Principal Investigators. NIH Career Development (K) Awards: Association. Taking Your Research Career to New Heights. Provided By:

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1 NIH Career Development (K) Awards: Taking Your Research Career to New Heights Presented By: Christopher Dant, PhD Provided By: Principal Investigators Association Principal Investigators Association 9990 Coconut Road, Ste 316 Bonita Springs, FL

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4 Dr. Francis Collins, Director NIH 1

5 Advancing translational sciences Accelerating discovery through technology Enhancing the evidence base for healthcare decisions Encouraging New Investigators, New Ideas About NIH K awards Contents of a K award Candidate Section Research Strategy Writing strategies 2

6 NIH Institutes each have their own: Mission Budget Activities Ways of doing things Own personality K emphasis When you re planning to submit a K, check with program directors from different institutes to determine their specific policies and interest in your application. 3

7 Career Awards (K series) support early-stage researchers to enhance their careers as biomedical researchers to independence US Citizens, Non-Citizen Nationals, Permanent Residents (except K99) They usually require that at least 75% effort be devoted to the research project and to career development for 3-5 years. Most K s cannot be renewed. The university must usually agree to release the PI from most teaching, clinical, and administrative duties. In return, NIH will pay the PI's salary, up to certain limits. Not for research alone a K is research training Not a fellowship that pays a stipend (F or T grants) Mentored Ks are not for established PIs Not for researchers without a PhD, MD, MD/PhD, or equivalent Principal Investigators on R01 or subproject Principal Investigators on a R01 or P01 are not eligible to apply 4

8 3-5 years in length Provide salary and research support Grant contains both a training plan and a research plan Includes a team of mentors, co-mentors, advisors, etc. Goal: transition to research independence New Investigator (NI) Has not been PI on a significant NIH research grant (R01) Can have held small research grants (e.g., R03, R21), K awards, Fellowships (F) Early Stage Investigator (ESI) An investigator within 10 years of doctorate or completing residency Status defined in your era Commons profile 5

9 Program Description K01 Mentored Research Scientist Development Award Career development in a new area of research K08 K07 K23 K25 K99/R00 Mentored Clinical Scientist Research Development Award Career development for those with clinical doctoral degree in biomedical/behavioral research, including translational research if patient research, see K23. Academic Career Award Supports academic and research expertise in biomedical research and to enhances the educational or research capacity at the grantee institution (Development and Leadership Awards) only at 5 Centers Mentored Patient-Oriented Research Career Development Award Development of the independent research scientist for patient research if not patient-oriented research in biomedical area, see K08. Mentored Quantitative Research Career Development Award To foster interdisciplinary collaboration in biomedical research by supporting career development experiences for scientists with quantitative and engineering backgrounds. NIH Pathway to Independence Award. Provides 5 years support in 2 phases: I.1-2 years of mentored support for highly promising postdoctoral fellows. II.Up to 3 years of independent support contingent on securing an independent research position. Program K22 Description Career Transition Award Support to an individual postdoctoral fellow in transition to a faculty position. 3 years, not renewable. K99/R00 NIH Pathway to Independence Award. Provides 5 years support in 2 phases: I.1-2 years of mentored support for highly promising postdoctoral fellows. II.Up to 3 years of independent support contingent on securing an independent research position. 6

10 K01 supports salary and protected time (3-5 y) for an intensive, supervised career development experience in the biomedical, behavioral, or clinical sciences leading to research independence. Some ICs use the K01 award for individuals who propose to train in a new field or for individuals who have had a hiatus in their research career because of illness or pressing family circumstances. Other ICs use the K01 award to increase research workforce diversity by providing enhanced research career development opportunities. NIH Academic Career Award (K07) provides support to increase the pool of individuals with developing academic and research expertise in a particular healthrelated field, as a way to increase the overall pool of individuals capable of research or teaching in the identified area. The Academic Career Award supports K07 Development awards for more junior level candidates and K07 Leadership awards for more senior individuals with acknowledged scientific expertise and leadership skills. 7

11 NIH Mentored Clinical Scientist Research Career Development Awards (K08) program that provides support and protected time to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in biomedical and behavioral research, including translational research. Individuals with a clinical doctoral degree interested in conducting translational non-patient-oriented research. 8

12 NIH Mentored Patient-Oriented Research Career Development Award (K23) supports the career development of investigators who have made a commitment to focus their research endeavors on patient-oriented research. Individuals with a clinical degree who are interested in further career development in biomedical research that is not patient-oriented should refer to the Mentored Clinical Scientist Career Development (Parent K08) Award Mentored Quantitative Research Career Development Award (K25) supports investigators whose quantitative science and engineering research has thus far not been focused primarily on questions of health and disease. The K25 award provides support and protected time for a period of supervised study and research for productive professionals with quantitative (e.g., mathematics, statistics, economics, computer science, imaging science, informatics, physics, chemistry) and engineering backgrounds to integrate their expertise with NIH-relevant research. 9

13 K99: Mentored research experience for up to 2 years. Salary + research expenses R00: Transition to research independence as junior faculty for up to 3 years. Requires offer and acceptance of tenure-track, full-time assistant professor position (or equivalent) $249k total costs yearly Applicants: no more than 5 years of postdoctoral research training at the time of initial application or resubmission Non-US citizens may apply, but institution must be domestic

14 People with disabilities People with disadvantaged backgrounds Family income below established thresholds Rural, inter-city, or other environments inhibiting persons from obtaining knowledge, skills, abilities for a research career People from Racial and ethnic groups African Americans Hispanics, Latinos American Indians or Alaskan Natives Native Hawaiians and other Pacific Islanders 11

15 NRSA Predoc NRSA Postdoc F30, F31 F32 Small Research Grant R03 U-Series Cooperative Grants SBIR, STTR R41/R42 P-Series Program Project/Center Predoc T32 Postdoc T32 Exploratory/Development Grant R21 Research Project Grant R01 Grad or Med School Postdoc or Residency Early Middle Senior Pathway to Independence K99/R00 Career Transition Award K22 Ment Research K01 Ment Clinical K08 Ment Patient- Orient K23 Midcareer Patient- Oriented K24 Independent Scientist K02 Senior Scientist Award K05 NRSA Senior Fellow F33 Ment Quant RCDA K25 12

16 K TYPE All NIH NHLBI NCI K01 Mentored Research Scientist K07 Academic Career Award NINDS K08 Mentored Clinical Scientist Career K22 Career Transition K23 Mentored Patient Oriented Research K25 Mentored Quantitative Research K99 Pathway to Independence AVERAGE SUCCESS RATE, ALL NIH, ALL K s 35.5 May differ for K s and Institutes generally $75-100k salary and $30-50k research support. For K08/K23, NIGMS provides up to $100,000 salary (plus fringe benefits) and up to $50,000 for supplies and research-related expenses. For K01, NHLBI provides up to $75,000 (plus fringe) per year and up to $30,000 for research support. 13

17 For the mentored K99 phase, applicants may request (in direct costs) Salary support of up to $100,000 per year plus applicable fringe benefits and up to $30K for researchrelated costs per year. For the independent R00 phase, applicants may request up to $249,000 in total costs per year Includes salary, fringe benefits, research allowance, Facilities and Administrative costs Supplies Animal/patient costs Travel to scientific meetings Equipment Technical support Statistical consultation services Tuition 14

18 A valuable tool to access any F or K grant You should know how to use this website 15

19 Section Candidate Information & Career Development Plan Research Plan Statements of Support K Contents Material Requested Candidate background Career Goals and Objectives Career Development & Training Activities Training in Responsible Conduct of Research Specific Aims + Research Strategy Statements by Mentor, Co-Mentor, Consultants 12 pg Environment and Institutional Commitment to Candidate Description of Institutional Environment Institutional Commitment to Candidates Research Career Development 3-5 reference letters not from the Mentor/Co-Mentor Letters of Reference From established scientists (referees) that address candidate s qualifications, training, interests and potential for becoming an independent scientist. Uploaded in era commons 31 Career Award Candidate Section 2. Candidate s Background 3. Career Goals and Objectives 4. Career Development/Training Activities During Award Period 5. Training in the Responsible Conduct of Research 6. Mentoring Plan (when applicable) 16

20 Detail your professional responsibilities at your institution and elsewhere and their relation to proposed K activities Your prior training and how it relates to your objectives and long-term career plans Your previous research efforts, including any publications, prior research interests, and experience (not detailed in biosketch) Trajectory to an independent investigator You must commit at least 9 person-months (75% effort) to the career development program and related career development activities START with summary of your long-term goals. My long-term goal is to become an independent clinical investigator and leader in the study of diffuse lung disease. To continue my progress towards this goal, I am proposing an observational prospective study addressing specific hypothesis surrounding the role of gastroesophageal reflux in Idiopathic Pulmonary Fibrosis (IPF), a timely and important topic. Specifically, I am interested in studying 3 primary topics: (1) the clinical characteristics of reflux in patients with IPF, (2) the biomarkers of reflux and microaspiration in patients with IPF, and (3) the impact of reflux and microaspiration on outcomes in patients with IPF. The knowledge and experience gained from this proposal will allow me to successfully compete for R01 funding to validate these findings in a multicenter trial utilizing the resources of the NIH-funded IPFNet. 17

21 How does the award fit into past and future research career development? If there are consistent themes or issues that have guided previous work, make them clear If your work has changed direction, give the reasons It is important to justify the award and how it will enable you to develop or expand your research career Include a timeline and plan to apply for subsequent R grant support Your career plan should: Show a logical progression from prior research and training experiences to the training and research for award period and on to independent investigator status. Justify the need for further career development to become an independent investigator. Utilize the relevant research and educational resources of the institution. 18

22 POINT OUT deficiencies: I have made progress in developing my clinical research skills, but there are three important areas in which I require additional training, mentoring, and experience: (1) multidisciplinary collaboration with clinical and basic scientists, (2) the design and implementation of prospective study design with involvement in the IPFnet, and (3) advanced study design and biostatistical methodology. In the following section, I present a detailed career development plan designed to enable me to acquire the additional training and mentored research experience I need to address these deficiencies and compete successfully for R01 funding, thereby achieving independence as a clinical investigator. Describe new/enhanced research skills and knowledge you will acquire For mentored awards, describe structured activities coursework or technique workshops which are part of the developmental plan Didactic training AND professional skills training (teaching, mentoring, writing, eg.) Discuss each activity, include a percentage of time by year, explain how activity relates to the proposed research and the career development plan DETAILS! 19

23 The candidate and the mentor are jointly responsible for the preparation of the career development plan. The sponsor/mentor may form an advisory committee to assist with the development of a program. The didactic (if any) and the research aspects of the plan must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the candidate's career goals. Describe the professional responsibilities/activities (including other research projects) beyond the minimum required 75% effort commitment to the career award explain how these responsibilities/activities will help ensure career progression to achieve independence. Additional technical training, not incremental advances in what you already know Didactic training Depends on your educational level and background Traditional and non-traditional training (this course!) Professional training What you will need to be an independent scientist Includes communication, mentoring, teaching, management, and leadership skills Think about what your mentor does in his/her careerand emulate that! 20

24 Goes beyond the standard stuff Lab meetings, journal clubs, attending the obvious National/International meeting, mentoring, teaching Based on your career goals and not a standard institutional template. Demonstrate that there is a meaningful interaction between the mentor and the mentee Meaningful letters and specifics help Involves a mentoring team when appropriate Mentor/co-mentor Work diverges from mentor s expertise Show evidence that you mean what you say. You MUST include a plan for instruction in responsible conduct of research (RCR). Now 1 page outside of the 12. If you fail to include one or it s inadequate, your application will be incomplete and won't be reviewed until you provide an acceptable plan of instruction. You must include 5 instructional components: 1. Format of instruction 2. Subject matter 3. Faculty participation 4. Duration 5. Frequency 42 21

25 43 The plan for the candidate's training and research career development Your research, developmental activities (seminars, scientific meetings, training in the responsible conduct of research, and presentations). Expectations for publications over the entire period of the proposed project. What aspects of the proposed research project the candidate will be allowed to take with him/her to start their own research program. 22

26 Nature and extent of supervision and mentoring of the candidate, and commitment to the candidate's development. Your anticipated teaching load (number and types of courses or seminars), clinical responsibilities, administrative assignments, and the portion of time available for research. Plan for transitioning you from the mentored stage to the independent stage by the end of the project period of the award. The mentor should describe previous experience as a mentor, including type of mentoring (e.g., graduate students, career development awardees, postdoctoral students), number of persons mentored, and career outcomes. IMPORTANT! 23

27 Co-mentor must specifically address their role in the career development plan and how the responsibility for the candidate s development is shared with the mentor. Describe respective areas of expertise and how they will be combined to enhance the candidate s development. Also describe the nature of the resources that will be committed. Not your mentor/co-mentor Develop effective working relationships with potential investigators providing references They should be familiar with your qualifications, training, and interest Keep them updated as to your progress Make their job easy by providing them your: Current biosketch, reprints Draft of K award You may be asked to draft the letter they will sign 48 24

28 Letters should address are criteria by which you will be evaluated: Potential for conducting research Evidence of originality Adequacy of scientific background Quality of research endeavors or publications to date Commitment to patient-oriented research Need for further research experience and training A great program and stellar academic record help, but to get the best score, you need to show reviewers that you can establish a research career Your Career Development Plan (CDP) is as important as your Research Plan Explain how K will be a vital step toward your ultimate career goal and move you toward scientific independence Outline both career development plan and research plan to see common elements Specify training and courses that you will participate in, how often you'll meet with consultants, and how all of this will help you reach independence 50 25

29 Your career development plan is vital: what you plan to learn should be reflected in your career development plan. Outline your training plan and your research plan to see common elements. You ll be scored on an appropriate plan to develop your research skills necessary to accomplish your research. Your K is a stepping stone for R01 NIH wants you to make that transition

30 Reviewers will look closely at your Research Plan: Specific Aims and Research Strategy. They will evaluate whether it is appropriate for and tailored to your experience level and if it allows you to develop the skills and knowledge needed for further career advancement. Make sure you relate the proposed research to your scientific career goals, and you are able to achieve your objectives in the time you request. 53 When designing a research plan for a K award, remember: The research plan is a training vehicle. The research plan should be well integrated with your career development training plan. The research plan is a means to achieve independence. The research plan should be viewed as a precursor for a subsequent R01. 27

31 10. Specific Aims Career Award Research Plan 11. Research Strategy 11.1 Significance 11.2 Innovation 11.3 Approach 1 State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved 2 List succinctly the specific objectives of the research proposed, e.g. o o o o o o test a stated hypothesis create a novel design solve a specific problem challenge an existing paradigm or clinical practice address a critical barrier to progress in the field, or develop new technology 28

32 FIRST paragraph Define the problem/critical need and gap(s) in knowledge short background leading up to the stated problem and knowledge gap Proposed solution to problem and gap by proposing hypothesis(es) Specific Aims Objectives that test the hypotheses addressing the critical need e.g., to develop, measure, determine, identify Avoid vague aims, e.g., to explore Expected Outcomes leading to impact on the field Impact probability your study will be successful and will exert a powerful sustained influence on the field (derived from significance and innovation) If it won t work, it has no impact, even with high significance Address the immediate problem AND your long-term goals 1 Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses. 2 Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields. 1 Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved. 29

33 1 Explain how the application challenges and seeks to shift current research or clinical practice paradigms. 2 Describe novel theoretical concepts, approaches or methodologies, instrumentation or intervention(s) to be developed or used, and any advantage over existing methodologies, instrumentation or intervention(s). 3 Explain refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation or interventions. Research does not necessarily have to create a new paradigm To be innovative it can Shift a current paradigm Offer new combination of known methods leading to new perspectives Refine existing model, technology 30

34 Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. How will data be collected, analyzed, and interpreted as well as any resource sharing plans as appropriate? Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims. If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high-risk aspects of the proposed work. Preliminary Studies/Progress Report Study design/study strategy Experimental approach Experiments to address each SA Emphasize Unique methods but abbreviate standard methods, especially if used in Preliminary Studies Methods not previously used collaborators Use tables and figures to illustrate complex experiments with multiple arms or repetitions under different conditions Study Design Interpretation of results Even if your experiment is well designed, its interpretation is vital to the reviewer Link the interpretation to your proposed SA and hypothesis 31

35 Potential Pitfalls and Alternative Approach Roadblocks to your experimental approach and how you would adjust the approach to move forward Failure to see weak points gives reviewers impression your approach is careless and less likely to succeed For early-stage PI, strategy to establish feasibility with methods Future Directions Discuss what s likely not feasible for this grant period, and what your future studies will focus on Focus on gaining independence with plans for an R01 Milestones and Timeline By each aim, provide quantitative benchmarks for assessing your progress over the grant years 32

36 66 33

37 Candidate Career Development Plan Research Strategy Environment/Institution Mentor/Consultants Describe the qualities and potential of the candidate with reference to: 1 Potential for conducting research 2 Evidence of originality 3 Adequacy of scientific background 4 Quality of research endeavors/publications to date 5 Commitment to health-oriented research 6 Need for further research experience and training 34

38 Whether there is a strong context for career development, particularly in a new area that follows from prior training and research Candidate s accomplishments and promise for independence=r01 Available support to achieve research and training goals (operational costs of these grants will not be sufficient on their own) letter from chair of department 69 Receipt Review Start Feb 12 June/July Sept or Dec June 12 Oct-Nov April October 12 Feb/Mar July 35

39 Understand the intent of the mentored K award. To help promising new investigators achieve research independence (i.e., to compete successfully for R01 funding). Therefore, preparing for the R01 grant application you will submit during the later part of the K award should be the organizing principle of the K grant application. 36

40 Make a compelling argument why you need a K award Explain exactly how additional training and mentored research experience will enable you to compete successfully for R01 funding. Be specific: give concrete examples of areas where you need additional training or experience to conduct the proposed research or areas where you are deficient that are directly related to your research career goals. Develop a career development training plan that is unique to you. Given your previous training and research experience, and your short- and long-term career goals, propose a mix of didactic training and hands- on research experience that make perfect sense for you (and only you). 37

41 Candidate Strong publication history: 2 or more first author, handful of middle author Quality of the application itself Writing of high quality and easy to follow Attention to detail for administrative items like vert. animals Completeness, clearly shows significant time invested Clarity of intention to be a leader in academic biomedical research reflected in letters and mentor statement Letters with enthusiastic support Career Development Plan VERY IMPORTANT This is training: how will it extend your abilities? Include some short or long courses to strengthen new areas List journal clubs, lab meetings, seminars, national meetings Show how you will improve on your weaknesses and make an academic niche you can thrive in 38

42 Mentor Primary mentor must write an impressive Mentor Statement Discuss candidate potential for independence Discuss training skills, commitment, and history They must make clear that your research is your own and they will not compete with you Secondary mentors should support your weak areas and support training in those areas Research Strategy Easy to follow Doable Not overly ambitious Obvious impact How will it put you in a position to be independent at the end? Will it lead to a long-term research program? How will the K work lead to an R grant? 39

43 Environment/Institution Resources to do your research: are they available? Any direct support for you: Appointment Space Funding Intellectual environment that will support your research Any promises for positions, chair letters, etc. Candidate Productivity issues, weak letters, inadequate training, sloppy application Sponsor Unfocused research, no funding, mentorship experience limited or unimpressive, limited resources Proposal Poor quality of research Little relevance to training Incoherent training plan Lack of significance, impact Environment Little involvement of other faculty Inadequate resources from Institution and Department 40

44 Strong and visible potential for independence Strong background and training plan Innovative and well-conceived research plan Adherence to instructions strong writing with obvious impact and significance Strong support from mentor team, consultants, institution Good match to agency priorities Reviewers are Over-committed, over-worked and tired Inherently skeptical and critical Often only peripherally interested in your work Make their job easier with Well-organized, clearly written prose Lots of section headings and breaks in the writing Repeat important points at several places in the application Well designed flow diagrams, charts, figures 41

45 Avoid irritating them by Exceeding page limits, using small fonts and narrow margins Putting information in the wrong section Omitting or mislabeling references/figures Not providing the requested information Submitting an application that is sloppy or full of typographical errors Christopher Dant, PhD Web: Specialized in the Following: Manuscripts NIH P, R, K, T grant mechanisms Seminars & Classes Pharmaceutical Publications Abstracts, Presentations, & Posters for Medical Congresses 42

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