K-Awards - [email protected]

Report
Nuts and Bolts of K Award Grant
Submission Process
Denise Wynn, MBA
Training Coordinator
Office of Research Administration
January 9, 2014
Definitions
•
•
•
•
•
CDA – Career Development Award
K – Career Development Award
FOA – Funding Opportunity Announcement
SF424 R&R – electronic application form packet name
Adobe forms – current forms used by applicants that
DO NOT have system-to-system capacity
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Multiple Systems Working Together
• SPS: Sponsored Projects System
• Grants.Duke: faculty interface with SPS
• Grants.gov: single portal to apply for Federal grant funding – used
by all 26 Federal grant-making agencies
• eRA Commons: NIH electronic system
– Retrieves applications from Grants.gov
– Validates data submitted
– Provides status/award information
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Registration Requirements
eRA Commons registration
• Principal investigators (including fellows)
– must have a PI Commons account to submit
electronically
• Send Name, Preferred Login name, and email
address to Department Business Office or
[email protected]
• Account will be established and affiliated with Duke University
• Must validate account (confirm/complete Personal Profile
information) UPDATE YOUR PROFILE
May require up to 2 weeks to process. Must be able to log into Commons
account before applications are submitted.
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K-Awards - Mentor & Ref Letters
MENTOR
REF
LTRS
Mentored Research Scientist Development
Yes
Yes
K02
Independent Scientist Award
No
No
K05
Senior Scientist Award
No
No
K07
Academic Career Award
*
*
K08
Mentored Clinical Scientist Development
Yes
Yes
K18
Career Enhancement Award
Yes
Yes
K22
Career Transition Award
*
Yes
K23
K23 Mentored Patient-Oriented Research CDA
Yes
Yes
K24
Mid-Career Investigator Award in Patient Oriented
No
No
K25
Mentored Quantitative Research CDA
Yes
Yes
K26
Midcareer Investigator Award in Mouse Pathobiology
Research
No
No
K99/R00
NIH Pathways to Independence (PI) Award)
Yes
Yes
PROGRAM
DESCRIPTION
K01
*Varies with career status and source of award. Check the FOA
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K-Awards - Reference Letters
• Electronic submission of reference letters is a
separate/independent process from submitting an
application.
• Reference letters are submitted by the Referee directly
via eRA Commons (referee does not need to log on to
Commons)
• Letters may be submitted prior to application receipt at
Commons but must be submitted no later than the
application deadline. (NOT-OD-11-079)
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Reference Letters
Most Mentored CDAs require at least three but no more than five reference
letters.
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Applicant's PI Commons User ID
PI's last name as it appears on the Commons account
Funding Opportunity Announcement (FOA) number
FOA opening date and application submission deadline
Letters are limited to 2 pages in PDF format
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What to include in the Reference Letter
Describe the qualities and potential of the candidate for the career
development award program for which support is being requested.
This should include your evaluation with special reference to:
• potential to become an independent research scientist;
• evidence of originality;
• adequacy of scientific background;
• quality of research endeavors or publications to date, if any;
• commitment to health-oriented research; and
• need for further research experience and training
• any additional related comments that the referee may wish to provide
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Submitting Reference Letters
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Reference Letters – cont.
• Upon receipt of reference letter, both the Referee and the
Candidate will receive a confirmation email
• Candidates can check status on eRA Commons
– Log in to your account
– Check Status screen
• Applications that are missing the required letters may be
delayed in review or may not be accepted
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Grants.Duke.edu
•
•
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Use NetID
and NetID
Password
Internet
access
Click Edit
SPS Status:
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
Init: Department entering data

PNCA: Routing to departments for approval

PCA: In ORA for review and approval

Awaiting Submission: Ready for PI “release”
Grants.Duke
• Displays info
from SPS
• PI name links to
Commons User
Name and
Degrees
Menu includes
• Opportunity
• Attachments
• Check
• Release
• Print Preview
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Grants.Duke
•
Validate Commons
User Name
•
Confirm account is
ACTIVE by logging into
eRA Commons
•
Information in NIH
Commons should
match info in
Grants.Duke
•
Enter degrees to
appear in proposal
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Grants.Duke
Delegates
• Delegates may
upload files
• Delegates
CANNOT submit
proposals
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Adding Delegate to Grants.Duke
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K-Awards
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K-Awards
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K-Awards
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Grants.Duke
• Opportunity
•
Check number
against Grants.gov
• Identifies
available form
packets
• Checks title of
opportunity
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PA-09040
K-Awards - Instructions
• Applications are NEW unless resubmitting
• Start date set by NIH – depends on submission
cycle
• Attach Introduction ONLY if you are resubmitting
application - limited to 3 pages
• Project Summary/Abstract – limited to 1 page
• List of Referees – attach under Additional
Attachments
• Facilities – describe institutional facilities and
resources available to candidate
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K-Awards - Biosketch
Candidate’s Biographical Sketch
• Biographical sketch limited to 4 pages
• Position Title: “current” and “projected” position titles may be provided
• Education – include month and year of degree conferred and professional
certification within last 10 years
• Personal Statement: Briefly describe why your experience and qualifications
make you particularly well-suited to receive the K award for which you are
applying.
• Professional experience: begin with first position held and end with current
position – Employment, Honors and professional societies/advisory committees
• Publications – complete reference; if supported by NIH, provide the PMCID –
visit the Medical Center Library http://www.mclibrary.duke.edu/ for guidance.
• Research support – ongoing and complete, most relevant first, list title, dates,
overall goals and responsibilities
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K-Awards - Mentors
• Mentors are listed as Key – no effort required
• Attached updated Biosketch for each mentor, co-mentor,
or consultant (limited to 4 pages)
• Attached Current and Pending Support for Mentors & Comentors
– Modified version of Other Support; excludes overlap
statement and level of effort, does not need to be
comprehensive
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K-Awards - Budget Instructions
• Only the candidate is listed in the budget
• Identify effort committed to project
– must be at least amount stated in FOA
– Based on institutional effort
• Only Current Institutional Base Salary is assigned
– excludes VA and PDC salaries
– If a change in salary is anticipated, Business Office must provide
written authorization
• Duke requires K Confirmation form (for competing
submissions) and K TPE form (for competing or if changes
since last non-competing) to be completed
• http://research.som.duke.edu/research-administration/grantadministration/nih/k-award-resources
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K-Awards - Budget Instructions
• Facilities & Administrative (indirect) costs are always 8%
Modified Total Direct Cost (MTDC)
• All other costs (Support personnel, Consultants,
Equipment < $5000, Supplies, Travel, Other) grouped as
Materials and Supplies.
• Equipment =>$5,000, Pt. Care, tuition costs etc. will be
entered into appropriate “Excluded Direct” category
• Consortium costs will be entered into
“Consortium/Subaward” category
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K-Awards - Budget justification
Detailed description for specific items needed as part of the
Research Development Support costs
– Equipment
– Supplies
– Other personnel
– Subcontracts
– Tuition
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K-Awards - Special Instructions
Project Summary/Abstract (Do not exceed 1 page):
Include the candidate's immediate and long-term career goals, key
elements of the research career development plan, and a
description of the research project
Facilities & Other Resources: Provide detailed description of the
institutional facilities and resources available to the candidate. The
information provided is of major importance in establishing the
feasibility of the goals of the career development plan.
Other Attachments: All mentored K applications must include a
list of Referees. The list should include the name of the referee,
departmental affiliation and institution. This same list is also
provided in the Cover Letter.
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K-Awards - Cover Letter
• Required for mentored K awards – must include the list of
referees
• Optional for independent K awards, however applicants
are strongly encouraged to include this component
• Cover letter is only for internal NIH use and will not be
shared with peer reviewers.
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K-Awards - Proposal
12 page limitation (will allow up to 15 pages for white space)
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Candidate’s background
Career goals and objectives
Career Development/Training activities during award period
Training in the Responsible Conduct of Research
Research Strategy
Prepare as one document and split into separate PDFs to
upload to Grants.Duke
Caution: Exceeding Page limitation will prevent acceptance
of application by NIH.
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For resubmissions only – 1 Page Limit
Included in 12
PAGE LIMIT
Background: additional information not described in Biosketch such as research
or clinical training
Career Goals: describe past scientific history, indicating how award fits into past
and future research career development; justify award and how it will enable
you to develop or expand your research career; include timeline
Career Development: describe new enhanced research skills and knowledge you
will acquire as a result of the proposed award; describe structured activities
and course work; include percentage of time involved in each activity
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Training in the Responsible Conduct of Research – 1 Page Limit
• Describe a plan to acquire training
• No specific curriculum or formal requirements
• Topics include
– Conflict of interest
– Responsible authorship
– Research misconduct
– Use of human and animal subjects
– Data management and data-sharing
Resources: Duke University Graduate School offers courses; Responsible Conduct of
Research Course is offered by Trent Center for Bioethics; Duke University Clinical
Research Training Program,…
Plans and Statements of Mentor and Co-Mentor - required for specific
FOAs - 6 Page Limit
– Describe commitment to serve as mentor to other investigators
– previous mentoring activities
– Available pool of mentees
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6 Page Limit
Statements of Support: to be completed by mentor, co-mentor,
consultants, and contributors – all statements converted to ONE single
pdf file.
Plan for candidate’s training and research career development
– Include developmental activities, such as seminars, scientific meetings, and
presentations
– Discuss expectations for publications over the entire project period
– Define aspects of the research project the candidate will take with him/her
to start their own program
– Source of anticipated support for the candidate’s research project
– Nature and extent of supervision and mentoring
– Candidate’s anticipated teaching load, clinical responsibilities, committees
and administrative assignments and the portion of time available for
research for the period of the award
– Plan for transitioning the candidate to independence
– Mentor should describe previous experience as a mentor, number of
mentees and career outcomes
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Description of Institutional Environment: 1 Page Limit
– Document strong, well-established research program related to
candidate’s area of interest
– List key faculty members relevant to the candidate’s proposed
developmental plan
– Describe necessary facilities and other resources will be made available
– Describe opportunities for intellectual interactions with other
investigators
– Describe courses offered, journal clubs, seminars, and presentations
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Institutional Commitment: 1 Page Limit
Must be signed by Chair of sponsoring department
– Use institutional letterhead
– Describe commitment to candidate and candidate’s career development
independent of the K award
– State commitment to provide protected, adequate time to research and
career development for the entire project period
– Agree to release the candidate from other duties and activities to devote
the required percentage of time for development of a research career and
the continuation of salary should not be contingent upon the receipt of the
award
– State that equipment, facilities and resources necessary for the structured
research career development experience, including appropriate office and
laboratory space and access to clinical and research populations
– State commitment for retention, development and advancement of the
candidate during period award
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Excluded
from page
limit
INCLUDED IN 12 PAGE LIMIT +
1 PAGE FOR SPECIFIC AIMS
Excluded from
page limit
Abstract: limited to 1 page
Project Narrative: Relevance statement – 2 to 3 sentences describing the
relevance of the research to public health; use plain language that can be
understood by lay audience
Bibliography: any reference cited in proposal, included full reference and PMCID
numbers -visit the Medical Center Library http://www.mclibrary.duke.edu/
for guidance.
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Excluded from
page limit
INCLUDED IN 12 PAGE LIMIT + 1
PAGE FOR SPECIFIC AIMS
Excluded from
page limit
Specific Aims: broad, long-term objectives and the goal of the specific research
proposed – recommended 1 page
Background and Significance: Briefly sketch background leading to application,
critically evaluate existing knowledge, and identify gaps project will fill…
Preliminary Studies/Progress Report: Describe candidate’s studies pertinent to
application…
Research Design & Methods: Describe research design conceptual or clinical
framework, procedures, and analyses to be used to accomplish the specific
aims of the project...
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Excluded
from page
limit
INCLUDED IN 12 PAGE LIMIT +
1 PAGE FOR SPECIFIC AIMS
Excluded from
page limit
Inclusion Enrollment Report: renewal applications involving human
subjects
Progress Report Publication List: renewal application publications
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List Referees in cover letter
List Referees here
Attach files as need
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Attach files as needed
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Grants.Duke
• Check
• Limited validation
• Errors must be
corrected
• Warnings should
be evaluated
carefully to
determine if
corrections are
necessary
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Grants.Duke
• Check
continued
• Quick review
of sections
(PDFs) that
have been
attached
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Grants.Duke
• Print Preview
• SF 424 R&R forms
similar to NIH
Commons
• Save PDF copy on
local drive
• Count lines
and pages for
sections
• Check
formatting
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System-to-System via Grants.Duke
• Complete SPS and route for approval
– ORA will review and approve administrative sections
– ORA will set status to Awaiting Submission
• Complete Grants.Duke
–
–
–
–
Upload all required files in PDF
Check application for errors
PI must Release application for submission
Releasing on due date jeopardizes successful
transmission to NIH
• Grants.Duke will electronically submit proposal to
Grants.gov
– Track application status via Grants.Duke
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Grants.Duke
• Release
• Validation
check
• Combined with
administrative
and budget
information in
SPS
• Streamed via
xml to
Grants.gov
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Grants.Duke
• Assurances
• PI must sign
• NIH requires
unique
signature and
date for each
application
• Generates a
SnapShot of
application
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Grants.Duke
• Receipt from
Grants.gov
• Provides time
and date of
acceptance
• Provides Grant
Number
assigned to
application
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Submission Tracking Status
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Email Notifications
• Grants.gov
– sends emails to the Institution Signing Official
– generate a Grants Tracking Number
• eRA Commons
– Sends emails to the Institution SO and the PI
• Validations Complete/Check Assembled Application =
application received
• ACTION REQUIRED TO CONTINUE NIH GRANT
APPLICATION SUBMISSION = application with errors
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Timeline
• Complete SPS proposals must be routed to ORA seven (7)
business days prior to deadline
• Grants.gov may take up to 2 days to validate proposal
If errors, application will be rejected.
Make corrections and resubmit
• eRA Commons may take up to 1 day to validate
If errors, application will be rejected
Make corrections and resubmit
Reminder: Releasing on due date jeopardizes
successful transmission to NIH.
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NIH Errors – NO application generated
• Notify ORA to reset application
• Correct errors
• Notify ORA corrections are complete
• Resubmit – release science in Grants.Duke
• If after deadline, include cover letter explaining why
application is late – will be considered under NIH’s late
policy
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Validate Proposal on eRA Commons
• Check submission status in eRA Commons
• Check Assembled Application
– If the application is acceptable, no further action is
necessary. Will route to Center for Scientific Review within
2 days.
– If the application does not correctly reflect the submitted
application -- some part of the application was lost during
the submission process or did not transfer correctly –
application must be “rejected” by SO. PI will need to send
an email to Grants Specialist or Director in ORA to “reject”.
– PI will correct and resubmit
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Advice
 Read and follow all application instructions for the specific agency – Start
early
 Reminder: Releasing on due date jeopardizes successful transmission to
NIH.
 ALL files must be in PDF
 NO headers or footers: do not use the NIH PI name headers and page
numbers
 MAINTAIN appropriate fonts, type size and line spacing
 MAINTAIN .5" margins on all sides: when converting from Word to PDF,
make sure settings are NOT set to "fit to page"; this function reduces the
text size below the acceptable NIH size
 NIH recommends completing all the science in one document then
breaking it into the individual PDFs: follow page limits set by the
mechanism. When separated, white space can add up to 3 pages: for
example; the R21 limit is 15 pages, when separated, it should NOT be
more than 18 pages
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Word and PDF help
•
•
•
•
In Word, set Orphans and Widows = ON
In Word, use tables to insert graphics and photos
Make sure graphs and pictures do not extend into margin
For changed text in resubmission, make sure line is within
margin
• To convert forms, open document, click Print, select Adobe
PDF, and Print – this should flatten the file and remove form
fields
• Select page size as 8.5” x 11”
• Size of pdf/application <40 mg
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Special Instructions for Individuals with
Multiple Research Appointments
• When an individual holds multiple appointments involving support
for research activities, information from each appointment must be
included.
• List each appointment separately and include enough information
on the type of appointment; (e.g., full time academic or 3/8 VA) so
that an assessment of an individual’s commitment can be made.
• Current (not older than one year), approved MOU (Memorandum of
Understanding) must be on file with ORA Prior to submission.
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Help at Duke
• Departmental Business Office
• Office of Research Administration 684-5175
• DHTS Help Desk 684-2243
Request the RAD On Call person be paged
• For NetID user names and NetID passwords contact DHTS Help
Desk 684-2243
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References
•
NIH Application Guide – Section 7 - Preparing an Individual Research
Career Development Award (CDA) Application (“K” Series)
– http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ad
obe_VerC.pdf
•
ORA Website – K Award Resources
– http://research.som.duke.edu/research-administration/grantadministration/nih/k-award-resources
•
NIH Page Limits
– http://grants.nih.gov/grants/forms_page_limits.htm
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Questions?

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