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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) 

Program Official (PO)
staff member who oversees a scientific program and the progress of grants and contracts in a portfolio. This title is most frequently used to refer to the scientific or technical representative for grants, but the generic "program official" term also may refer to a Project Officer 
Project Officer
the NIH staff member designated as a Contracting Officer's Technical Representative (COTR) to coordinate the substantive aspects of an acquisition from its development through to contract award and administration. Also known as Contracting Officer's Technical Representative ( COTR ).
if the funding mechanism is a contract. Also known as Health Scientist Administrators or Program Director.
of any changes in your study such as:

  • Protocol amendments, suspensions or termination.
  • Change in Informed Consent 
    Informed Consent
    a person's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects research.
    or IRB 
    Institutional Review Board (IRB)
    a board or committee designated by an institution to ensure the protection of rights and welfare of human research subjects and reporting to the Office for Human Research Protection (OHRP). IRBs make ongoing independent determinations to approve, require modifications in, or disapprove research protocols based on whether human subjects are adequately protected. Also known as Research Ethics Boards (REB) or Ethics Committee (EC).
    approval status.
  • Annual IRB and IBC 
    Institutional Biosafety Committee (IBC)
    oversight group convened by a research institution under NIH Guidelines for Research Involving Recombinant DNA Molecules to review recombinant DNA research and ensure its legal use. IBCs may also review other biohazardous research, including biodefense select agents.
    approvals.
  • Issues related to patient accrual or retention.
  • Serious adverse events.
  • FDA 
    Food and Drug Administration (FDA)
    is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. Food and Drug Administration Homepage
    , DSMB 
    Data and Safety Monitoring Board (DSMB)
    an independent committee that reviews clinical trial progress and safety, and advises the appointing body whether to continue, modify, or terminate a trial. This is sometimes called a Data Monitoring Committee (DMC). (see Data and Safety Monitoring Policy image of word document icon (120 KB))
    or OSMB 
    Observational and Safety Monitoring Boards (OSMB)
    independent monitoring group whose principal role is to regularly monitor regularly data from large or complex observational studies and to review and assess the performance of its operations. Whether an OSMB is needed is determined on a case-by-case basis by NHLBI.
    communications.
  • New staff human subjects 
    Human Subject
    Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction 
    Interaction
    any communication or other interpersonal contact between an investigator and a human subject. For more information, go to definitions in 45 CFR 46.102 and full 45 CFR 46.
    or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA.
    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 
    Award
    provision of funds by NIH, based on an approved application and budget or progress report, to an organizational entity or an individual to carry out a project or activity.
    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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