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) of any changes in your
study such as:
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
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.
- Protocol amendments, suspensions or termination.
- Change in Informed Consent
Informed Consent or IRB
a person's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects research.
Institutional Review Board (IRB) approval status.
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).
- Annual IRB and IBC approvals.
- Issues related to patient accrual or retention.
- Serious adverse events.
Food and Drug Administration (FDA) , DSMB
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
Data and Safety Monitoring Board (DSMB) or OSMB
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
Observational and Safety Monitoring Boards (OSMB) communications.
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.
- New staff human subjects
Human Subject training documentation.
Legally defined term for living persons about whom an investigator obtains specimens or data through direct 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.
Some changes to your study may need prior approval by NHLBI
- 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 terms and conditions, or undertaking any
activities disapproved or restricted as a term of 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.
- 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