1. Writing an Effective K Application
P. Kay Lund, PhD,
Henry Khachaturian, PhD,
Division of Biomedical Research Workforce
Office of the Director
National Institutes of Health

2. NIH includes 27 Institutes and Centers
National Library
of Medicine
Center for
Information
Technology
Scientific Review
Fogarty
International
Center
National Institute
of Arthritis and
Musculoskeletal
and Skin Diseases
of Diabetes and
Digestive and
Kidney Diseases
of Dental and
Craniofacial
Research
National Institute on
Deafness and Other
Communication
Disorders
National Eye
Institute
National Heart,
Lung, and Blood
on Alcohol Abuse
and Alcoholism
National Cancer
on Drug Abuse
of Environmental
Health Sciences
of Mental Health
of Neurological
Disorders and
Stroke
of Allergy and
Infectious Diseases
Minority Health and
Health Disparities
on Aging
of Child Health
and Human
Development
National Human
Genome Research
of Nursing Research
National Center
for Complementary
and Integrative
Health
for Advancing
Translational
Sciences
Clinical Center
National Institute of
Biomedical Imaging
and Bioengineering
of General
Medical Sciences
Office of the Director
Office of Extramural Research
Division of Biomed Research Workforce (DBRW)
Office for Scientific Workforce Diversity
Office Intramural Training and Education

3. FY 2017 Operating Budget: $33,187,696M
Training: $841,246
Career: $688,702
Total: $1,
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos
NIH Budget Office:

4. Postdoctoral and Early Research Career Training
Graduate/ Clinical Training
Postdoctoral Training/Clinical Residency
Early Research Career
Established Investigator
K01, K07, K25
K08, K23
K22,
K99
K22, R00
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos
Loan Repayment Programs
Diversity Supplements

5. NIH Research Training Website
Launched in 2015, one stop for funding opportunities
Useful resource for trainees and early stage faculty
Modifications and integration with new DBRW website in progress
Separate components – separate slide for matrix

6. Career (K) Kiosk https://researchtraining.nih.gov/programs/fellowships

7. Timeline for K Applications
Receipt Date:
Feb 12 (Mar 12)
Jun 12 (Jul 12)
Oct 12 (Nov 12)
Review:
Jun/July
Oct/Nov
Feb/Mar
Council:
October
January
May
Award Date:
December
April
July
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

8. Tips for Writing an Effective K Application
Start Early
Develop a Strategy
Plan Your Application
Application Requirement
Review Criteria
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

9. Clinical Trials in K Awards
Funding Opportunity Announcements (FOA) will either permit PD/PI to conduct independent clinical trials or will not permit independent clinical trials but encourage, where relevant, clinical trials research experience under mentor guidance
Independent Clinical Trial: Led and funded by the PD/PI of the K application, may be an independent ancillary trial to a larger trial, may be a feasibility study. Will require completion of the human subjects/clinical trial form.
Clinical Trials Research Experience: K applicant will gain experience, participate in a clinical trial led by a mentor (responsible for funding and documentation)
Learn more at

10. Start Early
Start at least 6 months prior to the application due date (or begin planning even sooner)
Get an NIH Commons account at least a month before the application deadline
Know your organization's Authorized Organizational Representative (AOR) to assist with the application
Notify your referees early and give them plenty of time to submit letters of reference (ensure they have current CV and aims of grant)
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

11. Develop a Strategy (1 of 2)
Assess your career situation and needs. Is there added value to a K award? Why not another funding mechanism?
Check which NIH Institute or Center (IC) funds K awards in your research area
Schedule a phone call with an NIH Program Officer to discuss your research area, training needs and career development plans
Assess the field and the competition. See what is being funded by NIH: Research Portfolio Online Reporting Tools (RePORT:
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

12. Develop a Strategy (2 of 2)
Identify mentor(s) and collaborators- discuss your plans, project and career development needs early to be sure they are on board
Consider your strengths and areas for growth?
Can you fill any gaps and gain essential experiences with proposed mentor, collaborators or consultants?
Identify essential resources and support needed and consider if this is available within your organization – or must be obtained elsewhere
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

13. Plan Your Application
Coordinate with your mentor(s) – a K application is a collaboration between you and your mentor(s)
Put together a review committee to assist planning and provide critical feedback
Draft a short description of your specific aims and discuss these with the committee – chalk talk, diagrams, central hypotheses, scope
Be sure the project is distinct from your mentor’s research and that the mentor is supportive of future independence
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

14. New Research Directions
Don't Propose Too Much
Avoid an “over-ambitious” project – but it should be novel and significant!
Your hypothesis should be testable and aims doable with the resources you are requesting (and mentor support)
The scope of your hypothesis and aims should match available time and resources
Your research and career development objectives should be related/matched
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos
New Research Directions
Career Development
EXAMPLES
RNA Sequencing
Novel imaging approaches
Bioinformatics workshop & courses
Expert collaborator + core facility

15. Application Requirements
Candidate Qualifications, Career Goals and Objectives
Mentor(s), Collaborators, and Consultants
Institution’s Environment and Commitment to the Candidate
Specific Aims
Research Strategy
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

16. A Few Tips as You Write Make Life Easy for Reviewers:
Write clearly and concisely
Label all components clearly
Make sure figures and legends are readable
Avoid TMI – a figure is worth a thousand words!
Guide the reviewers with graphics as much as possible
Edit and proofread
Know These Review Problems and Solutions:
Write a compelling argument for why your career will be advanced to independence and enhanced by receiving a K award
Write for both experts and non-experts in your field
Cite the work of experts as reading articles in the field
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

17. Candidate’s Qualifications
Biographical Sketch:
Education/training
Contributions to science – background, findings, influence/impact, your specific role, cite publications or research products
Personal statement – your research experience and other qualifications for this K award
Research support – ongoing and completed research projects, accomplishments of you and your mentor(s)/colleague(s) attesting to qualifications of the research team
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

18. Candidate’s Background
Can coordinate with information in the biosketch, but make sure key information is provided here, even if it repeats biosketch
Commitment to an academic research career
Interactions, collaborations
Research achievements experience and potential
Other relevant experience (leadership, teaching, mentoring)

19. Career Goals and Objectives of the K Award
New or enhanced research skills you will gain
Other activities to enhance your research career, e.g., courses, workshops, techniques, teaching, mentoring (including ‘soft skills’ management, leadership)
If you have changed research direction, discuss the reasons and justify how it will help you to develop your research career
Provide a career development timeline, including plans to apply for subsequent grant support
Career development can include a visit to another laboratory, to learn new technologies or approaches (network for the future!)
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

20. Sponsor/Mentor(s), Collaborators, Consultants
Primary/Key Sponsor/Mentor(s) must explain how they will tangibly contribute to the development of the applicant
Discuss research and career development activities:
Regular interactions with applicant, how interactions and proposed activities advance applicant’s research and career
Document sources/amounts of anticipated support for the applicant’s research project
Mentor(s) should discuss the plans for transitioning the candidate to independence by the end of the K award- and convey clear support for the pathway to independence
Provide details of previous experience as a mentor and outcomes of mentees
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

21. Institutional Environment & Commitment
Document a strong, well-established research program related to the candidate's interests
Experienced faculty, facilities and resources
Opportunities for intellectual interactions, e.g., journal clubs, seminars, and presentations
Research Centers or Program Projects which may provide resources and interactions to promote your success
Commitment to the candidate’s career development independent of the K award
Adequate office and lab space, time and support to the candidate for the period of K award
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

22. Specific Aims of the Project
Test a central hypothesis & sub-hypotheses
Solve a specific problem & address a critical barrier to progress in the field
Challenge an existing paradigm or develop new technology
All members of the review panel may read this page
State the problem, why you can solve it, what’s new & the hypothesis and sub-hypotheses related to each aim
A summary figure helps!
End with why completing the aims will be a major contribution to the biomedical field or clinical practice and to your career development
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

23. A Few Tips on the Hypothesis
Strong, testable hypotheses rather than advance in technology or ‘collecting’ information
Aim 2 should still be doable/meaningful if aim 1 does not pan out
Ask questions that prove or disprove a hypothesis rather than use a method to search for a problem or simply collect information
Methods are the means to perform your experiments. Your experimental results and appropriate statistical analyses will prove or disprove your hypothesis
The hypothesis must be testable during the the K award and with the level of available resources
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

24. Research Strategy (1 of 3)
Significance:
The importance of the problem you are trying to solve
How your study and anticipated results will improve scientific knowledge, technical capability, or clinical practice in one or more fields
How existing concepts, methods, technologies, treatments, or interventions may be impacted if the proposed aims are achieved
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

25. Research Strategy (2 of 3)
Innovation:
How your proposed research will challenge or improve current research or clinical practice paradigms
Novel theoretical concepts, approaches, methodologies, or interventions that may be developed or used
Advantages over existing approaches, methodologies, instrumentation, or interventions
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

26. Research Strategy (3 of 3)
Approach:
Methods and analyses to test the hypotheses and accomplish the specific aims (attention to positive and negative controls or randomization where appropriate).
Benchmarks for success anticipated to achieve the aims.
Potential problems and alternative strategies.
For early stages of development, describe strategies to establish feasibility and manage high-risk aspects of the proposed work.
Rigorous experimental design – power calculations, sufficient N, biological variables, appropriate statistical tests and authentication of reagents.
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

27. Career Award Review Criteria
Scored Review Criteria:
Candidate
Career Development Plan, Goals and Objectives
Research Plan (Includes review of Scientific Premise, rigorous experimental design, biological variables)
Mentor(s), Consultants(s), Collaborator(s)
Environment and Institutional Commitment to the Candidate
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

28. Career Award Review Criteria (1 of 4)
Candidate:
Research, academic and/or clinical record
Commitment and potential to develop as an independent and productive researcher
Quality of letters of reference (referees know you!)
Career Development Plan, Goals and Objectives:
Contribute substantially to the scientific development of candidate
Content, scope, phasing, and duration of the plan in the context of prior experience
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

29. Career Award Review Criteria (2 of 4)
Research Plan:
Scientific and technical merit of the research question, design and methodology
Strong premise, rigorous experimental design and statistical analyses, unbiased approach, addresses relevant biological variables
Relevance of the proposed research to the candidate‘s career objectives
Is the research plan appropriate to the stage of research development and developing the research skills described in the career development plan?
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

30. Career Award Review Criteria (3 of 4)
Mentor(s), Consultants(s), Collaborator(s):
Qualifications, funding, and statement by Mentor(s), collaborators, and/or Consultants
Clear commitment and plan for career development and pathway to independence
Mentors and collaborators must have real roles – i.e. be clearly involved and have the time to commit
Environment and Institutional Commitment to the Candidate:
Assurance that minimum 75% effort will be devoted to research and related activities
Capable faculty and research facilities
Assurance that the candidate is considered an integral part of the institutional research program
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

31. Career Award Review Criteria (4 of 4)
Additional Review Criteria:
Protection of Human Subjects
Inclusion of Women, Minorities, and Children
Care and Use of Vertebrate Animals
Biohazards
Additional Review Considerations:
Responsible Conduct of Research
Select Agents
Authentication of key biological or chemical resources
Resource Sharing Plans
Budget and Period of Support
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

32. Rigor in K Award Application and Review
Element of Rigor
Section of Application
Criterion Score
Additional Review Consideration
Contribute to Overall Impact?
Scientific Premise
Research Strategy
Significance NA
Yes
Scientific Rigor
Approach
Consideration of Relevant Biological Variables Such as Sex
Authentication of Key Biological and/or Chemical Resources
New Attachment
Adequate or Inadequate No
Starting with applications received for the January 25, 2016 due date and beyond

33. About Grants http://grants.nih.gov/grants/about_grants.htm
Receipt & Referral
Grants Basics
Grants Process Overview
Peer Review
Plan Your Application
Pre-Award Process
How to Apply
Post-Award Monitoring and Reporting

34. THANK YOU !
QUESTIONS ?
Keep the Joy in Research Writing a Grant is Fun
Trainees and Mentees Provide a
Scientific Family Forever

35. Research Career Development Awards (K-Awards – Goals & Types)
Goal: Develop a diverse pool of highly trained scientists, in appropriate scientific disciplines, to address the Nation's biomedical, behavioral, and clinical research needs
Institutional Career Development Programs:
Awards to an institution to support career development activities for appointees (scholars) selected by the institution
Requires a program director and experienced faculty to serve as mentors
Individual Career Development Programs:
Applicants must identify a mentor at a domestic (U.S.) institution
Mentor must be well-funded and have significant experience and commitment to advancing the career of the scholar
Significant institutional commitment is critical to success of application
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

36. K-Awardees or Appointees
Must be citizens, non-citizen nationals, or lawfully admitted for permanent residence in the U.S. at the time of award/appointment
Must have a research or clinical doctoral degree from an accredited domestic (U.S.) or foreign institution
Must have a full-time appointment at the institution, and commit a minimum of 9 person-months (75% of full-time professional effort) to research career development
Cannot be former PD/PIs on major NIH research grants (e.g. R01 equivalent), or other individual career development (K) awards.
Appointees to institutional K12/KL2 awardees are eligible to apply for individual K
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos
K-Kiosk:

37. Individual Mentored K Awards
Support protected time for intensive, mentored career development experience : expectation for transition to an independent Research Intensive position
K01 Research Scientist: Biomedical or behavioral sciences
K08 Clinical Scientist: Individuals with clinical doctoral degrees pursuing translational research—application of basic research discoveries toward the diagnosis, management, and prevention of human disease
K23 Patient Oriented: Investigators committed to Patient-Oriented Research (POR – direct interaction with human subjects; research on mechanisms of human disease, therapeutic interventions, clinical trials, and development of new technologies)
K22 Transition: Facilitates transition from the mentored stage to the independent stage, typically transition from postdoctoral training to independent (e.g., assistant professor) position
K99/R00 Pathway to Independence: Facilitates rapid transition from a mentored postdoctoral position to independent research position (No more than 4 years from doctorate or residency at the time of application)

38. Brief Overview of Grant Process
Department of Health and Human Services
Part 1. Overview Information
National Institutes of Health (NIH)
Funding Opportunity Title
NIH Pathway to Independence Award (Parent K99/R00) PA
FOA
Program Staff
Application
Feedback & Revision
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos
NIH
Award
CSR
Institute/Center
Study Section and Council Review

39. Responsible Conduct of Research
Discuss the five components outlined in the NIH Policy:
(1) Format, (1) Subject Matter, (3) Faculty Participation, (4) Duration, and (5) Frequency
Is the plan appropriate for your career stage, and will it enhance your understanding of ethical issues related to research?
Document any prior participation in RCR training and/or propose plans to receive additional instruction
DBRW chief = Kay Lund, Economic analysis = Misty, Ryan, Policy = Jennifer, Henry and Lisa- Photos

40. Diversity Supplement
Administrative supplement to an existing, actively funded research grant Designed to:
Support candidates from underrepresented groups who “wish to develop research capabilities…participate in…career development experiences”
Support many career stages from undergraduate to faculty
Could be a bridge to a K for postdoctoral researchers or early stage faculty
Add to ongoing research and career development
Expectation of a subsequent application for NIH support
Diversity workforce
PA :
Administratively reviewed by the Institute or Center (IC) funding the original grant
Note: different ICs have different deadlines and policies