Navigating the K Award Process CTSI K Award Workshop

January 10, 2013

Carol M. Mangione, MD, MSPH Professor of Medicine and Public Health

Career Development Awards (K Awards) for Individuals with a Health-Professional Doctorate

Types of CDAs • K01: To qualify, you need to be a clinician or Ph.D. in the

fields of epidemiology and outcomes research and must have accomplished independent research experience after earning your degree.

• K08: You are seeking salary and research support for full time supervised career development in health related research that does not involve patients.

• K12: Provides support to an institution for the development of independent scientists. Most, but not all K12 s focus on the careers of physician scientists (required element in CTSA).

Types of CDAs • K23: You have completed specialty training and are

seeking salary and research support for full time supervised career development in patient oriented research

• K99/R00: Purpose is to provide an opportunity for scientists to receive both a 1 to 2 year “mentored” K (phase 1) and a 3 year independent “R” (phase 2) in the same award. To qualify, you must have a clinical or research doctorate and no more than five years of postdoctoral research training at the time of application.

• See the K award wizard to help you select the correct mechanism:

• http://grants.nih.gov/trainingcareerdevelopmentawards.htm • Diversity Supplements: After administrative review these

are added onto a funded grant, with extra resources for the trainee to develop and conduct mentored research

Timing: When to Apply to NIH:

Timing: When to Apply to Institution:

Time Commitment and Salary Caps

• Time Commitment: • 75% full time effort (50% for

neurosurgeons) • Salary Cap increased to:

• 95K for K08 and K23 and 105K for K02 (May 18, 2012, NOT-NS-12-018)

Support from Other Awards: NOT-NS-09-015 • “Within the first 3 years of a mentored K award, those who

obtain an R01 or federal equivalent, may obtain up to 80% of their institutional base salary, as long as the R01 represents an expansion of the K award project”

• “A minimum of 75% effort must still be devoted to the K award during the first 3 years of support.”

• “During the final two years of the K, additional salary may be obtained from the awarded R01, or from another R01, for effort exceeding the 80% level. If appropriate or desired, the level of effort on the mentored K award may be reduced to a minimum of 50% during the last two years of the award.”

• If you have R01 support during the final 2 years of the K…In accordance with present NIH policy, additional salary support may also be obtained from the R01 or federal equivalent

Additional Salary Support while on a CDA

• During the last two years of a mentored career development award (K01, K08, K22, K23, K25), NIH will permit you to receive concurrent salary support from any peer-reviewed grant from any federal agency, if you meet the following criteria: – You are a PI on a competing research project grant, or

director of a subproject on a multi-component grant, from NIH or another Federal agency.

– Your K award is active. – Under those circumstances, you may reduce your K

award's time and effort to 50% person months.

Governmental Alphabet Soup

• NIH - National Institutes of Health • AHRQ - Agency for Healthcare Research

and Quality • PCORI – Patient Centered Outcomes

Research Institute • RFA - Request for application • RFP - Request for proposals • PA - Program announcement

Approach of the NIH U.S. Government

Congressional Appropriation

NIH funds allocated to each institute

Investigator Initiated Institute Initiated

RO-1 K awards NRSA

RFP - contracts RFA - grants

Organization of the NIH • Establish relationships with the program officers

at the institutes in your research area • Each Institute handles career development funds

in slightly different ways – Review their websites • 2 parts:

– Program- Includes the Institutes that set the research priorities

– Review - CSR or Center for Scientific Review • Evaluates the scientific merits of the proposals • http://www.csr.nih.gov

NIH Review Process

• Takes about 9-10 months at best • Initial Administrative review • Importance of the title and “steering the proposal” • Peer Review - Study sections made up of scientists

from universities and other institutions • Most applications are not funded on the first round • You can resubmit one time within 37 months of

the original submission

NIH Review Process

• Final decision by Council -- where the previous contact with administrators can matter!

• If successful, final administrative procedures to set up the budget

• K-08 and K-23 and NRSAs are specifically designed to train and advance the careers of junior and mid-level faculty

Candidate Mentor

Career Development Plan

Research Plan

Institutional Environment

Mentored K Awards: Review

Mentored K Awards: Review Candidate Prior Research Experiences

•Potential for conducting research. •Evidence of originality

Publications (first-author); productivity Likelihood of research independence Justification of need for additional research

mentoring Letters of Reference

Mentor Track record in mentoring Appropriate scientific expertise Research funding and publications Commitment to mentoring candidate

(letter of support)

Mentored K Awards: Review

Institutional Environment Necessary resources for proposed research and career

development Interactions with other investigators Detail opportunities for research and career development Institutional commitment to candidate assurances that the institution intends the candidate to

be an integral part of its research program commitment to protect at least 75% of the

candidate’s effort for proposed career development activities

Mentored K Awards: Review

Career Development Plan Activities other than research alone that

will facilitate transition to independence Additional coursework to fill-in gaps? Grant-writing workshops? Seminars, journal clubs Participation in K30 program?

Mentored K Awards: Review

Research Plan Should include new research training Hypothesis- vs. discovery-driven Provide a logical path to research independence

(away from mentor) Detailed experimental plan with potential pitfalls,

expected outcomes, alternative approaches (K99/R00:distinct research phases)

Mentored K Awards: Review

Key to a Strong Career

Development Training Plan

• Understand the intent of the mentored K award is to help new investigators achieve independence (i.e., R01-level funding). – Preparing for the R01 grant application that the

candidate will submit at the end of the K award should be the organizing principle of the K grant application, which includes both a training plan and a research plan.

Career Development Training Plans

• Make a compelling argument why the mentee needs a K award. – Identify critical gaps or deficiencies in the

mentee’s knowledge or skills. – Explain how additional training or mentored

research experience in these areas will enable the mentee to compete successfully for R01 funding.

– Be specific; provide examples.

Career Development Training Plans

• Develop a career development training plan that is uniquely suited to the mentee. – Given their previous training and research

experience, mentees should propose a mix of didactic training and hands-on research experience that address the gaps or deficiencies in their knowledge or skills.

– Fully exploit the training opportunities available.

– The training plan should be as carefully thought out and presented as the research plan.

Helping Candidates Develop a K Award Research Plan

• The research plan is a training vehicle. Should be well integrated with the candidate’s training plan and provide an opportunity to acquire new skills

• The research plan is a means to achieve independence. Should be viewed as a precursor for the next state of research – ideally, an R01.

• Mentored K awards provide limited funding. The scope needs to be appropriate and feasible ($25K-$50K/year).

General NIH Reviewer Guidelines

Significance • Does this study address an important

problem? Do you make a compelling case? • If the aims of the application are achieved,

how will scientific knowledge be advanced?? • What will be the effect of these studies on

the concepts or methods that drive this field? How might this change the field? Be convincing!!!

Approach • Are the conceptual framework, design, methods,

and analyses adequately developed, well-integrated, and appropriate to the aims?

• Does the applicant acknowledge potential problem areas and consider alternative tactics?

• Is there an appropriate work plan included? • Does the project include plans to measure

progress toward achieving the stated objectives? How will you know when you are half way there?

Innovation

• Does the project employ novel concepts, approaches or methods?

• Are the aims original and innovative? • Does the project challenge or advance

existing paradigms or develop new methodologies or technologies?

Investigator

• Is the investigator appropriately trained and well suited to carry out this work?

• Is the work proposed appropriate to the experience level of the principal investigator and other significant investigator participants?

• Is there a prior history of conducting (fill in area) research? Does not fund empty aspirations!

Environment • Does the scientific environment contribute to

the probability of success? • Do the proposed experiments take advantage

of unique features of the scientific environment or employ useful collaborative arrangements?

• Is there evidence of institutional support? • Is there an appropriate degree of commitment

and cooperation of other interested parties as evidence by letters detailing the nature and extent of the involvement?

Budget

• Are all requests justified scientifically • Do special items have quotes • Is the project feasible with the given

budget – Low budget often viewed worse than high

budget, • Low budget - applicant does not understand what is

need to do the work - may worsen the score – -High budget -: will get cut but usually not

worsen score, unless really high

Other Key areas • Protection of human subjects (closely

reviewed) – HIPAA plan – data and safety monitoring plan – inclusion of women, minorities & children – recruitment plan – evidence (not plan) of proposed

partnerships • Animal welfare • Biohazards • Evaluation

NIH grant application scoring system

• 9-point rating for the impact/priority score with 1 = Exceptional and 9 = Poor.

• Ratings in whole numbers only (no decimal).

Approach of the NIH RO-1, NRSA, or K application

CSR assigns the application to 1) Study Section 2) An Institute

Study Section assigns a Priority Score (1-9)

Institute uses the Priority Score to rank the application among those received from various study sections

Advisory Council reviews the priorities

Applications are funded in order of priority until the money runs out!

Funding Climate

0

500

1,000

1,500

2,000

2,500

3,000

3,500

4,000

4,500

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

NUMBER OF RESEARCH CAREER AWARDS*

* Includes both individual and institutional awards. The actual number of individual participants is higher.

Fiscal Year

Num

ber

of A

war

ds

TOTAL AND AVERAGE AWARD AMOUNT OF INDIVIDUAL RESEARCH CAREER AWARDS

$0

$100

$200

$300

$400

$500

$600

$700

$800

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007$0

$20

$40

$60

$80

$100

$120

$140

$160

Fiscal Year

Tota

l Aw

ard

Am

ount

(in

mill

ions

)

Aver

age A

war

d A

mou

nt

(in th

ousa

nds)

Total Award Amount Average Award Amount

NUMBER OF INDIVIDUAL RESEARCH CAREER AWARDS

BY INSTITUTES AND CENTERS

Fiscal Year

NIH Institutes and Centers

Num

ber o

f Aw

ards

199819992000200120022003200420052006

NCMHDNCCAMFICNIBIBNLMNHGRI

NIGMSNIN

RNIEHS

NCRRNEINID

CRNID

CDNIAAA

NIAMSNIC

HDNIANIDA

NINDS

NIAIDNID

DKNCINIM

HNHLB

I

0

100

200

300

400

500

600

NIH CAREER DEVELOPMENT (K) GRANTS Competing Applications, Awards, Success Rates and Total Funding

by NIH Institutes/Centers and Activity Code Made with Direct Budget Authority Funds

Fiscal Year 2010

Number of Applications

Reviewed

Number of Applications

Awarded

Success Rate Total Funding

K01 465 185 39.8% $24,377,709

K08 480 211 44.0% $30,787,581

K23 558 211 37.8% $31,635,065

See Table #204 at “report.nih.gov/FileLink.aspx?rid=551” for more details.

NIH CAREER DEVELOPMENT (K) GRANTS Competing Applications, Awards, Success Rates and Total Funding

by NIH Institutes/Centers and Activity Code Made with Direct Budget Authority Funds

Fiscal Year 2011

Number of Applications

Reviewed

Number of Applications

Awarded

Success Rate

Total Funding

K01 441 151 34.2% $19,779,309

K08 425 177 41.6% $26,461,116

K23 599 203 33.9% $31,036,760

See Table #204 at “report.nih.gov/FileLink.aspx?rid=551” for more details.

Diversity Supplements FY07 41

NIH Office of Extramural Research: Prepared July 2008

Fiscal Year 2007

NIHResearch Supplements

toPromote Diversity

42

FISCAL YEARS 1990-2008

SUPPLEMENTS TO INDIVIDUALS FROM UNDERREPRESENTED GROUPS OR DISADVANTAGED BACKGROUND

NIH-WIDE TRENDS

Number of Awards

0

200

400

600

800

1000

1200

1400

1600

1990

1992

1994

1996

1998

2000

2002

2004

2006

2008

Fiscal Year

Expenditures (millions)

$0

$10

$20

$30

$40

$50

$60

$70

$80

$90

1990

1992

1994

1996

1998

2000

2002

2004

2006

2008

Fiscal Year

Diversity Supplements FY07 45

*Eligible grant mechanisms: R01, R10, R18, R22, R24, R35, R37, R41, R42, R43, R44, P01, P20, P30, P40, P41, P50, P51, P60, U01, U10, U19, U41, U42, U54, S06.

NIH-WIDE TRENDS

FISCAL YEARS 1990-2007

EXPENDITURES AS A PERCENTAGE OF EXPENDITURES FOR ELIGIBLE RESEARCH GRANT AWARDS*

SUPPLEMENTS TO INDIVIDUALS FROM UNDERREPRESENTED GROUPS OR DISADVANTAGED BACKGROUND

0.00%

0.10%

0.20%

0.30%

0.40%

0.50%

0.60%

0.70%

1990

1992

1994

1996

1998

2000

2002

2004

2006

2008

Fiscal Year

Perc

enta

ge o

f Exp

endi

ture

s

Questions?

• More coming up from Dr. Salusky on proposal preparation