promising investigators to secure tenured research position & R01 grant earlier in their careers: mentored postdoctoral phase (K99) & independent investigator phase (R00)(aggregate of up to 5 yrs of support); both phases require 75% effort • Typically for seasoned postdocs with up to 5 years experience • K99 Phase (1-2 yrs): Provides a level of salary support comparable with other junior-level K-awards (NIDCD: up to $105k/yr) plus an allowance for research costs (NIDCD: $25k/yr) • R00 Phase (up to 3 yrs): Provides up to $249k TC/yr • US citizens & non-citizens, including postdoc fellows in Federal agencies (e.g., Intramural NIH research fellows) eligible to apply

18. NIH Pathways to Independence Award (K99/R00)-cont- • Transition to the R00 phase contingent on securing an appropriate extramural tenure-track junior-level faculty (or equivalent) position & NIH administrative review • Application Receipt Dates: June 12, Oct 12, Feb 12 http://grants.nih.gov/grants/guide/pa-files/PA-07-297.html http://grants.nih.gov/grants/guide/contacts/pa-07-297_contacts.htm http://grants1.nih.gov/grants/new_investigators/QsandAs.htm

19. Guidance for Crafting a Successful K99/R00 Application • Justify need for further mentoring(particularly if staying in same department & lab as current postdoc experience) • K99 Research Plan distinct/dissociable from mentor’s research program • Show productivity(first-authored research pubs)to date & high promise as an independent investigator • Requisite plan for evaluating/monitoring candidate’s progress toward independence

20. Guidance for Crafting a Successful K99/R00 Application (cont.) • Career Development Plan well laid-out, fits candidate’s career goals & facilitates transition to independence • K99/R00 Research Plan adequately detailed for reviewers to fully evaluate, well-integrated, laying out a programmatic line of research

21. NIH Loan Repayment Program (LRP) Goal: Provide an incentive for “health professionals” (broadly defined) to proactively integrate clinical research, pediatric research and other targeted research areas into their career trajectories

22. Two NIH-wide Extramural Loan Repayment Programs (LRPs) • Clinical Research LRP Defined by the NIH as “Patient-Oriented Research” • Pediatric Research LRP Research directly related to diseases, disorders, &/or other conditions in children

23. NIH Loan Repayment Program (LRP) • Must be a US citizen or permanent resident • Doctoral degree holders engaged in clinical research or pediatric research for two years from the LRP award date for at least 50% effort • Qualifying research funding source: nonprofit institution/agency (including a university) or governmental agency • Educational debt must equal at least 20% of institutional base salary • Provides up to $35k (plus associated Federal taxes) per year for up to two years (aggregate of up to $70k+); renewable

24. Clinical/Pediatric New/Renewal LRP Applications Reviewed & Awarded NIH-wide

25. NIDCD vs. NIH-wide Success Rates for FY07 LRP Applications • NIDCD Success Rate ~74% (35/47 applications assigned to & reviewed by NIDCD) • NIH-wide Success Rate ~52% (1,292/2,504 applications) • Of the 35 NIDCD LRP awards: • 40% are renewal awards • 27 PhDs (15 SLPs & Audiols); 8 MDs & MD/PhDs (4 ORLs)

26. LRP Application Submission & Information Resources On-line application process (www.lrp.nih.gov): Sept 1 - Dec 1 Check NIH GUIDE or LRP homepage in summer NIH Office of Loan Repayment www.lrp.nih.gov LRP Help Line: (866) 849-4047 Daniel A. Sklare, Ph.D. NIDCD LRP Coordinator Tel: 301-496-1804 Email: sklared@nidcd.nih.gov

27. Funding Rates of NIDCD R01 & New Investigator R01 ApplicationsDuring FYs 02-06 by PI Specialty

28. NIDCD Initiatives for Facilitating Emergence of Independent Clinician-Investigators • Now provides up to $80k per year for research-related costs (“research development support”) for new K08/K23 awards (NOT-DC-08-002; http://grants.nih.gov/grants/guide/notice-files/NOT-DC-08-002.html) • Partnering with leadership of Audiology to develop research vision/culture encouraging AuD students to pursue training in clinical & translational auditory research • Ruth L. Kirschstein National Research Service Award Short-Term Institutional Research Training Grants (T35) (06/03/05) http://grants1.nih.gov/grants/guide/pa-files/PA-05-117.html; http://grants.nih.gov/grants/guide/contacts/pa-05-117_contacts.htm • Seeking to partner with professional societies to develop national mentoring networks

29. Short-Term Institutional Research Training Grants (T35) for AuD Students • Developing Research Careers in the Hearing Sciences; Dept of Hearing & Speech Sciences, Bill Wilkerson Center, Vanderbilt University; Program Director: Linda Hood, PhD • Short-Term Research Training for AuD Students; Boys Town National Research Hospital; Program Director: Walt Jesteadt, PhD • Predoctoral Summer Training Program in Auditory Research; National Center for Rehabilitative Auditory Research (NCRAR); Portland VA Research Foundation; Program Director: Marjorie Leek, PhD The Academy and Audiologists in Academia (AAA); Vol 4; Issue 2

30. NIDCD Initiatives for Facilitating Emergence of Independent Clinician-Investigators • NIDCD Administrative Research Supplements to Promote Emergence of Independent Otolaryngologist-Investigators [two-year administrative supplement awards to active NIDCD R01s and P50s for junior (ass’t prof) clinical faculty in otolaryngology] • Awardee works within research scope of parent grant • Awardee submits follow-up K08/K23 or R03 application in Yr 2 • Up to $100K per year for 50% commitment of effort • Application Dates: May 1 & Nov 1, ’08 (one-time issuance with two receipt dates)

31. Benchmarks for success: High but reachable R01 funding Applicant

32. NIDCD Extramural Research Training Program Contact (Across NIDCD Scientific Program Areas) Daniel A. Sklare, Ph.D. Research Training Officer Tel: 301-496-1804 Email: sklared@nidcd.nih.gov NIH Research Training website: http://grants1.nih.gov/training/extramural.htm NIH New Investigator website: http://grants2.nih.gov/grants/new_investigators/index.htm