Veterans Medical Research Foundation

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101 on NIH GrantsUnderstanding the Roles of

VMRF and the Principal Investigator When Administering NIH Grants

Last updated: December 2006

Veterans Medical Research Veterans Medical Research FoundationFoundation

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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.

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Overview

NIH Grant Management ToolsNIH Grant Management Tools Pre-award: preparation and submission of Pre-award: preparation and submission of

ProposalProposal Post Award Administration: what should be Post Award Administration: what should be

done once the grant has been awardeddone once the grant has been awarded Close-Out ProcedureClose-Out Procedure Record RetentionRecord Retention VMRF Reporting RequirementsVMRF Reporting Requirements

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Grant Management Tools

VMRF Website provides links to resource information, VMRF Website provides links to resource information, such as institutional requirements, policies and procedures, such as institutional requirements, policies and procedures, subject matter experts (i.e. Contracts & Grants subject matter experts (i.e. Contracts & Grants Administrator), and other contact information.Administrator), and other contact information. Information posted @ Information posted @ http://www.vmrf.org/vmrf/main.asphttp://www.vmrf.org/vmrf/main.asp

NIH website links:NIH website links: http://grants2.nih.gov/grants/policy/nihgps_2003/index.ht

m

http://grants2.nih.gov/grants/forms.htm http://era.nih.gov/

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Overview of the Grant Cycle

Congress Authorizes Program

President Requests Funds

Congress Appropriates Funds

Federal Agency may develop program regulations to guide program

implementation

Agency usually advertises availability of funds

- Several months before posted deadline -

VMRF applies for assistance. Principal Investigator signs as PI.

- From the time decision is made to apply to deadline (1 – x months) -

Pro

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Aut

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A

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App

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Sol

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Agency reviews applications and selects proposals for funding.

- Typically 8-9 month review period -

VMRF / PI conduct approved project; Agency monitors award.

- Approval approx. 10 months after deadline; Project period per New Grant Award -

VMRF / PI close out award at the end of the project period.

- Close-out documentation due within 90 days after project complete -

Gra

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Adm

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Gra

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-Out

Beginning of VMRF’s activities in support of applying for and managing grant funds

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Pre-Award: Preparation and Submission of Proposal

Who is responsible for Who is responsible for what? what? Role of the Principal Role of the Principal

Investigator (PI)Investigator (PI) Role of VMRFRole of VMRF

Proposal TimelineProposal Timeline Transitioning from Pre- Transitioning from Pre-

to Post Awardto Post Award

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Role of the Principal Investigator

1.1. IdeaIdea2.2. Identifies location of research administration Identifies location of research administration

Based on VMRF/UCSD Agreement, 50% or more of study Based on VMRF/UCSD Agreement, 50% or more of study mustmust occur in VA/VMRF space for a project to be occur in VA/VMRF space for a project to be administered by VMRFadministered by VMRF

3.3. Identifies Key Personnel & other personnel Identifies Key Personnel & other personnel (supplies (supplies

and other expenses, as needed) and other expenses, as needed) for projectfor project4.4. Prepares application Prepares application (application guidelines posted at (application guidelines posted at

http://grants1.nih.gov/grants/forms.htmhttp://grants1.nih.gov/grants/forms.htm))

(a) Abstract(a) Abstract(b) Budget justification, including budget detail(b) Budget justification, including budget detail(c) Bio sketches for Key Personnel(c) Bio sketches for Key Personnel(d) Resources page(d) Resources page(e) Research plan(e) Research plan

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The VMRF Contracts and Grants Administrators The VMRF Contracts and Grants Administrators (858.552.8585 x 7606) will support PIs and their staff to (858.552.8585 x 7606) will support PIs and their staff to

prepare the proposal submission to the NIHprepare the proposal submission to the NIH

Confirms PI eligibility / gets PI registered on eRA Commons if neededConfirms PI eligibility / gets PI registered on eRA Commons if needed Requests budget information from PIRequests budget information from PI Prepares the following:Prepares the following:

NIHNIH requirements requirements

(a) PHS SF424 Application administrative sections(a) PHS SF424 Application administrative sections(b) PHS SF424 Budget section for year 1(b) PHS SF424 Budget section for year 1(c) PHS SF424 Budget section for entire project period(c) PHS SF424 Budget section for entire project period(d) PHS SF424 NIH checklist;(d) PHS SF424 NIH checklist;

VMRFVMRF requirements requirements(e) Conflict of Interest (Form 2000) for PI (e) Conflict of Interest (Form 2000) for PI andand Key Personnel Key Personnel(f) VMRF Checklist for PI and VASDHS Service Chief signature(f) VMRF Checklist for PI and VASDHS Service Chief signature(g) Signed PI Assurance Form(g) Signed PI Assurance Form

Role of VMRF C&G Administrators

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Compiles and submits proposal to appropriate agencyCompiles and submits proposal to appropriate agency Assures compliance: If Human Subject and/or Animal Assures compliance: If Human Subject and/or Animal

Subject approval is not obtained prior to grant submission, Subject approval is not obtained prior to grant submission, VMRF Contracts & Grants Administrator follows up with VMRF Contracts & Grants Administrator follows up with investigator, as necessary, to ensure appropriate paperwork investigator, as necessary, to ensure appropriate paperwork has been submitted to appropriate committee (IRB or has been submitted to appropriate committee (IRB or IACUC), as these approvals must be received before NIH IACUC), as these approvals must be received before NIH will release award. Grant proposal also submitted to IRC will release award. Grant proposal also submitted to IRC and R&D committees for approval.and R&D committees for approval.

Role of VMRF C&G Administrators CONTINUED

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The Proposal Timeline

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)

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The Proposal Timeline CONTINUED

For the NIH standard Schedule of For the NIH standard Schedule of Postmarked Receipt Dates, Review and Postmarked Receipt Dates, Review and Award Cycles visitAward Cycles visit http://grants1.nih.gov/grants/funding/submissiohttp://grants1.nih.gov/grants/funding/submissio

nschedule.htmnschedule.htm All SF424 applications must be in response to a All SF424 applications must be in response to a

FOA, including the R01.FOA, including the R01.

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Responsible Responsible PartyParty

ActionAction TIMELINETIMELINE

(1)(1) Principal Principal Investigator Investigator

(PI)(PI)

Contact VMRF Contact VMRF (Contracts & Grants (Contracts & Grants

Administrator)Administrator) regarding submission regarding submissionAs early as possible, As early as possible,

but preferably 1 but preferably 1 month prior to grant month prior to grant

deadlinedeadline

(2)(2) VMRF VMRF (Contracts & Grants (Contracts & Grants

Administrator)Administrator)

Confirm PI and institution Confirm PI and institution eligibility; identify grant deadline eligibility; identify grant deadline and applicable grant policiesand applicable grant policies

ImmediatelyImmediately

(3)(3) PI PI GENERATE final grant proposal:GENERATE final grant proposal: AbstractAbstract Budget JustificationBudget Justification Biosketches for Key PersonnelBiosketches for Key Personnel Resources pageResources page Research PlanResearch Plan

2 weeks2 weeksprior to due dateprior to due date

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(5)(5) VMRF VMRF (Contracts & (Contracts &

Grants Grants Administrator)Administrator)

INPUT information into internal INPUT information into internal database and prepare the following:database and prepare the following:

NIH PHS SF424 Application NIH PHS SF424 Application Cover and Admin sectionsCover and Admin sections Budget sectionsBudget sections Detailed budget section Detailed budget section (Even if not required by NIH)(Even if not required by NIH) NIH checklist componentNIH checklist component

VMRF documents VMRF documents (to be pre-filled as (to be pre-filled as much as possible by VMRF staff, but much as possible by VMRF staff, but completed by PI)completed by PI) VMRF Checklist VMRF Checklist Conflict of Interest Form 2000Conflict of Interest Form 2000 PI Assurance FormPI Assurance Form

Upon receipt of first Upon receipt of first draft of grant draft of grant

proposalproposal

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Grants Office)Grants Office)

REVIEW PI’s grant proposalREVIEW PI’s grant proposal Budget – Correct calculations, if Budget – Correct calculations, if necessary necessary Forms – Correct and completeForms – Correct and completeforms being used, if necessary forms being used, if necessary Formatting requirements for PHS Formatting requirements for PHS SF424:SF424: Grant cover component –addresses Grant cover component –addresses and data must be correct and data must be correct Resources page – ensure Federal (i.e. Resources page – ensure Federal (i.e. VA) resources will be utilized and are VA) resources will be utilized and are listed on this pagelisted on this page NIH checklist – Ensure correct base & NIH checklist – Ensure correct base & current VMRF IDC rate are listedcurrent VMRF IDC rate are listed Animal and/or Human Subject data Animal and/or Human Subject data addressed (if applicable) in appropriate addressed (if applicable) in appropriate sections, as well as in the research plansections, as well as in the research plan

1-2 weeks 1-2 weeks prior to deadlineprior to deadline

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Compile and submit to grants.govCompile and submit to grants.gov 5 days 5 days prior to deadlineprior to deadline



Grants.gov & eRA Commons Grants.gov & eRA Commons

Confirmation of receipt to PIConfirmation of receipt to PI

Coordinate w/PI handling any Coordinate w/PI handling any changes within 2-day period changes within 2-day period Re-submit as necessary Re-submit as necessary

Obtain hard copy from PI via eRA Obtain hard copy from PI via eRA commons- make internal copiescommons- make internal copies

SUBMISSION COMPLETE

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What Can Go Wrong?TRANSITIONING FROM PRE- TO POST- AWARD

COMPLIANCE: Approval is not received for Human COMPLIANCE: Approval is not received for Human Subject and/or Animal use from appropriate committee Subject and/or Animal use from appropriate committee by just-in-time deadline. This may delay review or by just-in-time deadline. This may delay review or award of grant.award of grant. NIH uses “just-in-time” procedures to allow an applicant NIH uses “just-in-time” procedures to allow an applicant

to submit a proposal without certification of IRB to submit a proposal without certification of IRB approval of proposed use of human subjects, verification approval of proposed use of human subjects, verification of IACUC approval of the project’s proposed use of live of IACUC approval of the project’s proposed use of live vertebrate animals or evidence of compliance with the vertebrate animals or evidence of compliance with the education in the protection of human research education in the protection of human research participants. These approvals are necessary in order for participants. These approvals are necessary in order for the project to be reviewed and/or awarded, depending on the project to be reviewed and/or awarded, depending on human or animal use and agency.human or animal use and agency.

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What Can Go Wrong?TRANSITIONING FROM PRE- TO POST-AWARD

Notice of Grant Award (NGA) from NIH may not be on Notice of Grant Award (NGA) from NIH may not be on time time oror is reflective of back-dated start date when is reflective of back-dated start date when received.received. Until VMRF receives an NGA for the initial award no costs can Until VMRF receives an NGA for the initial award no costs can

be incurred by the applicant for the project, including the hiring be incurred by the applicant for the project, including the hiring of personnel, if applicant has no other funds with VMRF.of personnel, if applicant has no other funds with VMRF.

In some instances, however, In some instances, however, exceptions may apply. exceptions may apply. NIH has NIH has waived cost-related and other prior-approval requirements for waived cost-related and other prior-approval requirements for many activities and expenditures, and provided authority for many activities and expenditures, and provided authority for these activities and expenditures to a grantee. These operating these activities and expenditures to a grantee. These operating authorities are termed “authorities are termed “expanded authorities,expanded authorities,” which entitles ” which entitles VMRF to administer some Federal funds without prior VMRF to administer some Federal funds without prior permission from the awarding agency in terms of permission from the awarding agency in terms of approvals/disapprovals of budgetary issues.approvals/disapprovals of budgetary issues.

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What is VMRF permitted under “Expanded Authority?”Under Expanded Authorities, VMRF can do the following:Under Expanded Authorities, VMRF can do the following: Approve pre-award spending 90 days before NGA is issued if indication Approve pre-award spending 90 days before NGA is issued if indication

has been given that the grant will be funded.has been given that the grant will be funded. Allow carryover of un-obligated balances from one budget period to the Allow carryover of un-obligated balances from one budget period to the

next.next. Allow a nAllow a no cost extension (eo cost extension (extension of final budget period up to a year xtension of final budget period up to a year

without additional NIH funds).without additional NIH funds). Transfer performance of substantive programmatic work to a third party (by Transfer performance of substantive programmatic work to a third party (by

consortium agreement).consortium agreement).

VMRF must exercise proper stewardship, as the NIH may disallow the VMRF must exercise proper stewardship, as the NIH may disallow the costs if it determines through audit or otherwise, that the costs do not costs if it determines through audit or otherwise, that the costs do not meet the parameters of allowability, allocability, reasonableness, necessity meet the parameters of allowability, allocability, reasonableness, necessity and consistency.and consistency.

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Post Award AdministrationNow that the grant is awarded . . .

What does NIH require What does NIH require for compliance? VMRF?for compliance? VMRF?

What is the PI’s role?What is the PI’s role? What are non-competitive What are non-competitive

continuations? continuations? What is SNAP?What is SNAP?

What are competitive What are competitive continuations?continuations?

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Post Award AdministrationWhat happens when a grant is awarded?

1.1. Notice of Grant Award (NGA) received by VMRF.Notice of Grant Award (NGA) received by VMRF.2.2. VMRF reviews and compares NGA with submitted proposal VMRF reviews and compares NGA with submitted proposal

- budget period, project period, award amounts, reporting - budget period, project period, award amounts, reporting and contact information.and contact information.

3.3. VMRF assigns fund VMRF assigns fund number and verifies full number and verifies full compliance (e.g. receipt compliance (e.g. receipt of VA committee approvals).of VA committee approvals).**

4.4. When VMRF notifies PI of When VMRF notifies PI of award, spending may begin. award, spending may begin.

5.5. VMRF sets up monthly VMRF sets up monthly expenditure reports for PI to expenditure reports for PI to monitor spendingmonitor spending

VMRF is governed by the Cost VMRF is governed by the Cost Principals for Non-Profit Principals for Non-Profit

Institutions as identified within Institutions as identified within OMB Circular A-122 OMB Circular A-122

(http://www.whitehouse.gov/om(http://www.whitehouse.gov/omb/circulars/a122/text/a122.htmlb/circulars/a122/text/a122.html))

*For more information on Compliance, please visit http://www.vmrf.org/research-admin/Index-Emp.html on the right hand side of the page

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Post Award AdministrationWhat does VMRF monitor on awarded funds?

VMRF Contracts and Grants Administrators monitor VMRF Contracts and Grants Administrators monitor personnel expenses allocated to grant funds.personnel expenses allocated to grant funds.

VMRF Contracts and Grants Administrators prepare and VMRF Contracts and Grants Administrators prepare and route Personnel Agreements (if required).route Personnel Agreements (if required). Definition: an agreement between UCSD, a UCSD Definition: an agreement between UCSD, a UCSD

employee and VMRF established for long-term UCSD employee and VMRF established for long-term UCSD employees to have continuity of their UCSD benefits for employees to have continuity of their UCSD benefits for the employee while working on a VMRF project.the employee while working on a VMRF project.

VMRF notifies PIs monthly of grant expenditures and VMRF notifies PIs monthly of grant expenditures and potential budget concerns.potential budget concerns.

VMRF monitors and communicates financial forecasting for VMRF monitors and communicates financial forecasting for budget/project period. budget/project period.

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Post Award AdministrationWhat are non-competitive continuations?

Non-Competitive Continuation defined:Non-Competitive Continuation defined:

Projects lasting more than 12 months must provide annual progress reports Projects lasting more than 12 months must provide annual progress reports to NIH to ensure the project is progressing as appropriate before the funds to NIH to ensure the project is progressing as appropriate before the funds for the subsequent budget year can be released. This process is for the subsequent budget year can be released. This process is “noncompetitive,” in that the Principal Investigator only needs to inform “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) 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 and is not competing for funding that is incorporated into the current project period.project period.

The "Grant Progress Report" (PHS 2590) is submitted to and approved by The "Grant Progress Report" (PHS 2590) is submitted to and approved by NIH to noncompetitively fund each additional budget period within a NIH to noncompetitively fund each additional budget period within a previously approved project period. previously approved project period. (http://grants1.nih.gov/grants/forms.htm)(http://grants1.nih.gov/grants/forms.htm)

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Post Award Administration Noncompetitive Continuation process:

1.1. VMRF Contracts & Grants Administrator notifies PI of when the VMRF Contracts & Grants Administrator notifies PI of when the Progress Report is due to VMRF for NIH submission (annual Progress Report is due to VMRF for NIH submission (annual progress reports are due to NIH two (2) months prior to the start of progress reports are due to NIH two (2) months prior to the start of a new budget period). a new budget period).

2.2. VMRF Contracts & Grants Administrator generates: VMRF Contracts & Grants Administrator generates: (a) NIH Face page (PHS 2590), Project Report Summary (page 2, (a) NIH Face page (PHS 2590), Project Report Summary (page 2, which includes the SNAP questions) and Key Personnel listing which includes the SNAP questions) and Key Personnel listing (b) VMRF Checklist and Conflict of Interest (must be updated (b) VMRF Checklist and Conflict of Interest (must be updated annually).annually).

3. 3. PI responds to SNAP questions, completes progress report and PI responds to SNAP questions, completes progress report and provides all necessary documentation to VMRF.provides all necessary documentation to VMRF.

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What is SNAP?SStreamlined treamlined NNon-Competing on-Competing AAward ward PProcess; rocess; Annual progress report;Annual progress report;

Under SNAP, the NIH Grants Management Officer Under SNAP, the NIH Grants Management Officer negotiates the direct costs for the entire project period, negotiates the direct costs for the entire project period, eliminates the need for annual budget submissions and eliminates the need for annual budget submissions and any negotiations, and reduces the information NIH any negotiations, and reduces the information NIH requires to review and approve non-competing requires to review and approve non-competing continuation awards and to monitor these awards. continuation awards and to monitor these awards.

SNAP provides PIs with a mechanism of support that SNAP provides PIs with a mechanism of support that facilitates science while simplifying administration facilitates science while simplifying administration during the project period while keeping NIH updated on during the project period while keeping NIH updated on progress.progress.

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What is SNAP? CONTINUED

As part of the progress report, the As part of the progress report, the PI must address the following questions: must address the following questions: Has there been a change in the other support of key personnel since Has there been a change in the other support of key personnel since

the last reporting period?the last reporting period? If yes, Other Support pages are required for those key personnel. If yes, Other Support pages are required for those key personnel.

Will there be, in the next budget period, a significant change in the Will there be, in the next budget period, a significant change in the level of effort for key personnel from what was approved?level of effort for key personnel from what was approved? If yes, reasons must be stated and Other Support pages must be If yes, reasons must be stated and Other Support pages must be

included.included. Is it anticipated that an estimated unobligated balance (including prior Is it anticipated that an estimated unobligated balance (including prior

year carryover) will be greater than 25 percent of the current year’s year carryover) will be greater than 25 percent of the current year’s total budget?total budget? If yes, justifiable reasons are required, along with how this will If yes, justifiable reasons are required, along with how this will

be avoided in the future.be avoided in the future.

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Post Award AdministrationWHAT ARE NON-COMPETITIVE CONTINUATIONS?

4.4. VMRF Contracts & Grants Administrator submits Grant Progress VMRF Contracts & Grants Administrator submits Grant Progress Report to agency identified within Notice of Grant Award (NGA)Report to agency identified within Notice of Grant Award (NGA)

5.5. VMRF receives and verifies annual NGAVMRF receives and verifies annual NGA

6.6. VMRF renews personnel agreements (if applicable)VMRF renews personnel agreements (if applicable)

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Competitive Continuation defined:Competitive Continuation defined:

A request for funding to renew a project period that would A request for funding to renew a project period that would otherwise expire. The request is considered a new grant, but otherwise expire. The request is considered a new grant, but allows allows the PI to continue and/or build upon the research to date. the PI to continue and/or build upon the research to date.

Competitive continuations are reviewed on a different cycle than Competitive continuations are reviewed on a different cycle than “new” grants. “new” grants. TypicallyTypically, the review is more expeditious due to , the review is more expeditious due to receipt of previous project funding.receipt of previous project funding.

Post Award AdministrationWHAT ARE COMPETITIVE CONTINUATIONS?

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The competitive continuation should include The competitive continuation should include information on progress made with previously information on progress made with previously (or currently) funded project as an introduction (or currently) funded project as an introduction to the new research plan.to the new research plan.

PHS SF424 Electronic Application is used. PHS SF424 Electronic Application is used. (see http://grants1.nih.gov/grants/forms.htm)(see http://grants1.nih.gov/grants/forms.htm)

Post Award AdministrationWHAT ARE COMPETITIVE CONTINUATIONS?(CONTINUED)

POST-AWARD

COMPLETE

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Close-Out Procedure

When should close-out When should close-out begin?begin?

What are the steps to What are the steps to close-out the grant? close-out the grant? For NIH? For VMRF? For NIH? For VMRF? For Principal For Principal Investigator?Investigator?

When is the grant When is the grant considered completely considered completely closed?closed?

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Close-Out Procedure1.1. 90 days 90 days beforebefore a project period ends, VMRF internally a project period ends, VMRF internally

increases monitoring of grant fund spending, as well as increases monitoring of grant fund spending, as well as notifies the Human Resources department that alternative notifies the Human Resources department that alternative funding sources will be required for personnel expenses. funding sources will be required for personnel expenses.

If no other sources are available, identified personnel will If no other sources are available, identified personnel will be terminated from their VMRF employment.be terminated from their VMRF employment.

2.2. When project ends, VMRF Contracts & Grants Administrator When project ends, VMRF Contracts & Grants Administrator notifies PI of upcoming Final Progress Report and Final notifies PI of upcoming Final Progress Report and Final Invention Statement (Form HHS 568) for NIH. Forms are due Invention Statement (Form HHS 568) for NIH. Forms are due within 90 days within 90 days afterafter end date or in accordance with NGA. The end date or in accordance with NGA. The PI is responsible for completion of aforementioned; once PI is responsible for completion of aforementioned; once completed documents are received by VMRF, final completed documents are received by VMRF, final documentation is submitted to the appropriate agency.documentation is submitted to the appropriate agency.

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Close-Out Procedure CONTINUED

3.3. VMRF completes and submits the FSR-269, which is the VMRF completes and submits the FSR-269, which is the final financial status report for the entire project period. final financial status report for the entire project period.

4.4. VMRF reviews internal administrative file for VMRF reviews internal administrative file for completeness. If complete, file is closed. HR and completeness. If complete, file is closed. HR and Accounting departments ensure appropriate measures are Accounting departments ensure appropriate measures are taken so that no further expenses will hit the fund. taken so that no further expenses will hit the fund.

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Record Retention

NIH Requirement:NIH Requirement: Grantees generally must Grantees generally must retain financial and retain financial and programmatic records, programmatic records, supporting documents, supporting documents, statistical records, and all statistical records, and all other records that are other records that are required by the terms of a required by the terms of a grant for grant for 3 years3 years from the from the date the annual FSR is date the annual FSR is submitted.submitted.

VMRF Procedure:VMRF Procedure: Internally, Internally, once the grant is closed, once the grant is closed, records are kept on-site records are kept on-site for for 18 months18 months. After this . After this time, records are time, records are transported to storage for transported to storage for a period of a period of 3 to 7 years, 3 to 7 years, depending on the nature of depending on the nature of the records. the records.

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QUESTIONS?

Additional information can be easily accessed via the following:Additional information can be easily accessed via the following:

VMRF Website:VMRF Website: www.vmrf.org www.vmrf.org

VMRF Main Line:VMRF Main Line: 858.552.8585 x7606858.552.8585 x7606

UCSD IRB:UCSD IRB: http://irb.ucsd.eduhttp://irb.ucsd.edu

NIH:NIH: http://grants2.nih.gov/grants/oer.htmhttp://grants2.nih.gov/grants/oer.htm

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