Navigating the K Award ProcessCTSI K Award Workshop
February 13, 2014
Carol M. Mangione, MD, MSPHProfessor of Medicine and Public Health
Career Development Awards (K Awards) for Individualswith 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
*
Timing: When to Apply to NIH
Timing: When to Apply
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 NIHU.S. Government
Congressional Appropriation
NIH funds allocated to each institute
Investigator Initiated Institute Initiated
RO-1K awardsNRSA
RFP - contractsRFA - 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
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 CTSI Translational Science
Training Program (TSTP)?
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 applications
CSR assigns the application to1) Study Section2) 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
Nu
mb
er o
f 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
Tot
al A
war
d A
mou
nt
(in
mil
lion
s)
Ave
rage
Aw
ard
Am
oun
t(i
n t
hou
san
ds)
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
NIH CAREER DEVELOPMENT (K) GRANTSCompeting Applications, Awards, Success Rates and Total Funding
by NIH Institutes/Centers and Activity CodeMade 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) GRANTSCompeting Applications, Awards, Success Rates and Total Funding
by NIH Institutes/Centers and Activity CodeMade 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.
NIH CAREER DEVELOPMENT (K) GRANTSCompeting Applications, Awards, Success Rates and Total Funding
by NIH Institutes/Centers and Activity CodeMade 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.
NIH CAREER DEVELOPMENT (K) GRANTSCompeting Applications, Awards, Success Rates and Total Funding
by NIH Institutes/Centers and Activity CodeMade 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.
Institute Success Rate 2010
SuccessRate 2011
SuccessRate 2012
Pay line 2012
Pay line2013
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
NIHResearch Supplements
toPromote 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
Per
cen
tag
e o
f E
xpen
dit
ure
s
Questions?
• More coming up from Dr. Salusky on proposal preparation