[email protected] If you have not registered, do so to provide support for CTSI training activities To Register contact: Eve J. Johnson.

[email protected]

If you have not registered, do so to provide support for CTSI training activities

To Register contact: Eve J. Johnson

[email protected]

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

Upload PI Biosketch

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 !

Non-modular budget

• 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

Cayuse 424

Cayuse 424

Who submits your grant?Not you !

Who gets the money?Not you !

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 …

Questions ?