Whenever a protocol is amended, it must be sent to the 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).
for review. Once the amendment (and in some cases,
the revised Informed Consent form ) has been approved, your NHLBI National Heart, Lung, Blood Institute (NHLBI)a
NIH 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) 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.
should be notified by sending the updated protocol
with amendments clearly outlined, the updated consent form
and the IRB approval letter.
In the event that your study is suspended or terminated
by the IRB, by a 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).
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.
For trials conducting drug, device, or gene therapy research, the 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 must also
be notified of any changes to the protocol, suspensions or
terminations.
Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov