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Education Module
K08 and K23 Funding

Introduction

Getting funded is critical for early career investigators.  Mentored Career Development Awards are an important funding mechanism for individuals early in their careers.  Applying for funding is a lengthy process, but it doesn't have to be complicated.

This module will help individuals understand the National Institutes of Health Mentored Career Development Award funding mechanism.  This module highlights important components of a Mentored Career Development Award application, with tips for success.

Upon completion of this module, individuals should be able to:

• Describe the NIH Mentored Career Development Award mechanism
• Identify individuals who are eligible to apply for the NIH Mentored Career Development Awards
• Discuss important elements of the application and application process

This module was designed as a resource for junior faculty and fellows who wish to pursue careers as clinician-scientists in academic medicine.  This module may also be useful for mentors of early career clinician-scientists and program directors.

Overview: NIH Mentored Career Development Awards

The National Institutes of Health is the single largest source of career development funding.  There are two types of Mentored Career Development Awards: (1) Mentored Clinical Scientist Development (K08) Award; and (2) Mentored Patient-Oriented Research Career Development (K23) Award.

K08 and K23 Funding

The K08 funding mechanism is for individuals whose research is laboratory-based.  The K23 funding mechanism is for individuals whose research is patient-based.  Both K08 and K23 awards provide 3-5 years of funding, with up to $75,000 per year for salary support plus fringe benefits and $25,000 per year for research support and supplies.

Funding Cycles and Deadlines

There are three funding cycles per year.  Application deadlines are February 1, June 1, and October 1.

Other Support

The National Institutes of Health allows K award recipients to receive concurrent salary support from a competing NIH research grant when they are the principal investigator.

Who Should Apply?

Ideal candidates are just completing fellowship years or are early career faculty (within the first three years of first academic appointment).  Applicants too early in their careers may be more appropriately supported on a T32 grant.  Applicants later in their careers may not benefit from additional mentoring.  Applicants cannot apply after receiving their first R01 award.

Important Elements of the Application

There are several important elements that are evaluated for K08 and K23 awards.  These include:

• The candidate
• The mentor
• The career development plan
• Advisory Committee
• Institutional support for the candidate
• Research plan, including the potential of the proposed research to train the applicant for an independent career

Each of these elements is discussed in detail below.

The Candidate

In the application, the candidate must demonstrate his/her ability to develop into an independent researcher.  The candidate must also demonstrate his/her commitment to becoming an independent researcher and must provide a description of how the award will aid in accomplishing his/her career goals (both short- and long-term).

The Mentor

The mentor is an important component of  a Mentored Career Development Award application. 

The mentor should be an independent clinician-scientists with external research grant support.  The mentor should be successful in the area of science being pursued by the applicant.  A credible mentor record should be demonstrated, including the number of previous mentees and what these mentees are presently doing.

All mentors must write a Mentor's Statement.  This statement should include a description of how the applicant's career will be enhanced by the award and mentoring experience.  Didactic training that the mentee will undergo during the award period should be described.  The mentor-mentee experience should be described in detail, including the frequency and nature of meetings.  It is important that the mentor's statement matches what the applicant describes in the application.

The Career Development Plan

The applicant should describe, in detail, what he/she hopes to achieve during the award period.  This should include specific goals for research productivity and manuscript preparation.  The applicant should describe how he/she will gain the necessary knowledge and skills to become an independent researcher (i.e., formal didactic training).  All applicants must receive training in the responsible conduct of research.  This should be clearly expressed in the application.  The career development plan should include a description of the mentoring experience, including the frequency of meetings with the mentor (i.e., weekly, monthly) and the nature of meetings with the mentor (i.e., email, phone calls, in person).

Advisory Committee

An Advisory Committee, which will oversee the applicant's research experience, should be described.  This should include the structure of the committee (i.e., number of members) and goals of the committee.  Members of the Advisory Committee should have a history of mentoring.  Ideally, members of the Advisory Committee are on-site.  NIH biosketches of advisory members should be included in the application.  Letters of intent to participate in the Advisory Committee should also be included.  Letters of intent should include a description of the frequency of meetings and goals of the meetings.

Institutional Support

The candidate should describe how the institution will aid in the successful development of the proposed career and research plan.  An institutional letter of support is required for most career development awards.  This should include a description of the commitment to the candidate (i.e., providing protected research time, providing additional resources such as laboratory/office space, administrative staff, access to copying/printing equipment).

Research Plan

The research plan should be well thought through and clearly articulated.  It is useful to have the mentor review this section after an initial draft.  The research plan should address an important scientific question, be directly relevant to the applicant's career objectives, be suitable for developing the applicant's research skills, be feasible and technically appropriate.  The research plan typically consists of the following sections:

• Specific Aims
• Background and Significance
• Preliminary Results
• Methods

Guidelines for each of these sections are described below.

Research Plan: Specific Aims

This section should include a description of what the applicant hopes to accomplish and why.  A useful strategy is to write an overall objective, and then more focused primary and secondary aims.

Research Plan: Background and Significance

This section should include a description of the scope and significance of the study problem.  Relevant literature should be discussed, including a discussion of potential limitations to the current literature.

Research Plan: Preliminary Results

Inclusion of preliminary data differs by award mechanism.  Preliminary data may be required, so be sure to check the specific award application requirements.  When including preliminary data, some basic guidelines should be followed:

• Use figures and tables when possible to clarify the data
• Label figures and tables appropriately
• Label legends appropriately
• Show controls

Research Plan: Methods

This section should include a description of how the applicant will accomplish the specific aims of the proposed research.  The following information should be included:

• Research design
• Study population
• Data collection procedures and instruments
• Key variables
• Analytic plan (including sample size and power calculations when applicable)

All methodological decisions should be justified.  For complex analysis, a biostatistician may need to be consulted.  The quality of data (i.e., reliability, validity) should be discussed.  Potential biases or problems should also be discussed, with proposed possible solutions or alternative approaches.  A realistic detained timeline should be included.

Research Plan: Abstract/Summary

If request or required, an abstract or summary should be provided.  This should be written after the research plan has been developed and reviewed by the mentor.  The abstract should describe a summary of the research plan, and how the research will aid the candidate in developing research skills and accomplishing his/her career goals.  The specific aims, significance of the proposed research, and important elements of the research methods should also be included.

Application Process

There are three phases in the application process:

• Application (described in steps 1-5 below)
• Review (described in steps 6-8 below)
• Post-Review (described in steps 9-12 below)

All of these steps are discussed in detail below.

Application Process: Step 1

The first step is to locate the appropriate Institute and Mentored Career Development Award.  There are 27 NIH institutes (see: http://www.nih.gov/icd/index.html).  Review each Institute's mission and decide which Institute's scientific area best fits your proposed research.  Use the appropriate Institute's website to determine if you, preliminary, meet all eligibility requirements for applying for a Mentored Career Development Award.

Some useful resources include:

• National Heart Lung and Blood Institute: www.nhlbi.nih.gov/about/org/mission.htm
• National Institute of Diabetes and Digestive and Kidney Diseases: www.niddk.nih.gov/welcome/mission.htm
• National Cancer Institute: www.nci.nih.gov/aboutnci/overview/mission

Application Process: Step 2

Locate the appropriate Institute Program Official.  The Program Official is also known as a Health Scientist Administrator (HSA) and is responsible for the programmatic, scientific, and technical aspects of a grant.  Contact the HAS to determine if your proposed application fits into his/her program and to verify that you have selected the appropriate Mentored Career Development Award.  Discuss your career development plans, mentor, research topic, and training with the HAS.

Application Process: Step 3

Plan your grant application.  Use NIH and other resources.  Join the NIH listserv to receive notices and announcements regarding changes in policies of application forms.

Application Process: Step 4

Submit your application to the NIH Center for Scientific Review (CSR).  If a receipt date falls on a weekend, it will be extended to the following Monday.  If a receipt date falls on a holiday, it will be extended to the following workday.  Once your application is received at CSR, it will be reviewed by staff and subsequently assigned to an Institute and Program.

Application Process: Step 5

The Center for Scientific Review sends notification to the applicant.  The notification includes the applicant's assignment and the names of NIH officials.

Application Process: Step 6

The Scientific Review Administrator (SRA) is your contact person.  During the review phase, any contact with an NIH official should be with the SRA.  Contact the SRA if you have a recent publication, new preliminary data, or a transfer to a new institution.

Application Process: Step 7

Mentored Career Development Awards are reviewed by the Institute's Special Emphasis Panels (SEPs).  These are formed on an ad-hoc basis.

Application Process: Step 8

Approximately two weeks after review, the applicant will receive a priority score via mail.  A priority score is defined by the NIH as, “a numerical rating that reflects the scientific merit of the proposed research relative to the state of science.” 

Approximately eight weeks after review, the applicant will receive a Summary Statement with a cover letter from the HAS.  The Summary Statement contains a combination of the reviewers' written comments, recommendations of the study section and a recommended budget.

Application Process: Step 9
The applicant should re-contact the HAS if he/she has any questions regarding the summary statement.

Application Process: Step 10
Just-in-Time information will be requested by the Institute's Grants Operations/Management Branch.  These branches are the financial management units of the Institutes.  Just-in-Time information must be sent back to the Branch.  Any financial-related questions should be referred to the Branch.

Application Process: Step 11
If your application is funded, the HAS will send you a letter with this information.  This is not an official notice.  The official notice is sent by the Grants Operations/Management Branch as a Notice of Grant Award, sent via email to the applicant's institutional business official.

Application Process: Step 12
If an application is not funded, the applicant may consider resubmitting an amended application.  Mentored Career Development Awards allow up to three submissions.  Reviewers will provide comments and it is important to read these thoroughly and to respond to the comments in the Introduction to Revised Applications section.  The reviewers from the first submission will not necessarily be the reviewers for the second or third submissions.

Preparation Tips
The applicant will need to set aside several months (typically 2-3) to prepare a Mentored Career Development Award application.  Coordination of the various components is critical.  The application should read uniformly (i.e., if the applicant proposes didactic coursework, the mentor should describe the same coursework).

Question and Answer
This question and answer section is designed to test your knowledge of audits in clinical research.  Answers are provided so that you can ensure you know the right answer.  No credit is given for completing these questions.

Question 1
Question: True or false.  CDC is the single largest source of career development funding.
Answer: False.  NIH is the single largest source of career development funding.

Question 2
Question: What types of Mentored Career Development Awards exist?
Answer: K08 and K23 awards.

Question 3
Question: True or false.  Mentors must write a Mentor's Statement for inclusion with a K08 or K23 application.
Answer: True. The Mentor's Statement should include a description of how the applicant's career will be enhanced by the award and mentoring experience.  It should also describe the didactic training that the mentee will undergo, and the mentor-mentee experience (including frequency and nature of meetings).

Additional Resources and References

• Gill T, McDermott M, Ibrahim S, et al.  Getting funded: career development awards for aspiring clinical investigators.  Journal of General Internal Medicine.  2004; 19(5 pt 1):472-478.
• Poncz M, Iannone R, Werner E.  Hematology.  Hematology grants workshop.  2003:590-596.