NIH and New and Early Stage
Investigators
Michael A. Sesma, Ph.D.
N a t i o n a l I n s t i t u te o f G e n e ra l
M e d i c a l S c i e n ce s
Let’s review… the first steps in developing a
competitive application
 Get to know the NIH Program Director for
your scientific area
 Contact them about your research ideas
Fit with institute mission and priorities
 Best grant mechanism or program for you
 Best study section for review
 Technical assistance with the application process

 Are you a New or Early Stage Investigator?

Programs for transition to independence and for NI/ESI
Who is a New Investigator or
An Early Stage Investigator?
 A New Investigator is a Principal Investigator who
has not previously competed successfully as a PD/PI
for a “significant independent” NIH research grant.
 Significant Independent NIH research grant = R01
 An Early Stage Investigator is a PD/PI within 10
years of their terminal degree or clinical residency
training and has not yet previously competed
successfully as PD/PI for a “significant independent”
NIH research grant.
http://grants.nih.gov/grants/new_investigators/index.htm
Who are the NIH New Investigators?
Average Age and Degree Type of First-Time Investigators on
R01-Equivalent Grants* (Fiscal Years 1980-2013)**
48.0
46.0
Averge Age (Years)
44.0
42.0
40.0
MD-PhD
38.0
MD Only
36.0
PhD Only
34.0
32.0
Fiscal Year
Grant Programs for Career Transitions and Newly
Independent Investigators
 Career Transition Award Programs:
 K22; K99/R00; K12
 Mentored Career Development Awards:
 K01; K08; K23; K25
 Programs for Newly Independent Faculty:
 R03; R21
 High Risk, High Reward Programs:
 NIH Director’s New Innovator Award
 NIH Director’s Early Independence Award
 NIH Research Project Grant: R01
 New Investigator Initiatives
 And the Loan Repayment Program
Career Transition Award – K22
 K22: NCI, NHLBI, NIAID, NIDCR, NIMH, NINDS, NIEHS
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To support mentored, non-independent investigators in
transitioning to their first independent tenure-track faculty
research position (or equivalent)
For Postdoctoral investigators in the NIH Intramural Program or
at domestic institutions
Support for 3-5 years
NCI: Transition Career Development Award – within 2 years of
first independent cancer research position (PAR-12-121;
Diversity PAR-12-062)
NIAID: Research Scholar Development – no more than 5 years of
postdoctoral training – apply as a postdoctorate – grant awarded
when in a tenure-track position (PAR-12-156)
Career Transition Awards – K99/R00
K99/R00 NIH Pathway to Independence (PI) Award
To facilitate timely transition from mentored postdoctoral research position
to stable independent research position with independent NIH or other
research support at an earlier stage than is currently the norm.
 K99-Mentored phase - support to obtain additional mentored training,
complete research, publish results, and bridge to an independent research
position.

R00 Independent phase - research grant to establish an independent research
program and prepare application for regular research grant support (R01).
PA-14-042: http://grants.nih.gov/grants/guide/pa-files/PA-14-042.html
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
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For individuals with less than 4 years postdoctoral training
Project Period: K99 - up to 2 years; R00 - up to 3 years
Budget and Duration: see specific NIH Institute and Center
Non-citizens are eligible
Institutional Career Development - K12
Mentored Clinical Scientist Development Program Awards (K12)
grant to an institution for the development of independent
clinical scientists:
 NCI: Paul Calabresi Career Development Award for Clinical Oncology (K12)




(PAR-13-201)
NEI: The NEI Mentored Clinical Scientist Development Program Award
(K12) (PAR-12-002)
NIDA: NIDA Mentored Clinical Scientists Development Program Award in
Drug Abuse and Addiction (K12) (PAR-13-163)
NINDS: Neurological Sciences Academic Development Award (K12) (PAR13-362)
NIGMS: Institutional Research and Academic Career Development Awards
(IRACDA) (K12) (PAR-13-290)
Mentored Career Development Awards
Grants provide support for “protected time” (3-5 years) for an intensive, mentored
career development experience to facilitate launch of independent research careers
and enhance competitiveness for new research project grant (R01)
 K01 Mentored Research Scientist Development Award

For investigators in the biomedical, behavioral or clinical sciences to supports intensive
research career development under the mentorship of an established researcher.
 K08 Mentored Clinical Scientist Research Career Development Award

for individuals with a clinical doctoral degree to support an intensive, mentored research
career development experience in the fields of biomedical and behavioral research,
including translational research.
 K23 Mentored Patient-Oriented Research Career Development Award

For investigators seeking to focus on Patient-Oriented research, i.e., “research conducted
with human subjects (or on material of human origin including cognitive phenomena) for
which an investigator directly interacts with human subjects.”
 K25 Mentored Quantitative Research Development Award

For investigators from quantitative science and engineering research backgrounds
seeking to to integrate their expertise with NIH-relevant research.
http://grants.nih.gov/training/careerdevelopmentawards.htm
Review Criteria for Career Development Awards
 Candidate
 Career Development Plan Goals and Objectives
 Research Plan
 Mentor(s), Co-mentor(s), Consultants,
Collaborators
 Environment & Institutional Commitment to
Candidate
Review Criteria compared:
http://grants.nih.gov/grants/peer/guidelines_general/Review_Criteri
a_at_a_glance.pdf
Non-Mentored Career Development Awards
Career Development Grants used by some ICs to advance
investigators early in their independent careers
 K02 (PA-14-045)
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FIC: Independent Scientist in Global Health Award – within 7
years of last doctoral degree or fellowship
NINDS: Independent Scientist Award – years 1-3, salary, fringe,
and supplies – years 4-5: if the applicant obtains an R01 or
equivalent grant, salary and fringe
 K07 (PA-11-192)
 NCCAM and NIAAA: Academic Career Award (Development
Award) – for more junior investigators who are interested in
developing academic and research expertise
Small Grants (R03) for New Investigators
 NIAMS: Small Grant Program For New Investigators
 NIDCD: Small Grant Program – within 7 years of
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degree or fellowship
NIDCR: Small Grant Program for New Investigators
NIDDK: Small Grant Program for NIDDK
K01/K08/K23 Recipients
NIDA: Behavioral Science Track Award for Rapid
Transition (B/START)(I/START)
$50K per year, 2 years, non-renewable
Research Grant Programs to Consider
• NIDCR: Small Research Grants for Data Analysis and Statistical
Methodology applied to Genome-wide Data (R03)
• “Investigators who have not previously received funding from NIDCR as a Principal
Investigator are encouraged to apply.”
• NIDA: Early Career Award in Drug Abuse & Addiction (ECHEM) - R21/R33
•
A Phased Innovation grant for new-to-NIH, newly independent investigators and
investigators without previous NIH funding to conduct basic chemistry research applied
to drug abuse and addiction and relevant to the NIDA’s Mission.
• The R21 is a research grant mechanism, but not a new investigator grant
•
•
•
•
NIAID: “New investigators who feel unready to compete for an R01 are using the R21
successfully to gather preliminary data for their R01 applications.”
NIAMS: “Projects that will be considered a lower priority include new investigator starter
grants.”
NIDDK: “R21s should NOT be used by new investigators to gather preliminary data for a
standard R01.”
NINDS: “FY 2009 success rates for NINDS R21 New Investigators: 11% vs. NINDS R01
New Investigators: 19%”
NIH Director’s High Risk High Impact Awards for
New Investigators

New Innovator Award
 Early Stage Investigators proposing
high potential, impact research
 Unusual flexibility in pursuing
research objectives
 Up to $1.5M for 5 years

Early Independence Award
 Junior Investigators within 12
months of doctoral degree and ready
for research independence
 Up to $1.25M for 5 years

Institutions may actively recruit
eligible EIA candidates
http://commonfund.nih.gov/highrisk
NIH
Director’s
What’s
Novel?Early Independence Award (EIA)
New PhD or MD locates an institution
willing to host
• Must be within 12 months before or
after graduation
• Must demonstrate exceptional
creativity, maturity, management
skills
• Research relevant to NIH mission
• Strong letters of recommendation
Institution may actively recruit
eligible EIA candidates
• Institution ensures independent lab
space/supplies/staff
space/staff/equipment
• Appointment up to 5 years
• Protected research time for development as
researcher
• Proposed research complements and
enhances institution’s programs
• Institution may choose to retain candidate
Age of Early Stage Investigators at first major independent
research award, and Awardees of programs to facilitate
transition to independence
Type of Classification
Early Stage Investigators
Targeted New Scientist Programs
Number of
Awardees
785
Number of
Awardees
Average Age Median Age
39.2
39
Average Age Median Age
Outstanding New Environmental Scientist
(ONES) in 2011
<11
36.9
37
Biobehavioral Research Award for Innovative
New Scientist (BRAINS)
<11
36.4
36
NIH Director's New Innovator Award Program
NIH Pathway to Independence Award (R00)
NIH Director's Early Independence Awards
45
153
14
37.4
36.2
32.1
37
36
32
NIH R01 Grant – The Gold Standard
The NIH Research Project Grant (R01):
• The original and historically oldest grant mechanism used by NIH.
• Support for research relevant to the mission of the NIH.
• Investigator-initiated or response to a specific Funding Opportunity
Announcement (FOA).
• Support for a discrete, specified, circumscribed project conducted by
the named investigator(s) in an area representing the investigator's
specific interest and competencies.
• R01 grants awarded to organizations of all types. The Principal
Investigator/Project Director writes application, is responsible for
conducting the research. The applicant is the research organization.
• Awarded for 1-5 years with a budget justified by the proposed work.
Implementation of NI/ESI policies
•
At Study Section, NI/ESI R01 applications are identified to reviewers so that
appropriate consideration of their career stage can be applied during review.
•
NI/ESI applications are “clustered” during review to enable evaluation as a group
and distinguish from Established Investigators.
•
Multi-PI projects are identified for consideration of NI/ESI status only if ALL of the
listed PIs qualify as NI/ESI.
•
Staff in the NIH institutes and centers are apprised of NI/ESI status, which may be
considered when applications are selected for award.
•
NI/ESI applicants are eligible for the “Full Implementation to Shorten the Review
Cycle for New Investigator R01 Applications Reviewed in Center for Scientific
Review (CSR) Recurring Study Sections”.
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-083.html
Update notice: NOT-OD-11-057.html
New Investigator R01 Initiatives
• New Investigators/Early Stage Investigators (NI/ESI) R01 applications
receive special attention at Council as high program priority or equivalent.
• Flexible payline for NI/ESI scored R01 applications.
• No imposed reductions in duration and amount of awards (beyond the
recommendations of the initial review group) for NI/ESI.
• Fund NI/ESI R01 applications to achieve a designated success rate rather
than setting a specific payline.
• Supporting ESI R01s for five years (many Institutes fund R01 for 4 years
•
for established PIs)
Partial “bridge” funding
http://grants.nih.gov/grants/new_investigators/
IC specific Strategies for NI/ESI Applications
 NHLBI: priority funding for the first competitive renewal. (1) The
individual cannot be a principal investigator on an Independent Scientist
and/or other non-mentored career award or on another R01 or a subproject director on a multi-project award, and (2) must be currently
holding a position at a domestic institution with a faculty rank up to and
including an Associate Professor or equivalent.
 NIAAA: ESIs just beyond the nominal payline are invited to submit a letter
to respond to the summary statement critiques. Responses reviewed by
Program staff, and when deemed appropriate, the application may be
recommended to Institute Director for award.
 NICHD: Special funding consideration will be given to research project
grant applications submitted by new investigators supported by NICHD
Career Development Awards (Ks).
Let’s review… the first steps in developing an
competitive application
 Get to know the NIH Program Director for
your scientific area
 Contact them about your research ideas
 Fit
with institute mission and priorities
 Best grant mechanism or program
 Best study section for review
 Technical assistance with the application process
 Are you a New/Early Stage Investigator?
Consider the R01 Grant
Loan Repayment Program
 Commit to perform research for 2 years, and the NIH
repays up to $35,000 per year of your qualified
educational debt and covers the resulting taxes.
 You must be conducting research in of the following 5
areas:
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Clinical Research
Pediatric Research
Contraception & Infertility Research
Health Disparities Research
Clinical Research for Individuals from Disadvantaged
Backgrounds
http://www.lrp.nih.gov/
To Reiterate…
Get to know the Program
Director for your scientific
area!
Grant Writing for Success
Writing the Application
Start early and develop good ideas
Seek advice and critical input from colleagues
Talk to your NIH Program Official(s)
Use the NIH and OER webpage resources
http://grants.nih.gov
• Follow instructions carefully, remember review
criteria
• Submit your application
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Questions?
M S E S M A @ N I G M S . N I H . G OV