NIH Career Development Programs NIH Career Development Programs and Early-Stage Investigatorsand Early-Stage Investigators

Henry Khachaturian, Ph.D.NIH Extramural Program Policy Officer

Director of Policy, NIH Loan Repayment ProgramsOffice of Extramural Research, NIH

Email: hk11b@nih.gov

1

NIH Office of Extramural Research

EB2013/FASEB – April 2013

National Institutes of Health

Our mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability.

World’s largest source of funding for biomedical research

Support more than 300,000 research personnel at over 3,000 universities and research institutions

27 Institutes and Centers (ICs) with specific research agendas

Research Project Grants:53.0%

Intramural Research:

10.0%

R&D Contracts:11.0%

Research Centers:

10.0%

Career Dev. 2.1%

Other Research:3.5%

All Other:2.0%

Research Mgmt & Support:

5.0%

Research Training:

2.5%

$767,132 Training $626,778 Career$1,393,910

$767,132 Training $626,778 Career$1,393,910

NIH Budget Office: http://officeofbudget.od.nih.gov/index.htm

3

FY 2015 President’s Budget: $30,361,653

NRSA Individual and Institutional Training Awards Career Development Awards Pathways to Independence Award (K99/R00) Career Award Review Criteria New and Early-Stage Investigators NIH Loan Repayment Programs

4

NIH New Investigators Programs

Predoctoral Individual NRSA (F31)Predoctoral Individual NRSA (F31)Predoctoral Individual MD/PhD NRSA Predoctoral Individual MD/PhD NRSA

(F30)(F30)Postdoctoral Institutional Training Postdoctoral Institutional Training (T32)(T32)Postdoctoral Individual NRSA (F32)Postdoctoral Individual NRSA (F32)

Small Grant Small Grant (R03) (R03) Research Project Research Project Grant (R01)Grant (R01)

Independent Scientist Award (K02)Independent Scientist Award (K02)

Senior Scientist Award (K05Senior Scientist Award (K05) )

Career StageCareer Stage ‘‘Formal’ Training/Career AwardsFormal’ Training/Career Awards

GRADUATE/GRADUATE/MEDICALMEDICALSTUDENTSTUDENT

POSTPOSTDOCTORALDOCTORAL

EARLYEARLY

MIDDLEMIDDLE

SENIORSENIOR

CA

REER

CA

REER

Predoctoral Institutional Training Grant (T32)Predoctoral Institutional Training Grant (T32)

NIH Pathway to Independence (PI) Award NIH Pathway to Independence (PI) Award (K99/R00)(K99/R00)Mentored Research Scientist Development Mentored Research Scientist Development Award (K01)Award (K01)Mentored Clinical Scientist Development Mentored Clinical Scientist Development Award (K08)Award (K08)Mentored Patient-Oriented RCDA (K23)Mentored Patient-Oriented RCDA (K23)Mentored Quantitative RCDA (K25)Mentored Quantitative RCDA (K25)

Midcareer Investigator Award in Midcareer Investigator Award in Patient-Oriented Research (K24) Patient-Oriented Research (K24) Exploratory/Exploratory/

Develop-ment Develop-ment Grant (R21) Grant (R21)

Pre-BacPre-Bac Pre-Bac Institutional Training Grant (T34)Pre-Bac Institutional Training Grant (T34)

Training & Career Development Support 2014

55

‘‘Informal’ Training Informal’ Training and Careerand CareerDevelopment on Development on RPGs and RPGs and SupplementsSupplements

Research AwardsResearch Awards

$767M$767M

$627M$627M

Advice for Mapping Your Career With NIH

Review Institute/Center (IC) priorities and goals. Each IC has a research training and career development program.

Learn the NIH application and review process

Identify the grant programs offered by each IC

Make early contact with program officers

Find innovative, well-respected mentors and collaborators

Study successful grant applications- talk to your mentor

Propose your best and most creative ideas

Career Path for a Research Doctoral Degree (Ph.D. or equivalent)

Graduatestudent

IndependentPIPh.D.

Faculty Position

T32 F31F32or

T32K22 R01 R37K02

T32- Institutional training grant (NRSA)-has pre-& postdoc slotsF30 and F31- Individual predoc fellowship (NRSA) (some ICs only support Diversity F30/31s)F32- Individual postdoc fellowship (NRSA)F33- Sr. postdoc fellowship (NRSA)R03- Small GrantR21- Exploratory/Developmental Research GrantR01- Research grant

F33R21R03

Diversity Supplements

K99/R00

PsUs

K02- Independent Scientist AwardK22- Research Scholar Development AwardK99/R00- Pathway to Independence AwardR37- Merit awardP01- Program Project GrantU01- Cooperative Agreement

Career Path for a Clinical Docotoral Degree (M.D. or equivalent)

Medical Student

IndependentPIM.D.

FacultyPosition

T35T32or

F32R01 R37

K08or

K23K22

Clinical Training

K02 K24

T35- Short-term Training Grant for Health Professional StudentsF33- Sr. Postdoctoral Fellowship (NRSA)K08- Mentored Clinical Scientist Development AwardK23- Mentored Patient-Oriented Research Career Development AwardK24- Mid-Career Investigator in Patient-Oriented ResearchK07, K12- IC specificPlus all mechanisms from Ph.D. track

F33R21K99/R00

Diversity Supplements

F30

Authorized by Sections 301 and 405 of PHS Act. 42 U.S.C. 241 and 284; Regulations at 45 CFR 74 & 92

K-Awards provide “protected time” to engage in research and enhance research capabilities.

Early, mid, & senior level awards. Majority require 75% of full time research effort. Applicants must hold a research or health professional

doctoral degree. U.S. citizenship or permanent residency required. 2 types of awards:

Individual, e.g. K01, K02, K08, K18, K22, K23, K24, K25, K99/R00 Institutional, e.g. K12, CTSA (KL2)

Research Career Development Authority

9

U.S. Citizens, Non-Citizen Nationals, Permanent Residents (except K99/R00).

Research doctoral degree (K01, K02), but some require clinical doctoral degree (K08, K23, K24).

Must devote a minimum of 75% effort to research and career development activities. There are exceptions.

Previous NIH Principal Investigators may be Ineligible. Principal Investigators on R03 or R21 are eligible to apply

(except K99/R00). Principal Investigators on R01 or subproject Principal

Investigators on a P01 are not eligible to apply.

10

Career Development Award Eligibility

Individual Mentored: K01: Mentored Research Scientist Development Award

K08: Mentored Clinical Scientist Development Award

K23: Mentored Patient-Oriented Research Development Award

K25: Mentored Quantitative Research Development Award

K99/R00: NIH Pathway to Independence (PI) Award

Institutional Mentored: K12: Institutional Mentored Research Scientist Development Program

Individual Non-Mentored (Independent): K02: Independent Scientist Research Development Award

K24: Mid-Career Patient-Oriented Research Development Award

11

Selected Career Development Awards

Provides an intensive, mentored research experience for a period of up to 5 years.

Minimum of 75% full-time professional effort is required (based on 12 person months appointment).

Candidates must have a research doctorate and postdoctoral experience.

Caution: Not an extension of postdoctoral training!

Varied and limited NIH Institute and Center participation: Some ICs use for Re-Entry

Some ICs use to pursue new research area

Requires plan for independence.

12

Mentored Research Scientist Career (K01)

Supervised research experience for individuals with health professional degree who are committed to a career in laboratory research.

Phased award periods: didactic experience followed by hands-on research experience.

Provides up to five years of salary and Research support and protected time.

Must demonstrate need for a period of intensive research focus to enhance career.

Must commit a minimum of 9 person-months (75% of full-time professional effort) to award.

13

Mentored Clinical Scientist Career (K08)

Supervised research for clinically trained professionals with a commitment to focus on patient-oriented research (POR).

Must have completed clinical training, including specialty/sub-specialty, if applicable, prior to award.

Provides up to five years of salary and Research support and protected time.

Must demonstrate need for a period of intensive research focus to enhance career.

Must commit a minimum of 9 person-months (75% of full-time professional effort) to award.

14

Mentored Patient-Oriented Research (K23)

Patient-Oriented Research (POR) is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator directly interacts with human subjects. This area of research includes: Mechanisms of human disease;

Therapeutic interventions;

Clinical trials, and;

The development of new technologies.

15

Qualifying Research for K23

Mentored experiences for scientists from quantitative and engineering backgrounds interested in pursuing health-related research.

Minimum of 75% full-time professional effort is required (based on 12 person months appointment).

Candidates must have a research doctorate and ideally some postdoctoral experience.

Unique among NIH K awards in that eligibility spans the postdoctoral to senior faculty levels, although some Institutes have exceptions to this general rule.

16

Mentored Quantitative Scientist (K25)

K99: Mentored research experience for up to 2 years.

R00: Transition to research independence as junior faculty for up to 3 years.

Applicants: no more than 5 years of postdoctoral research training at the time of initial application or resubmission.

Non-U.S. citizens may apply, but institution must be domestic.

Transition to R00 phase requires offer and acceptance of tenure-track, full-time assistant professor position (or equivalent).

17

Pathway to Independence Award (K99/R00)

Institutional Mentored Research Scientist Development Program—Award is made to the institution.

Enhance research career development for individuals, selected by the institution, who are training for careers in specified research areas.

Provides institutions with a greater capacity and flexibility for mentoring junior investigators.

All other provisions of individual K awards apply to the award recipient.

Not transferable to another institution.

Usually solicited by a Funding Opportunity Announcement.

18

Institutional Career Development Program (K12)

Foster development of outstanding scientists who can make significant contributions to their field of research.

Provides up to five years of salary support and “protected time” for newly independent scientists.

Must demonstrate need for a period of intensive research focus to enhance career.

Must have independent peer-reviewed research support at the time of award.

Must commit a minimum of 9 person-months (75% of full-time professional effort) to award.

19

Independent Scientist Award (K02)

Attract and retain talented individuals to the challenges of patient-oriented research (POR).

Provides up to five years of salary support and “protected time” for mid-career scientists.

Enable mid-career clinician scientists to devote more time to POR, and sever as mentors to new clinical investigators.

Provides protected time to investigators who have their own independent peer-reviewed research support.

Must commit between 3 and 6 person-months (25% to 50% of full-time professional effort) to award.

20

Midcareer Investigator Award in POR (K24)

Use SF 424 – Part I, Section 7: Supplemental Instructions for Preparing an Individual Research Career Development Award (CDA) Application.

Submission dates for new applications: February 12, June February 12, June 12, October 12.12, October 12.

For resubmissions: March 12, July 12, November 12.March 12, July 12, November 12. Institutes and Centers use of career awards is highly

variable. Read announcement and instructions carefully and call the NIH staff!

In K announcements, see contact Webtable for participating Institutes and Centers.

21

Career Award Application and Due Dates

~800

~3500

~500

0

500

1,000

1,500

2,000

2,500

3,000

3,500

4,000

4,500

5,000

(Individual)

(Institutional) (Individual)

Mentored K Awards

Independent K Awards

Number of individuals appointed to institutional career award positions is an estimate.

Num

ber o

f Pos

ition

sIndividual & Institutional Positions on Ks: FY 2014

22

Success Rate of K01 Awards

23

0

100

200

300

400

500

600

700

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

Fiscal Year

App

licati

ons

and

Aw

ards

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Succ

ess

Rat

e

Reviewed Awarded Success Rate

Success Rate of K08 Awards

24

0

100

200

300

400

500

600

700

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

Fiscal Year

App

licati

ons

and

Aw

ards

-20%

0%

20%

40%

60%

80%

100%

Succ

ess

Rat

e

Reviewed Awarded Success Rate

One Award Only

Success Rate of K23 Awards

25

0

100

200

300

400

500

600

700

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

Fiscal Year

App

licati

ons

and

Aw

ards

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Succ

ess

Rat

e

Reviewed Awarded Success Rate

Success Rate of K99 Awards

26

0

200

400

600

800

1,000

1,200

2007 2008 2009 2010 2011 2012 2013 2014

Fiscal Year

App

licati

ons

and

Aw

ards

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Succ

ess

Rat

e

Reviewed Awarded Success Rate

My Application

xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

$$$

Center for Scientific Review

Assigns IRG in CSR or IC

Scientific Review Group

Evaluates Scientific Merit

Institute or Center (IC)

Evaluates Relevance

Advisory Council

Recommends Action

IC DirectorAllocates Funds

PI / Institution Submits application

Conduct Research

Revision / Resubmission

The NIH Review Process

Candidate:Candidate: Potential to develop as an independent and productive

researcher. Candidate’s academic, clinical (if relevant), and research

record. Evidence of the candidate’s commitment to meeting the

program objectives to become an independent investigator.

Letters of reference from well-established scientists: Evidence that the candidate has a high potential for becoming an independent investigator.

Career Award Review Criteria (1 of 5)

Career Development Plan/Career Goals & Objectives:Career Development Plan/Career Goals & Objectives: Likelihood that the plan will contribute substantially to the

scientific development of the candidate leading to scientific independence.

Appropriateness of contents, scope, phasing, and duration of the career development plan in the context of prior training/research experience and the stated training and research objectives for achieving research independence.

Adequacy of plans for monitoring and evaluating the candidate’s research and career development progress.

Career Award Review Criteria (2 of 5)

Research Plan:Research Plan: Significant and scientific/technical merit of the proposed

research question, design, and methodology. Relevance of the research plan to the candidate’s research

career objectives. Appropriateness of the research plan to the stage of

research development and as a vehicle for developing the research skills described in the career development plan.

Career Award Review Criteria (3 of 5)

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s):Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s): Qualifications of the mentor(s) in the area of the proposed

research, and previous experience in fostering the development of independent investigators.

Mentor(s) Statement: Candidate’s potential and his/her strengths and areas needing improvement.

Quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate.

Mentor’s description of the elements of the research career development activities, including formal course work adequate.

Mentor’s research productivity and peer-reviewed support.

Career Award Review Criteria (4 of 5)

Environment and Institutional Commitment to the Candidate:Environment and Institutional Commitment to the Candidate: Adequacy and appropriateness of research facilities and

resources including faculty capable of productive collaboration with the candidate.

High quality, research-intensive environment for scientific and professional development of the candidate.

Strength of the sponsoring institution’s commitment to the candidate including devoting a minimum of 9 person-months (75% of full-time professional effort) to research and career development activities.

Assurance that the institution intends the candidate to be an integral part of its research program.

Career Award Review Criteria (5 of 5)

Resources:Resources: NIH Extramural Training Mechanisms:

http://grants1.nih.gov/training/extramural.htm

Ruth L. Kirschstein National Research Service Award (NRSA): http://grants1.nih.gov/training/nrsa.htm

NIH Career Development Awards: http://grants1.nih.gov/training/careerdevelopmentawards.htm

33

NIH Office of Extramural Research

Small Grant Program (R03)

Overview:Provides limited funding for a short period of time to support a variety of types of projects, including:

Pilot or feasibility studies Collection of preliminary

data Secondary analysis of

existing data Small, self-contained

research projects Development of new

technology, etc.

Program Features:

Limited to two years of funding Direct costs generally up to $50,000 per yearNot renewable Utilized by more than half of the NIH Institutes and Centers

Institute and Center contacts and policies: See Funding Opportunity Announcement

Exploratory/Developmental Research (R21)

Overview:Encourages new, exploratory and developmental research projects by providing support for the early stages of project development.Sometimes used for pilot and feasibility studies.Preliminary data are not required but may be included if available.Limited to up to two years of funding.

Program Features:

Combined budget for direct costs for the two year project period usually may not exceed $275,000No preliminary data is generally requiredMost Institutes and Centers utilize the R21 program

Institute and Center contacts and policies: See Funding Opportunity Announcement

Academic Research Enhancement Award (R15)Academic Research Enhancement Award (R15)

Overview:Supports small-scale research projects in the biomedical and behavioral sciences conducted by faculty and students at educational institutions that have not been major recipients of NIH research grant funds.

Goals of the Program:Support meritorious researchExpose students to researchStrengthen the research environment of the institution

Program Features:

Project period is limited to 3 years.Direct costs are limited to $300,000 over the entire project period.Grants are renewable.Preliminary data are not required.

Institute and Center contacts and policies: See Funding Opportunity AnnouncementR151@mail.nih.gov

36

New and Early-Stage Investigators

Concerns have been raised for decades about scientists spending long periods of time as postdoctoral appointees, unable to set their own direction

Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research (2005)

Becoming an independent research is taking longer and longer

Age at First R01 Equivalent Award from NIH: FY 1980-2009

Revised New and Early Stage Investigator Policies (NOT-OD-09-013)

NIH is finding new methods to encourage funding (and hiring) of early-stage investigators

Goal of funding new investigatorsat same rate as established investigators submitting new projects

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

New and Early-Stage Investigators

A new program to allow exceptional young investigators to “skip” the post-doc!

Definition of New Investigator

A PD/PI who has not previously competed successfully for a significant NIH independent research award, other than the following awards:

Research Project Grants: R00, R03, R15, R21, R25, R90, (RL9, RL5), R34, R36, (R41, R43), R55, R56, SC2, SC3

All training Grants: T32, T34, T35, T90, D43 All Fellowships: F awards Mentored Career Awards: All individual and institutional

mentored K awards Loan repayment contracts: L30, L32, L40, L50, L60 Instrumentation, Construction, Education, Health Disparity

Endowment Grants, or Meeting Awards: G07, G08, G11, G13, G20, R13, S10, S15, S21, S22

Definition of Early Stage Investigator

A PD/PI who qualifies as a New Investigator is considered an Early Stage Investigator 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).

Implementing the Early Stage Investigator Policy: eRA Commons profiles include degree and residency completion dates

Encouraging early transition to research independence: Modifying the NIH New Investigator policy to identify Early Stage Investigators

Can request an extension of the Early Stage Investigator Period

New Investigators receive special attention at Council as high program priority or equivalent.

Increased payline for scored R01 applications from New Investigators.

No imposed reductions in duration and amount of awards (beyond the recommendations of the initial review group) for New Investigators.

Fund applications to achieve a designated success rate rather than setting a specific payline for New Investigators applying for R01s.

New Investigator Initiatives

Support creative new investigators with highly innovative research ideas at early career stages.

No preliminary data required. Evaluate pre-application—Invite full application. Potential for significant impact on an important biomedical

or behavioral research problem. Applicants must hold independent research position at a

domestic institution. Doctoral degree or completed internship/residency within

past 10 years. Must commit at least 25% of research effort. There are no citizenship or residency requirements.

NIH Director’sNew Innovator Award

Inspired in some respects by programs at Carnegie, Whitehead, UCSF, and other institutions showing that exceptional individuals do not require a post-doc to undertake pioneering research.

Solicited and incorporated input from research community.

First year will be a pilot (~10 awards) to test ideas and process, but may be scaled up in subsequent years.

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.”Francis Collins, Nature, 2010

NIH Director’s Early Independence Award

Program Features:

An institution may submit up to two applications

Awards will be up to $250K per year (direct costs) for up to 5 years

NIH Director’s Early Independence Award (EIA)

New PhD or MD locates an institution willing to host them for an EIA

•Must be within 12 mo. 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/space/equipment•Appointment up to 5 yrs•Protected research time for development as researcher•Proposed research complements and enhances institution’s programs •Institution may choose to retain candidate

Extramural Loan Repayment Programs

Clinical Research

Pediatric Research

Health Disparities Research

Contraception and Infertility Research

Clinical Research for Individuals from Disadvantaged Backgrounds

In exchange for a two-year research commitment, NIH repays qualified educational debt up to $35,000 per year. Payments made to lenders.

Research must be funded by a domestic nonprofit, university or U.S. federal, state or local government entity.

Recipients conduct research for an average of at least 20 hours per week over a quarter.

Tax liability on the loan payments is partially offset.

Apply September 1 – November 15.

1,600 researchers funded each year. Success rate is 40 percent for new applicants and 70 percent for renewals.

Additional Information: http://www.lrp.nih.gov/

Extramural Loan Repayment Programs