NIH Mentored Career Development Awards (K Series) Part 1

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NIH Mentored Career Development Awards (K Series)
Part 1

• Thomas Mitchell, MPH
• Department of Epidemiology Biostatistics
• University of California San Francisco

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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.

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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.

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Selected NIH K Award Mechanisms
Mentored Independent Mid-Career
K01 K02 K24
K08 K22
K07 R00
K12
K23
K25
K99
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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.

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Types of Mentored Career Development Awards
(contd)

• 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

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Types of Mentored Career Development Awards
(contd)

• 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.

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Types of Mentored Career Development Awards
(contd)

• 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.

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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.

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Amount of Funding per year K01 K08 K23
Salary Support 50K - 150K (75K) 75K - 105K (75K) 75K - 180K (75K)
Research/ Training 20K - 50K (25K) 20K - 90K (25K) 25K - 50K (25K)
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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.

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General Tips on MentoredK Awards (contd)

• 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.

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General Tips on Mentored K Awards (contd)

• 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.

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General Tips on Mentored K Awards (contd)

• 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.

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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

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The Candidate

• 2. Candidates 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.

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The Candidate Review Criteria

• Quality of the candidates 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.

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Review Criteria (contd)

• Appropriateness of the content and duration of
  the proposed didactic and research phases of the
  award.
• Consistency of the career development plan with
  the candidates career goals and prior research
  experience.

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2. Candidates 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 1st person (I).

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2. Candidates Background

• Give examples of the opportunities youve 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).

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2. Candidates 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.

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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.

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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.

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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.

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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
  9-1015am 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.