Carol M. Mangione, MD, MSPH Barbara A. Levey MD & Gerald S. Levey MD Endowed Chair Professor of Medicine and Public Health at UCLA Associate Director, UCLA Clinical and Translational Science Institute Program Leader, Research Education, Training and Career Development Program (CTSI-ED)

1. Navigating the K Award Process
CTSI K Award Workshop
July 9, 2015
Carol M. Mangione, MD, MSPH
Barbara A. Levey and Gerald S. Levey
Professor of Medicine and
Health Policy & Management

2. Types of CDAs
• K01: For clinicians or Ph.D.s in the fields of
epidemiology and outcomes research, must have
accomplished independent research experience
after earning your degree.
• K08: Salary and research support for full time
supervised career development in health related
research that does not involve patients.
• K12/KL2: Support awarded to an institution for
the development of independent scientists.
• K23: Salary and research support for full time
supervised career development in patient
oriented research, must have completed specialty
training

3. Types of CDAs
• K25: Supports career development of investigators with
quantitative scientific and engineering backgrounds
outside of biology or medicine who have made a
commitment to focus their research endeavors on
behavioral and biomedical research (basic or clinical).
• K99/R00: Provides 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 four 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/training/careerdevelopmentawards.
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

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

5. http://grants.nih.gov/training/careerdevelopmentawards.htm

6. Timing: When to Apply to NIH

7. Timing: When to Apply

8. 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

9. Additional Salary Support while
on a CDA (NOT-OD-08-065)
• During the last two years of a mentored career
development award (K01, K07, K08, K22, K23,
K25, KL2), 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 when the R, P or U grant is
submitted
– Under those circumstances, you may reduce your K
award's time and effort to 50% person months.

10. 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

11. 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.

12. NIH Resubmissions (NOT-OD-14-074)
 NIH and AHRQ will accept a new application following an unsuccessful
resubmission application. The new application need not demonstrate
substantial changes in scientific direction compared to previously reviewed
submissions, and must not contain an introduction to respond to the critiques
from the previous review.
 NIH will not accept duplicate or highly overlapping applications under review at
the same time(NOT-OD-09-100). This means that the NIH will not accept: -
• a new application that is submitted before issuance of the summary
statement from the review of an overlapping resubmission application.
• a resubmission application that is submitted before issuance of the summary
statement from the review of the previous new application.
• an application that has substantial overlap with another application pending
appeal of initial peer review (NOT-OD-11-101).
 The NIH will not accept a resubmission that is submitted later than 37 months
after the receipt date of the initial new, renewal, or revision application.
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-
140.html#sthash.MUZVeRSX.dpuf

13. 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

14. 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

15. 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

16. 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

17. 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!

18. NIH grant application scoring system
• 9-point rating for the impact/priority score with 1
= Exceptional and 9 = Poor.
• Ratings in whole numbers only

19. 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

20. General NIH Reviewer
Guidelines

21. 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!!!

22. 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?

23. 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?

24. 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!

25. 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?

26. 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

27. 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

28. Funding Climate

29. Career Development Award Trends 1998-2010

30. 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.

31. 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.

32. 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 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
See Table #204 at “report.nih.gov/FileLink.aspx?rid=551” for more details.

33. 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 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
See Table #204 at “report.nih.gov/FileLink.aspx?rid=551” for more details.

34. 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 2014
Number of
Applications
Reviewed
Number of
Applications
Awarded
Success
Rate
Total
Funding
K01 579 200 35% $28,425,228
K08 394 158 40% $24,953,839
K23 524 201 38% $32,567,685
See Table #204 at “report.nih.gov/FileLink.aspx?rid=551” for more details.

35. Institute Success
Rate 2012
Success
Rate 2013
Pay line
2012
Pay line
2013
Pay line
2014
NCI 13.6 13.7 7 9 9
NHLBI 14.7 16.9 10 11 12
NIDDK 19.8 21 13 11 13
NIA 15.5 13.6 11 11 11
NIMH 21.6 18.7 10 10-20 10-20
Success Rates and Pay Lines

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

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