New Grant Guidelines:Rigor and Transparency

Mitchell Wong, MD, PhDDirector, KL2 Program

Call for change• Concern over reproducibility and

transparency in methods and reporting of findings

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

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

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?

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

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

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.

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.

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

UCLA CTSI KL2 Translational Science

AwardMitchell Wong, MD, PhDDirector, KL2 Program

https://ctsi.ucla.edu/education/pages/kprogram

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

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

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

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

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

Selection Criteria1. Proposed research- Quality, innovation, significance,

feasibility, promise for future funding, relevance to interdisciplinary, translational research

2. Candidate- Training, productivity, promise3. Mentor- Track record in mentorship and research,

commitment to candidate4. 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

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)

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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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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