"Perspectives from the NIH Study Section" Keith C. Norris, MD, FASN, FACP Professor and Executive VP for Research and Health Affairs, Charles R. Drew University Assistant Dean for Clinical and Translational Science, UCLA

1. Perspectives from the NIH Study Section
UCLA CTSI K Award Workshop
Keith C. Norris, MD, FASN, FACP
Professor and Executive VP for Research and Health Affairs, Charles R. Drew University
Assistant Dean for Clinical and Translational Science,
Geffen School of Medicine, UCLA

2. Perspectives from the NIH Study
Section
NIH Career Award (K) Programs
UCLA CTSI K Award Workshop
Keith C. Norris, MD, FASN, FACP
Professor and Executive VP for Research and Health
Affairs, Charles R. Drew University
Assistant Dean for Clinical and Translational Science,
Geffen School of Medicine, UCLA

3. NIH Career Award (K) Programs
• Overview of K Awards
• The Review of K awards
• General NIH Reviewer Guidelines

4. Mentored K Awards:
What are they?
• Support mechanisms that provide
mentored research experiences to gain
additional expertise in a new research
area or in an area that will significantly
enhance research capabilities.

5. Mentored K Awards: Objective
• It is expected that the mentored
research and career development
experience will lead to an
independent and productive
research career

6. Mentored K Awards:
Which One?
• K01: Mentored Research Scientist Development Award
• K08: Mentored Clinical Scientist Development Award
• K23: Mentored Patient-Oriented Research
Development Award
• K99/R00: NIH Pathway to Independence (PI) Award
• K12: Institutional Mentored Research Scientist
Development Program

7. Common K Award Features
• Must have a full-time appointment at applicant
organization
• Duration: three, four, or five years
• Salary – legislative cap *
• Research/development – usually 25K
*Amounts vary by participating NIH Institute

8. Common K Award Features (cont’d)
• Level of Effort:
– generally >75 percent toward K12 activities and
the remainder toward other clinical and teaching
pursuits consonant with the award objectives.
– In final 2 years may now reduce effort on K if
replaced by effort as a PD/PI or subproject PD/PI
provided they remain in mentored situation.
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html

9. K12: Options for Institutions
• K12: Institutional Mentored Research Scientist
Development Program
– Enhance research career development for
individuals, selected by the institution, who are
training for careers in specified research areas
– Provides institutions with a greater capacity for
mentoring junior investigators
– Not transferable to another institution
– Usually solicited by a Funding Opportunity
Announcement (FOA)

10. Mentored Clinical Research
Scholar Program Award (K12)
• Train and retain clinicians in clinical research
investigation
• Provide clinicians with both didactic experience
and supervised research training in more than one
discipline
• Accommodate candidates with varying levels of
research experience
• Allow clinicians engaged in patient-based or basic
biomedical research to bring a clinical dimension
to the research enterprise

11. Mentored K Awards: Review
 Candidate
 Mentor
 Career Development Plan
 Research Plan
 Institutional Environment

12. Mentored K Awards: Review
 Candidate
 Prior Research Experiences
• Potential for conducting research.
• Evidence of originality
 Publications (first-author); productivity
 Likelihood of research independence
 Justification of need for additional
research mentoring
 Letters of Reference

13. Mentored K Awards: Review
 Mentor
 Track record in mentoring
 Appropriate scientific expertise
 Research funding and publications
 Commitment to mentoring
candidate (letter of support)

14. Mentored K Awards: Review
 Institutional Environment
 Necessary resources for proposed
research and career development
 Interactions with other investigators
 Detail opportunities for research and
career development
 Institutional commitment to candidate
 assurances that the institution intends the candidate to be
an integral part of its research program
 commitment to protect at least 75% of the candidate’s
effort for proposed career development activities

15. Mentored K Awards: Review
 Career Development Plan
 Activities other than research alone that
will facilitate transition to independence
 Additional coursework to fill-in gaps?
 Grant-writing workshops?
 Seminars, journal clubs
 Participation in K30 program?

16. Mentored K Awards: Review
 Research Plan
 Should include new research training
 Hypothesis- vs. discovery-driven
 Provide a logical path to research independence
(away from mentor)
 Detailed experimental plan with potential pitfalls,
expected outcomes, alternative approaches
 (K99/R00:distinct research phases)

17. Helping Candidates Develop a Strong
Career Development Training Plan
• Understand the intent of the mentored K
award is to help new investigators achieve
independence (i.e., R01-level funding).
– Preparing for the R01 grant application that the
candidate will submit at the end of the K award
should be the organizing principle of the K grant
application, which includes both a training plan
and a research plan.

18. Career Development Training Plans
• Make a compelling argument why the
mentee needs a K award.
– Identify critical gaps or deficiencies in the
mentee’s knowledge or skills.
– Explain how additional training or mentored
research experience in these areas will enable the
mentee to compete successfully for R01 funding.
– Be specific; provide examples.

19. Career Development Training Plans
• Develop a career development training plan
that is uniquely suited to the mentee.
– Given their previous training and research
experience, mentees should propose a mix of
didactic training and hands-on research
experience that address the gaps or deficiencies in
their knowledge or skills.
– Fully exploit the training opportunities available.
– The training plan should be as carefully thought
out and presented as the research plan.

20. Helping Candidates Develop a
K Award Research Plan
• The research plan is a training vehicle. Should
be well integrated with the candidate’s training plan
and provide an opportunity to acquire new skills
• The research plan is a means to achieve
independence. Should be viewed as a precursor
for the next state of research – ideally, an R01.
• Mentored K awards provide limited funding.
The scope needs to be appropriate and feasible
($25K-$50K/year).

21. General NIH Reviewer
Guidelines

22. Significance
• Does this study address an important
problem? Do you make a compelling case?
• If the aims of the application are achieved,
how will scientific knowledge be advanced??
• What will be the effect of these studies on
the concepts or methods that drive this
field? How might this change the field? Be
convincing!!!

23. Approach
• Are the conceptual framework, design, methods,
and analyses adequately developed, well-
integrated, and appropriate to the aims?
• Does the applicant acknowledge potential
problem areas and consider alternative tactics?
• Is there an appropriate work plan included?
• Does the project include plans to measure
progress toward achieving the stated objectives?
How will you know when you are half way there?

24. Innovation
• Does the project employ novel concepts,
approaches or methods?
• Are the aims original and innovative?
• Does the project challenge or advance existing
paradigms or develop new methodologies or
technologies?

25. Investigator
• Is the investigator appropriately trained and
well suited to carry out this work?
• Is the work proposed appropriate to the
experience level of the principal investigator
and other significant investigator participants?
• Is there a prior history of conducting (fill in
area) research? Does not fund empty
aspirations!

26. Environment
• Does the scientific environment contribute to the
probability of success?
• Do the proposed experiments take advantage of
unique features of the scientific environment or
employ useful collaborative arrangements?
• Is there evidence of institutional support?
• Is there an appropriate degree of commitment
and cooperation of other interested parties as
evidence by letters detailing the nature
and extent of the involvement?

27. Budget
• Are all requests justified scientifically
• Do special items have quotes
• Is the project feasible with the given
budget
– Low budget often viewed worse than high budget,
• Low budget - applicant does not understand what is
need to do the work - may worsen the score
– -High budget -: will get cut but usually not worsen
score, unless really high

28. Other Key areas
• Protection of human subjects (closely
reviewed)
– HIPAA plan
– data and safety monitoring plan
– inclusion of women, minorities & children
– recruitment plan
– evidence (not plan) of proposed partnerships
• Animal welfare
• Biohazards
• Evaluation

29. NIH grant application scoring system
• 9-point rating for the impact/priority score with 1
= Exceptional and 9 = Poor.
• Ratings in whole numbers only (no decimal).

30. Helpful Hints for K Awards
 Read the FOA; contact program staff to discuss your
eligibility and proposed plan!
 Read the Instructions in the PHS 398 application kit!
 Observe page limitations
 Give yourself and your mentor enough time
 Give references and letters of support enough time
 Career Development Plan should be appropriate
considering previous experience
 Capable and experienced mentor? Co-mentor?
 Project should have merit as research and as career
development mechanism
 Arrange for pre-review

31. K Award Success

32. "The greatest obstacle to discovery
is not ignorance –
it is the illusion of knowledge
-Daniel Boorstin

33. Career Development Programs
• K Kiosk at:
http://grants.nih.gov/training/careerdevelopmentawards.htm
• Career Award Wizard at:
http://grants.nih.gov/training/kwizard/index.htm