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Each institutional review or ethics board ( IRB 

) will review your research at least annually or more frequently as they deem appropriate.   It is the responsibility of the investigator to submit the proper documentation to the institutional board and obtain approval to continue the research on the timeline mandated by the IRB.  The approvals must be sent to 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.

or Clinical Trials Specialist 

Clinical Trials Specialist (CTS)
individual who works as part of the program staff on clinical research projects, managing and overseeing clinical and operational activities of the project.

at NHLBI.

IRB , IEC or REB	Annual approval required
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.	Annual approval required for gene therapy studies
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	Annual approval required for gene therapy studies
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). / 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.	Review as determined by the board (usually1-2 times per year

If IRB approval of a specific study expires before continuing review and approval occur, you must stop all research activities involving human subjects 

related to that study, except where you judge that it is in the best interests of already enrolled subjects to continue to participate. When you make this judgment, you must promptly notify your IRB. When the IRB reviews the decision, it may decide whether it is in the best interests of already enrolled subjects to continue to participate in the research by considering the best interests of subjects either one at a time or as a group. If an IRB determines that it is not in the best interests of already enrolled subjects to continue to participate, you must stop all human subjects research activities, including intervening or interacting with subjects, or obtaining or analyzing identifiable private information about human subjects. You may resume the human subjects research activity once continuing review and approval by the IRB has occurred.

Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov