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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 !. Pedro Fernandez-Funez, PhD Assistant Professor Department of Neurology.

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Link to course Lectures

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

  2. Proposal preparation:How to put all the pieces together – on time ! Pedro Fernandez-Funez, PhD Assistant Professor Department of Neurology

  3. Objectives • Understand the complexity of the NIH grant proposal • Identify all the components • Provide a timeline to complete the proposal on time

  4. A good guide for completing your proposal Russell and Morrison The Grant Application Writer’s Workbook www.grantcentral.com/workbook_nih_sf424_shortened.html

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. Upload PI Biosketch

  14. Upload Key person Biosketch

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

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

  17. 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

  18. Step 3: The Budget trap ! • NIH does not require detailed budget if you request is standard: $250K/year for R01 • Budget justification

  19. Non-modular budget

  20. You don’t have to submit a detailed budget to the NIH, if below 250K/year • BUT, you HAVE to your college !

  21. 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

  22. 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

  23. 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

  24. 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

  25. Who submits your grant?

  26. 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

  27. Timeline for submission 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

  28. Step 6: 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

  29. Step 4: PeopleSoft/MYUFL II • 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

  30. Step 4: 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 Dean’s office for approval. If faculty are from different Colleges, needs approval by each College Dean’s before COM will approve

  31. Step 4: 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 within normal deadline

  32. 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 are just trying to follow University rules

  33. 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

  34. Questions ? Many thanks to Heather Chitty for help preparing this presentation

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