Mission of the National Institute on Deafness and Other Communication Disorders (NIDCD)

1. NIH Research Career Development Programs for Allied Health Professionals: The NIDCD Experience and BeyondDaniel A. Sklare, PhDResearch Training Officer, NIDCD/NIHEnhancing Faculty Research Career Development NAPRAH, March 14, 2007

2. Mission of the National Institute on Deafness and Other Communication Disorders (NIDCD) Conducts and supports biomedical and behavioral research and research training in the normal and disordered processes of: -Hearing -Balance -Smell -Taste -Voice -Speech -Language

3. Today’s Goals • The Challenge: Launching an NIH-Funded Independent Academic Research Career • Transitioning to the New Independent Investigator Career Stage:NIDCD/NIH Career Development (K-) Award Programs, Small Grant (R03) Program & NIH Loan Repayment Program (LRP) • Anyone for Research in Human Communication Disorders?NIDCD Outreach to Health Professional Groups

4. Launching an NIH-Funded Independent Academic Research Career

5. NIH Extramural Research Funding Opportunities: The Present and Near-Term Future • NIH FY07 Budget Estimate (~$28.6 Billion) rising very slightly (+0.36%) from FY06 • Yet, we need a cadre of well-trained new investigators for research pipeline when research funding opportunities again open up • Like Navy pilots, the best prepared applicants will compete successfully, even in the toughest times

6. The Facts of Life for Academic Researchers • Increasingly keen competition for grant support • Resources are either constant or diminishing • Typically, ~12-25% of applications are funded • Extramural research funding is an increasingly important litmus test for academic recruitment, promotion and tenure • Grantwriting skills and thorough understanding of the review and funding process essential for an academic research career

7. Am I Prepared for an Academic Research Career? • Highly committed to/passionate about scientific inquiry in my field • Identify and stay focused on my short-term and long-term research and career goals • Build grantwriting skills and a thorough understanding of the review-funding process • Know my field, the literature/leaders, controversies/camps, relevant funding sources and agency program contacts

8. Am I Prepared for an Academic Research Career? • Proactively search for and continually stay informed on funding opportunities • Network voraciously • Build tenacity and mentally prepare for criticism and rejection • Forge my research program as an entrepreneur building my own new small business

9. Your Keys to Success • Your research idea/proposal • Your training and mentorship plan • Your commitment & tenacity • Your grantwriting skills

10. Transitioning to the New Independent Investigator Career Stage K-Award Programs for the Junior Investigator

11. NIH Research Career Development Awards: Goals & Expectations • Identify and support those candidates from a diverse pool who have the highest potential to advance the Nation’s health • Facilitate the transition of such individuals from the research training stage to the independent investigator stage • Underlying expectation from this support, if fruitful, is a fundable full-scale research grant, typically, a New Investigator R01

12. Value of NIH Research Training • Sets high standards that enhances quality for all biomedical training efforts • Leverages Federal funds by cost sharing with awardees • Provides a network of research training opportunities at major academic research institutions • Enhances awardees’ research career success • More publications • More likely to apply for and receive subsequent research grant support

13. NIH Research Training & Career Development Support: Federal-Institutional Partnership • Sponsoring Institutions Commit • Space • Laboratory resources & equipment • Protected time for participants and mentors • Stipend/salary supplementation • Accept 8% indirect costs (F&A)- significant reduction from negotiated rates

14. Research Training and Career Development Programs Loan Repayment Program (LRP)oan Repayment Program (LRP) • Principal Investigator • Team Scientist Undergraduate Predoc Postdoc MSTP Research Career Development Award (K) Program Ruth L. Kirschstein National Research Service Award (NRSA) Program

15. 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 (K22, K99/R00) • Junior-Midcareer Mentored Research Scientist Development Award (K01)

16. Number of NIH Research Project Grant (RPG) Awardees with Previous NRSA and/or Career Development Award SupportFY 1995 - FY 2004 18,154 (68%) Number of RPG Awardees 8,566 (32%) NRSA 3% of NIH budget K-awards 2% of NIH budget NRSA supports 18% of Federally supported S&E grads & postdocs Yields 32% of NIH researchers

17. NIDCD Mentored Clinician-Investigator Career Development (K08/K23) Awards • Mentored Clinical Scientist Development Award (K08) • Career development in basic research http://grants1.nih.gov/grants/guide/pa-files/PA-06-512.html http://grants.nih.gov/grants/guide/contacts/pa-06-512_contacts.htm • Mentored Patient-Oriented Research Career Development Award (K23) • Sister program to the K08 http://grants.nih.gov/grants/guide/pa-files/PA-05-143.html

18. NIDCD Mentored Clinician-Investigator Career Development (K08, K23) Awards Foster the development of junior academic (or equivalent) clinicians • with substantive prior research experience • having the highest potential to develop into independent clinician-investigators competitive for R01 funding • seeking to integrate both clinical practice and basic or clinical research trajectories in their careers

19. NIH Definition of “Patient-Oriented Research” Research conducted on human subjects or on material of human origin in which the investigator or colleague directly interacts with human subjects • mechanisms & consequences of human disease • epidemiologic, behavioral, outcomes or health services research • development of new technologies • therapeutic interventions & clinical trials

20. The Academic Clinical Community Views the K08/K23 Award • “Jumpstart” to a career in research & validation that awardee is a viable clinician-scientist • Transforms the awardee from a neophyte clinician-scientist to a full-fledged researcher • 75% “protected time” is the most vulnerable infringement, even within the most supportive clinical departments • Award’s primary mission can conflict with the service-providing institution’s primary mission and greatest revenue source- patient care • Challenge for subsequent R01 funding is an ongoing obstacle to establishing an independent research career trajectory

21. NIDCD Mentored Clinician-Investigator Career Development (K08/K23) Awards • Eligibility • Clinically-trained junior faculty member (or equivalent in nonacademic setting) on clinician-scientist career trajectory having two or more years of prior research experience (since undergraduate education) • Not a PI, past or present, on an NIH research grant [except for the NIDCD Small Grant (R03)]

22. NIDCD Mentored Clinician-Investigator Career Development (K08/K23) Awards • Provisions • Requires at least 75% professional effort for three, four or (typically) five years of mentored research training • Provides salary (full institutional salary level up to $105K/yr) & research development support (up to $50K/yr)

23. NIDCD Mentored Clinician-Investigator Career Development (K08/K23) Awards • Special Requirements • Primary sponsor at home institution or within reasonable distance (~100 miles) • Graduate-level course in biostats & research design in Year One • External advisory committee to provide outside expert advice & ensure institutional commitment to terms of award

24. The Successful NIDCD K-Award Application

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

26. Before Submitting a Career Development Application • Maximize lead time in writing the application (speed is the enemy of quality) • Carefully read/follow all current instructions for the grant program you’re applying for [PAs, Institute-specific guidelines, application forms • Then consult with the appropriate program officer if you have questions • Write the application yourself, with guidance from your sponsor/mentor

27. Before Submitting a Career Development Application- cont.- • Write an original application; it can relate to, but not be a “cut-and-paste” from your sponsor’s application or funded grant • Exercise caution at this career stage about tackling a research domain engulfed in spirited controversy or polarization within the field • Pre-review your draft proposal with knowledeable, critical in-house funded investigators [beyond your sponsor(s)] outside your field • Register with NIH eRA Commons through your institutional Office of Sponsored Research

28. Essential Guidance in Crafting a Grant Proposal • Know your targeted review committee membership expertise/perspectives (albeit, ad hoc reviewers recruited to fill voids of expertise) • Write the application to engender reviewer enthusiasm, and, thereby advocacy • Present your ideas in a compellingly clear, readable and logical fashion • Reviewers come to a preliminary assessment of your proposal upon reading the overview section- framing of the problem, statement of specific research aims, background & significance • Anticipate potential problems with your experiments and offer alternative strategies

29. Successful Grant Applications… • Address an important need or knowledge gap in the field • Generally constitute a hypothesis-driven, hypothesis-generating or milestone-driven research plan • Technically meritorious • Written with maximal clarity & compelling logic flow • Convey enthusiasm about the project

30. Successful Grant Applications…- cont - • Are complete, with respect to experimental detail • Anticipate potential problems & offer alternative experimental strategies • Offer high training potential to a candidate who inspires reviewer confidence • Dovetail the candidate with the sponsor(s) well • Demonstrate commitment of the sponsor(s) to the candidate and career development plan

31. NIH Mentored K-Award Review Criteria • Candidate • Career Development Plan • Research Plan • Training in the Responsible Conduct of Research • Mentor, Co-Mentor(s), Consultant(s), and Collaborator(s) • Environment & Institutional Commitment to the Candidate

32. Characteristic Features of a Successful NIDCD K08/K23 Applicant • Substantive prior research experience • First author on published or in-press experimental research papers • Held a small peer-reviewed research or seed grant from a funding agency or professional society • Garnered strong institutional support from the applicant institution (e.g., a favorable research start-up package; protected research time)

33. What Tempers Reviewers’ Enthusiasm for a K08/K23 Application? • Serious conceptual or technical flaws in the research plan • Insufficient experimental detail to assess the research plan • Lack of appropriate scientific expertise and mentorship in the research environment • Qualified mentorship team, but guidance with the research & career development plans not apparent • mentor(s) likely didn’t review the application, raising question of commitment to the candidate • Grossly ambitious research plan needing refocusing or streamlining

34. Transitioning to the New Independent Investigator Career Stage The K99/R00, R03 & LRP Programs

35. Recently Reissued: PA-07-297; 01/12/07NIH Pathway to Independence Award (K99/R00) • Nurture highly promising investigators to secure a 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 • K99 Phase (1-2 yrs): Provides a level of salary support comparable with the 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, notably, Intramural NIH research fellows, eligible to apply

36. 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 • Calling all promising K99/R00 applicants! 150-200 awards expected to be made NIH-wide this year; fewer applications to NIDCD to date than expected • 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

37. NIDCD Small Grant (R03) Program • An NIDCD-specific program reviewed by NIDCD (not the tranNIH R03 Program) • For advanced postdocs transitioning to independence and new investigators • Applicant PI must be no more than 7 calendar years from terminal degree (excluding years of clinical training) • Supports preliminary small-scale research designed to launch a more expansive research program (K-award or R01)

38. NIDCD R03 Program (cont) • Provides up to $100K per year for up to three years • 10-page research plan • Provides a testing ground for the challenging task of writing a competitive R01 • Transferable across institutions http://grants.nih.gov/grants/guide/pa-files/PAR-07-287.html

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

40. Two NIH-wide Extramural Loan Repayment Programs (LRPs) Clinical Research LRP • “Patient-Oriented Research” Pediatric Research LRP • research directly related to diseases, disorders, and/or other conditions in children

41. 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 • Research funding source: nonprofit institution/agency 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 $70k+); renewable

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

43. Of the 34 NIDCD LRP Awards for FY06: • NIDCD Success Rate well aboveNIH-wide Success Rate of ~51% • Awards ranged from $5k-89k (M=$33k) • Seventeen (50%) are renewal awards • Eleven awardees (32%) hold an NIH grant(3 F32s, 3 K08/K23s, 3 R03s, 1 R21, 1 R01) • 29 PhDs(8 SLP/Sp Sci; 7 Audiol/Hr Sci) 4 MDs (3 ORLs), 1 MD/PhD (ORL)

44. LRP Application & Other Information Resources On-line application process, announced in the summer, runs from early Sept to early Dec NIH Office of Loan Repayment www.lrp.nih.gov LRP Help Line: (866) 849-4047 IC LRP Coordinator

45. NIDCD Outreach to Health Professional Groups

46. Currently-Active NIDCD K08/K23 Awardees by PI Specialty MD-ORLMD-nonORLPhD1TOTAL 17 (47%) 11 (31%) 8 (22%) 36 14 Speech-Language Pathologists, 1 Audiologist & 3 Others 02/07

47. NIDCD K08/K23 Otolaryngologist (ORL) Awardees: What We Know • The development of an independent surgeon-investigator requires: great dedication, long hours, a focused work ethic, a departmental research culture and commitment, successful faculty role models, and substantial support beyond the departmental start-up package; • Surgical skills must be refined over the early years of clinical practice; this is critical for career success; • Predominantly (clinical) fellowship trained;

48. NIDCD K08/K23 ORL Awardees: What We Know • Almost all have their own laboratories and require technician support (in addition to equipment & supplies); • K-award research development support (RDS) ($50k/yr) not sufficient to support their research; most must garner supplemental support from institutions, state or professional/voluntary society small grants; • Their major concerns: length of time for career start-up; family/spousal time demands; lack of departmental support (but not wanting for salary)

49. NIDCD & NIH New Mentored Clinician-Investigator K-Awardees (FY95-01): Follow-up R01 Submissions & Awards

50. NIDCD K08/K23 Awards to Clinician-Investigators: What We Conclude • The NIDCD K08/K23 Program is not yielding our desired return-on-investment!