FAQs

FAQs
  • When does the "renewal clock" start ticking on my approval?
    When a protocol is subject to full review, the IRB approval begins on the date of the convened Board meeting at which the protocol was reviewed. If, at that meeting, the Board requires modifications before it will issue approval, the renewal period still begins on the date of the convened meeting.

    For example, Dr. Smith submits a protocol for full review at the December 12, 2001 IRB meeting. In that meeting, the Board approves the protocol provided that certain language is added to the consent form. Dr. Smith receives this notification on December 15, 2001, but does not submit a revised consent form until February 3, 2002. The renewal date for approval of the protocol is still December 12, 2002 because that date is one year after the Board issued its approval of the protocol.

    On the other hand, the Board may defer approval and send the application back to the researcher for resubmission. If this occurs, then the renewal period would begin on the date of the convened meeting at which the Board actually approved the protocol, with or without required modifications.