Explanation of the UCLA CTSI KL2 Award and the new NIH guidelines on Rigor & Premise. Mitchell D. Wong, MD, PhD Professor of Medicine at UCLA Executive Co-Director, Specialty Training and Advanced Research (STAR) Program Director, UCLA CTSI KL2 Program Presentation date: February 09, 2017

1. New Grant Guidelines:
Rigor and Transparency
Mitchell Wong, MD, PhD
Director, KL2 Program

2. Call for change
• Concern over reproducibility and
transparency in methods and reporting of
findings

3. Four Areas of Focus
• Premise
• Design
• Variables
• Authentication
Basis of prior knowledge for the proposed research
Rigorous study design for robust and unbiased results
Consideration of relevant biological variables
of key biological/chemical resources
http://grants.nih.gov/reproducibility/index.htm

4. NIH Description of Premise
• What is the research that forms the basis for the
proposed research question?
• Describe the general strengths and weaknesses of
prior research that is crucial to support the
application
• How will the proposed research address weaknesses
or gaps in knowledge?
• Scientific premise will be reviewed as part of
Research Plan criterion for CDAs (or Significance for
other grants)
• NIH will not prescribe a “formula” for addressing
scientific premise.
http://grants.nih.gov/grants/peer/guidelines_general/Reviewer_Guidance_on_Rigor_and_Transparency.pdf

5. My Approach (Research
Strategy)
• Significance:
• Premise:
• Innovation:
Why is this research question important?
What is and is not known from prior scientific
research?
How will the proposed research add to
our scientific knowledge?

6. Rigor
• “The strict application of the scientific method to
ensure robust and unbiased experimental design,
methodology, analysis, interpretation and
reporting of results.”
• ”Full transparency in reporting experimental
details”
• Will be assessed as part of the Research Plan
criterion for CDAs (Approach criterion for other
grants)
http://grants.nih.gov/reproducibility/index.htm

7. Elements of Rigor
• Study design
• Appropriate controls
• Replication of experiments
• Randomization
• Blinding
• Sample size/power
• Statistical Methods
• Missing data
• Confounding variables
• Selection bias
Adapted from presentation by Jennifer Kemp, U of Colorado

8. Consideration of relevant
biological variables
• Consideration of “critical factors affecting health
or disease in vertebrate animals or human
subjects.”
• Consideration of sex as a biological variables must
be addressed.
• Other biological variables: age, weight, genetic
strain.
• Can be taken into account in the Approach or
Research Plan criterion score.

9. Resource Authentication
• Key biological/chemical resources:
- May differ from lab to lab or over time
- Could influence research data
- Integral to proposed research
• Separate attachment (1 page or less) and should
not include authentication data.
• Will be reviewed after scoring grant.

10. Additional Sources for Instructions
• https://www.nih.gov/research-training/rigor-reproducibility
• http://grants.nih.gov/reproducibility/index.htm
• http://grants.nih.gov/reproducibility/faqs.htm

11. UCLA CTSI KL2
Translational Science
Award
Mitchell Wong, MD, PhD
Director, KL2 Program
https://ctsi.ucla.edu/education/pages/kprogram

12. Award Overview
• Career development support for junior
faculty within the UCLA CTSI Consortium
• Interdisciplinary, translational science
(basic, clinical and HSR)
• Similar in structure to K08/K23 award

13. Support
• Annual award, renewable for up to 3 years and
contingent on the UCLA CTSI competitive
renewal.
• Support
– $75k salary plus benefits
– $25k research support
– $4k for tuition or coursework
– $2k for travel
– $1500 for statistical support in addition to in-
kind support from DOM Stats

14. Eligibility
• Doctoral level research degree or professional
degree (with advanced research training)
• Faculty level title as of July 1st
of the application
year at a UCLA CTSI Institution
• Commit 75% of effort to translational research
and aims of the KL2 (50% minimum for some
specialties like surgery)
• U.S. Citizen or non-citizen national, permanent
U.S. resident

15. Eligibility (Prior/Pending
Grants)
• May have had a small grant (R03, R21)
• May have had prior K12 funding (total K12 + KL2
funding cannot exceed 5 years).
• Cannot have:
– Prior or current PI of a NIH R01 or equivalent grant
(direct costs>$100k per year)
– Prior or current PI of a K08/K23 or other NIH K award
– Prior or current PI of a VA Career Development or R01
Equivalent grant
– PI of a pending K award application, pending R award in
similar area
– Current co-investigator funding on an R01/Project grant

16. Future Funding for KL2
• KL2 Awardees may apply for K08/K23 or VA CDAs
– Must relinquish KL2 if awardee receives NIH/VA CDA
– Total CDA funding (KL2/K12 + individual CDA) cannot
exceed 5 years. Some institutes (i.e. NICHD, NHLBI)
allow 6 years.
• KL2 Awardees may apply for R01, Program grants
– Must maintain 75% effort on KL2 in year 1
– May decrease to 50% effort in last 2 years of K support

17. Selection Criteria
1. Proposed research- Quality, innovation, significance,
feasibility, promise for future funding, relevance to
interdisciplinary, translational research
2. Candidate- Training, productivity, promise
3. Mentor- Track record in mentorship and research,
commitment to candidate
4. Educational Plan- Well described and planned, fit with
research plan, provides candidate with new skill set
5. (Environment)- Commitment from institution,
department/division, availability of support and
resources to conduct research and educational plan

18. Application Components
• Letter of intent- Name, mentor, title, biosketch, specific aims (to
help KL2 selection committee identify appropriate reviewers)
• Project Summary/Abstract (30 lines of text)
• Specific Aims (1 page)
• Program Plan (12 pages)- Research, Education and Career Plan
• Authentication of Key Biological and/or Chemical Resources (1 page)
• Human Subjects (when applicable)
• Animal Subjects (when applicable)
• Training in the Responsible Conduct of Research (1 page)
• Letters of Support from Mentoring Team (6 pages maximum)
• Institutional Letter of Support (2 pages maximum)
• Mentoring Team NIH Biosketches
• Candidate’s NIH Biosketch and NIH Other Support Pages
• Budget and budget justification
• References
• Data and Safety Monitoring Plan (when applicable)
• Appendices allowable (e.g. letter of support for use of equipment or
data)

19. Annual Application Timeline
• Letter of intent deadline: early February
• Application deadline: late February
• Applicant interviews: early May
• Awardees will be notified by late May-early June
• Grant start date July 1st
• Funds will not be released until IRB/IACUC
approval(s) are received AND research protocol
has been approved by the NCATS Program Officer

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21. The Grant Library
•Currently K Grant Proposals, R01 Grant Proposals, U
Grant Proposals and new format NIH Biosketches
•Secure platform for sharing grants
•Video instructions on how to request access:
•http://ctsi.ucla.edu/funding/pages/sample
•TO access:
•http://intranet.ctsi.ucla.edu
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