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Link to course Lectures. http://neurology.ufl.edu/divisions-2/neuroscience/gms-6096-introduction-to-nih-grant-writing-for-biomedical-sciences/. Proposal preparation: How to put all the pieces together – on time !. Pedro Fernandez-Funez, PhD Assistant Professor Department of Neurology.

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Link to course lectures
Link to course Lectures

http://neurology.ufl.edu/divisions-2/neuroscience/gms-6096-introduction-to-nih-grant-writing-for-biomedical-sciences/


Proposal preparation how to put all the pieces together on time

Proposal preparation:How to put all the pieces together – on time !

Pedro Fernandez-Funez, PhD

Assistant Professor Department of Neurology


Objectives
Objectives

  • Understand the complexity of the NIH grant proposal

  • Identify all the components

  • Provide a timeline to complete the proposal on time


A good guide for completing your proposal
A good guide for completing your proposal

Russell and Morrison

The Grant Application Writer’s Workbook

www.grantcentral.com/workbook_nih_sf424_shortened.html


Getting started
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


Preview key documents
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


Preview additional documents
Preview: Additional documents

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


Timeline for submission
Timeline for submission

Announce intent to submit

3-4 months

Aims, Sign+Innov

for Dept. presentation

2.5 months

Complete Research

Strategy for COM

1 month

R01 deadline

Received by NIH

Aims, Sign+Innov

for COM review

2 months

Final Submission

10-15 days

Title, Biosk, budget

COI, humans? Animals?

3 months

Budget justific, Animals,

humans, facilities

1.5 months

-Upload to NIH form

-Upload on PeopleSoft

-Approvals: PI(s), Chair(s), Dean

-COM-RAC review

-DSR-UF review and submit

Feb 6

Oct

Nov 21

Dec 6

Jan 6

Jan 23

Nov 6

Jun 5

Feb

Mar 19

Apr 5

May 5

May 22

Mar 5

Oct 5

Jun

Jul 23

Aug 5

Sep 5

Sep 21

Jul 5


Step 1 intent to submit
Step 1: 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


Step 2 gather information
Step 2: Gather Information

3-4 months before submission deadline

  • After reviewing announcement, your grants’ specialist will request a Title and the Key personnel for the proposal

  • Then, all key personnel will receive a COI (conflict of interest) form for signatures

  • Your grants’ specialist will request updated Biographical Sketches for each key person



Early items for grant submission
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


Upload pi biosketch
Upload PI Biosketch



Human subjects
Human Subjects

Includes the following items:

  • Protection of Human Subjects

  • Inclusion of Women and Minorities

  • Inclusion of Children

  • Targeted Planned Enrollment form


Vertebrate animals
Vertebrate Animals

  • If Applicable, Vertebrate Animals section

  • Numbers and power calculations

  • Veterinary care

  • Identification of terminally sick animals and euthanasia procedures


Other documents
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


Step 3 the budget trap
Step 3: The Budget trap !

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

  • Budget justification



  • You don’t have to submit a detailed budget to the NIH, if below 250K/year

  • BUT, you HAVE to your college !


Subcontract consortium
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


Subcontract consortium ii
Subcontract/Consortium II

  • Signed Financial Conflict of Interest forms

  • Site information/Face Page

  • Biographical Sketches for all key persons at their site

  • 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


Step 4 sf 424 nih package
Step 4: 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


  • They also review all documents to make sure they comply with guidelines

  • Then, they convert each document into PDF and upload into package

  • If your grant budget is over $250K, they also have to input a detailed budget, which can be time consuming because the system does not carry any information from year to year



Step 5 completing the science
Step 5: Completing the science guidelines

  • 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


Timeline for submission1
Timeline for submission guidelines

Announce intent to

submit to Heather

3-4 months

Aims, Sign+Innov

for Dept. presentation

2.5 months

Complete Research

Strategy for COM

1 month

R01 deadline

Received by NIH

Aims, Sign+Innov

for COM review

2 months

Final Submission

10-15 days

Title, Biosk, budget

COI, humans? Animals?

3 months

Budget justific, Animals,

humans, facilities

1.5 months

-Upload to NIH form

-Upload on PeopleSoft

-Approvals: PI(s), Chair(s), Dean

-COM-RAC review

-DSR-UF review and submit

Feb 6

Oct

Nov 21

Dec 6

Jan 6

Jan 23

Nov 6

Jun 5

Feb

Mar 19

Apr 5

May 5

May 22

Mar 5

Oct 5

Jun

Jul 23

Aug 5

Sep 5

Sep 21

Jul 5


Step 6 peoplesoft myufl
Step 6: PeopleSoft/MYUFL guidelines

  • 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


Step 4 peoplesoft myufl ii
Step 4: PeopleSoft/MYUFL II guidelines

  • We normally enter a separate project for each department involved, this is known as a 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


Step 4 peoplesoft myufl iii
Step 4: PeopleSoft/MYUFL III guidelines

  • 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


Step 4 peoplesoft myufl iv
Step 4: PeopleSoft/MYUFL IV guidelines

  • 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 within normal deadline


Remember
Remember ! guidelines

  • 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 are just trying to follow University rules


And … guidelines

  • 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


Questions
Questions ? guidelines

Many thanks to Heather Chitty for help preparing this presentation


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