Navigating the K Award Process CTSI K Award Workshop July 9, 2015

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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: 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

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6 Timing: When to Apply to NIH

7 Timing: When to Apply

8 Time Commitment and Time Commitment: Salary Caps 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 ) 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 ) 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 peerreviewed 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 See NOT-OD Appointments 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 ) 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 ). 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 ). 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.

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 RO-1 K awards NRSA Institute Initiated 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

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:

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, wellintegrated, 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

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 K % $24,377,709 K % $30,787,581 K % $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 K % $19,779,309 K % $26,461,116 K % $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 K % $22,586,026 K % $23,254,142 K % $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 K % $21,515,902 K % $19,659,367 K % $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 K % $28,425,228 K % $24,953,839 K % $32,567,685 See Table #204 at report.nih.gov/filelink.aspx?rid=551 for more details.

35 Success Rates and Pay Lines Institute Success Rate 2012 Success Rate 2013 Pay line 2012 Pay line 2013 Pay line 2014 NCI NHLBI NIDDK NIA NIMH

36 Research Supplements to Promote Diversity in Health-Related Research (Admin Supp) PA

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