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 training and are transitioning to a faculty position.

3. Key Features of Mentored K Awards 3 – 5 years in length Provide substantial salary support but limited research funding. Contain both a training plan and a research plan. Includes a team of mentors, co-mentors, advisors, etc. Goal: transition to research “independence”.

4. Selected NIH K Award Mechanisms MentoredIndependentMid-Career K01K02K24 K08K22 K07R00 K12 K23 K25 K99

5. Types of Mentored Career Development Awards K01 Mentored Research Scientist Development Award: provides for an intensive, supervised career development experience in the biomedical, behavioral, or clinical sciences leading to research independence. Some NIH institutes use this award for individuals who propose to train in a new field. Other NIH institutes use this award to increase research workforce in particular types of research.

6. Types of Mentored Career Development Awards (cont’d) K22 (example for NIAID*) Career Transition Award: Provides 2 years of funding, once the candidate (postdoctoral fellow) has attained a full-time faculty position (to be achieved within 12 months of the award). *K22s differ widely across NIH Institutes

7. 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.

8. 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.

9. Newest Types of Mentored Career Development Awards 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.

10. Amount of Funding per year K01K08K23 Salary Support $50K - $150K ($75K) $75K - $105K ($75K) $75K - $180K ($75K) Research/ Training $20K - $50K ($25K) $20K - $90K ($25K) $25K - $50K ($25K)

11. General Tips on Mentored K Awards 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 at the end of the K award should be the organizing principle of the K grant application.

12. 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 or experience in order to conduct the proposed research or areas where you are deficient that are directly related to your research career goals.

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

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

15. 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: 3-5 letters of recommendation

16. The Candidate 2. Candidate’s background 3. Career goals and objectives 4. Career development activities during award period 5.Training in the responsible conduct of research Suggested length: 2-3 pages – remember, Sections 2 – 5 plus the Research Strategy section (Section 11) combined cannot exceed 12 pages.

17. 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.

18. 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.

19. 2. Candidate’s Background Suggested length: Less than 1 page. 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 training opportunities or research projects). OK to use 1 st person (“I”).

20. 2. 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. Highlight early evidence of productivity (e.g., pursuing a specific question, analyzing data, presenting or publishing your results). Describe any formal research training (e.g., TICR, MPH).

21. 2. Candidate’s Background Tip: Begin this section with a summary statement regarding your long-term research career goals. Example: “ My 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.

22. 3. Career Goals and Objectives Suggested length: 1 - 2 paragraphs The research plan you propose should include some specific “challenges,” for which you need additional training and/or experience to accomplish successfully. These “deficits” in your training/experience then become the focus of your career development training plan.

23. 3. Career Goals and Objectives Describe the specific areas where you have deficiencies (e.g., primary data collection, biostatistics, qualitative research methods). Example: I have made progress in developing my clinical research skills, but there are three important areas where I require additional training, mentoring, and experience: (1) multi-disciplinary 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.

24. 4. Career Development Activities During Award Period Suggested length: 1 - 2 pages. List the specific training areas you will pursue to acquire the new set of skills you need. 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. Describe in detail how you will gain this training, such as through specific courses, individualized tutorials, or practical experience gained from conducting the research. See Examples 1 and 2.

25. 5.Training in the Responsible Conduct of Research Format: To ensure general proficiency, I will take the UCSF course “Responsible Conduct of Research” (EPI 201), which is designed to address the requirements of NIH for education of investigators about ethical issues in human subject research. It consists of 7 hours of lecture during which trainees learn through case discussions how to identify and resolve common ethical dilemmas that arise in clinical research, how research on human subjects is regulated by the federal government, and what constitutes research misconduct. Notably, this course requires trainees to present and resolve ethical considerations in their own research proposals. Finally, this formal coursework will be supplemented by an on-line course on human subjects training required by the UCSF Committee on Human Research (CHR). Subject matter: In the UCSF Responsible Conduct of Research Course (EPI 201), trainees learn how to identify and resolve common ethical dilemmas that arise in clinical research, how research on human subjects is regulated by the federal government, and what constitutes research misconduct. The on-line trainings by the UCSF CHR includes an overview of the regulations that govern human subjects research, as well as training modules of the Health Insurance Portability and Accountability Act as it applies to research. I will continue to update my training in research ethics annually. Faculty participation: Dr. Bernard Lo, UCSF Professor of Medicine, is the course director for the UCSF Responsible Conduct of Research Course (EPI 201). Dr. Lo is also the Director of the UCSF Program in Medical Ethics and is a renowned biomedical ethicist who wrote the required text for the UCSF Responsible Conduct of Research Course (EPI 201) (Ethical Issues in Clinical Research: A Practical Guide by Bernard Lo, Lippincott Williams & Wilkins, 2009). Duration on instruction: I will have over nine hours of training in the EPI 201 course (Tuesdays 9-10:15am for seven weeks) Frequency of instruction: I will receive my most intensive instruction in responsible conduct of research during the first two years of this proposal. However, I will continue to receive guidance from my mentors and scientific advisors throughout all five years of this proposal.