1. A reviewer’s perspective on K-awards:
Jerrold Turner, M.D., Ph.D.
Professor and Associate Chair
Department of Pathology
K08 Awardee,
Member, NIH (NIDDK) Research Training Study
Section subcommittee C), (Chair )

2. Success is possible!

3. Vesell and Mandel. Science (1982)
“One of America's great strengths… its research capability in the basic biomedical sciences… is being eroded as a consequence of inflation, reduction in moneys available for direct costs of research, and by present policies...”
“Scientists are now spending an inordinate part of their time writing and rewriting grant proposals...”
Vesell and Mandel. Science (1982)

4. Annualized, Inflation-Adjusted NIH Budget Growth
Loscalzo. N Engl J Med (2006)

5. Number of NIH K Awards* Fiscal Years 1997-2006
*Includes both individual and institutional awards. The actual number of individual participants is higher.

6. Trends in Number of Individual NIH K Awards, by Institute or Center, Fiscal Years 1997-2006
NCI
NIDDK
NIAID

7. NIDDK Success Rates for K01-K08, Fiscal Years 1996-2006

8. Who should apply? K01 - Mentored Research Scientist Development Award
“The K01 award is intended to provide research support for a three to five-year transition period between postdoctoral training and a career in independent investigation.”
NOT a postdoctoral fellowship award (e.g. NRSA)
Should have an independent academic lab BEFORE the end of the award
MUST have significant preliminary data AND Career development plan
K08 – Mentored Clinical Scientist Development Award
“The K08 award is intended to provide three to five years of research support in the transition between fellowship or trainee experience or clinical training and a career in independent investigation for clinically-trained individuals.”
NOT for any M.D. (clinically-trained!)
K99/R00 – NIH Pathway to Independence (PI) Award
“The K99/R00 Pathway to Independence Award Program (PI) is designed to facilitate receiving an R01 award earlier in an investigator’s research career.”
MUST be a “superstar” ready for high-profile independence within 1-2 years
CANNOT already have faculty appointment
Does not require citizenship/green card
Very few awarded!
Call your Program Director Call your Program Director Call your Program Director

9. Review Criteria K01K08 >60% <40% <30% >70% R01
Investigator:
Training background, productivity, potential, career development plan
Are the parts good quality?
Do they fit well together?
INVESTIGATOR
Environment:
Mentor, collaborator, space, resources, institutional commitment
Approach:
Will experiments work? And when they don’t?
Can I “sell” this package to the committee?
Significance:
Impact on field?
SCIENCE
Innovation:
Technique/Reagent
Topic/Perspective

10. K Awards – Submission Requirements (and Review Criteria)
Candidate
Career Development Plan
Research Plan
Mentor(s)/Consultant(s)/Collaborator(s)
Environment and Institutional Commitment to the Candidate
Letters of Reference
Budget

11. K Awards – Submission Requirements
i. Candidate
Describe the candidate’s training background including prior research interests, experience and publications.
Describe how the candidate’s training background relates to his or her long-term career plans.
Describe the candidate’s commitment to a career in research.
Describe the candidate’s professional responsibilities at the grantee institution.
Provide evidence of the candidate’s potential to develop into an independent investigator.

12. The candidate
Is this the person that we (study section) want to support (i.e. encourage NIH council to give it precious training funds to)?
Biosketch. Must have first-author research publications. Good to fill-out with middle authorship, but first-author is much better.
If publications OK, did applicant drive the research?
Tell me the story
a) why you do it
b) what you did
c) what was learned
Tell by your narrative, sponsor’s statement, and recommendation letters (choose your recommenders carefully; these are an important way the committee will get to know you – consider the source) .
You outline the case. Have letters support it (draft them yourself if you can)

13. K Awards – Submission Requirements ii. Career Development Plan
Present a plan that shows a logical progression from training to K08 award and then to independence.
Justify the need for further career development to become an independent investigator.
Include didactic components (course work, seminars, workshops, conferences, etc.) – must be relevant to the candidate’s career goals.
Include a time table for career transition and publication plan.
Include an advisory committee with plans to monitor the candidate’s progress.

14. Career Development Plan
What does this person want to be in 3-5 years?
Is it a worthwhile goal?
Is applicant have right attributes/background for goal?
Does goal make use of current attributes
For K08, is plan right for “Physician-Scientist”
Is there synergy between research and clinical activities?
Will research aid clinical perspective?
Will clinical perspective aid research?
If CDP is successful…
Will applicant be a clone of mentor?
Will applicant have unique niche or outlook?
Will applicant be competitive for R01?
Good CDPs usually…
include classes, lots of seminars, presentations, meetings, etc.
broad interactions with various faculty, ideally stretching mentor’s network

15. K Awards – Submission Requirements
iii. Research Plan
Provide a sound research project that is consistent with the candidate’s level of research development and objectives of his or her career development plan.
Include:
Specific aims
Background and Significance
Progress Report/Preliminary Studies
Research Design and Methods
Human Subjects (include plans for data and safety monitoring for phases I and II trials)
Vertebrate Animals
Training in the Responsible Conduct of Research
References

16. The Application – Specific Aims
PHS398 Instructions:
List the broad, long-term objectives and what the specific research proposed in this application is intended to accomplish. State the hypotheses to be tested. One page is recommended.
The Specific Aims page is key to a successful grant.
Linkage of individual components within the Specific Aims section and elimination of extraneous detail are key to leading your reviewers to a position of advocacy.
Outlining is your key to developing linkage and to avoiding unnecessary detail.

17. Progression of strong SA section
GAP in knowledge
OBJECTIVE of this application
(career development!)
Central HYPOTHESIS
SPECIFIC AIMS
EXPECTED OUTCOMES
(career development!)

18. Research Plan
1) Is it right for the applicant and CDP?
Read it like any research plan
Aims clear?
Reasonable basis?
Seem important?
Reasonable plan to achieve aims?
Appropriate expertise available?
Are possible outcomes clear and worthwhile?
Do: Spoon-feed
Don’t: Shove down readers throat

19. Research Plan - Anticipate what reviewers will ask
What is the central hypothesis? - validity, clarity.
Is the question important and novel? - potential impact
Are the specific aims logical and feasible? - organization
Since goal is independence, is there a plan (time line) for next grant submissions (R03, R01)?

20. K Awards – Submission Requirements
iv. Mentor
The mentor and the candidate are responsible for the planning, direction, monitoring and execution of the program.
Track record in training and placing independent investigators.
Has sufficient independent research support.
Provide the following information: (i) research qualifications and experience as a research director, (ii) a plan to describe the nature of supervision and mentoring, (iii) a plan for transitioning the candidate to independence, and (4) a plan for monitoring the candidate’s progress.
Signed statements from consultant(s) and collaborator(s).

21. K Awards – Submission Requirements
v. Environment/Institutional Commitment
The sponsoring institution must document a strong and well-established research and career development program related to the candidate’s area of interest.
Provide a statement of commitment of the candidate’s development into an independent investigator – the commitment should not be contingent upon the award.
Describe resources, facilities and enrichment programs (seminar, workshops, etc.) available to the candidate.
Provide assurances of the minimal protected effort.
Letter of agreement form GCRC or CTSA.

22. Global questions reviewers will ask
What is the potential for independence of the candidate?
Is the mentor qualified?
Are the proposed experiments feasible?
Is there compelling preliminary data?
Is there a predictable flow to the proposal?
Are the facilities, environment and resources adequate?

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