Study Renewal vs. Closure

Sites receive a WCG IRB Site Continuing Review Reports when the expiration date is approaching. Federal regulations allow the IRB to perform continuing review of the research within 30 days before the IRB approval period expires and retain the anniversary of the expiration date of the initial IRB approval as the expiration date of each subsequent one-year approval period. The Board generally conducts the study renewal review 20-30 days prior to the expiration date listed on the Approval letter. Review fees apply for the continuing review service and review is carried out unless WCG IRB receives a study closure notice prior to the Board’s renewal review. If a closure notice is received by WCG IRB before the expiration date, but after the Board’s continuing review, the site will still be billed for the renewal review. To avoid unnecessary reviews and fees, do not delay reporting a study closure to WCG IRB if the expiration date is approaching. Please note that if you plan to close a study that is approaching its expiration date, no study activities may take place on or after the expiration date. For example, if the study’s expiration date is June 15, no study activities may take place on June 15 or following.

If the Board approves the continuing review for an additional review period, an Approval letter is forwarded to the investigator and other study contacts as applicable. The Approval letter states “Approval includes: Study and Investigator for an additional continuing review period. This approval expires on the date noted above.” Approval of the study encompasses renewal of the protocol, all previously approved amendments or revisions, and the existing consent and study materials as previously approved.

If, at the time of renewal, the Board determines that a modification to the consent form is necessary, the Approval letter will indicate approval of a consent form and will be accompanied by a revised consent form.