Michael A. Sesma, Ph.D.National Institute of General

Medical S ciences

NIH and New and Early Stage Investigators

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

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Average Age and Degree Type of First-Time Investigators on R01-Equivalent Grants* (Fiscal Years 1980-2013)**

MD-PhDPolynomial (MD-PhD)MD OnlyPolynomial (MD Only)

Fiscal Year

Ave

rge

Age

(Y

ears

)Who are the NIH New Investigators?

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 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) AwardTo 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 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) (PAR-

13-362) 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

CandidateCareer Development Plan Goals and ObjectivesResearch PlanMentor(s), Co-mentor(s), Consultants,

CollaboratorsEnvironment & Institutional Commitment to

Candidate

Review Criteria compared: http://grants.nih.gov/grants/peer/guidelines_general/Review_Criteria_at_a_glance.pdf

Non-Mentored Career Development Awards

Career Development Grants used by some ICs to advance investigators early in their independent careersK02 (PA-14-045)

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 InvestigatorsNIDCD: Small Grant Program – within 7 years of

degree or fellowshipNIDCR: Small Grant Program for New InvestigatorsNIDDK: 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

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 Early Independence Award (EIA)

Type of Classification Number of Awardees Average Age Median Age

Early Stage Investigators 785 39.2 39

Targeted New Scientist Programs Number of Awardees 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 45 37.4 37NIH Pathway to Independence Award (R00) 153 36.2 36NIH Director's Early Independence Awards 14 32.1 32

Age of Early Stage Investigators at first major independent research award, and Awardees of programs to facilitate

transition to independence

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.

• 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.htmlUpdate notice: NOT-OD-11-057.html

Implementation of NI/ESI policies

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” fundinghttp://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 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 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: 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

MSESMA@NIGMS.NIH.GOV

Questions?