 |
Must
I obtain continuing review from the IRB?
Each institutional review or ethics board 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 Director or Clinical Trial 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. |
