NIH 101: What You Need to Know! Daniel Sklare, PhD

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NIH 101 What You Need to Know!Daniel Sklare,
PhD Lana Shekim, PhD, NIDCDPeggy McCardle,
PhD, NICHDASHA LfS 08 Conference
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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)
• QAs

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Introduction to NIH 101
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Environment of the Research Scientist Competing
for NIH Funding
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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

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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.

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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

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Winning the Big Prize- Your First NIH GrantWhat
the instructions wont 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

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Winning the Big Prize- Your First NIH GrantWhat
the instructions wont 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

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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.

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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

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NIH Extramural Staff
Program
Review
Grants Management
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Find the Funding Agency/Component (i.e., NIH
Institute) Whose Scientific Mission Funding
Priorities Fit Your Proposal

• Consult relevant program officer before 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)

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Recent Research Training/Career Development
Initiatives
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NIH Research Training Career Development
Awards Goals Expectations

• Identify support those candidates from a
  diverse pool with highest potential to advance
  Nations 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

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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)

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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

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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
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• 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/Q
  sandAs.htm

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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
  mentors research program
• Show productivity (first-authored research pubs)
  to date high promise as an independent
  investigator
• Requisite plan for evaluating/monitoring
  candidates progress toward independence

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Guidance for Crafting a Successful K99/R00
Application (cont.)

• Career Development Plan well laid-out, fits
  candidates 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

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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

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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

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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

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Clinical/Pediatric New/Renewal LRP Applications
Reviewed Awarded NIH-wide
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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)

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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 [phone]
• Daniel A. Sklare, Ph.D.
• NIDCD LRP Coordinator
• Tel [phone]
• Email sklared_at_nidcd.nih.gov

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Funding Rates of NIDCD R01 New Investigator
R01 ApplicationsDuring FYs 02-06 by PI Specialty
Funding Rate MD/ ORLS MD/ Non ORLs MD/ PhDs PhD/ SLPs PhD/ Auds Non- Clinical PhDs
R01 Applics 26 (32/121) 29 (28/97) 35 (44/125) 26 (41/155) 21 (21/101) 31 (573/1844)
New PI Applics 27 (8/30) 50 (5/10) 30 (7/23) 30 (9/30) 20 (2/10) 37 (95/260)
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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/NO
  T-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/gra
  nts/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

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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

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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 (asst 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)

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Benchmarks for success High but reachable
R01 funding
Applicant
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NIDCD Extramural Research Training Program
Contact (Across NIDCD Scientific Program Areas)

• Daniel A. Sklare, Ph.D.
• Research Training Officer
• Tel [phone]
• Email sklared_at_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/in
  dex.htm