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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,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,Todays Goals,The Challenge: Launching an NIH-Funded Independent Academic Research CareerTransitioning 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,Launching an NIH-Funded Independent Academic Research Career,NIH Extramural Research Funding Opportunities: The Present and Near-Term Future,NIH FY07 Budget Estimate ($28.6 Billion) rising very slightly (+0.36%) from FY06Yet, we need a cadre of well-trained new investigators for research pipeline when research funding opportunities again open upLike Navy pilots, the best prepared applicants will compete successfully, even in the toughest times,The Facts of Life for Academic Researchers,Increasingly keen competition for grant supportResources are either constant or diminishingTypically, 12-25% of applications are fundedExtramural research funding is an increasingly important litmus test for academic recruitment, promotion and tenureGrantwriting skills and thorough understanding of the review and funding process essential for an academic research career,Am I Prepared for an Academic Research Career?,Highly committed to/passionate about scientific inquiry in my fieldIdentify and stay focused on my short-term and long-term research and career goalsBuild grantwriting skills and a thorough understanding of the review-funding processKnow my field, the literature/leaders, controversies/camps, relevant funding sources and agency program contacts,Am I Prepared for an Academic Research Career?,Proactively search for and continually stay informed on funding opportunitiesNetwork voraciouslyBuild tenacity and mentally prepare for criticism and rejectionForge my research program as an entrepreneur building my own new small business,Your Keys to Success,Your research idea/proposalYour training and mentorship planYour commitment & tenacityYour grantwriting skills,Transitioning to the New Independent Investigator Career Stage,K-Award Programs for the Junior Investigator,NIH Research Career Development Awards: Goals & Expectations,Identify and support those candidates from a diverse pool who have the highest potential to advance the Nations healthFacilitate the transition of such individuals from the research training stage to the independent investigator stageUnderlying expectation from this support, if fruitful, is a fundable full-scale research grant, typically, a New Investigator R01,Value of NIH Research Training,Sets high standards that enhances quality for all biomedical training effortsLeverages Federal funds by cost sharing with awardeesProvides 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,NIH Research Training & Career Development Support: Federal-Institutional Partnership,Sponsoring Institutions Commit SpaceLaboratory resources & equipmentProtected time for participants and mentorsStipend/salary supplementation Accept 8% indirect costs (F&A)- significant reduction from negotiated rates,Research Training and Career Development Programs,Ruth L. Kirschstein National Research Service Award (NRSA) Program,Loan Repayment Program (LRP)oan Repayment Program (LRP),Research Career Development Award (K) Program,Principal InvestigatorTeam Scientist,Postdoc,Predoc,Undergraduate,MSTP,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-)AwardsMentored Junior Clinician-Investigator Awards (K08, K23)Early-Stage Career Transition Awards (K22, K99/R00)Junior-Midcareer Mentored Research Scientist Development Award (K01),Number of NIH Research Project Grant (RPG) Awardees with Previous NRSA and/or Career Development Award SupportFY 1995 - FY 2004,18,154 (68%),8,566 (32%),Number of RPG Awardees,NRSA 3% of NIH budget K-awards 2% of NIH budgetNRSA supports 18% of Federally supported S&E grads & postdocs Yields 32% of NIH researchers,NIDCD Mentored Clinician-Investigator Career Development (K08/K23) Awards,Mentored Clinical Scientist Development Award (K08)Career development in basic research/grants/guide/pa-files/PA-06-512.html/grants/guide/contacts/pa-06-512_contacts.htm Mentored Patient-Oriented Research Career Development Award (K23)Sister program to the K08/grants/guide/pa-files/PA-05-143.html,NIDCD Mentored Clinician-Investigator Career Development (K08, K23) Awards,Foster the development of junior academic (or equivalent) clinicians with substantive prior research experiencehaving the highest potential to develop into independent clinician-investigators competitive for R01 fundingseeking to integrate both clinical practice and basic or clinical research trajectories in their careers,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 subjectsmechanisms & consequences of human diseaseepidemiologic, behavioral, outcomes or health services researchdevelopment of new technologiestherapeutic interventions & clinical trials,The Academic Clinical Community Views the K08/K23 Award,“Jumpstart” to a career in research & validation that awardee is a viable clinician-scientistTransforms the awardee from a neophyte clinician-scientist to a full-fledged researcher75% “protected time” is the most vulnerable infringement, even within the most supportive clinical departmentsAwards primary mission can conflict with the service-providing institutions primary mission and greatest revenue source- patient careChallenge for subsequent R01 funding is an ongoing obstacle to establishing an independent research career trajectory,NIDCD Mentored Clinician-Investigator Career Development (K08/K23) Awards,EligibilityClinically-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),NIDCD Mentored Clinician-Investigator Career Development (K08/K23) Awards,ProvisionsRequires at least 75% professional effort for three, four or (typically) five years of mentored research trainingProvides salary (full institutional salary level up to $105K/yr) & research development support (up to $50K/yr),NIDCD Mentored Clinician-Investigator Career Development (K08/K23) Awards,Special RequirementsPrimary sponsor at home institution or within reasonable distance (100 miles)Graduate-level course in biostats & research design in Year OneExternal advisory committee to provide outside expert advice & ensure institutional commitment to terms of award,The Successful NIDCD K-Award Application,Find the Funding Agency & Component (i.e., NIH Institute) Whose Scientific Mission & Funding Priorities Fit Your Proposal,Missions consult relevant program officer before crafting an applicationFrame research plan to help the funding agency achieve its missionKnow 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, ),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 youre applying for PAs, Institute-specific guidelines, application forms Then consult with the appropriate program officer if you have questionsWrite the application yourself, with guidance from your sponsor/mentor,Before Submitting a Career Development Application- cont.-,Write an original application; it can relate to, but not be a “cut-and-paste” from your sponsors application or funded grantExercise caution at this career stage about tackling a research domain engulfed in spirited controversy or polarization within the fieldPre-review your draft proposal with knowledeable, critical in-house funded investigators beyond your sponsor(s) outside your fieldRegister with NIH eRA Commons through your institutional Office of Sponsored Research,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 advocacyPresent your ideas in a compellingly clear, readable and logical fashionReviewers come to a preliminary assessment of your proposal upon reading the overview section- framing of the problem, statement of specific research aims, background & significanceAnticipate potential problems with your experiments and offer alternative strategies,Successful Grant Applications,Address an important need or knowledge gap in the fieldGenerally constitute a hypothesis-driven, hypothesis-generating or milestone-driven research planTechnically meritoriousWritten with maximal clarity & compelling logic flowConvey enthusiasm about the project,Successful Grant Applications- cont -,Are complete, with respect to experimental detailAnticipate potential problems & offer alternative experimental strategiesOffer high training potential to a candidate who inspires reviewer confidenceDovetail the candidate with the sponsor(s) wellDemonstrate commitment of the sponsor(s) to the candidate and career development plan,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,Characteristic Features of a Successful NIDCD K08/K23 Applicant,Substantive prior research experienceFirst author on published or in-press experimental research papers Held a small peer-reviewed research or seed grant from a funding agency or professional societyGarnered strong institutional support from the applicant institution (e.g., a favorable research start-up package; protected research time),What Tempers Reviewers Enthusiasm for a K08/K23 Application?,Serious conceptual or technical flaws in the research planInsufficient experimental detail to assess the research planLack of appropriate scientific expertise and mentorship in the research environmentQualified mentorship team, but guidance with the research & career development plans not apparentmentor(s) likely didnt review the application, raising question of commitment to the candidateGrossly ambitious research plan needing refocusing or streamlining,Transitioning to the New Independent Investigator Career Stage,The K99/R00, R03 & LRP Programs,Recently Reissued: PA-07-297; 01/12/07NIH Pathway to Independence Award (K99/R00),Nurture highly promising investigators to secure a tenured research position 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/yrUS citizens & non-citizens, including postdoc fellows in Federal agencies, notably, Intramural NIH research fellows, eligible to apply,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 fewer applications to NIDCD to date than expectedApplication Receipt Dates: June 12, Oct 12, Feb 12/grants/guide/pa-files/PA-07-297.html/grants/guide/contacts/pa-07-297_contacts.htm/grants/new_investigators/QsandAs.htm,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),NIDCD R03 Program (cont),Provides up to $100K per year for up to three years10-page research planProvides a testing ground for the challenging task of writing a competitive R01 Transferable across institutions/grants/guide/pa-files/PAR-07-287.html,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,Two NIH-wide Extramural Loan Repayment Programs (LRPs),Clinical Research LRP“Patient-Oriented Research”Pediatric Research LRPresearch directly related to diseases, disorders, and/or other conditions in children,NIH Loan Repayment Program (LRP),Must be a US citizen or permanent residentDoctoral 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 agencyEducational debt must equal at least 20% of institutional base salaryProvides up to $35k (plus associated Federal taxes) per year for up to two years (aggregate of $70k+); renewable,Clinical/Pediatric New/Renewal LRP Applications Reviewed & Awarded NIH-wide,Of the 34 NIDCD LRP Awards for FY06:,NIDCD Success Rate well above NIH-wide Success Rate of 51%Awards ranged from $5k-89k (M=$33k)Seventeen (50%) are renewal awardsEleven 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),LRP Application & Other Information Resources,On-line application process, announced in the summer, runs from early Sept to early DecNIH Office of Loan Repayment LRP Help Line: (866) 849-4047IC LRP Coordinator,NIDCD Outreach to Health Professional Groups,Currently-Active NIDCD K08/K23 Awardees by PI Specialty,MD-ORL MD-nonORL PhD1 TOTAL17 (47%) 11 (31%) 8 (22%) 361 4 Speech-Language Pathologists, 1 Audiologist & 3 Others 02/07,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;,NIDCD K08/K23 ORL Awardees: What We Know,Almost all have their own laboratories and require technician support (in addition to equipment lack of departmental support (but not wanting for salary),NIDCD & NIH New Mentored Clinician-Investigator K-Awardees (FY95-01): Follow-up R01 Submissions & Awards,NIDCD K08/K23 Awards to Clinician-Investigators: What We Conclude,The NIDCD K08/K23 Program is not yielding our desired return-on-investment!,NIDCD Initiatives for Facilitating Emergence of Independent Clinician-Investigators,Research Supplements for Junior Clinical Faculty in Otolaryngology (under development)Competitive supplement program to R01