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Must I obtain continuing review from the IRB?

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) or Clinical Trials Specialist at NHLBI.

IRB , IEC or REB

Annual approval required

IBC

Annual approval required for gene therapy studies

FDA

Annual approval required for gene therapy studies

DSMB / OSMB

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

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