[e-mail]

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pedro.fernandez_at_neurology.ufl.edu
If you have not registered, do so to provide
support for CTSI training activities To Register
contact Eve J. Johnson Eve.Johnson_at_medicine.ufl
.edu
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Mail list to send relevant info to all attendees
Watch video and PPT _at_ http//neurology.ufl.edu/di
visions-2/neuroscience/gms-6096-introduction-to-ni
h-grant-writing-for-biomedical-sciences/
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Proposal preparation How to put all the pieces
together on time !

• Pedro Fernandez-Funez, PhD
• Assistant Professor Department of Neurology

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Objectives

• Understand the complexity of the NIH grant
  proposal
• Identify all the components

• Provide a timeline to complete the proposal on
  time

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A good guide for completing your proposal
Russell and Morrison The Grant Application
Writers Workbook www.grantcentral.com/workbook_n
ih_sf424_shortened.html
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Getting Started

• Preliminary work recent published papers, strong
  hypothesis, continue work
• New, revolutionary idea

• Identify PA specific to your area of interest or
  parent announcement

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Preview Key documents
Documents to upload and submit Minimum of 12
Scientific proposal ?Abstract ?Narrative ?
Specific Aims ?Research Strategy ?References
Information ?Cover letter ?PI
Biosketch ?Resource sharing ?Facilities,
Environment ?Equipment
Budget ?Modular/detailed budget ?Budget
justification
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Preview Additional documents
Extra documents Key Personnel
Biosketch Support letter(s) Consortium Multi
ple PI Proprietary info
Regulatory documents (depending on proposed
research) Human subjects IRB
permit Vertebrate animals IACUC permit
Documents to upload and submit 15-20
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Timeline for submission
Announce intent to submit 3-4 months
Feb 6
Jan 23
Jan 6
Dec 6
Nov 21
Oct
Nov 6
Jun 5
May 22
May 5
Apr 5
Mar 19
Feb
Mar 5
Oct 5
Sep 21
Sep 5
Aug 5
Jul 23
Jun
Jul 5
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Intent to Submit

• At least a whole cycle in advance (4 months)
• Notify your grants person and send the
  announcement for submission to them
• Once your grants person receives the
  announcement/guidelines for the submission, they
  will review and identify specific rules

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• Keep in mind, the more key personnel, the longer
  the process
• Start working on your internal draft budget
• You will send Word documents to your grants
  person for each piece of the proposal

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Early Items for grant submission

• By 3 months before submission deadline
• Biographical sketches for ALL key persons
• Facilities and other resources Office/lab space,
  core labs, etc
• Equipment- Equipment available in lab or building
• Resource Sharing Plan Needs to be completed to
  show how you plan to share resources
• grants.nih.gov/grants/funding/424/SF424_RR_Guide_G
  eneral_Adobe_VerB.pdf

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Upload PI Biosketch
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Human Subjects

• Includes the following items
• Protection of Human Subjects
• Inclusion of Women and Minorities
• Inclusion of Children
• Targeted Planned Enrollment form

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Targeted/Planned Enrollment Table Targeted/Planned Enrollment Table Targeted/Planned Enrollment Table Targeted/Planned Enrollment Table Targeted/Planned Enrollment Table Targeted/Planned Enrollment Table
This report format should NOT be used for data collection from study participants. This report format should NOT be used for data collection from study participants. This report format should NOT be used for data collection from study participants. This report format should NOT be used for data collection from study participants. This report format should NOT be used for data collection from study participants. This report format should NOT be used for data collection from study participants.
Study Title
Total Planned Enrollment Total Planned Enrollment

TARGETED/PLANNED ENROLLMENT Number of Subjects TARGETED/PLANNED ENROLLMENT Number of Subjects TARGETED/PLANNED ENROLLMENT Number of Subjects TARGETED/PLANNED ENROLLMENT Number of Subjects TARGETED/PLANNED ENROLLMENT Number of Subjects TARGETED/PLANNED ENROLLMENT Number of Subjects
Ethnic Category Ethnic Category Ethnic Category Sex/Gender Sex/Gender Sex/Gender
Ethnic Category Ethnic Category Ethnic Category Females Males Total
Hispanic or Latino Hispanic or Latino Hispanic or Latino
Not Hispanic or Latino Not Hispanic or Latino Not Hispanic or Latino
Ethnic Category Total of All Subjects Ethnic Category Total of All Subjects Ethnic Category Total of All Subjects
Racial Categories Racial Categories Racial Categories
American Indian/Alaska Native American Indian/Alaska Native American Indian/Alaska Native
Asian Asian Asian
Native Hawaiian or Other Pacific Islander Native Hawaiian or Other Pacific Islander Native Hawaiian or Other Pacific Islander
Black or African American Black or African American Black or African American
White White White
Racial Categories Total of All Subjects Racial Categories Total of All Subjects Racial Categories Total of All Subjects
The Ethnic Category Total of All Subjects must be equal to the Racial Categories Total of All Subjects. The Ethnic Category Total of All Subjects must be equal to the Racial Categories Total of All Subjects. The Ethnic Category Total of All Subjects must be equal to the Racial Categories Total of All Subjects. The Ethnic Category Total of All Subjects must be equal to the Racial Categories Total of All Subjects. The Ethnic Category Total of All Subjects must be equal to the Racial Categories Total of All Subjects. The Ethnic Category Total of All Subjects must be equal to the Racial Categories Total of All Subjects.
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Vertebrate Animals

• If Applicable, Vertebrate Animals section
• Numbers and power calculations
• Veterinary care
• Identification of terminally sick animals and
  euthanasia procedures

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Other documents

• Cover letter Not required, but important for
  selection of study section and institute
• Letters of Support- Required for, collaborators,
  consultants, consortiums. You may also include
  letters of support from anyone you deem
  appropriate
• Institute Director, your Chairman can be helpful
  if you need department or institute resources or
  their expertise
• Send them a draft with important info title, how
  will they help you, etc

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The Budget trap !

• NIH does not require detailed budget if you
  request is standard 250K/year for R01
• Budget justification

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Non-modular budget
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• You dont have to submit a detailed budget to the
  NIH, if below 250K/year
• BUT, you HAVE to your college !

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Subcontract/Consortium

• Anyone from outside Institution involved in your
  submission adds another layer to the process.
• Need extra items from the other Institution
  before we can even finish our budget !
• Rule If this person is doing a portion of the
  work, it will be a subcontract vs. consultant
• Budget and Budget Justification
• Short Statement of Work to be done at their site

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Subcontract/Consortium II

1. Signed Financial Conflict of Interest forms
2. Site information/Face Page
3. Biographical Sketches for all key persons at
   their site
4. Most importantly need a Consortium Agreement
   signed by PI and the Authorized Official for
   their Institution. The Consortium Research
   offices want everything finalized and submitted
   for signature at least 2 weeks in advance

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SF 424 NIH package

• Once your grants person receives all of the
  information, fill in the NIH package
• Your grants person has a lot of information to
  fill out in the package for each grant submitted

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Step 5 Completing the science

• Project Summary/Abstract- 30 lines or less
• You will need to send an introduction to
  application only if this is a resubmission.
• Specific Aims- 1 page !!!
• Research Strategy Page limits by mechanism or
  guidelines (12 p. R01, 6 p. R21, R03)
• Significance and Innovation 1 page, part of
  Research Strategy
• References Cited-Full citations, no page limits

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Cayuse 424
New software that allows PI to prepare grant
application on their own
http//research.ufl.edu/research/proposal/cayuse/c
ayuse-proposal.htmlsearch
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Cayuse 424
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Cayuse 424
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Who submits your grant?Not you !
Who gets the money?Not you !
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PeopleSoft/MYUFL

• Your grants person must enter your proposal
  information into PeopleSoft/MYUFL before it can
  go to NIH
• Entering the proposal into PeopleSoft/MYUFL can
  take time the more key personnel, the more
  departments/colleges are involved in
  review/signatures

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PeopleSoft/MYUFL II

• Normally enter a separate project for each
  department involved, known as subproject
• Once everything is ready in PeopleSoft/MYUFL, the
  proposal is submitted in PeopleSoft/MYUFL for
  routing
• Each person with a subproject on your grant must
  approve in the system

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PeopleSoft/MYUFL III

• Once Faculty approve the proposal, it routes to
  the Chair of each Department involved
• Once the Chairs approve, it goes to the Deans
  office for approval. If faculty are from
  different Colleges, needs approval by each
  College Deans before COM will approve

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PeopleSoft/MYUFL IV

• Once all Colleges have approved the proposal,
  proposal is forwarded to DSR (Division of
  Sponsored Research), where it will be reviewed at
  UF level and submitted to NIH via Grants.gov
• If your deadline is regular cycle, the system may
  crash at the last moment !
• No more 2-day period to revise submission after
  deadline. The revision has to be done prior to
  normal deadline

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Remember !

• Give plenty of time for your grants specialist
  to process everything !
• Follow Sponsor guidelines (pages, margins, types)
• The more key personnel involved the more time it
  takes to submit
• Your grants person is not the enemy, they help
  you follow University rules

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And

• Be responsive to requests from your grants
  people. After all, it is YOUR grant
• Please remember, your grants person does not
  submit directly to NIH. There are many internal
  steps to get it through the system

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Questions ?