Navigating the K Award Process

Navigating the K Award Process CTSI K Award Workshop

February 4, 2016 Carol M. Mangione, MD, MSPH

Barbara A. Levey and Gerald S. Levey Professor of Medicine and

Health Policy & Management

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

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

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

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









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

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.

http://www.niaid.nih.gov/ncn/glossary/default5.htm

http://www.niaid.nih.gov/ncn/glossary/default5.htm

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.

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

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

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!

NIH grant application scoring system

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

• Ratings in whole numbers only

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

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

Funding Climate

Career Development Award Trends 1998-2010

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


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


Reviewed


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


Reviewed


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


Reviewed


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




Fiscal Year 2014


Reviewed


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


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

NHLBI: Promising News for Biomedical Science (FY2016)

Research Supplements to Promote Diversity in Health-Related Research

(Admin Supp) – PA 12-149

Questions?

• More coming up from Dr. Salusky on proposal preparation

Education

Navigating the K Award Process