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How do I manage changes to my grant?

You must comply with the terms and conditions of your award. Always promptly inform your Program Official (PO) of any changes in your study such as:

  • Protocol amendments, suspensions or termination.
  • Change in Informed Consent or IRB approval status.
  • Annual IRB and IBC approvals.
  • Issues related to patient accrual or retention.
  • Serious adverse events.
  • FDA , DSMB or OSMB communications.
  • New staff human subjects training documentation.

Some changes to your study may need prior approval by NHLBI such as:

  • Spending money more than 90 days before the start date of a new or recompeting award.
  • Changing key personnel.
  • Changing the grantee organization.
  • Changing the status of the grantee organization.
  • Adding a foreign component to a domestic organization, even if no money will go to the foreign site.
  • Taking a second extension of a final budget period.
  • Changing award terms and conditions, or undertaking any activities disapproved or restricted as a term of award.
  • Using salary funds in a career (e.g., K23) award for a new purpose.
  • Having alterations and renovations exceeding $300,000 in total costs.
  • Making any change in your project that constitutes a change in scope.

You must submit a Progress Report each year in order to continue to receive funding. For more details on these reports go to “How do I manage my budget?”

Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

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