1. pedro.fernandez@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@medicine.ufl.edu

2. 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

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

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

5. Russell and Morrison The Grant Application Writer’s Workbook www.grantcentral.com/workboo k_nih_sf424_shortened.html A good guide for completing your proposal

6. 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

8. 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

9. 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

10. Timeline for submission Feb 6 Jun 5 Oct 5 Final Submission 10-15 days Jan 23 May 22 Sep 21 Complete Research Strategy for COM 1 month Jan 6 May 5 Sep 5 Aims, Sign+Innov for COM review 2 months Dec 6 Apr 5 Aug 5 Nov 21 Mar 19 Jul 23 Aims, Sign+Innov for Dept. presentation 2.5 months Nov 6 Mar 5 Jul 5 Title, Biosk, budget COI, humans? Animals? 3 months Oct Feb Jun Announce intent to submit 3-4 months R01 deadline Received 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

11. 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

12. 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

13. 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.pdfgrants.nih.gov/grants/funding/424/SF424_RR_Guide _General_Adobe_VerB.pdf

15. Upload PI Biosketch

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

17. 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 Category Sex/Gender FemalesMalesTotal 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.”

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

20. 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

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

23. Non-modular budget

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

25. 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

26. 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

27. 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

29. 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

31. 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

32. Cayuse 424

34. Who submits your grant? Not you ! Who gets the money? Not you !

35. 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

36. 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

37. 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

38. 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

39. 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

40. 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 …

41. Questions ?