Writing the NIH K Award Isidro B. Salusky, MD Distinguished Professor of Pediatrics at UCLA Chief, Division of Pediatric Nephrology Director, Clinical Translational Research Center Associate Dean of Clinical Research

1. Isidro B. Salusky, MD
Distinguished Professor of Pediatrics
Division Chief, Pediatric Nephrology
Director, Clinical Translational Research Center
Associate Dean for Clinical Research
David Geffen School of Medicine at UCLA

2. • Intensive, supervised research experience in the fields of biomedical
and behavioral research, including translational research
• Participating ICs vary in programmatic and budgetary specifics, and
in size and duration of awards
• Candidate must devote a minimum of 9 person months (75% of full-
time professional effort) to specified research plan
• In general, candidates can request 3-5 years, depending on
individual needs to achieve research independence
• Awards are not renewable and are not transferable from one PI to
another
• Not all ICs utilize the K08 so prospective applicants should contact
the relevant NIH staff for IC-specific information on restrictions

3. • Electronic template system (UCLA Cayuse) for online fill-in of
Cover Components and other SF 424 “form pages,” e.g.,
institutional and candidate information, other senior/key
personnel, project/performance site locations, budget data,
Checklist
• Project Summary/Abstract: Candidate, Environment, and Research
(1 page maximum, including the candidate's immediate and long-
term career goals, key elements of the research career
development plan, and description of the research project)
• Project Narrative (Relevance Statement, 2-3 sentences, no jargon)
• Facilities and Other Resources: Documentation of key resources
for the proposed research, training, career development

4. • Specific Aims (1 page)
• Career Development Plan Sections: Candidate's Background, Career
Goals, and Objectives; Career Development/Training Activities during
Award Period; Training in the Responsible Conduct of Research +
Research Strategy Sections: Significance, Innovation, Approach = 12
pages total (including figures, tables, graphs, etc.)
• Bibliography and Literature Cited
• Human Subjects Sections: Protection of Human Subjects, Inclusion of
Women and Minorities, Targeted/Planned Enrollment Table, Inclusion of
Children
• Other Research Plan Sections: Vertebrate Animals, Select Agent
Research, Consortium/Contractual Arrangements, Resource Sharing Plan

5. • Cover Letter (obligatory)
• Letters of Reference (minimum 3, maximum 5): due
by the application receipt deadline date
• Statements of Support from Mentor, Co-Mentors,
Consultants, Contributors
• Appendix (optional)

6. SPECIAL REQUIREMENT: Mentor(s)
• Applicant must name a primary sponsor/mentor, who
together with the candidate is responsible for the
planning, direction, and execution of the career
development program.
• The mentor should be recognized as an accomplished
investigator in the proposed program and have a track
record of success in training similar investigators.
• The mentor should have sufficient independent support
to cover the costs of the proposed project in excess of
the allowable costs of this award.
• Candidates may also nominate co-mentors as
appropriate to the goals of the specified research
program.

7. • Experience
• Availability
• Interest to work
• Track record with previous mentees
• Adequate resources: grant support
• The choice of one or two senior scientists is the single
most important decision

8. SPECIAL REQUIREMENT: Institutional Environment
• Demonstrate your institution’s strong, well-established
record of career development activities and faculty
qualified in biomedical, behavioral, or clinical-
translational research to serve as mentors. (CTSI award if
available)
• Demonstrate the institution’s commitment to your
development as a productive investigator and
willingness to allow the protected time needed to
complete your career development program .
• Describe a career development program that will
maximize the use of this environment, including
available facilities and resources.

9. Candidate’s Background
• Describe your commitment to an academic career
in patient-oriented research for the K23 OR
biomedical/behavioral research for the K08.
• Describe your professional responsibilities in the
grantee institution and elsewhere and show their
relation to the proposed activities on the career
award.
• Present evidence of your ability to interact and
collaborate with other scientists.
• Describe prior training and how it relates to your
objectives and long-term career plans.

10. Candidate’s Background (cont.)
• Describe your research efforts to this point in your research
career, including publications and prior research interests
and experience.
• Provide evidence of your potential to develop into an
independent investigator.
• Include a statement that you will commit at least 9 person-
months (75% of full-time professional effort) to the
research program and related career development
activities. The mentor or department chair must agree and
provide a statement in the application documenting that
this percentage of your time will be protected.

11. Career Development/Training Activities
• You and your mentor(s) are jointly responsible for the preparation of the
Career Development Plan. A timeline is often helpful. The
sponsor/mentor may form an advisory committee to assist with the
development of the program of study or to monitor your progress
through the career development 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 your career goals. You must demonstrate you
have received training or will participate in courses such as data
management, epidemiology, study design (including statistics), hypothesis
development, drug development, as well as the legal and ethical issues
associated with research on human subjects.
• Describe your professional responsibilities/activities, including other
research projects, beyond the minimum required 75% effort commitment
to the K award. Explain how these responsibilities/activities will help
ensure career progression to achieve independence as an investigator.

12. • Specific Aims 1
• First three items of Candidate Information (Candidate's Background, Career Goals and Objectives, and
Career Development/Training Activities During Award Period and Research Strategy 12
(for all sections combined)
• Training in the Responsible Conduct of Research 1
• Statements by Mentor, Co-Mentors, Consultants, Contributors 6
• Description of Institutional Environment 1
• Institutional Commitment to Candidate’s Research Career Development 1
• Biographical Sketch 4

13. Specific Aims and Research Strategy sections follow
the R01 model:
– SPECIFIC AIMS (1 page)
•What do you intend to do?
– RESEARCH STRATEGY (12 pages, including Career Development Plan)
– Significance
•What has already been done in the field(s) and why is the proposed project important in the context
of prior work?
– Innovation
•What is novel about the proposed project and how will it advance the field(s)?
– Approach
•How are you going to achieve the specific aims of the project?

14. • One page limit
• One paragraph introduction to the topic: Broad enough to provide
background information yet narrow enough to provide focus for the
project
• 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
• List succinctly the specific objectives of the research proposed, e.g., to 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
• Focus and rewrite/hone

15. • Explain the importance of the problem or critical
barrier to progress in the field that the proposed
project addresses.
• Explain how the proposed project will improve
scientific knowledge, technical capability, and/or
clinical practice in one or more broad fields.
• Describe how the concepts, methods, technologies,
treatments, services, or preventative interventions
that drive this field will be changed if the proposed
aims are achieved.

16. • Outline the background for the
current proposal
• Critically evaluate current knowledge
– Supporting information
– Conflicting information
– Your own data, if available
• Identify gaps in existing knowledge
that the project will fill
• Link to specific aims or hypotheses
• Link to broader, long-term objectives

17. • Outline the background
– Not a general review
– Select salient features and focus on key issues
– Provide perspective
– Develop concepts
• Evaluate current knowledge
– Consider conflicting views and acknowledge work
that has already been done
– Be knowledgeable
– Be diplomatic
– Be precise

18. • Identify key areas where information is missing and
innovation is needed to fill knowledge gaps
– Focus the attention of the reviewer
• Make it interesting
• Sell the product
– Provide new information, either your own or others
– Offer new perspectives
• Describe how the specific aims or hypotheses will fill
gaps in our current knowledge
• Together, Specific Aims, Significance, and Innovation
should provide an integrated and compelling
justification for the project

19. • Describe the overall strategy, methodology, and analyses to be used to accomplish
the specific aims of the project. Unless addressed separately in the Resource
Sharing Plan, include how the data will 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.
• Point out any procedures, situations, or materials that may be hazardous to
personnel and precautions to be exercised. A full discussion on the use of select
agents should be included in the Select Agents Research section of the application.

20. • Describe the work to be done to
– Address each specific aim
– Test each hypothesis
• Outline how each study or
experiment will address the specific
aims or hypotheses described
previously

21. • Organization is important
• Follow a logical sequence
• Describe methods to be used
– General (overview)
• Study design
• Lab procedures
• Statistical procedures
• Justify
– Specific studies or experiments
• Technical / methodological issues
• Document

22. General Methods
• Clinical project
– Measurement instruments
– Study population
– Recruitment
– Longitudinal follow-up
• Laboratory project
– Cell or tissue culture methods
– Specific analytical procedures
• Precision and accuracy of methods
• Previous experience

23. Experimental Procedures
• Describe experiments in sufficient detail
– How they are done
– Data to be obtained
– How data are analyzed
– Results expected
– Conclusions reached
• Expected findings
• Unexpected findings
• Alternative interpretations
• Additional studies
• Relate results and interpretation to
specific aims / hypotheses

24. Experimental Procedures
• To address Specific Aim #1
– Experiment #1
– Experiment #2
• To address Specific Aim #2
– Experiment #3
– Experiment #4
– Experiment #5

25. Experimental Procedures
• To address Specific Aim #1
– Experiment #1
• Procedure
• Analysis / interpretation

26. • Can this person do the work?
– Proven methods
– Technical expertise
– Resources available
– Study population
• Access
• Follow-up
– Background and experience
– Publications
– Collaborators

27. • Propose a research project that is consistent with your level of
research development and objectives of your career
development. The research description should demonstrate not
only the quality of your research thus far but also the novelty,
significance, creativity, and approach, as well as your ability to
carry out the research.
• While the focus of the K23 award is patient-oriented research,
complementary laboratory research directly related to patient-
oriented research may be proposed in the application, thereby
providing an opportunity for a career development experience in
translational research.
• The application must also describe the relationship between your
mentor’s research and your proposed research plan.
• If more than one mentor is proposed, their respective areas of
expertise and responsibility should be described.

28. Statements by Mentor and Any Co-Mentors
•The application must include a statement from the mentor, providing
(1) information on his/her research qualifications and previous experience as a research
supervisor
(2) a plan that describes the nature of the direct supervision and mentoring that will
occur during the proposed award period, as aligned with the Research Strategy
(3) a plan for your career progression to move from the mentored stage to independent
research investigator status during the project period of the award, including identification
of aspects of the proposed research that you will be able to take into your independent
position
(4) a plan for monitoring your research, publications, and progression toward
independence
(5) documentation of the availability of sufficient research support and facilities for high-
quality research
(6) description of courses, seminars, and opportunities for interaction with other
scientists and trainees, including training in career skills such as grant writing and effective
presentations

29. Statements by Mentor and Any Co-Mentors (cont.)
•Similar information must be provided by any co-mentor (s). If more than one co-mentor is
proposed, the respective areas of expertise and responsibility of each should be
described. Co-mentors should clearly describe how they will coordinate the mentoring of
the candidate. If any of the co-mentors are not located at the home institution, a
statement regarding the modes and frequency of communication with you should be
provided.
•The primary mentor must agree to provide annual evaluations of your progress as required
in the annual progress report.

30. Statement by Consultants and/or Contributors
• Signed statements must be provided by each
consultant/collaborator, confirming participation in
the project and describing their specific roles.
• Collaborators and consultants do not need to
provide biographical sketches, but each must
clearly document appropriate expertise in the
proposed areas of consulting/collaboration.
• Collaborators/consultants are generally not directly
involved in the development of the career of the
candidate as an independent investigator.

31. Data and Safety Monitoring Plan (when applicable):
• Individual NIH institutes may have specific requirements for
data and safety monitoring of clinical trials. Candidates
proposing to conduct clinical trials should consult with relevant
IC staff.
• A plan for data and safety monitoring must be included in
research plans involving phase I or phase II clinical trials. In
general, this requirement may be satisfied in the application by
providing documentation that the sponsoring institution has an
approved plan in place and providing a brief description of the
key elements of the plan.

32. • Electronic submission of reference letters is a separate process from
submitting an application electronically. Reference letters are submitted
directly by the referees through the eRA Commons; must be submitted
NO LATER THAN application submission due date.
• You must arrange to have at least 3 (but no more than 5) letters of
reference submitted on your behalf. The letters should be from well-
established scientists (referees) and should address your qualifications
and competence as well as your potential for becoming an independent
investigator. These letters should be from individuals not directly
involved in the application, but who are familiar with your educational
background, training, and interests.
• Applications that are missing the required letters of reference may be
delayed in the review process or not accepted.

33. Description of Institutional Environment
•Document a strong, well-established, high-quality
research and career development environment
related to your area of interest, including key
faculty members and other investigators capable
of productive collaboration with you.
•Describe how the institutional research
environment is particularly suited for the
development of your research career and the
pursuit of the proposed research plan.
•Describe the resources and facilities that will be
available to you, including the UCLA CTSI Clinical
Translational Research Center (CTRC).

34. Institutional Commitment to Candidate’s Research Career Development
•Institution (e.g., department chair) must provide a statement of commitment to your
development into a productive, independent investigator and to meeting the
requirements of this award. It should be clear that the institutional commitment to
the candidate is not contingent on receipt of this career award.
•Provide assurances that you will be able to devote a minimum of 9 person-months
(75% of full-time professional effort) to the fulfillment of the career development
program. The remaining effort should be devoted to activities related to the
development of your career as an independent clinician scientist, e.g., clinic
responsibilities, teaching, and/or additional research activities.
•Provide assurances that you will be provided with appropriate office and laboratory
space, equipment, and other resources and facilities (including access to clinical
and/or other research populations) to carry out the proposed career development
plan.

35. Institutional Commitment to Candidate’s Research Career Development
•Provide appropriate time and support for any proposed mentor(s) and/or other staff
consistent with the career development plan.
•If you will be using CTSI resources (letter Dr Dubinett) and/or specific aspects of CTSI
such as CTRC during the course of the award, include a letter of agreement from the
CTRC Program Director (Dr Salusky) as part of the application.