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Navigating the NIH K Award Process

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UCLA CTSI K Workshop

Learn to navigate through the possible career development awards (CDAs) available to you and which you should target.

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
Leader, UCLA CTSI Workforce Development
Presentation date: February 09, 2017

Published in: Education
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Navigating the NIH K Award Process

  1. 1. Navigating the K Award Process CTSI K Award Workshop February 9, 2017 Carol M. Mangione, MD, MSPH Barbara A. Levey and Gerald S. Levey Professor of Medicine and Health Policy & Management
  2. 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. 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. 4. Career Development Awards (K Awards) for Individuals with a Health-Professional Doctorate
  5. 5. http://grants.nih.gov/training/careerdevelopmentawards.htm
  6. 6. Timing: When to Apply to NIH
  7. 7. Timing: When to Apply
  8. 8. Time Commitment & Salary Caps • Time Commitment: • 75% full tie effort (50% for surgeons in some specialties) • Salary Cap (NIH) increased to: • $100K for K08 and K23 (December 17, 2015, NOT- OD-16-032) • Salary Cap (NHLBI) increased to: • $100K for K01, K02, K08, K22, K23, K25, and K99 (March 29, 2016, NOT-HL-16-309). • There is variability and exceptions at the Institute level, check the website for your institute.
  9. 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. 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. 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. 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. 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 • FOA – Funding opportunity annoucement
  14. 14. Approach of the NIH U.S. Government Congressional Appropriation NIH funds allocated to each institute Investigator Initiated Institute Initiated R awards K awards NRSA RFP - contracts RFA – grants FOA - either
  15. 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. 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. 17. Approach of the NIH R, 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. 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. 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. 20. General NIH Reviewer Guidelines
  21. 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!!! • Address the NEW scientific premise in this section
  22. 22. Approach • Are the conceptual framework, design, methods, and analyses adequately developed, well- integrated, and appropriate to the aims? • Address the NEW scientific rigor criteria in this section • 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. 23. Rigor & Transparency (NEW) • Scientific Premise: The key data introduced by the applicant to justify the project. • Scientific Rigor: The strict application of the scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting results. http://grants.nih.gov/reproducibility/index.htm
  24. 24. Rigor & Transparency (NEW) • Consideration of Relevant Biological Variables: critical factors affecting health or disease in vertebrate animals or human subjects. • Plan for Resource Authentication : key biological and/or chemical resources are those that may differ from lab to lab or over time, could influence the research data, and are integral to the proposed research. http://grants.nih.gov/reproducibility/index.htm
  25. 25. Review of Rigor & Transparency (NEW) http://grants.nih.gov/grants/peer/guidelines_general/Reviewer_Guidance_on_Rigor_and_Transparency.pdf
  26. 26. 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?
  27. 27. 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!
  28. 28. 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?
  29. 29. 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
  30. 30. 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
  31. 31. Funding Climate
  32. 32. Career Development Award Trends 2006-2015 Data from report.nih.gov/FileLink.aspx?rid=551. Funding is the amount for each FY, and not for the life of the project.
  33. 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 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.
  34. 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 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.
  35. 35. 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.
  36. 36. 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.
  37. 37. 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 2015 Number of Applications Reviewed Number of Applications Awarded Success Rate Total Funding K01 598 201 34% $28,444,404 K08 430 170 40% $26,471,252 K23 589 206 35% $33,702,155 See Table #204 at “report.nih.gov/FileLink.aspx?rid=551” for more details.
  38. 38. Institute Success Rate 2012 Success Rate 2013 Success Rate 2014 Success Rate 2015 Pay line 2012 Pay line 2013 Pay line 2014 Pay line 2015 NCI 13.6 13.7 14.1 13 7 9 9 9 NHLBI 14.7 16.9 18.2 21.9 10 11 12 13 NIDDK 19.8 21 22.9 20.3 13 11 13 13 NIA 15.5 13.6 15.9 19.6 11 11 11 8 NIMH 21.6 18.7 19.4 20.4 10 10-20 10-20 10-20 Success Rates and Pay Lines Success Rates: https://report.nih.gov/success_rates/Success_ByIC.cfm Pay Lines: https://www.einstein.yu.edu/administration/grant-support/nih-paylines.aspx
  39. 39. NHLBI: Promising News for Biomedical Science (FY2016)
  40. 40. Research Supplements to Promote Diversity in Health-Related Research (Admin Supp) – PA 12-149
  41. 41. Questions? • More coming up from Dr. Salusky on proposal preparation

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