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How do I report amendments, suspensions and terminations?

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 
Consent form
a person's voluntary agreement, based upon adequate knowledge and understanding, to participate in 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.
research. Also known as Informed Consent.
) 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). (see Data and Safety Monitoring Policy image of word document icon (120 KB))
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

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