Annual continuation of IRB approval is required for all human subjects research projects which are not Exempt. The Principal Investigator is responsible for fulfilling requirements associated with continuing review in time for the IRB to carry out review prior to the expiration date of the current IRB approval. The form should be submitted at least 15 days before the study’s expiration date for expedited review projects and 30 days before expiration for projects requiring full board review to ensure adequate time for the IRB to process the continuing review.
The expiration date for your project is located on the initial IRB approval letter for your project, or on the last continuing review approval letter.
The Office of Research Compliance generates continuing review reminder notices for each active study. The Principal Investigator (and advisor, if this is a student project) will receive the continuation reminder by email, typically at least 30 days in advance for expedited review projects and at least 60 days in advance for projects requiring full board review.
Investigators are strongly encouraged to devise an additional system for ensuring the submission of continuing reviews. It is your responsibility to ensure that your project approval does not expire. If you misplace the continuation form or do not receive a continuation form from the Office of Research Compliance, you may either contact them for a replacement, or use the following form:
If all research-related interventions or interactions with human subjects have been completed and all data has been de-identified, the research project can now be closed. A continuation form should be completed for projects which are closed so that the IRB has a record of the final subject numbers for your project and can close out the file for your project.
If IRB approval expires before continuing review and approval occur, investigators must stop all research activities involving human subjects related to that study, 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. 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. Investigators may resume the human subjects research activity once continuing review and approval by the IRB has occurred.
Investigators have up to 30 days after the study expires to obtain approval. Otherwise, the IRB will close the study and a new IRB application will have to be submitted in order to resume the research.