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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