NIH and New and Early Stage Investigators

Joanna M. Watson, PhDProgram 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 DefinitionSignificant independent NIH research grant: Any NIH research project grant other than the following small or early stage research grants:

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:

Instrumentation, Construction, Education, Health Disparity Endowment Grants, or Meeting AwardG07, 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).

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

Implementation of ESI definition

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Fiscal Year

NIH First Time R01-Equivalent Awardees FY 1985-2010

NIH Exceeds New Investigator Goals since FY 2007

R01-Equivalent awards include R01, R23, R29, and R37 grants.

UPDATE: 2011 New Investigators: 1776

R01 - Equivalent Grants, New (Type 1) Success Rates, by Career Stage of Investigator

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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

MD-PhD

MD Only

PhD Only

NIH Mechanisms to Encourage Funding (and hiring) of Early-Stage Investigators

Support outstanding early-stage investigators as they pursue high risk/high reward research

Support exceptional, early career scientists to skip the post-doc

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

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: 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

Pathway to Independence Award (K99/R00)

NIH Director’s Early Independence Award (EIA)

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

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.”

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

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)

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 PIONEER NEW INNOVATOR

EARLY INDEPENDENCE

What? 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

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 not required

Preliminary data requirements less stringent than R01 award

Preliminary data not required

Preliminary data not required

For more information: http://commonfund.nih.gov/highrisk

Who? All career stages, applications from teams of investigators welcome

All career stages Early stage Investigators Junior investigators (within 1 year of Ph.D. or medical residency)

21

National Institutes of Health

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis andMusculoskeletaland Skin Diseases

National CancerInstitute

National Instituteon Aging

National Instituteof Child Healthand HumanDevelopment

National Instituteof Allergy andInfectious Diseases

National Instituteof Diabetes andDigestive andKidney Diseases

National Instituteof Dental andCraniofacialResearch

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Institute onDeafness and OtherCommunicationDisorders

National EyeInstitute

National HumanGenome ResearchInstitute

National Heart,Lung, and BloodInstitute

National Instituteof Mental Health

National Instituteof NeurologicalDisorders andStroke

National Instituteof GeneralMedical Sciences

National Instituteof Nursing Research

National Libraryof Medicine

National Centerfor Complementaryand AlternativeMedicine

FogartyInternationalCenter

National Centerfor AdvancingTranslational Sciences

National Instituteof Biomedical Imaging and Bioengineering

No funding authority

NIHClinical Center

Centerfor Information Technology

Center for Scientific Review

National Center on Minority Health and Health Disparities

Office of the Director Office of Extramural Research

Mentored Career Development AwardsThese 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 careersK02

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 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 RecipientsNINR: Small Grants for Behavioral Research in

Cancer ControlNIDA: 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

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

New and Early Stage Investigators — the Program Perspective

Take Home Messages

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

Many directions and opportunities at the NIH