Veterans Medical Research Foundation

1. 101 on NIH GrantsUnderstanding the Roles of VMRF and the Principal Investigator When Administering NIH GrantsLast updated: December 2006 Veterans Medical Research Foundation

2. Objective of this presentation: Provide a clear delineation of the roles and responsibilities of the Principal Investigator and the Veterans Medical Research Foundation in the administering of NIH grants; Offer the key tools to ensure compliance with applicable Federal statutes, regulations, and policies; and Create an awareness of how VMRF can be of assistance to PIs and their staffs.

3. Overview • NIH Grant Management Tools • Pre-award: preparation and submission of Proposal • Post Award Administration: what should be done once the grant has been awarded • Close-Out Procedure • Record Retention • VMRF Reporting Requirements

4. Grant Management Tools • VMRF Website provides links to resource information, such as institutional requirements, policies and procedures, subject matter experts (i.e. Contracts & Grants Administrator), and other contact information. • Information posted @ http://www.vmrf.org/vmrf/main.asp NIH website links: • http://grants2.nih.gov/grants/policy/nihgps_2003/index.htm • http://grants2.nih.gov/grants/forms.htm • http://era.nih.gov/

5. Beginning of VMRF’s activities in support of applying for and managing grant funds Overview of the Grant Cycle Program Authorization / Appropriation Applications Solicited / Funded VMRF applies for assistance. Principal Investigator signs as PI. - From the time decision is made to apply to deadline (1 – x months) - Congress Authorizes Program President Requests Funds Agency reviews applications and selects proposals for funding. - Typically 8-9 month review period - Congress Appropriates Funds Federal Agency may develop program regulations to guide program implementation Grant Administration VMRF / PI conduct approved project; Agency monitors award. - Approval approx. 10 months after deadline; Project period per New Grant Award - Agency usually advertises availability of funds - Several months before posted deadline - Grant Close-Out VMRF / PI close out award at the end of the project period. - Close-out documentation due within 90 days after project complete -

6. Pre-Award: Preparation and Submission of Proposal • Who is responsible for what? • Role of the Principal Investigator (PI) • Role of VMRF • Proposal Timeline • Transitioning from Pre- to Post Award

7. Role of the Principal Investigator • Idea • Identifies location of research administration • Based on VMRF/UCSD Agreement, 50% or more of study must occur in VA/VMRF space for a project to be administered by VMRF • Identifies Key Personnel & other personnel (supplies and other expenses, as needed) for project • Prepares application (application guidelines posted at http://grants1.nih.gov/grants/forms.htm) (a) Abstract (b) Budget justification, including budget detail (c) Bio sketches for Key Personnel (d) Resources page (e) Research plan

8. Role of VMRF C&G Administrators The VMRF Contracts and Grants Administrators (858.552.8585 x 7606) will support PIs and their staff to prepare the proposal submission to the NIH • Confirms PI eligibility / gets PI registered on eRA Commons if needed • Requests budget information from PI • Prepares the following: NIH requirements (a) PHS SF424 Application administrative sections (b) PHS SF424 Budget section for year 1 (c) PHS SF424 Budget section for entire project period (d) PHS SF424 NIH checklist; VMRF requirements (e) Conflict of Interest (Form 2000) for PI and Key Personnel (f) VMRF Checklist for PI and VASDHS Service Chief signature (g) Signed PI Assurance Form

9. Role of VMRF C&G Administrators CONTINUED • Compiles and submits proposal to appropriate agency • Assures compliance: If Human Subject and/or Animal Subject approval is not obtained prior to grant submission, VMRF Contracts & Grants Administrator follows up with investigator, as necessary, to ensure appropriate paperwork has been submitted to appropriate committee (IRB or IACUC), as these approvals must be received before NIH will release award. Grant proposal also submitted to IRC and R&D committees for approval.

10. Definitions: Budget Period: An interval of time (usually 12 months each) into which a project period is divided for budgetary and funding purposes. Project Period: The total time for which support of a project has been programmatically approved. The total project period comprises the initial competitive segment, any subsequent competitive segments resulting from a competing continuation award, and non-competing extensions. Modular Budget Grant: As part of NIH’s streamlining and reinvention initiatives, a simplified budget reporting feature is used allowing grantees to request total direct costs not exceeding $250,000 per year for the entire project period rather than requesting funds each budget period. (Use Modular Budget Component in PHS SF424) The Proposal Timeline Terms To Know

11. The Proposal Timeline CONTINUED • For the NIH standard Schedule of Postmarked Receipt Dates, Review and Award Cycles visit • http://grants1.nih.gov/grants/funding/submissionschedule.htm • All SF424 applications must be in response to a FOA, including the R01.

12. The Proposal Timeline CONTINUED

13. The Proposal Timeline CONTINUED

14. The Proposal Timeline CONTINUED

15. The Proposal Timeline CONTINUED SUBMISSION COMPLETE

16. What Can Go Wrong?TRANSITIONING FROM PRE- TO POST- AWARD • COMPLIANCE: Approval is not received for Human Subject and/or Animal use from appropriate committee by just-in-time deadline. This may delay review or award of grant. • NIH uses “just-in-time” procedures to allow an applicant to submit a proposal without certification of IRB approval of proposed use of human subjects, verification of IACUC approval of the project’s proposed use of live vertebrate animals or evidence of compliance with the education in the protection of human research participants. These approvals are necessary in order for the project to be reviewed and/or awarded, depending on human or animal use and agency.

17. What Can Go Wrong?TRANSITIONING FROM PRE- TO POST-AWARD • Notice of Grant Award (NGA) from NIH may not be on time or is reflective of back-dated start date when received. • Until VMRF receives an NGA for the initial award no costs can be incurred by the applicant for the project, including the hiring of personnel, if applicant has no other funds with VMRF. • In some instances, however, exceptions may apply. NIH has waived cost-related and other prior-approval requirements for many activities and expenditures, and provided authority for these activities and expenditures to a grantee. These operating authorities are termed “expanded authorities,” which entitles VMRF to administer some Federal funds without prior permission from the awarding agency in terms of approvals/disapprovals of budgetary issues.

18. What is VMRF permitted under “Expanded Authority?” Under Expanded Authorities, VMRF can do the following: • Approve pre-award spending 90 days before NGA is issued if indication has been given that the grant will be funded. • Allow carryover of un-obligated balances from one budget period to the next. • Allow a no cost extension (extension of final budget period up to a year without additional NIH funds). • Transfer performance of substantive programmatic work to a third party (by consortium agreement). VMRF must exercise proper stewardship, as the NIH may disallow the costs if it determines through audit or otherwise, that the costs do not meet the parameters of allowability, allocability, reasonableness, necessity and consistency.

19. Post Award AdministrationNow that the grant is awarded . . . • What does NIH require for compliance? VMRF? • What is the PI’s role? • What are non-competitive continuations? • What is SNAP? • What are competitive continuations?

20. Notice of Grant Award (NGA) received by VMRF. VMRF reviews and compares NGA with submitted proposal - budget period, project period, award amounts, reporting and contact information. VMRF assigns fund number and verifies full compliance (e.g. receipt of VA committee approvals).* When VMRF notifies PI of award, spending may begin. VMRF sets up monthly expenditure reports for PI to monitor spending VMRF is governed by the Cost Principals for Non-Profit Institutions as identified within OMB Circular A-122 (http://www.whitehouse.gov/omb/circulars/a122/text/a122.html) Post Award AdministrationWhat happens when a grant is awarded? *For more information on Compliance, please visit http://www.vmrf.org/research-admin/Index-Emp.html on the right hand side of the page

21. Post Award AdministrationWhat does VMRF monitor on awarded funds? • VMRF Contracts and Grants Administrators monitor personnel expenses allocated to grant funds. • VMRF Contracts and Grants Administrators prepare and route Personnel Agreements (if required). • Definition: an agreement between UCSD, a UCSD employee and VMRF established for long-term UCSD employees to have continuity of their UCSD benefits for the employee while working on a VMRF project. • VMRF notifies PIs monthly of grant expenditures and potential budget concerns. • VMRF monitors and communicates financial forecasting for budget/project period.

22. Post Award AdministrationWhat are non-competitive continuations? Non-Competitive Continuation defined: Projects lasting more than 12 months must provide annual progress reports to NIH to ensure the project is progressing as appropriate before the funds for the subsequent budget year can be released. This process is “noncompetitive,” in that the Principal Investigator only needs to inform the NIH of the progress a project has made over the previous budget year(s) and is not competing for funding that is incorporated into the current project period. The "Grant Progress Report" (PHS 2590) is submitted to and approved by NIH to noncompetitively fund each additional budget period within a previously approved project period. (http://grants1.nih.gov/grants/forms.htm)

23. Post Award AdministrationNoncompetitive Continuation process: • VMRF Contracts & Grants Administrator notifies PI of when the Progress Report is due to VMRF for NIH submission (annual progress reports are due to NIH two (2) months prior to the start of a new budget period). • VMRF Contracts & Grants Administrator generates: (a) NIH Face page (PHS 2590), Project Report Summary (page 2, which includes the SNAP questions) and Key Personnel listing (b) VMRF Checklist and Conflict of Interest (must be updated annually). 3. PI responds to SNAP questions, completes progress report and provides all necessary documentation to VMRF.

24. What is SNAP? Streamlined Non-Competing Award Process; Annual progress report; Under SNAP, the NIH Grants Management Officer negotiates the direct costs for the entire project period, eliminates the need for annual budget submissions and any negotiations, and reduces the information NIH requires to review and approve non-competing continuation awards and to monitor these awards. SNAP provides PIs with a mechanism of support that facilitates science while simplifying administration during the project period while keeping NIH updated on progress.

25. What is SNAP? CONTINUED As part of the progress report, the PI must address the following questions: • Has there been a change in the other support of key personnel since the last reporting period? • If yes, Other Support pages are required for those key personnel. • Will there be, in the next budget period, a significant change in the level of effort for key personnel from what was approved? • If yes, reasons must be stated and Other Support pages must be included. • Is it anticipated that an estimated unobligated balance (including prior year carryover) will be greater than 25 percent of the current year’s total budget? • If yes, justifiable reasons are required, along with how this will be avoided in the future.

26. Post Award AdministrationWHAT ARE NON-COMPETITIVE CONTINUATIONS? • VMRF Contracts & Grants Administrator submits Grant Progress Report to agency identified within Notice of Grant Award (NGA) • VMRF receives and verifies annual NGA • VMRF renews personnel agreements (if applicable)

27. Post Award AdministrationWHAT ARE COMPETITIVE CONTINUATIONS? Competitive Continuation defined: A request for funding to renew a project period that would otherwise expire. The request is considered a new grant, but allows the PI to continue and/or build upon the research to date. Competitive continuations are reviewed on a different cycle than “new” grants. Typically, the review is more expeditious due to receipt of previous project funding.

28. Post Award AdministrationWHAT ARE COMPETITIVE CONTINUATIONS?(CONTINUED) • The competitive continuation should include information on progress made with previously (or currently) funded project as an introduction to the new research plan. • PHS SF424 Electronic Application is used. (see http://grants1.nih.gov/grants/forms.htm) POST-AWARD COMPLETE

29. Close-Out Procedure • When should close-out begin? • What are the steps to close-out the grant? For NIH? For VMRF? For Principal Investigator? • When is the grant considered completely closed?

30. Close-Out Procedure • 90 days before a project period ends, VMRF internally increases monitoring of grant fund spending, as well as notifies the Human Resources department that alternative funding sources will be required for personnel expenses. • If no other sources are available, identified personnel will be terminated from their VMRF employment. • When project ends, VMRF Contracts & Grants Administrator notifies PI of upcoming Final Progress Report and Final Invention Statement (Form HHS 568) for NIH. Forms are due within 90 days after end date or in accordance with NGA. The PI is responsible for completion of aforementioned; once completed documents are received by VMRF, final documentation is submitted to the appropriate agency.

31. Close-Out Procedure CONTINUED • VMRF completes and submits the FSR-269, which is the final financial status report for the entire project period. • VMRF reviews internal administrative file for completeness. If complete, file is closed. HR and Accounting departments ensure appropriate measures are taken so that no further expenses will hit the fund.

32. NIH Requirement: Grantees generally must retain financial and programmatic records, supporting documents, statistical records, and all other records that are required by the terms of a grant for 3 years from the date the annual FSR is submitted. VMRF Procedure: Internally, once the grant is closed, records are kept on-site for 18 months. After this time, records are transported to storage for a period of 3 to 7 years, depending on the nature of the records. Record Retention

33. QUESTIONS? Additional information can be easily accessed via the following: VMRF Website: www.vmrf.org VMRF Main Line: 858.552.8585 x7606 UCSD IRB: http://irb.ucsd.edu NIH: http://grants2.nih.gov/grants/oer.htm