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Must I obtain continuing review from the IRB?

Each institutional review or ethics board ( 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).
) 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). (see Data and Safety Monitoring Policy image of word document icon (120 KB))
/ 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 

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.
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

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