R-Series Grant Submission Process

1. R-Series Grant Submission Process April 23, 2014 OGC Pre-Award Team

2. Getting Started • Identify an NIH announcement to which you would like to respond • Send “Planning to Submit a Grant” form to OGC: A Pre-Award Specialist will be assigned to your project (see template in packet - #1) • Pre-Award will send a start-up email containing all the relevant information about due dates and other requirements for the grant to be submitted. (see template in packet - #2). • Submit Application to the WPIC Research Committee: http://www.wpic.pitt.edu/research/rescomm/default.htm

3. Getting Started • Current Parent Announcements: • PA-13-302:  Research Project Grant (Parent R01) • PA-13-304: NIH Small Research Grant Program (Parent R03) • PA-13-303: NIH Exploratory Developmental Research Grant Program (Parent R21) • PA-12-212: NIH Support for Conferences and Scientific Meetings (Parent R13/U13) • A new SF424 package is now required for most announcements: ADOBE-FORMS-C (ADOBE-FORMS-B are still applicable for certain RFPs)

4. Getting Started • The University of Pittsburgh requires that all Key Personnel (except consultants) complete the following trainings (see Resources page in packet for links): • Conflict of Interest Superform (PHS Funding) (updated annually – April 15) • Training Modules: • CITI Portal: • Conflict of Interest Module (CITI Portal) • Responsible Conduct of Research Module (CITI Portal) • Human Subjects Research in Social and Behavioral Sciences And / Or • Human Subjects Research in Biomedical Science • ISER Modules • HIPAA Researchers Privacy Requirements (Formerly RPF Module 6) • Use of Laboratory Animals in Research and Education - Update

5. Getting Started • Once you receive the start-up email from your pre-award specialist, respond by sending a list of all personnel who should be included on the application as well as each person’s effort. • The specialist will take this information and create a budget for you in Excel using the current salaries and pro-rating them for the announcement’s start date. The template will also be adjusted to account for the correct fringe and indirect cost rates. • Once completed, the template will be emailed to you and you will be responsible for adding the rest of the necessary budget expenses. • If you prefer to use your own template, you may fill out the personnel section and send to us for review – we will ensure all salaries, fringe, and indirects rates are updated in compliance with the application rules.

6. Budget • Other Expenses (examples): • Research Associate / Data Analyst • Human Subjects / Animals • Participant Payments / Per Diems • Consultants • Scans • Travel • Subcontracts • Etc.

7. Internal Budget • Initial Budget Period – Personnel Section • Packet - # 3 • % Effort on this award • Total Requested = Salary + Fringe • Fringe – automatic calculation based on salary requested • Calendar Months populate automatically based on % effort input • Current base salaries

8. Internal Budget • Initial Budget Period – Other Expense Section • Total Direct Costs for Year 1

9. Internal Budget • Full 5 year budget.

10. Budget • Internal Budget is finalized – What’s next? • Depending on your announcement, you will have two budget options: Modular and Detailed • In order to know which to use, you’ll need to look at the internal budget that you just created and finalized with your pre-award specialist and read the following guidelines

11. Modular Budget • Modular Budgets - Used for certain research grants requesting $250,000 or less per year in direct costs • Applicable to R01, R03, R15, R21, and R34 applications and some special RFA/PAs • Modular Budgets are requested in $25,000 increments and do not require any detail for the various expense categories • A Modular Budget Justification should include only Personnel (Key personnel, staff, and consultants) and should not include any justifications for other non-personnel expenses. Consortiums must also have their own personnel justification (if applicable) • Do NOT assign a percent effort to any consultants • If you are using a Modular Budget, you will still need to provide a full detailed budget for internal processing (Excel template)

12. Modular Budget • Calculating Modular Directs and Indirects: • Step 1: Use the Subtotal Direct Cost line for Modular Amounts and round to next highest increment then add the Subcontract Indirects: • Modular Amount + Subcontract Indirects = Total Direct Costs Requested • Year 1: $250,000 + $6,050 = $256,050 • Year 2: $250,000 + $6,232 = $256,232 • Year 3: $250,000 + $6,418 = $256,418 • Year 4: $250,000 + $6,611 = $256,611 • Year 5: $250,000 + $6,809 = $256,809

13. Modular Budget • Step 2: Next, take the Total Direct Costs Requested, minus any exclusions, to calculate the Modified Total Direct Cost amounts: Total Direct Costs Requested - Exclusions = Modified Total Direct Costs • Year 1: $256,050 - $ 9,765 = $246,285 • Year 2: $256,232 - $43,705 = $212,527 • Year 3: $256,418 - $47,600 = $208,818 • Year 4: $256,611 - $43,278 = $213,333 • Year 5: $256,809 - $28,977 = $227,832

14. Modular Budget • Step 3: Next, take the Modified Total Direct Cost amounts and multiply by the indirect rate (in this case, 54%): Modified Total Direct Costs x Indirect Rate = Indirect Costs • Year 1: $246,285 x 54.0% = $132,994 • Year 2: $212,526 x 54.0% = $114,765 • Year 3: $208,818 x 54.0% = $112,762 • Year 4: $213,333 x 54.0% = $115,200 • Year 5: $227,832 x 54.0% = $123,029 Total Indirects = $598,750

15. Modular Budget • Step 4: Lastly, take the total Direct Costs + Indirect Costs to calculate the Total Costs Requested: Total Direct Costs + Indirect Rate = Total Costs • Year 1: $256,050 + $132,994 = $389,044 • Year 2: $256,232 + $114,765 = $370,997 • Year 3: $256,418 + $112,762 = $369,180 • Year 4: $256,611 + $115,200 = $371,811 • Year 5: $256,809 + $123,029 = $379,838 • Totals: $1,282,120 + $598,750 = $1,880,870

16. Modular Budget • Packet - # 4 • Modular Amount • Current Indirect % Rate • Modified Total Direct Costs • SubK F&A • Total Direct Costs • Indirect Costs • Total Costs – Year 1

17. Modular Budget • Total Modular Amount • Total SubK F&A • Total Direct Costs • Total Indirects • Total Costs • Put this number in Items 15a and 15c on Cover Component Page

18. Detailed Budget • Detailed budgets (SF424) have detailed categories for all of the project’s expenses • A detailed budget is used for submissions requesting more than $250,000 per year in direct costs and for certain RFAs where specifically required no matter the direct cost amount requested • A Detailed Budget Justification should address all budget items including Personnel (Key personnel, staff, and consultants) and non-personnel expenses • If the application includes a subcontract, the consortium will also need to provide a full budget justification

19. Detailed Budget • The NIH Direct Cost Cap is generally set at $500,000 per year (unless otherwise specified). • Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs) must carry out the following steps: • 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as plans are being developed for the study; • 2) Obtain agreement from the IC staff that the IC will accept the application for consideration for award; and, • 3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application. • This policy applies to all new, renewal, revision, or resubmission applications. See NOT-OD-02-004.

20. Budget • Looking at the NIH budget Cap: • To know whether or not you are within the NIH cap limits (either under $250,000/year or $500,000/year, look at the subtotal direct costs line – DO NOT include subcontract indirects.

21. SF424 Budget Page 1 • Packet - # 5 • Principal Investigator and other Senior/Key personnel Effort, Salary, and Fringe. • Calendar Months can never be zero. • Do NOT enter consultants in this section • Section will add up to 7 more slots plus the first line for the PI for a total of 8 Key Personnel lines

22. SF424 Budget Page 2 • Other Personnel Section will add up to 6 slots for staff positions. • Packet - # 5 • Enter Other Personnel here. Only the position needs to be entered – names are not required • If applicable, equipment costs over $5,000 per unit are entered here. • Travel costs

23. SF 424 Budget Page 3 • Do not use this section for participant payments even though that’s what the label says – for training grants only.

24. SF424 Budget Page 3 • Enter other expenses in appropriate categories listed here • Modified Total Direct Cost Rate can be found in the Excel budget on the F&A Calc Tab • Total Direct Costs for this budget period • Indirect Costs requested • Total Costs for this budget period • Upload Budget Justification • Click to move on to next budget period

25. SF 424 Budget Page 4 • Totals for each category over entire grant project period – automatically tallies as you fill in each budget period. • Total Costs requested for entire project period – put this number in Items 15a and 15c on Cover Component Page

26. Budget Justification Budget Justifications for detailed budgets need to address every single item listed on the budget and it should follow the same order as the budget. For modular budgets, list only personnel (including consultants) Always list personnel first, then consultants, then other expenses. Do NOT assign a percent effort to any consultants Justifications for other expenses should be detailed – do not write generic descriptions!

27. Budget Justification Current Hot Topic – possible audit for the University of Pittsburgh • Administrative/clerical salaries are not generally allowable as direct charges to federal sponsored projects • Unless the expense is specifically identified and directly benefits the goals of the project • Budgeted and approved by the sponsor • Supported by a detailed justification of need • Direct Charging of admin/clerical salaries may be appropriate when a project is: • Program Project Grant or Center Grant • R01 if it involves extensive data accumulation, database management, or clinical trials • Extensive travel and meeting arrangements for a large number of participants • Project whose focus is the preparation of manuals, technical reports, and books

28. Budget Justification • Examples of services NOT to be budgeted as a direct cost include: • Account monitoring or reconciliation • Initiating expense documents • Meeting arrangements for small groups • Typing general correspondence • Preparation of progress reports • In order to charge admin/clerical salaries to a federally sponsored project, the cost should be specifically identified with a project objective and the cost explicitly listed in the proposed budget • Description of the responsibility • An explanation of how the responsibility relates to the activities of the project • The anticipated cost

29. SF424 Application • Use both the announcement and the NIH instructions to complete the application • NIH instructions can be found at http://grants.nih.gov/grants/funding/424/index.htm • Announcement instructions always supersede the general NIH instructions • Go to grants.gov, type in announcement number, download application packet and save to desktop OR • You can find a link to the application within your announcement.

30. NIH Update Supplemental Grant Application Instructions 11. Parts II (Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan and Policies) and III (Policies, Assurances, Definitions, and Other Information) of the instructions are now located in a separate “Supplemental Grant Application Instructions” document.

31. When you click on the link to download the application, you will receive this window first. Pitt is registered in the SAM system so you can ignore this and just hit the “Proceed to Application Download Screen” button.

32. Make sure opportunity number matches FOA Form Version • Some of the optional documents may be required depending on the announcement or if the grant includes a subaward. New form requires that you check the boxes rather than move documents from the left to the right.

33. SF424 Application • Grant Application Package includes all the appropriate forms: the components that are required as well as those that are optional. • Fields highlighted in red and shaded in yellow are mandatory!

34. Always select “Application” • Packet - #6 • Information moved to the Face Page – was previously on the Cover Page Supplement form • Mark appropriate application type

35. PI address, etc, has now shifted down to the 2nd part of the Face Page • Total Cost amounts come from Section I total on Cumulative Budget page

36. SF424 Application • SF424 Cover Component • See packet for template - # 6 • Item 1: Type of Submission – Always choose “Application” • Item 8: Type of Application – • New – an application submitted for the first time • Resubmission – revised or amended application to address reviewer feedback • Renewal – used when competing for additional years of funding to continue project • Continuation – NIH does not use SF424 R&R continuation applications • Revision – Request for additional funds to expand scope (supplement)

37. SF424 Application • SF424 Cover Component • Title is limited to 81 characters (including spaces). If your title is longer, then the system will truncate it but it won’t cause any errors. • List your current office address under your contact information • Psychiatry is always the dept listed; Medicine is the Division • Psychiatry Faculty need to list only Psychiatry in the department field, even if they have a dual appointment

38. 3. The “Cover Letter Attachment” has been moved! It no longer has it’s own page and will be uploaded at the end of the “Face Page” instead.. NIH will continue to keep the Cover Letter separate from the assembled application image and available only to authorized staff.

39. SF424 Application • Cover Letter • The cover letter is optional, but encouraged. If included, it should contain the following items as relevant to your application: • Application title. • Funding Opportunity (PA or RFA) title • Request of an assignment (referral) to a particular awarding component(s) or Scientific Review Group (SRG) • List of individuals (e.g., competitors) who should not review your application and why • Disciplines involved, if multidisciplinary • For late applications include specific information about the timing and nature of the cause of the delay (includes PI being in a review group) • Explanation of any subaward budget components that are not active for all periods of the proposed grant. • Any required agency approval documentation for the type of application submitted (approval for applications $500,000+, approval for a Conference Grant or Cooperative Agreement (R13 or U13), etc)

40. SF424 Application • Project/Performance Site Location • Use the WPIC address or the address of where the work will physically be done (see packet - #7) • Primary Site needs to be a Pitt location • Can list other additional sites as needed

41. SF424 Application • Research and Related Other Project Information • Check boxes for Human Subjects and Animals • If answer “No” to IRB/IACUC Pending question, copy of approval must be provided to the Pre-Award specialist for the internal approval process • Human Subject Assurance Number: 00006790 • Animal Welfare Assurance Number: A3187-01 • Project Summary/Abstract – cannot exceed 30 lines • Project Narrative – cannot exceed 2 – 3 sentences • See template in packet - # 8

42. SF424 Application • Research and Related Senior/Key Person Profile • Must include eRA Commons username for the PI – if you do not have one, you can obtain one through the Office of Research by filling out the request form: https://www.pitt.edu/offres/ornihform.html • Biosketches – limited to 4 pages • For those of you who have any Patents, a “Patent Citations” has been added to section C, Selected Peer Reviewed Publications so you can now include them if necessary.

43. SF424 Application • PHS 398 Research Plan Attachments (check announcement for page limits) - Specific Aims – 1 page - Research Strategy – 6 or 12 pages (Since the inclusion attachments have been removed, the numbering in this section has shifted a little) (For page limits across all activity codes: http://grants.nih.gov/grants/forms_page_limits.htm) • Protection of Human Subjects, Inclusion of Women and Minorities, Targeted/Planned Enrollment and Inclusion of Children • All of these sections must be completed by applicants answering “yes” to the question “Are human subjects involved?” on the R&R Other Project Information form.

44. Planned Enrollment Report and the Cumulative Inclusion Enrollment Report • These forms are no longer separate PDF attachments. They each now have their own page within the packet and are fillable forms. They have also been reformatted so be careful entering the data. • The layout of both the Planned Enrollment Report and the Cumulative Inclusion Enrollment Report has been modified to reduce confusion about racial and ethnic information being distinct concepts. • The Planned Enrollment Report will now include the "More than one race" category. The "More than one race" category will be used for reporting the planned number of individuals who you believe will identify with more than one racial category. Currently, this category has only been available when reporting actual cumulative enrollment. • Additional Resources: Additional guidance regarding these changes as well as other topics related to the inclusion of women and minorities in clinical research can be found at: http://grants.nih.gov/grants/funding/women_min/women_min.htm. • The policies for the inclusion of women and minorities in clinical research and the required collection of participants' sex/gender, race, and ethnicity have not been modified.

45. SF424 Application • For Renewal/Revision/Resubmission Applications Only • Introduction Application – 1 page • Inclusion Enrollment (Renewal or Revisions only) • Progress Report Publication List (Renewal only) • Other PHS 398 Research Plan Attachments (if applicable) • Vertebrate Animals (Must be completed if you indicated that they are involved in this project) • Select Agent Research • Multiple PD/PI Leadership Plan • Consortium/Contractual Arrangements • Letters of Support (consultants) • Resource Sharing Plan(s)

46. SF424 Application Letters of Support • There are clarifications regarding the content. • Letters should stipulate expectations for co-authorship, and whether cell lines, samples or other resources promised in the letter are freely available to other investigators in the scientific community or will be provided to the particular investigators only. • For consultants, letters should include rate/charge for consulting services and level of effort/number of hours per year anticipated. • In addition, letters ensuring access to core facilities and resources should stipulate whether access will be provided as a fee-for-service. Appendix • Photographs or color images of gels, micrographs, etc., are no longer accepted as Appendix material. These images must be included in the Research Strategy.

47. SF424 complete – what next? • Review the application and check for Common Errors (see list in packet - # 9) • Make sure COI and Modules are complete • Attach the entire adobe application to an email and send it to your pre-award specialist by the deadline given in the start-up email • Specialist will review and make any necessary corrections and provide feedback • Final version will be emailed to you for approval and then the application will be sent through the internal review process

48. PI Signature Template • PI template replaces the old paper face pages – had a place for the PI to sign • Send PI Signature Template to Pre-Award • Submit as a signed paper original OR • Email: • Signed PDF Attachment OR • Document needs to be copied and pasted into the body of the email – cannot accept an unsigned attachment (ask pre-award for an unprotected version of document)

49. (Packet #10) Application Title NIH PI’s name Effort on Grant First Year of Project NIH Deadline

50. What’s Due When? • Due to the OGC 13 business days before the NIH deadline: • Final Budget • Final Budget Justification • SF 424 (R&R) Face Page • Abstract (draft) • PI Signature Template • Due to the OGC 8 business days before the NIH deadline: • Final, full SF424 application package • For a full list of deadlines, please go to our website https://inet.psychiatry.upmc.com/OGC/EGADueDates.htm