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UCLA CTSI KL2 Award, New NIH Guidelines on Rigor & Transparency

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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

Published in: Education
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UCLA CTSI KL2 Award, New NIH Guidelines on Rigor & Transparency

  1. 1. New Grant Guidelines: Rigor and Transparency Mitchell Wong, MD, PhD Director, KL2 Program
  2. 2. Call for change • Concern over reproducibility and transparency in methods and reporting of findings
  3. 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. 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. 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. 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. 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. 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. 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. 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. 11. UCLA CTSI KL2 Translational Science Award Mitchell Wong, MD, PhD Director, KL2 Program https://ctsi.ucla.edu/education/pages/kprogram
  12. 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. 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. 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. 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. 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. 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. 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. 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. 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 21
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