1. NIH and New and Early Stage Investigators
Joanna M. Watson, PhD
Program Director
National Cancer Institute

2. 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.

3. 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.

4. 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)
Dissertation Award (R36)
Small Business Technology Transfer Grant-Phase I (R41)
Academic Research Enhancement Award (R15)
Small Business Innovation Research Grant-Phase I (R43)
Exploratory/Developmental Grant (R21)
Shannon Award (R55)
Research Education Grants (R25, R90, RL9, RL5)
NIH High Priority, Short-Term Project Award (R56)
Clinical Trial Planning Grant (R34)
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)
Loan repayment contracts (L30, L32, L40, L50, L60)
All individual and institutional career awards (Ks)    
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

5. NIH New Investigators

6. 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)

7. 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.
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). 

8. 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 .
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).

9. 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”.
Update notice: NOT-OD html

10. NIH Exceeds New Investigator Goals since FY 2007
UPDATE:
2011 New Investigators: 1776
R01-Equivalent awards include R01, R23, R29, and R37 grants.

12. R01 - Equivalent Grants, New (Type 1) Success Rates, by Career Stage of Investigator
Data and chart description for this slide can be located at 12

13. Figure 1 shows the average age of NIH First-Time R01 Principal Investigators with either the MD, the MD/PhD, or the PhD during each fiscal year from 1980 to 2011.

14. NIH Mechanisms to Encourage Funding (and hiring) of Early-Stage Investigators
Support for outstanding post-docs to facilitate a timely transition from a mentored to an independent position
NIH Pathway to Independence Award (Parent K99/R00)
Support exceptional, early career scientists to skip the post-doc
NIH recognizes these concerns and is actively trying new methods to encourage funding and hiring of early-stage investigators.
Methods include:
(Notice OD ) implementing policies that have the goal of funding new investigators at the same rate as established investigators submitting new applications
(K99/R00) hastening and smoothening the transition from post-doc to independent position
(New Innovator) supporting outstanding early-stage investigators as they pursue unusually high risk but unusually high potential reward projects
Support outstanding early-stage investigators as they pursue high risk/high reward research

15. 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). 

16. Pathway to Independence Award (K99/R00)
Objective:
To assist postdoctoral investigators in transitioning to a stable independent research position
Candidate:
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

17. 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
An anticipated important additional component is to foster independence of those who are close to the receipt of their doctoral degree or completion of medical residency
“For the most creative of young scientists, nothing can equal the chance to have a lab of one's own.”
Exceptional early career scientists with the intellect, scientific creativity, drive, and maturity to flourish independently without the need for traditional post-doctoral training, most will still benefit from post-doc
For those junior scientists prepared to omit traditional post-doctoral training and move into independent academic positions at U.S. institutions directly upon completion of their graduate degrees (Ph.D., M.D., or equivalent)
Using existing models of similar independent fellows programs at Carnegie, the Whitehead, UCSF and other institutions that sometimes individuals don’t need a post-doc to undertake pioneering research; however, different in that this opens up opportunities to ANY institution in the US willing to host such individuals
Also, solicited and incorporated input from biomedical research community
Current year is a pilot (~10 awards) to test ideas and process, but may be scaled up and/or significantly retooled in subsequent years
Current year is a pilot (~10 awards) to test ideas and process, but may be scaled up in subsequent years

18. 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
These awards will be very selective; each institution may only submit two applications.
Junior scientists may identify a host institution and contact them directly to negotiate a position
Institutions may actively recruit exceptional junior scientists to apply for these positions. Importantly, an institution may elect to host an applicant for this program with the commitment to a position being contingent upon receipt of the award, and be willing to nurture the investigator as an independent researcher including the provision of independent lab space.
Early Independence Award projects will receive up to $250,000 in direct costs each year for up to 5 years.
The receipt date for fiscal year 2011 closed in January. The NIH expects to release the funding opportunity announcement for the coming year in October  

19. 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.
Similar in spirit to the Pioneer awards.
More mature than Early Independence Awards, New Innovator program now in its 5th year.
Looking for early career stage investigators who already have established an exceptional record of accomplishments and who propose risky, but potentially very high impact research objectives.
Awards allow for unusual flexibility, acknowledging that risky research can take a highly dynamic path.
Scope of research more ambitious than typical, modular budget R01.

20. High-Risk High-Reward Research Awards
TRANSFORMATIVE RESEARCH
EARLY INDEPENDENCE
PIONEER
NEW INNOVATOR
Junior investigators (within 1 year of Ph.D. or medical residency)
Who?
All career stages, applications from teams of investigators welcome
All career stages
Early stage Investigators
Transformative ideas that may involve large budgets
Creative scientists proposing paradigm shifting research
Early stage investigators proposing high potential impact research
Junior scientists ready for research independence
What?
All areas of basic, clinical and translational science within the NIH mission
Budget?
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
Prelim data?
Preliminary data requirements less stringent than R01 award
Preliminary data not required
Preliminary data not required
Preliminary data not required
For more information:

21. National Institutes of Health
Office of the Director
Office of
Extramural Research
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
National Institute
of Nursing Research
National Center on
Minority Health
and Health
Disparities
National Center
for Complementary
and Alternative
Medicine
Fogarty
International
Center
National Center
for Advancing
Translational
Sciences
National Library
of Medicine
National Institute
of Biomedical
Imaging and
Bioengineering
No funding
authority
NIH
Clinical Center
Center
for Information
Technology
Center
for Scientific
Review

22. 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. 

23. 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

24. 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)

25. 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)

26. 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%”

27. 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).

28. 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

29. 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

30. The Formula for Writing a Successful
Grant Application

31. Writing the 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 ( and OER ( webpages
Follow instructions carefully, remember review criteria

32. 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

33. Many directions and opportunities at the NIH
Take Home Messages
Many directions and opportunities at the NIH
Become familiar with the NIH Institute(s) that support your area of research (
Become familiar with the NIH 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