"NIH Electronic Grant Proposals (SF 424) – K23 and K08 Individual Career Develop Awards" Isidro Salusky, MD Distinguished Professor of Pediatrics Division Chief, Pediatric Nephrology Director, UCLA CTSI Clinical Translational Research Center Associate Dean for Clinical Research

1. NIH Electronic Grant Proposals (SF 424)
K23 and K08
Individual Career Development Awards
Isidro B. Salusky, MD
Distinguished Professor of Pediatrics
Division Chief, Pediatric Nephrology
Director, UCLA CTSI Clinical Translational Research Center
Associate Dean for Clinical Research

2. K23: NIH Mentored Patient-Oriented
Research Career Development Award
• Used to support the career development of investigators
who are committed to a patient-oriented research agenda
• Size and duration of awards vary by proposed career
development projects and by programmatic and budgetary
specifics of participating ICs
• 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
• All ICs utilize the K23 but prospective applicants should
contact the relevant NIH staff for IC-specific information

3. K08: NIH Mentored Clinical Scientist
Research Career Development Award
• 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

4. K23/K08 Application Outline
• 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

5. K23/K08 Application Outline (cont)
• 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

6. K23/K08 Application Outline (cont)
• 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)

7. K23/K08: NIH Mentored Research
Career Development Award
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.

8. K23/K08: NIH Mentored Research
Career Development Award
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.
• 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. K23/K08 Candidate Information and Career Development Plan
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. K23/K08 Candidate Information and Career Development Plan
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. K23/K08 Candidate Information and Career Development Plan
Career Goals and Objectives
Describe a systematic plan that
(1) shows a logical progression from prior research and
training experiences to the training and research
experiences that will occur during the career award period
and then to independent investigator status
(2) justifies the need for further career development to
become an independent investigator
(3) utilizes the relevant research and educational resources
of the institution

12. K23/K08 Candidate Information and Career Development Plan
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.

13. K23/K08 Candidate Information and Career Development Plan
Training in the Responsible Conduct of Research
• Applications must include a plan to obtain instruction in the responsible
conduct of research.
• Document prior instruction in responsible conduct of research during
your current career stage (including the date of last occurrence) and
propose plans to receive instruction in responsible conduct of research.
• Such plans must address five instructional components: format, subject
matter, faculty participation, duration of instruction, and frequency of
instruction.
• The plan may include career stage-appropriate, individualized
instruction or independent scholarly activities that will enhance your
understanding of ethical issues related to your specific research
activities and the societal impact of that research.
• The role of the sponsor/mentor in responsible conduct of research
instruction must be described.

14. K23/K08 Research Plan: Specific Aims and Research Strategy
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?

15. Specific Aims
• 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

16. K23/K08 Research Plan: Specific Aims and Research Strategy
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?

17. Research Strategy: Significance (1-2 pages)
• 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.

18. Significance
• 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

19. Significance
• 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

20. Significance
• Make the task of the reviewer easy
Develop a consistent sequence or pattern for the
discussion of the various specific aims or
hypotheses
Carry this sequence on through the Innovation
and Approach sections of the Research
Strategy
Carefully consider the placement of tables and
figures

21. Research Strategy: Innovation (1/2 to 1 pages)
• Explain how the application challenges and seeks to shift
current research or clinical practice paradigms.
• Describe any novel theoretical concepts, approaches,
methodologies, instrumentation, or interventions to be
developed or used, and any advantage over existing
methodologies, instrumentation, or interventions.
• Explain any refinements, improvements, or new
applications of theoretical concepts, approaches,
methodologies, instrumentation, or interventions.

22. Innovation
• 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

23. Research Strategy: Approach (5-7 pages)
• 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.

24. Approach
• 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

25. Approach
• 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

26. Approach
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

27. Approach
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

28. Approach
Experimental Procedures
• To address Specific Aim #1
Experiment #1
Experiment #2
• To address Specific Aim #2
Experiment #3
Experiment #4
Experiment #5

29. Approach
Experimental Procedures
• To address Specific Aim #1
Experiment #1
- Procedure
- Analysis / interpretation

30. New Application - Key Issues
• Can this person do the work?
Proven methods
Technical expertise
Resources available
Study population
- Access
- Follow-up
Background and experience
Publications
Collaborators

31. K23/K08 Research Plan: Specific Aims and Research Strategy
• 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.

32. K23/K08 Statements of Support
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

33. K23/K08 Statements of Support
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.

34. K23/K08 Statements of Support
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.

35. K23/K08 Cover Letter (Obligatory)
• Cover letter is only for internal use and will not be
shared with peer reviewers
• Must include the list of referees, with their names,
department affiliations, and institutions
• Also include the following information:
1. Application title.
2. Funding Opportunity (PA or RFA) title of the
NIH initiative
3. Request of an assignment (referral) to a
particular awarding component(s) or Scientific
Review Group (SRG)
4. List of individuals (e.g., competitors) who
should not review your application and why
5. Disciplines involved, if multidisciplinary

36. Essential Steps in
Patient-Oriented Research
• Identification of an appropriate topic
• Choosing the appropriate study design
• Definition of variables to be measured
• Designing a data form or questionnaire
• Data management and quality
techniques
• Analytic strategies
• Appropriate MENTOR

37. CRITERIA FOR GOOD
RESEARCH QUESTION
• Feasible Ethical
- Adequate number of subjects
- Adequate technical expertise
- Affordable in time and money
• Interesting Relevant
- To the investigator
• Novel
- Confirms or refutes previous findings
- Provides new findings
- Extends previous findings

38. MENTOR
• Experience
• Availability
• Interest to work
• Adequate resources: grant support
• The choice of one or two senior scientists is the
single most important decision

39. K23/K08 Research Plan: Specific Aims and Research Strategy
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.

40. K23/K08 Letters of Reference
• 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.

41. K23/K08 Environment and Institutional Commitment to the Candidate
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).

42. K23 Environment and Institutional Commitment to the Candidate
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.

43. K23 Environment and Institutional Commitment to the Candidate
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.

44. Important Notice for NINDS
K23 and K08 Applicants: As of
May 2012, the new salary cap is
$95,000.