1. GCO INFORMATION SESSION: YOU ASK, WE ANSWER NIH R01 A PPLICATION B ASICS P RESENTED BY : M ICHELLE H UMPHREYS G RANTS A NALYST II G RANTS AND C ONTRACTS O FFICE

2. NIH R01 A PPLICATION B ASICS Q: Why isn’t there a GCO Procedure Guide for NIH R01 Applications? 2 Short Answer: Because there are too many possible variables that can occur in an R01. Long Answer: NIH R01 applications have some of the broadest guidelines allowable in NIH grant mechanisms; the number of variables that can be proposed in an R01 and “if-then” instructions make it impossible to reduce to a 1-2 page guide.

3. NIH R01 A PPLICATION B ASICS NIH R01 Resources: 3 R01 Funding Opportunity Announcement (FOA) Instructions NIH Grants Policy Statement (GPS) (417 pages) Supplemental Grant Application Instructions guide (102 pages) NIH SF424 (R&R) Application Guide (253 pages)

4. NIH R01 A PPLICATION B ASICS Different types of FOAs 4 1.Parent Announcements (PARs) 2.IC-Specific Program Announcements (PAs) 3.Request for Applications (RFAs) How to find an R01 FOA: 1.http://www.grants.nih.gov/grants/guide/index.htmlhttp://www.grants.nih.gov/grants/guide/index.html 2.NIH IC websites (e.g. NIDDK, NHLBI) 3.Google

5. NIH R01 A PPLICATION B ASICS What is the R01 Funding Mechanism? 5

6. NIH R01 A PPLICATION B ASICS What are the SF424 Research & Related (R&R) forms? The SF424 is a formset used by the federal government, including NIH, to accept applications for grant funding. NIH uses a combination of the federal-wide SF424 R&R forms and agency-specific (PHS) forms in application packages. 6

7. NIH R01 A PPLICATION B ASICS SF424: Mandatory vs. Optional Forms 7

8. NIH R01 A PPLICATION B ASICS NIH Application Basics 8 Details are important! Adhere to guidelines for font, margins, format of attachments All attachments must be PDFs; do not use “Bundling” or “Portfolio” Naming rules for attachments – only include acceptable characters, do not use “&” or double spaces Watch out for invalid page sizes

9. NIH R01 A PPLICATION B ASICS NIH Application Basics 9 Carefully follow all attachment page limits R01 Standard Page Limits Specific Aims 1 Research Strategy 12 Biosketch 5 Project Summary30 lines of text Project Narrative 2-3 sentences

10. NIH R01 A PPLICATION B ASICS NIH Application Basics 10 Personnel Roles PD/PI: Leader of the project If multiple PIs on the application, all need the same role of PD/PI; one must be designated the Contact PI Multi-PIs can be from different institutions; NIH will make a single award to the Contact PI’s institution Application must contain a Multi-PI Leadership Plan NIH does not recognize the term “Co-PI”

11. NIH R01 A PPLICATION B ASICS NIH Application Basics 11 Personnel Roles Senior/Key Personnel: presented as having quantifiable effort that is necessary and integral to the project Usually given the role of Co-Investigator NIH will name all sponsor-identified Key Personnel in the Notice of Award (NOA)

12. NIH R01 A PPLICATION B ASICS NIH Application Basics 12 Personnel Roles Other Significant Contributor (OSC): individual with no measurable or paid effort on the grant but whose contribution is important for the project in an advisory capacity OSCs are listed in the SF424 Senior/Key Personnel form and Biosketch is included

13. NIH R01 A PPLICATION B ASICS NIH Application Basics 13 Personnel Roles Consultant: individual with an advisory and short-term role on the project If the Consultant is to be paid and is a faculty member at another institution, this is covered via a Subaward Refer to the MCW Corporate Policy on Proposal Budget Preparation for details

14. NIH R01 A PPLICATION B ASICS NIH Application Basics 14 Biosketch Required for all Senior/Key Personnel and OSCs New format required as of May 25, 2015 New resource for assistance: SciENcv 5 pages (previously 4) with 4 sections: A.Personal Statement B.Positions and Honors C.Contributions to Science D.Research Support

15. NIH R01 A PPLICATION B ASICS NIH Budget Forms 15 Two types of budget forms accepted for an R01 application 1.Modular Used if total direct costs are between $25,000 - $250,000 Must be in increments of $25,000 No line item detail provided 3 part budget justification as applicable: Personnel, Consortium, and Additional Narrative sections

16. NIH R01 A PPLICATION B ASICS NIH Budget Forms 16 Two types of budget forms accepted for an R01 application 2.R&R Detail Direct costs $250,001 - $500,000 Over $500,000 requires prior approval from NIH or allowed if specified in the RFA Provides line item detail for each budget category

17. NIH R01 A PPLICATION B ASICS NIH Budget Forms 17 2.R&R Detail Single detailed budget justification required; each category must be well justified and future year increases and changes addressed Personnel: List all Key Personnel, with base salary, calendar months effort, fringe benefit amount Non-Key Personnel positions can be grouped

18. NIH R01 A PPLICATION B ASICS NIH Budget Forms 18 2.R&R Detail Travel costs: identify travel to domestic versus foreign sites Provide details on supply costs; if office supplies are included, must have detailed justification Justify any increases or changes in future budget periods

19. NIH R01 A PPLICATION B ASICS NIH Budget Forms 19 2.R&R Detail If consortium sites are included, R&R detail budget forms and justifications must be completed for each site If site is foreign, F&A is capped at 8% If site has no negotiated federal F&A rate agreement, new default F&A rate allowed is 10%

20. NIH R01 A PPLICATION B ASICS NIH Budget 20 Indirect Costs (F&A) Determined by MCW’s Federally Negotiated Rate Agreement Rate based on where at MCW the majority of the research is taking place Most common default rates: On-Campus: 53%; 7/1/16 54% FMLH: 38% CRI: 52% Off-campus: 26% (CHW, clinics, etc.)

21. NIH R01 A PPLICATION B ASICS Compliance Areas 21 Need to identify use of Human Subjects Research (HSR)and/or Vertebrate Animal Research in the application If HSR is Exempt or requires designation by the IRB that it is Non-HSR, this should be determined by the IRB at application If using animals, detailed information is required in the Vertebrate Animals plan; identify all species

22. NIH R01 A PPLICATION B ASICS Consortium Site(s) 22 If the project involves collaboration with faculty at another institution, a Consortium must be proposed in the application Consortium Plan should detail the roles and relationship between sites Letter of Intent required for all sites at the time of application If R&R detail budget, need same level of detail for each Consortium site as MCW

23. NIH R01 A PPLICATION B ASICS R01 Submission Process 23 1.The R01 is assembled in eBridge. 2.After the FP is routed to GCO and approved by AOR, GCO generates the final version of the SF424 and it is submitted to Grants.gov. 3.The application is reviewed in Grants.gov and if it passes all validations, moves to eRA Commons. 4.R01 is validated in eRA Commons; if there are no Errors, there is the 2-day review window up until application deadline.

24. NIH R01 A PPLICATION B ASICS The End Questions? Email aor@mcw.eduaor@mcw.edu 24

25. NIH R01 A PPLICATION B ASICS NIH R01 and Application Resources NIH R01 Information: http://grants.nih.gov/grants/funding/r01.htm http://grants.nih.gov/grants/funding/r01.htm SF424 (R&R) Application Guide and Supplemental Instruction guide: http://grants.nih.gov/grants/funding/424/index.htm http://grants.nih.gov/grants/funding/424/index.htm NIH Grants Policy Statement (GPS): http://grants.nih.gov/grants/policy/nihgps/index.htm http://grants.nih.gov/grants/policy/nihgps/index.htm 25

26. NIH R01 A PPLICATION B ASICS GCO Resources Visit the GCO website: http://www1.mcw.edu/Grants-Contracts-Office.htm GCO FAQs http://www1.mcw.edu/Grants-Contracts- Office/FAQ.htm MCW Corporate Policy – Proposal Budget Preparation http://infoscope.mcw.edu/Corporate- Policies/Research/Grants-Contracts.htm 26