Navigating the K Award Process CTSI K Award Workshop

Navigating the K Award Process
CTSI K Award Workshop
February 13, 2014
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/KL2: 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

Time Commitment and
Salary Caps
• Time Commitment:
• 75% full time effort (50% for surgeons in
some specialties)
• Salary Cap increased to:
• 95K for K08 and K23 and 105K for K02
(May 18, 2012, NOT-NS-12-018)
• There is variability and exceptions at the
Institute level, check the website for your
institute

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 sub-project 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.

NIH Policy Concerning: Leave, Temporary
Adjustments to % Effort, and Part-Time
Appointments
• See NOT-OD-09-036
• Developed to accommodate personal or
family situations such as parental leave,
child care, elder care, medical conditions,
or a disability.
• Will not be approved to accommodate job
opportunities, clinical practice, clinical
training, or joint appointments

More on Part Time Status…
• Must submit a written request to the NIH awarding
institute requesting a reduction in effort to less than
75% for up to 12 continuous months
• Will be considered on a case-by-case basis
• In no case will it be permissible to work at less than
50% effort (equivalent to 6 person-months)
• At the time of application and initial award, must meet
the full-time appointment requirement as well as the
minimum 75% effort requirement
• Must commit at least 75% effort (of the part-time
appointment) to research and career development
activities.

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
• For detailed information on success rates:
http://report.nih.gov/success_rates/index.aspx
• 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

 Candidate
 Mentor
 Career Development Plan
 Research Plan
 Institutional Environment
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)

 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

 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 CTSI Translational Science
Training Program (TSTP)?

 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)

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 applications
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!

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
NumberofAwards

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
TotalAwardAmount
(inmillions)
AverageAwardAmount
(inthousands)
Total Award Amount Average Award Amount

NUMBER OF INDIVIDUAL RESEARCH
CAREER AWARDS
BY INSTITUTES AND CENTERS
Fiscal Year
NIH Institutes and Centers
NumberofAwards

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.

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

Fiscal Year 2012
Number of
Applications
Reviewed
Number of
Applications
Awarded
Success
Rate
Total
Funding
K01 522 168 32.2% $22,586,026
K08 371 157 42.3% $23,254,142
K23 555 203 36.6% $31,820,630

Fiscal Year 2013
Number of
Applications
Reviewed
Number of
Applications
Awarded
Success
Rate
Total
Funding
K01 483 160 33.1% $21,515,902
K08 346 124 35.8% $19,659,367
K23 555 178 32.1% $28,555,388

Institute Success
Rate 2010
Success
Rate 2011
Success
Rate 2012
Pay line
2012
Pay line
2013
NCI 17.1 13.8 13.6 7 9
NHLBI 19.9 17.4 14.7 10 11
NIDDK 25.9 20.7 19.8 13 11
NIA 14.5 16.1 15.5 11 11
NIMH 22.1 17.0 21.6 10 10-20 ??
Success Rates and Pay Lines

Research Supplements to Promote
Diversity in Health-Related Research
(Admin Supp) – PA 12-149

Diversity Supplements FY07 47
NIH Office of Extramural Research: Prepared July 2008
Fiscal Year 2007
NIH
Research Supplements
to
Promote Diversity

48
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 51
*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
PercentageofExpenditures

Questions?
• More coming up from Dr. Salusky on
proposal preparation

Navigating the K Award Process CTSI K Award Workshop

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