Whenever a protocol is amended, it must be sent to the IRB
Institutional Review Board (IRB) for review. Once the amendment (and in some cases,
the revised Informed Consent form
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).
Consent form ) has been approved, your NHLBI
a person's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects
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.
research. Also known as Informed Consent.
National Heart, Lung, Blood Institute (NHLBI) Program Official (PO)
National Institutes of Health (NIH)
the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers
that conduct and support biomedical and behavioral research. NIH Homepage
Institute that provides leadership for a national program in diseases of the heart, lung, and blood as well as blood resources, sleep disorders and the Woman's Health Initiative. NHLBI Homepage
Program Official (PO) should be notified by sending the updated protocol
with amendments clearly outlined, the updated consent form
and the IRB approval letter.
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.
In the event that your study is suspended or terminated
by the IRB, by a DSMB
Data and Safety Monitoring Board (DSMB) or for other reasons, your Program Official(PO) must be notified in writing. Please include
enough detail as to the reason(s) for suspension or termination
and any recommendations made by the IRB or 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
For trials conducting drug, device, or gene therapy research, the FDA
Food and Drug Administration (FDA) must also
be notified of any changes to the protocol, suspensions or
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
Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov