What should investigators do if IRB approval expires?
If IRB approval of a specific study expires before continuing review and approval occur, investigators must stop all research activities involving human subjects related to that study (45 CFR 46.103(b)), except where they judge that it is in the best interests of already enrolled subjects to continue to participate. When investigators make this judgment, they must promptly notify the IRB (45 CFR 46.103(b)(5)). When the IRB reviews the investigator’s 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, investigators must stop all human subjects research activities, including intervening or interacting with subjects, or obtaining or analyzing identifiable private information about human subjects (45 CFR 46.103(b)). I
