If IRB Approval Expires
If IRB approval expires before continuing review and approval occur, the investigator must stop all research activities related to that study, except when the investigator judges it to be in the best interest of current participants to continue.
When the investigator makes this judgment, s/he must notify the IRB promptly. When the IRB reviews the investigator’s decision, the Board will determine if it is in the best interest of participants currently enrolled in the study to continue to participate in the research. The Board will make this determination for participants either one at a time or as a group.
If the Board determines it is not in the best interest of current participants to continue, all research activities must stop. This includes intervening / interacting with subjects and/or obtaining or analyzing identifiable private information about the participant(s). (see 45 CFR 46.103(b)).
How To Resume The Study
The investigator may resume the research activity once continuing review and approval by the IRB has occurred.
Investigators have up to 60 days after the study expires to obtain approval. After 60 days, the IRB will permanently close the study and a new study must be submitted for review.