NIH and New and Early
Stage Investigators
Joanna M. Watson, PhD
Program Director
National Cancer Institute
R01 – The Gold Standard
The Research Project Grant (R01):
 The original and historically oldest grant mechanism used by NIH.
 Provides support for health-related research and development based on the
mission of the NIH.
 Can be investigator-initiated or can be submitted in response to a specific
Funding Opportunity Announcement (FOA).
 Is a grant award made to support a discrete, specified, circumscribed project
to be performed by the named investigator(s) in an area representing the
investigator's specific interest and competencies, based on the mission of the
NIH
 The NIH awards R01 grants to organizations of all types . Although the Project
Director/Principal Investigator writes the grant application and is responsible
for conducting the research, the applicant is the research organization.
New Investigator Definition
A Program Director or Principal Investigator (PD/PI) is
considered a New Investigator if he/she has not
previously competed successfully as a PD/PI for a
“significant independent” NIH research grant.
New Investigator Definition
 Significant independent NIH research grant: Any NIH research
project grant other than the following small or early stage research
grants:
Pathway to Independence Award-Research Phase (R00)
Small Grant (R03)
Academic Research Enhancement Award (R15)
Exploratory/Developmental Grant (R21)
Research Education Grants (R25, R90, RL9, RL5)
Clinical Trial Planning Grant (R34)
Dissertation Award (R36)
Small Business Technology Transfer Grant-Phase I (R41)
Small Business Innovation Research Grant-Phase I (R43)
Shannon Award (R55)
NIH High Priority, Short-Term Project Award (R56)
Competitive Research Pilot Projects (SC2, SC3)
 The PD/PI can be considered as a “New Investigator” if he/she has been the PD/PI
of, or received an award from, any of the following classes of awards:
Training-Related and Mentored Career Awards
All Fellowships (F awards)
All individual and institutional career awards (Ks)
Loan repayment contracts (L30, L32, L40, L50, L60)
All training grants (T32, T34, T35, T90, D43)
Instrumentation, Construction, Education, Health Disparity Endowment Grants, or Meeting Award
G07, G08, G11, G13, G20 S10, S15, S21, S22 R13
 Note regarding grants with Multiple PD/PIs: In the case of a grant application that involves more
than one PI, all PD/PIs must meet the definition of New Investigator to check “Yes” in the “New
Investigator” box
NIH New Investigators
Setting New Investigator Goals
 Goals based on rolling average for previous 5 years
 Numeric Goal for FY 2007 and 2008
 For 2009 and 2010 ICs were/are directed to maintain
comparable success rates for:
 Established Investigators submitting new
(Type 1) grant applications and New
Investigators
 In addition, a majority of New Investigators will be
Early Stage Investigators (ESIs)
Early Stage Investigators (ESIs)
 In 2009, NIH instituted a new ‘Early Stage
Investigator’ (ESI) category designed to accelerate
the early transition of new scientists to research
independence by receiving their first R01 earlier.
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-121.html
 A Program Director/Principal Investigator who qualifies as a
New Investigator is considered an Early Stage Investigator
(ESI) if he/she is within 10 years of completing his/her
terminal research degree or is within 10 years of completing
medical residency (or the equivalent).
Implementation of ESI Definition
 The NIH modified the collection of information on degree dates and
medical residency within the personal profile of the eRA Commons.
 PD/PIs must update their personal profile in the eRA Commons to
be considered for the ESI classification. Investigators who enter
degree and residency completion dates will be notified of their ESI
status by email.
 Procedures and guidelines for requesting an extension of the period
of ESI eligibility are in place to accommodate individuals with
various medical concerns, disability, pressing family care
responsibilities, or active duty military service (instructions in
Commons).
Implementation of ESI definition
 Applications from ESIs and New Investigators are identified to reviewers so
that appropriate consideration of their career stage can be applied during
review.
 Applications from ESIs and New Investigators are “clustered” during review to
enable evaluation as a group and distinguish from Established Investigators.
 An application with more than one PI is identified for consideration of ESI/NI
by reviewers only if ALL of the listed PIs qualify as New Investigators.
 Staff in the NIH institutes and centers are apprised of ESI and New Investigator
status and this factor is considered when applications are selected for award.
 New Investigators 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
NIH Exceeds New Investigator Goals since FY 2007
NIH First Time R01-Equivalent Awardees
FY 1985-2010
2,500
UPDATE:
2011 New
Investigators: 1776
2,000
1,809
Number of Awardees
1,684
1,500
1,000
500
0
Fiscal Year
R01-Equivalent awards include R01, R23, R29, and R37 grants.
R01 - Equivalent Grants, New (Type 1) Success Rates,
by Career Stage of Investigator
Figure 1. Average Age of Principal Investigators with MD, MD-PhD, or PhD at the
time of First R01 Equivalent Award from NIH, Fiscal Years 1980 to 2011
48.0
46.0
Age at First R01 Award
44.0
42.0
40.0
38.0
MD-PhD
36.0
MD Only
34.0
PhD Only
32.0
Fiscal Year
NIH Mechanisms to Encourage Funding
(and hiring) of Early-Stage Investigators
NIH Pathway to Independence
Award (Parent K99/R00)
Support for outstanding post-docs
to facilitate a timely transition
from a mentored to an
independent position
Support exceptional, early
career scientists to skip the
post-doc
Support outstanding early-stage
investigators as they pursue high
risk/high reward research
Pathway to Independence Award (K99/R00)
K99/R00 NIH Pathway to Independence (PI) Award
 To facilitate a timely transition from a mentored postdoctoral research
position to a stable independent research position with independent NIH
or other independent research support at an earlier stage than is
currently the norm.
 Two Phases: initial phase (K99) of mentored support to allow the
candidate time to obtain additional training, complete research, publish
results, and bridge to an independent research position. Second
phase(R00) provides support to conduct research toward establishing
his/her own independent research program and to prepare an application
for regular research grant support (R01).
http://grants.nih.gov/grants/guide/pa-files/PA-11-197.html
Pathway to Independence Award (K99/R00)
Objective:
Candidate:
To assist postdoctoral investigators in transitioning to a stable
independent research position
Senior postdoctoral fellows with no more than 5 years*
postdoctoral research experience about ready to become PIs.
Citizenship
No citizenship requirement
Mentor:
Established investigator(s) who can provide mentorship in both
research and career development; has the resources to
support the research; Fully supports the candidate’s transition
to independence
Award:
K99 phase (2 yrs): Up to $100K plus fringe benefits, and $30K
research support*
R00 phase (3 yrs): $249K/yr; At least 75% of the candidate’s
full-time professional effort**
* Changing to 4 years for applications due Feb 12, 2014
**See NIH Institute or Center as costs may vary
NIH Director’s Early Independence Award (EIA)
A new program to allow exceptional young investigators to “skip” the post-doc
“For the most creative of young scientists, nothing can equal the chance
to have a lab of one's own.”
 Inspired in some respects by programs at Carnegie,
Whitehead, UCSF, and other institutions that show
exceptional individuals do not require a post-doc to
undertake pioneering research
 Solicited and incorporated input from research
community
 Current year is a pilot (~10 awards) to test
ideas and process, but may be scaled up in
subsequent years
NIH Director’s Early Independence Award (EIA)
What’s Novel?
New PhD or MD locates an institution
willing to host
Institution may actively recruit eligible EIA
candidates
• 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 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
NIH Director’s New Innovator Award
 Seeking exceptionally creative early career stage individuals who
propose bold, risky ideas
 Early-stage investigators defined as those who have not received an NIH
R01 or similar grant and are within 10 years of completing their terminal
research degree or medical residency.
 Unusual flexibility in pursuing research objectives.
 Generous funding levels – up to $1.5M for 5 years.
High-Risk High-Reward Research Awards
TRANSFORMATIVE
RESEARCH
Who?
What?
All career stages,
applications from teams of
investigators welcome
Transformative ideas
that may involve large
budgets
PIONEER
NEW INNOVATOR
All career stages
Early stage Investigators
Creative scientists
proposing paradigm
shifting research
Early stage investigators
proposing high potential
impact research
EARLY
INDEPENDENCE
Junior investigators (within 1
year of Ph.D. or medical
residency)
Junior scientists ready for
research independence
All areas of basic, clinical and translational science within the NIH mission
Budget?
Prelim data?
Up to $25 million per year
for 5 years
Up to $500,000 per year
for 5 years
Up to $300,000 per year
for 5 years
Up to $250,000 per year
for 5 years
Preliminary data not
required
Preliminary data not
required
Preliminary data
not required
Preliminary data
requirements less stringent
than R01 award
For more information: http://commonfund.nih.gov/highrisk
National Institutes of Health
Office of
Extramural Research
Office of the Director
National Institute
on Aging
National Institute
on Alcohol Abuse
and Alcoholism
National Institute
of Allergy and
Infectious Diseases
National Institute
of Arthritis and
Musculoskeletal
and Skin Diseases
National Cancer
Institute
National Institute
of Child Health
and Human
Development
National Institute on
Deafness and Other
Communication
Disorders
National Institute
of Dental and
Craniofacial
Research
National Institute
of Diabetes and
Digestive and
Kidney Diseases
National Institute
on Drug Abuse
National Institute
of Environmental
Health Sciences
National Eye
Institute
National Institute
of General
Medical Sciences
National Heart,
Lung, and Blood
Institute
National Human
Genome Research
Institute
National Institute
of Mental Health
National Institute
of Neurological
Disorders and
Stroke
Fogarty
International
Center
National Center
for Advancing
Translational
Sciences
National Center on
Minority Health
and Health
Disparities
National Center
for Complementary
and Alternative
Medicine
NIH
Clinical Center
Center
for Information
Technology
National Library
of Medicine
Center
for Scientific
Review
National Institute
of Nursing Research
National Institute
of Biomedical
Imaging and
Bioengineering
No funding
authority
21
Mentored Career Development Awards
These grants provide support and “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
Non-Mentored Career Development Awards
These Career Development Grants are used by some ICs to
advance investigators early in their independent careers
 K02
 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
 NCCAM and NIAAA: Academic Career Award (Development
Award) – for more junior investigators who are interested in
developing academic and research expertise
Career Transition Awards
 K22: NCI, NHLBI, NIAID, NIDCR, NIMH,NINR, NLM
 NCI: Transition Career Development Award – within 2 years of first
independent cancer research position
 NIAID: Research Scholar Development – no more than 5 years of
postdoctoral training – apply as a postdoctorate – grant awarded when in
a tenure-track position
 NINR: Career Transition Award - provides up to 5 years of support in two
phases: 1) 2 years of mentored intramural experience for highly
promising, postdoctoral research scientists in an NIH intramural program,
2) 3 years of extramural support contingent on securing an independent
tenure-track or equivalent research position.
 NLM: Independent Career Development Award for Biomedical
Informatics – within 2 years of first independent cancer research position
– OR after a minimum of 2 years of postdoctoral training (apply as a
postdoctorate – grant awarded when in a tenure-track position)
New Investigator Specific R03s
 NIAMS: Small Grant Program For New Investigators
 NIDCD: Small Grant Program – within 7 years of
degree or fellowship
 NIDCR: Small Grant Program for New Investigators
 NIDDK: Small Grant Program for NIDDK
K01/K08/K23 Recipients
 NINR: Small Grants for Behavioral Research in
Cancer Control
 NIDA: Behavioral Science Track Award for Rapid
Transition (B/START)
Research Grants Available to All
 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 .
 R21 is a research grant mechanism 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%”
Special Funding Strategies for ESIs
 NHLBI: priority funding for the first competing 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 sub-project 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 NIAAA nominal payline are invited to
submit a letter to respond to the summary statement critique.
 These responses are reviewed by Program staff, and when deemed
appropriate, the application may be recommended to Institute
leadership 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).
Common Funding Strategies for ESIs
 Setting a flexible (better) payline for ESI R01
applications
 Limiting Institute-specific administrative cuts
 Supporting ESIs for 5 years (many Institutes only fund 4
year R01s)
 Partial “bridge” funding
http://grants.nih.gov/grants/new_investigators/
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:





Clinical Research
Pediatric Research
Contraception & Infertility Research
Health Disparities Research
Clinical Research for Individuals from Disadvantaged
Backgrounds
http://www.lrp.nih.gov/
The Formula for Writing a Successful
Grant Application
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 (www.nih.gov) and OER
(http://grants.nih.gov) webpages
 Follow instructions carefully, remember review
criteria
New and Early Stage Investigators — the
Program Perspective
Get to know the 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
Take Home Messages
Many directions and opportunities at the NIH
 Become familiar with the NIH Institute(s)
that support your area of research
(http://report.nih.gov)
 Become familiar with the NIH Guide
(http://grants.nih.gov/grants/guide/)
 Get to know the Program Director for your
scientific area
 Participate in workshops and symposia
 Participate in review of grant applications
 Don’t work in isolation
 Ask for input from colleagues before you
submit