(K23) Mentored Clinical Scientist Development Award

Report
Getting Funded:
NIH K and R Grants
Joel Tsevat, MD, MPH
Co-Director, CCTST
New Faculty Orientation
13 August 2014
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Getting Started
• K (Career Development Award) or R (Research Grant)?
• Allow at least 6 months for an R01, 10-12 months for a K award
• Figure out where to submit
– Talk to your mentor(s)
– Find a Funding Opportunity Announcement via NIH Guide for Grants
and Contracts or Grants.gov
– Look at specific Institute/Center websites
– Call the program officer!
• Read the instructions carefully: SF424 (R&R)
• Look at previous successful applications, especially in the case of K
awards
• Register with eRA Commons
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Career Development Awards
Medical
School
Internship/Residency
Specialty
Mentored Clinical Scientist
Development Award (K08)
Independent
Investigator
Mentored Patient-Oriented
Research CDA (K23)
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Common Types of K Awards
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K01 Mentored Research Scientist Development Award
K02 Independent Scientist Award
K07 Academic Career Award: Development vs. Leadership
K08 Mentored Clinical Scientist Development Award
K22 Career Transition Award
K23 Mentored Patient-Oriented Research Career Development
Award
• K24 Midcareer Investigator Award in Patient-Oriented Research
• K25 Mentored Quantitative Research Development Award
• K99/R00 Pathway to Independence Award
Use the Career Award Wizard to find the right one for you
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Common Features of NIH
Career Development Awards
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Salary, fringe benefits, research/development costs, 8% F&A
– Salaries capped between $75,000 and legislated cap ($179,900)
– Research/development costs generally $25,000 to $50,000
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Duration: 3-5 years
Entry-level awards require a mentor
More senior awards are sometimes renewable
Level of effort
– Mentored awards require full-time effort (defined as at least 75% on
research and the rest on other career development activities)
– More senior awards either 25% to 50% or full-time
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Eligibility
– Doctoral degree (generally)
– US citizen, non-citizen national, permanent resident
– Previous NIH principal investigators may be ineligible
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Anatomy of K Applications
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Introduction to application (for resubmissions only)
Candidate’s background
Career goals and objectives
Candidate’s plan for career development/training activities during award
period
Training in the responsible conduct of research
Candidate’s plan to provide mentoring (K24 and K05 applications only)
Plans and statements of mentor(s)
Letters of support from collaborators, contributors, and consultants
Description of institutional environment
Institutional commitment to candidate’s research career development
Specific aims
Research strategy
Etc.
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Common Types of R Grants
• R01 Research Project Grant
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Most common mechanism
Generally 3-5 years
No specific $ amount limit but need advance permission for > $500k/yr
Mostly for more established investigators but special dispensation for
new investigators
• R03 Small Grant
– 2 years
– Generally ≤ $50k/yr direct costs
• R21 Exploratory/Developmental Research Grant
– 2 years
– Total direct costs ≤ $275k
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Anatomy of an R Application
• Cover letter
– Title, FOA number, requested study section, list of
individuals/study sections who should not review, disciplines
involved if multidisciplinary
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Title
Project summary/abstract
Project narrative
Administrative sections
– Budget, budget justification
– Biosketches (with tailored personal statements), other support
pages
– Facilities and other resources
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
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Introduction to application (for resubmissions only)
Specific aims
Research strategy
– Significance
– Innovation
– Approach
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References
Human subjects, inclusion of women and minorities, inclusion of children
Certain other sections
Appendices and collaborative agreements
– Appendices are generally limited to surveys, questionnaires, and other data collection
instruments
– Do not use them to circumvent the 12-page research plan limit
– Don’t include manuscripts unless in press (max 3), letters of support, etc.
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Planned enrollment table
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Specific Aims
• By far the most important piece of the application
because it’s all that most reviewers will read
• Official instructions
– State concisely the goals of the proposed research and
summarize the expected outcome(s), including the impact
that the results of the proposed research will exert on the
research field(s) involved.
– List succinctly the specific objectives of the research
proposed, e.g., to test a stated hypothesis, create a novel
design, solve a specific problem, challenge an existing
paradigm or clinical practice, address a critical barrier to
progress in the field, or develop new technology.
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Specific Aims – Tips
• Should tell a story
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What is the public health or scientific problem (1-2 sentences)?
What is known about your research topic (2-3 sentences)?
What have you/your team done (don’t be modest!)?
What gap(s) remain (1-2 sentences)?
What questions will you answer (aims; hypotheses)?
Who, when, where, how (summarize methods, study sites, sample size,
etc.)?
– Summarize the impact (1-2 sentences)
• Career development awards should also weave in
– Gaps in your knowledge base and why you need additional training
– Mention of your mentorship team and environment
– Why you are perfectly positioned to do this – remember, career
development awards are about you!
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Significance
• Explain the importance of the problem or critical
barrier to progress in the field that the proposed
project addresses.
• Explain how the proposed project will improve
scientific knowledge, technical capability, and/or
clinical practice in one or more broad fields.
• Describe how the concepts, methods,
technologies, treatments, services, or preventative
interventions that drive this field will be changed if
the proposed aims are achieved.
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Innovation
• Explain how the application challenges and seeks to
shift current research or clinical practice paradigms.
• Describe any novel theoretical concepts, approaches
or methodologies, instrumentation or interventions to
be developed or used, and any advantage over
existing methodologies, instrumentation, or
interventions.
• Explain any refinements, improvements, or new
applications of theoretical concepts, approaches or
methodologies, instrumentation, or interventions.
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Approach
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Overview
Preliminary studies (results, feasibility)
Study subjects
Study procedures
Measurements (outcomes, predictor variables, confounders)
Statistical analysis
Data management and quality control
Resource sharing plans
Timetable and org chart
Limitations, potential problems, and alternative approaches
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Page Limits
Section
Page Limit*
Introduction to Resubmission
Application
1
Specific Aims
1
Research Strategy
12 or 6 (R03, R21)
Candidate’s Background, Career Goals
and Objectives, and Career
Development/Training Activities During
Award Period and Research Strategy (K
awards)
12
Plan for Instruction in the Responsible
Conduct of Research (K awards)
1
Letters from mentors (K awards)
6
Letters from collaborators (K awards)
6
Biosketch (per investigator)
4
Appendix
10 PDF attachments
*Double-check specific FOA instructions
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Letters of Reference for Career
Development Awards
PROGRAM
K01
K02
K05
K07
K08
K18
K22
K23
K24
K25
K26
K99/R00
DESCRIPTION
Mentored Research Scientist Development Award
Independent Scientist Award
Senior Scientist Award
Academic Career Award
Mentored Clinical Scientist Development Award
Career Enhancement Award
Career Transition Award
K23 Mentored Patient-Oriented Research Career Development Award
Mid-Career Investigator Award in Patient Oriented Research
Mentored Quantitative Research Career Development Award
Midcareer Investigator Award in Mouse Pathobiology Research
NIH Pathways to Independence (PI) Award
MENTOR
Yes
No
No
*
Yes
Yes
*
Yes
No
Yes
No
Yes
REFERENCE
LETTERS (3-5)
Yes
No
No
*
Yes
Yes
Yes
Yes
No
Yes
No
Yes
*Varies; check FOA
Note: these letters are from people not directly involved in the project
and are submitted through eRA Commons
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Review Process
• Submit grant to Center for Scientific Review
• 2 levels of review
– Special Review Group (SRG) – study section
– Advisory Council
• Assigned to Program Officer and SRG
– Scientific Review Administrator assigns to reviewers
– Reviewers write written reports and assign
preliminary scores
– Prior to SRG meeting, triage of applications scored in
bottom half
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Reviewers Scores
Overall Impact or
Criterion Strength
High
Medium
Low
Score
Descriptor
1
Exceptional
2
Outstanding
3
Excellent
4
Very Good
5
Good
6
Satisfactory
7
Fair
8
Marginal
9
Poor
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Review Criteria – Research Project Grants
Criterion
Score
Overall impact
1-9*
Significance
1-9
Investigators
1-9
Innovation
1-9
Approach
1-9
Environment
1-9
Human subject protection
Acceptable vs. not acceptable
Inclusion of women and
minorities
Acceptable vs. not acceptable
Inclusion of children
Acceptable vs. not acceptable
*Not necessarily an average of the other 5 criteria
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Review Criteria – Career Development
Awards
Criterion
Score
Candidate
1-9
Career development plan
1-9
Research plan
1-9
Mentors, collaborators
1-9
Environment and institutional
commitment to candidate
1-9
Human subject protection
Acceptable vs. not acceptable
Inclusion of women and
minorities
Acceptable vs. not acceptable
Inclusion of children
Acceptable vs. not acceptable
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Study Section Meeting
• Assigned reviewers summarize critiques
• Open discussion
• Final scoring of overall impact/priority
scores
• Summary statement prepared
• Program officer may or may not be
present
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Advisory Council
• NIH program staff assembles
applications/scores/percentiles
• Staff provide grant funding plan to Council
• Council reviews applications based upon
IC goals and advises Director
• IC Director makes final funding decision
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
A Few Notes on Style
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Application must be well written; corollary: sloppiness will kill it because it annoys the
reviewers and casts doubt on you as a researcher
Use basic font (Arial, Helvetica, Palatino Linotype, or Georgia 11) throughout
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Font for tables can be smaller but make sure it’s still legible
Avoid underlining – underlining went out with the typewriter
Use bold font for section headings and subheadings
Use italics sparingly – a word here, a few words there (e.g., for counterintuitive statements); don’t combine
with bold font
Bullets are fine
Indicate changes from previous version with vertical line in left margin
Use English and avoid jargon
Use active voice
Use common abbreviations liberally but don’t use many uncommon abbreviations;
add a table of abbreviations on p. 1 of text
Career development awards
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Include a table of activities (coursework, research, clinical) with respective percent efforts for each year
Gantt charts are useful; specify by quarter or even by month
1st person vs. 3rd person
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Before You Submit
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Understand the grant resubmission policy
– Old grant submission policy: 2 strikes (A0 and A1) and you’re out in the old ballgame
– For NIH and AHRQ grants, effective April 2014, following an unsuccessful
resubmission (A1) application, applicants may submit the same idea as a new (A0)
application, but without the ability to respond formally to the previous reviews
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Get your colleagues, friends, and enemies to read it before it goes out,
allowing ample time to make changes
Proofread, proofread, proofread
– Typos
– Grammatical errors
– References
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Try to avoid last-second edits
– If they are substantive changes, re-read entire draft to ensure internal consistency
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
CCTST Funding Opportunities
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
CCTST Funding Opportunities
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
References
• Hulley SB, Cummings SR, Browner WS, Grady DG,
Newman TB. Designing Clinical Research (4th ed.).
Philadelphia: Lippincott Williams & Wilkins; 2013.
• NIAID website:
http://www.niaid.nih.gov/researchfunding/newsletter/Pages/default.aspx
• NIH website:
http://grants.nih.gov/grants/writing_application.htm
• SF424 (R&R) Application Guide for NIH and Other
PHS Agencies (updated 25 July 2013)
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Funding Your Research-NSF
Michael Sokoloff, PhD
Department of Physics
University of Cincinnati
556-0533
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Divisions of the NSF
• Biological Sciences
• Computer Information, Science and
Engineering
• Education and Human Resources
• Engineering
• Environmental Research
• Geosciences
• Math and Physical Sciences
• Polar Research
• Social and Behavioral and Economic Sciences
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Additional Aspects
• Cyberinfrastructure
• Cross-cutting (e.g. Research Experiences for
Undergraduates)
• Integrative Activities
• International Activities, Collaboration
• Focus: Broadening Participation/Diversity
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Special Considerations
• Two review criteria for all proposals:
Intellectual Merit and Broader Impacts
• Data Management Plan
• Postdoc Mentoring Plan
• Certification Regarding Responsible Conduct
of Research (RCR)
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Limitations
• Research with disease-related goals, including work
on the etiology, diagnosis or treatment of physical or
mental disease, abnormality, or malfunction in human
beings or animals, is normally not supported. Animal
models of such conditions or the development or
testing of drugs or other procedures for their
treatment also are not eligible for support.
• Bioengineering that applies engineering knowledge to
problems in biology and medicine while advancing
engineering knowledge is eligible for support
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
NSF CAREER Grants
CAREER: The Faculty Early Career Development (CAREER)
Program is a Foundation-wide activity that offers the
National Science Foundation's most prestigious awards in
support of junior faculty who exemplify the role of teacherscholars through outstanding research, excellent education
and the integration of education and research within the
context of the mission of their organizations. Such
activities should build a firm foundation for a lifetime of
leadership in integrating education and research. NSF
encourages submission of CAREER proposals from junior
faculty members at all CAREER-eligible organizations and
especially encourages women, members of underrepresented
minority groups, and persons with disabilities to apply.
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
DOE CAREER Grants
The Office of Science of the Department of Energy
announces the fiscal year 2015 Early Career Research
Program. The funding opportunity for researchers in
universities and DOE national laboratories was announced
July 30, 2014. The Early Career Research Program, now in
its sixth year, supports the development of individual
research programs of outstanding scientists early in their
careers and stimulates research careers in the disciplines
supported by the DOE Office of Science. Opportunities
exist in the following program areas: Advanced Scientific
Computing Research (ASCR); Biological and Environmental
Research (BER); Basic Energy Sciences (BES), Fusion Energy
Sciences (FES); High Energy Physics (HEP), and Nuclear
Physics (NP). Mandatory pre-applications/pre-proposals are due at
5 PM Eastern Time on September 11, 2014.
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Preparing Proposals
• Talk to the Program Officers. They want to receive the
strongest applications possible, so they will offer good
guidance.
• Look at the abstracts of funded research online. See
what level of funding is typically provided.
• Attend the proposal preparation workshop offered by the
office of the VP for Research.
• Pretend that your application is an essay contest. Your
science must be excellent, but you are competing with
other excellent scientists. The quality of the prose, the
organization of the material, and the story you tell are
critical to your funding success.
• Ask for help. And give your mentors-to-be enough time.
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Funding Agencies
other than
NIH and NSF
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Sources of Support
1972 - 2012
• NSF
19 %
• NIH
12
• DOE
27
• DOD
11
• EPA
5
• Industrial
• Ohio
25
• Misc.
0.1
0.9
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Ohio
• Edison Sensor Technology Center
• Ohio Board of Regents
• Instrumentation Grants
• Ohio Technology Action Fund
•
Commercialization with industrial partner
• Ohio Third Frontier
• Wright Centers of Innovation
•
Institute for Development & Commercialization
•
of Advanced Sensor Concepts
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
UC Foundation
Thomas Seddon
Director, Corporation &
Foundation Relations
Susan Dunlap
Associate Director - Corporation &
Foundation Relations
Ph: 513-556-6361
[email protected]
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
What is
UC Foundation…
•
Separate 501 C 3 tax exempt organization whose sole mission is increasing
private (non- governmental) support for University of Cincinnati
programs, research, scholarships, equipment, etc.
•
College Fundraisers
– Alumni
– Faculty Staff Campaign
– Grateful Patient
– General Community
•
Central Units – Support College & University Wide Fundraising
– Annual Support - Mailings, Telefund, and Social Media
– Planned Giving
– Corporate Foundation & Relations (CFR)
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Partnering with CFR
Concept
Request for
Prospect
Support
Research
Feedback
LOI/Proposal
Submission
OR
Reporting
*Also compile and e-mail weekly RFP list
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Helpful Tips
• Use CFR as a resource
• Be a Good Partner
– Answer emails/phone calls
– Meet deadlines
– Be partner in monitoring/reviewing foundation
web-sites and publications
• Submit CV to faculty expertise database
• Share your network of colleagues, alumni &
friends
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
UC Corporate Partners Program
• The University of Cincinnati has enjoyed
a long history of corporate support and
has developed long-term relationships
with many corporations.
• Companies want to engage universities
on an enterprise, not just a philanthropic
basis, focusing their interactions that
provide strategic benefits and ROI.
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
University of Cincinnati
Corporate Partners Opportunities
There are many opportunities on the
UC campus for corporation/business
involvement. We need to maximize
the touch points to fully develop
each partnership.
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Corporate Partners
Opportunities

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


Recruit and Develop Talent
Training and Workforce Development
Entertain your Employees or Customers
Access UC’s Research Expertise
Transfer Technology
Partner with UC Forward
IT Solutions Center
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.
Corporate Partners
Opportunities
 Entrepreneurship & Community Development
Clinic
 Sponsor Events and Programs
 UC Corporate Alumni Network
 Matching Gift Programs
 Provide Goods and Services to UC
 Invest in the Future through Philanthropy
 Customized Options
The Clinical and Translational Science Awards (CTSA) is a registered trademark of DHHS.

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