1. NIH Mentored Career Development Awards (K Series) Part 1 Thomas Mitchell, MPH Department of Epidemiology & Biostatistics University of California San Francisco

2. Types of Mentored Career Development Awards There are a number of different mentored K awards that individuals with a research or health professional doctorate should consider. Most of these awards support individuals after they have completed clinical training and have accepted a faculty position.

3. Types of Mentored Career Development Awards (cont’d) K01s Mentored Research Scientist Development Award: provides career development in a new area of research. International Research Scientist Development Award (IRSDA): provides U.S. scientists with the opportunity to embark/enhance research careers related to global health.

4. Types of Mentored Career Development Awards (cont’d) K08 Mentored Clinical Scientist Development Award: development of the independent clinical research scientist. K12 Mentored Clinical Scientist Development Program Award: support for an institution for the development of independent clinical scientists.

5. Types of Mentored Career Development Awards (cont’d) K23 Mentored Patient-Oriented Research Career Development Award: Development of the independent research scientist in a clinical arena. K25 Mentored Quantitative Research Development Award: To foster interdisciplinary collaboration in biomedical research by supporting career development experiences for scientists with quantitative and engineering backgrounds.

6. Types of Mentored Career Development Awards (cont’d) K99/R00 NIH Pathway to Independence (PI) Award: Provides an opportunity for promising post- doctoral scientists to receive both mentored and independent research support from the same award.

7. General Tips on Mentored K Awards Understand the intent of the mentored K award. To help promising new investigators achieve independence as clinical investigators (i.e., to compete successfully for R01 funding). Therefore, preparing for the R01 grant application that you will submit at the end of the K award should be the organizing principle of the K grant application.

8. General Tips on Mentored K Awards (cont’d) 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/experience in order to conduct the proposed research or areas where you are deficient that are directly related to your research career goals.

9. General Tips on Mentored K Awards (cont’d) Develop a career development plan that is uniquely suited 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 makes perfect sense for you (and only you). Degree-granting programs (e.g., MPH or MAS) are appropriate for candidates with little or no previous formal training in clinical research, but even these should be “customized” whenever possible.

10. General Tips on Mentored K Awards (cont’d) For candidates with substantial previous formal training in clinical research, a plan that emphasizes “hands on” training is appropriate. Fully exploit the training resources available to you.

11. Writing a competitive mentored K award grant application 4 main sections of the grant application: The Candidate Statements by Mentors, Co-Mentors, and Collaborators Environment and Institutional Commitment to Candidate Research Plan Plus: 3 sealed letters of reference

12. Section 1: The Candidate 1.ACandidate’s background 1.BCareer goals and objectives: Scientific biography 1.CCareer development activities during award period Length: 4-8 pages: remember, Section 1 (Candidate) and Section 4 (Research Plan) are subject to 25-page limitation.

13. The Candidate: Review Criteria Quality of the candidate’s academic and clinical record. Potential to develop as an outstanding independent researcher. Likelihood that the career development plan will contribute substantially to the scientific development of the candidate.

14. Review Criteria (cont’d) Appropriateness of the content and duration of the proposed didactic and research phases of the award. Consistency of the career development plan with the candidate’s career goals and prior research experience.

15. 1.A Candidate’s Background Length: 1 page or less. Using your NIH biosketch as your guide, provide a personal narrative of your professional career. Explain why you made key career choices (e.g., to pursue specific kinds of clinical and research training opportunities or research projects). OK to use 1 st person (“I”).

16. 1.A Candidate’s Background Give examples of the opportunities you’ve had to engage in research (basic or clinical), as evidence of your long-standing commitment to research. Describe your role in these projects; highlight early evidence of productivity (e.g., pursuing a specific question, analyzing data, presenting or publishing your results). Describe any formal research training (TICR, MPH, etc).

17. 1.A Candidate’s Background Tip: Begin this section with a summary statement regarding your long-term research career goals. Example: “I am seeking a K23 award to evaluate and improve models of integrating the provision of contraceptive services in primary care. My ultimate goal is to improve birth outcomes by identifying targets for interventions to ensure effective use of contraception by women whose medical condition or medication use puts them at high risk of birth defects.”

18. 1.B Career Goals and Objectives Length: 2 - 3 pages Describe how you developed your current research focus (i.e., the evolution of your ideas that led you to the research proposed in the K award). In describing the research you’ve conducted, clearly indicate the role you played and the skills you acquired.

19. 1.B Career Goals and Objectives End this section with an assessment of your strengths and weaknesses with regard to the specific challenges that lie before you (i.e., the research plan outlined in the K award and the R01 project that will follow it). Indicate specific areas where you have deficiences and explain why gaining additional training and mentored research experience in these areas will be critical to achieving your short-term and long-term career development goals. Give concrete examples.

20. 1.C Career Development Activities During Award Period Length: 2 - 3 pages. Given the training areas you’ve indicated in Section 1.B, describe the specific training areas you will pursue to acquire these skills.

21. Example Using large databases to assess risk: The majority of my experience to date has involved working the relatively small datasets. However, exploration of adverse birth outcomes requires use of some of the largest databases available. To become more adept working with large databases, I have the following plans:

22. Example (cont’d) Coursework: I will enroll in Introduction to Risk and Demographic Statistics (140) at the UC Berkeley School of Public Health to develop my understanding of statistical methods that are useful in studying human mortality, morbidity, and natality. I will learn relevant statistical terminology and notation, critical appraisal of registry and census data, measurement of risk and introduction to life tables, and be introduced to computational systems and the analysis of mass data.

23. Example (cont’d) I will also enroll in Quantitative Risk Assessment (270E), where I will learn quantitative risk assessment skills, methods to assess population exposures from multiple pathways, and risk characterization with formal analysis of uncertainties. I will develop an understanding of the data used to classify chemical carcinogens and other toxic effects, as well as statistical, stochastic, and biologically-based models of dose-response relationships.

24. Example (cont’d) Practical Experience: I will work with Dr. Ruth Shaber to use data from Northern California Kaiser Permanente pharmacies that contain information on approximately 650,000 women of childbearing age. Working with this database will allow me to identify which potentially teratogenic medications are most frequently prescribed with use of highly effective contraception (see Specific Aim 1). In addtion, I will use these databases to evaluate whether an intervention designed to increase physician awareness of womens’ contraceptive behaviors is effective in limiting unsafe prescription of teratogenic medications (see Specific Aim 3).

25. Timeline of training activities See hand-out for example. Include relevant completed coursework and proposed coursework. Include important details (course titles and numbers). Organize by Training Area or Specific Aims, if possible. Insure consistency and completeness with written text.