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If you have not registered, do so to provide support for CTSI training activities
To Register contact: Eve J. Johnson
Watch video and PPT @:http://neurology.ufl.edu/divisions-2/neuroscience/gms-6096-introduction-to-nih-grant-writing-for-biomedical-sciences/
Mail list to send relevant info to all attendees
Proposal preparation:
How to put all the pieces together – on time !
Pedro Fernandez-Funez, PhD
Assistant Professor Department of Neurology
• Understand the complexity of the NIH grant proposal
• Identify all the components
• Provide a timeline to complete the proposal on time
Objectives
Russell and Morrison
The Grant Application Writer’s Workbook
www.grantcentral.com/workbook_nih_sf424_shortened.html
A good guide for completing your proposal
• Preliminary work: recent published papers, strong hypothesis, continue work
• New, revolutionary idea
• Identify PA: specific to your area of interest or parent announcement
Getting Started
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
Preview: Key documents
Budget:
✔Modular/detailed budget
✔Budget justification
Extra documents:
Key Personnel Biosketch
Support letter(s)
Consortium
Multiple PI
Proprietary info
Regulatory documents (depending on proposed research):
Human subjects
IRB permit
Vertebrate animals
IACUC permit
Documents to upload and submit: 15-20
Preview: Additional documents
Timeline for submission
Feb 6
Jun 5
Oct 5
Final Submission10-15 days
Jan 23
May 22
Sep 21
Complete Research Strategy for COM
1 month
Jan 6
May 5
Sep 5
Aims, Sign+Innovfor COM review
2 months
Dec 6
Apr 5
Aug 5
Nov 21
Mar 19
Jul 23
Aims, Sign+Innovfor Dept. presentation
2.5 months
Nov 6
Mar 5
Jul 5
Title, Biosk, budgetCOI, humans? Animals?
3 months
Oct
Feb
Jun
Announce intent to submit
3-4 months
R01 deadlineReceived by NIH
-Upload to NIH form -Upload on PeopleSoft -Approvals: PI(s), Chair(s), Dean -COM-RAC review -DSR-UF review and submit
Budget justific, Animals, humans, facilities
1.5 months
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
• 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
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_General_Adobe_VerB.pdf
Includes the following items:
•Protection of Human Subjects
•Inclusion of Women and Minorities
•Inclusion of Children
•Targeted Planned Enrollment form
Human Subjects
Targeted/Planned Enrollment Table
This report format should NOT be used for data collection from study participants.
Study Title:
Total Planned Enrollment:
TARGETED/PLANNED ENROLLMENT: Number of Subjects
Ethnic CategorySex/Gender
Females Males Total
Hispanic or Latino
Not Hispanic or Latino
Ethnic Category: Total of All Subjects *
Racial Categories
American Indian/Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
Racial Categories: Total of All Subjects *
* The “Ethnic Category: Total of All Subjects” must be equal to the “Racial Categories: Total of All Subjects.”
• If Applicable, Vertebrate Animals section
• Numbers and power calculations
• Veterinary care
• Identification of terminally sick animals and euthanasia procedures
Vertebrate Animals
• 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
Other documents
• NIH does not require detailed budget if you request is standard: $250K/year for R01
• Budget justification
The Budget trap !
• You don’t have to submit a detailed budget to the NIH, if below 250K/year
• BUT, you HAVE to your college !
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
1. Budget and Budget Justification
2. Short Statement of Work to be done at their site
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
Subcontract/Consortium II
SF 424 NIH package
• Once your grant’s person receives all of the information, fill in the NIH package
• Your grant’s person has a lot of information to fill out in the package for each grant submitted
• 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
Step 5: Completing the science
Cayuse 424
http://research.ufl.edu/research/proposal/cayuse/cayuse-proposal.html#search
New software that allows PI to prepare grant application on their own
PeopleSoft/MYUFL
• Your grant’s 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
• 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
PeopleSoft/MYUFL II
• Once Faculty approve the proposal, it routes to the Chair of each Department involved
• Once the Chairs approve, it goes to the Dean’s office for approval. If faculty are from different Colleges, needs approval by each College Dean’s before COM will approve
PeopleSoft/MYUFL III
• 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
PeopleSoft/MYUFL IV
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
• Be responsive to requests from your grants people. After all, it is YOUR grant
• Please remember, your grant’s person does not submit directly to NIH. There are many internal steps to get it through the system
And …