The document provides tips for writing NIH Career (K) award applications, including: 1. It outlines the various K award mechanisms for different career stages from postdoctoral training through assistant professor level. 2. It discusses the application process and identifies important elements of a successful application such as the research plan, career development plan, mentors, and institutional commitment. 3. It emphasizes starting early, getting feedback, and paying attention to eligibility requirements and submission guidelines.

1. Transitioning to independence: Tips For
Writing NIH Career (K) award applications
Brenda Fredericksen, PhD
Scientific Review Officer
NIAID, NIH
brenda.fredericksen@nih.gov
240-669-5052
1. Various award mechanisms available to junior investigators
2. The review process
3. Review criteria for R series and K series award applications
• Common problems
• New review criteria regarding rigor and transparency

2. Preparing an Application: Overview
• Submit via your
organizational representative
• Use eRA Commons to track
application
Identify a FOA that fits your
career stage and research
your research interests
• Read the FOA
• Follow
Application
Instructions
Prepare Application
Submit, Track & View
Application
Develop research
topic
• Needs to align with an IC
mission.
• Should be of high impact.
Find Opportunities

3. •Talk to your mentor and other NIH funded researchers.
•Talk with NIH staff about your idea and where it fits.
•Use NIH’s Research Portfolio Online Report Tool
(RePORT). http://RePORT.nih.gov/
Developing research ideas
• Organizational funding information
• NIH staff contacts
• Success rates
• Award trends
• Which ICs fund research like yours
• Projects similar to yours
• NIH-funded workforce data
• Potential collaborators
• NIH grantees in your area

4. Career Stages of Funding Programs

5. Type of FOA Description
Program
Announcements (PA)
examples: PAR, PAS
• Identifies areas of increased priority and/or emphasis
on particular funding mechanisms for a specific area of
science.
• Usually ongoing (3 yrs)
• Often use standard receipt dates
Parent Announcements • Type of program announcement
• Generally span the breadth of NIH mission
• By activity code (R01, R03, K awards, etc.)
• For “investigator initiated” or “unsolicited” research
ideas
• Eligibility criteria explained in the FOA
Requests for
Applications (RFA)
• Narrowly defined scope
• Usually single receipt date
• Set aside funds
• IC usually convenes review panel
Funding Opportunity Announcements (FOAs) Are
Used to Fund Extramural Research

6. Where to find FOAs
6
• Grants.gov (Home | GRANTS.GOV)
• NIH Guide for Grants and Contracts website:
http://grants.nih.gov/grants/funding/funding_program.htm
http://www.niaid.nih.gov/researchfunding/newsletter/pages/subscribe.aspx

7. Decide which K mechanism is best for you: NIAID
Career Development Awards (K) or NIH K Kiosk.
7
Ph.D./M.D.
Research training Phase
K25
K01-Research Scientist Development Award: Research or health-
professional doctoral degree. Development plans must be in epidemiology,
modeling techniques, and outcomes research.
NIAID Career Awards-Support by
Career Stage
K25

8. 8
NIAID Career Awards-Support by
Career Stage
PH.D./M.D.
Research training Phase
K25
K08-Mentored Clinical Scientist Research: Clinical doctoral degree (M.D.,
D.V.M.,O.D, PharmD), professional license to practice in the United States,
and current work in biomedical or behavioral research.
K23-Mentored Patient-Oriented Research Career Development Award:
Clinical doctorate, completed specialty or subspecialty training and the
research requires direct interaction with patients.

9. 9
K25 Mentored Quantitative Research Development Award: Candidate
must have an advanced degree in engineering or quantitative science, such
as Ph.D. or M.S.E.E.
Ph.D./M.D.
Research training Phase
K25K25
NIAID Career Awards-Support by
Career Stage
K22-NIAID Career Transition Award: Postdoctoral scientist with no more
than five years with plans to apply for an assistant professorship at an
academic institution. (non-mentored).
K99/R00-NIH Pathway to Independence Award: Clinical or research
doctorate and no more than four years of postdoctoral research. (NIAID
supports 2+2)

10. K99/R00 Pathway to Independence
PA-16-193: http://grants.nih.gov/grants/guide/pa-files/PA-16-193.html
10
Eligibility
• No more than 4 years of total aggregate postdoctoral experience at
the time of submission.
• Physician-scientists: Time spent in clinical training during
residency or clinical specialty is not counted towards K99/R00
eligibility
• No prior or current Career Development (K) awards or NIH research
grant (R01, R03 or R21).
• No current or previous position as an independent research
faculty. Clinical faculty member who does not hold an independent
research faculty position is eligible for the K99/R00 award
• Non-citizens with appropriate visa may apply
•NIAID limits the budget to 4 years of support: Mentored
phase (2 years) + Independent phase (2 years).

11. K22 Career Transition Award
PAR-14-341: http://grants.nih.gov/grants/guide/pa-files/PAR-14-341.html
• Not a mentored award.
• Postdoctoral fellow to PI transition.
• Goal: obtain & begin Asst. Prof position
• Eligibility
• No more than 5 years of related postdoctoral experience.
• No prior or current Career Development (K) awards, R01 or
equivalent funding.
• No current or prior position as an independent research
faculty.
11

12. Shawn Gaillard, Ph.D.
Research Training Officer
Office of Research Training and Special Programs
National Institute of Allergy and Infectious Diseases, NIH
5601 Fishers Lane, Rm 4F-30
Rockville, MD 20892-9823
Email: GaillardL@niaid.nih.gov
Office of Research Training and Special
Programs
https://www.niaid.nih.gov/researchfunding/traincareer/pages/career.aspx

13. Review Process for a Research Grant
9
Performs the
Research
Institution
Submits
Application
Allocates Funds
Center for Scientific
Review (CSR)
CSR
Evaluates for
Scientific Merit (1st
level)
Advisory Councils
& Board
Recommends Action
(2nd level)
Institute Director
Makes Funding
Decision
Grants.gov
eRA Commons
Division of Receipt and
Referral Assigns for review
Institute (IC)
Principal
Investigator
(PI)

14. 3 Overlapping Funding Cycles Per Year
Funding
Cycle
Receipt
Dates
Review
Meetings
Advisory
Council
Potential
Start
Date
Jan Feb Mar Apr May June July Aug Sept Oct Nov Dec1
Jan Feb Mar AprMay June July Aug Sept Oct Nov Dec2
Jan Feb Mar Apr May June July AugSept Oct Nov Dec3
Standardreviewcycle
Except for K99/R00:
Receipt Dates and
Review schedule
apply. Funding
decisions are made
once a year at
May/June council.
AIDS/HIVreviewcycle
Funding
Cycle
Receipt
Dates
Review
Meetings
Advisory
Council
Potential
Start
Date
May June July Aug Sept Oct Nov1
2
3
Jan Feb MarSept Oct Nov Dec
Jan Feb Mar Apr May June July

15. On-time Submission
• Important reminders:
• NIH recommends submitting early (days, not minutes!) to allow
time for correcting any errors found during the application viewing
window prior to the due date.
• NIH’s late policy does not allow corrections after the due date.
• All registrations must be completed before the due date.
Error-free applications must be accepted by Grants.gov with a time stamp on or
before 5:00 p.m. local time of the submitting organization on the due date
15
NOT-OD-15-039: Simplifying the NIH Policy for Late Application Submission:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-039.html

16. The NIH-specific Scoring System
• Reviewers give numerical scores for:
̶ Overall impact score
̶ Individual criterion scores
Overall impact Career development (K) awards: Likelihood for
the candidate to maintain a strong research program.

17. Evaluation Criteria (Ks)
5 Scored Review Criteria: (Considered in the Impact score)
 Candidate
 Career Development Plan/Plan to Provide Mentoring
 Research Plan
 Mentors, Co-Mentors, Consultants, Collaborators
 Environment and Institutional Commitment to the Candidate
Additional Review Criteria: (Considered in the Impact Score)
 Animal Welfare, Human Subjects Protections, Biohazards,
Resubmission (A1), and Renewal (K24)
Additional Review Considerations: (Does not affect impact score)
 Authentication of Key Resources, Training in the
Responsible Conduct of Research, Budget, Select
Agents, Resource Sharing

18. Candidate’s Background
• Research record/Productivity:
• Publications: Recently accepted manuscripts are acceptable
post-submission material. - See more at:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-
030.html#sthash.RSibaCYn.dpuf(http://grants.nih.gov/grants/fundin
g/post_submission_faq.htm). Must be submitted with concurrence
from the Authorized Organization Representative (AOR) of the applicant
organization.
• Awards
• Fellowships
• Clear commitment to independent research career
• Letters of Reference

19. Reference Letters
• Submitted directly by the referees.
• Allow adequate time for the referees to put together
a well-tailored reference letter.
• Minimum: 3 letters of reference; 5 maximum.
• Individual directly involved in the research project
can not provide a letter of reference.
Referees
• Must be received by the application submission
deadline.
• Make sure to attach the correct letter.
19

20. Career Development Plan and Career Goals
and Objectives
•Be specific; individualize your plan.
•Align career development goals with research
plan.
•Understand your strengths and deficiencies.
•Justify areas of training needed.
•Provide a specific timeline and pathway for
independence (R01 submission/goals).
•Involve your mentor. Plan for evaluation of progress
(with mentors).
20

21. Research Plan
• Strong significance to an important problem in public
health: IMPACT is high
• High degree of novelty and innovation
• Clear goals and approaches
• Feasibility
• Innovation
• Independent from Mentor’s research
• Timeline
• Pitfalls and alternative strategies
• Long term scope and plans for an independent
R01
21

22. Common Problems in Research Plans
• Lack of new or original ideas
• Absence of an acceptable scientific rationale
• Lack of experience in the essential methodology
• Questionable reasoning in experimental approach
• Diffuse, superficial, or unfocused research plan
• Over ambitious research plan
• Lack of sufficient experimental detail
• Lack of knowledge of published relevant work
• Uncertainty concerning future directions
• Grantsmanship
GET INPUT FROM NIH FUNDED INVESTIGATORS

23. Statements of Support
•Mentor(s):
•Mentor’s research expertise.
•Research support.
•Mentor’s training record.
•Clear plan for meeting with mentees, evaluation.
*K22 applications require a statement of support
from the current mentor.
23

24. Letters of Support
Collaborators:
Include letters from collaborator(s) outlining their
specific role in the project.

25. Institutional Environment/Commitment
•Institutional environment:
•List relevant research resources/logistics.
•Opportunities for collaboration and training.
•Institutional commitment (one page)
•Commitment to candidate and his/her independent
research career.
•Research support: space, equipment, technician,
supplementary funds for research.
25

26. K22 Specific Issues
Career Development plan:
• Describes plan for transition to independent investigator.
• Includes lab management, teaching, research skills, etc.
Research Strategy:
• How to gain independence from postdoctoral advisor and
achieve separation of the research program.
Statement of support from current mentor
• Required attachment that allows the current postdoctoral
advisor to provide information about their respective future
role and support to the candidate during the early phase as an
independent investigator.
26

27. 27

28. Review Questions Regarding Rigor and
Transparency
28
Research plan
• Is there a strong scientific premise for the project?
• Has the candidate presented strategies to ensure a
robust and unbiased approach, as appropriate for the
propose work?
• Has the candidate presented adequate plans to
address relevant biological variable, such as sex, for
studies in vertebrate animals or human subjects?

29. Examples of Scientific Premise
•Fundamental scientific principles or related work
•Existing literature or prior work in the field
•Broad gaps in the field that the research will fill
•Research to be supported or facilitated
•Needs to be addressed

30. Examples of Scientific Rigor
• Statistical procedures to determine appropriate group
sizes, numbers of animals, etc.
• Plans for data analysis
• Methods to reduce bias
• Procedures to ensure independent, blinded
measurements
• Procedures to improve precision and minimize
variability
• Criteria for subject inclusion or exclusion
• Addressing loss of experimental units or observations

31. • Have the investigators presented adequate plans to address
relevant biological variables, such as sex, for studies in
vertebrate animals or human subjects?
• The expectation is to study both sexes; strong scientific
justification needed to use a single sex.
31
Examples include:
• Sex
• Age
• Source
• Weight
• Genetic strain
Relevant Biological Variables
Approach – Review Questions

32. Authentication of Key Biological
and/or Chemical Resources
•Reviewers should comment on the plans presented for
authenticating key resources.
• In many cases, standards do not exist now.
• Data is not expected in the resource authentication plan.
Examples:
Cell lines
Specialty chemicals
Antibodies
Biologics
Not standard laboratory reagents

33. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html& Award Process
Training RCR:
• Plan to develop scholarly understanding of ethical
issues of individual’s research
• Must have Acceptable plan. Unacceptable means bar
to funding
• 5 parts:
• Format: face-to-face
• Subject matter: comprehensive
• Faculty participation: formal & informal
• Duration: 8+ hours
• Frequency: once every 4 years

34. General tips
• Start early
• Involve your mentor(s).
• Discuss your research idea with your Program Officer.
• Have NIH-funded colleagues read the application.
• Read Program Announcements
• Pay particular attention to eligibility requirements and
submission guidelines.
• Grantsmanship
• Submit early
• check for errors and completeness,
• contact eRA/Commons help desk right away if there are
problems with submission.
34

35. After the Review
35
Check eRA Commons (next slide)
(http://era.nih.gov/commons/index.cfm)
• Final Impact Score are available within 3 days after the
review meeting
• Summary statement available within 4 – 8 weeks to:
– PD/PI
– NIH Officials
– Advisory Council members
– NIH Program Officer (Point of Contact)

36. Summary statement example

37. Summary Statement (I)
37
• First page
– NIH Program Officer (upper left corner)
– This is your point of contact to discuss the outcome
of the review meeting
– Final Impact Score or other designation
– Percentile (if applicable)
– Codes (human subjects, vertebrate animals, inclusion)
 44 = bar to funding
 10 = no human subjects or vertebrate animals
 30 = involves human subjects or vertebrate animals
but the SRG had no concerns
– Budget request
•

38. Summary Statement (II)
38
• Subsequent Pages
– Resumé and Summary of Discussion (Discussed
applications only)
– Description (provided by applicant)
– Reviewer critiques Administrative Notes
– Meeting roster

39. Program Officials’ Role:
Funding Decisions
•At and After Review Meeting
•Note reviewer enthusiasms and concerns
•Discuss Summary Statements with applicants
•Advise on resubmission process
•At Advisory Council
•Report and address any unresolved review concerns
•Address requirements for foreign applications
39

40. After Peer Review
40
If the applications is funded, congratulations!
̶ May need to resolve 44 codes
̶ May need to submit Just-in-time information
Not Funded. Now What?

41. Regroup
• Take a deep breath
• Read summary statement
• Read it again
• Talk with your NIH program official
• Evaluate your options
• Revise & submit again?
• Choose a new research direction?
• Appeal the review outcome
• Acceptable reasons (NOT-OD-11-064):
http://grants.nih.gov/grants/guide/notice-files/NOT-
OD-11-064.html
• Differences of scientific opinion cannot be appealed

42. There is no amount of Grantsmanship
that will turn a bad idea into a good
one . . . .
. . . but there are many ways to
disguise a good idea.
Dr. William Raub
Past Deputy Director, NIH
Grantsmanship

43. NIH Policy on Post-Submission Application Materials:
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-030.html
Use NIH’s Research Portfolio Online Report Tool (RePORT).
http://RePORT.nih.gov/
NIAID Training and Career
https://www.niaid.nih.gov/researchfunding/traincareer/Pages/default.aspx
March 9, 2016 NIAID Funding News
Postdocs' Guide to Gaining Independence: Writing a Strong Grant Application
Grants.Gov>About Grants> How to Apply-Application Guide:
http://grants.nih.gov/grants/funding/424/index.htm
Helpful links
Contact information
Brenda Fredericksen
brenda.fredericksen@nih.gov
240-669-5052