Continuing Review

Every protocol* must be submitted for continuing review at least annually. The IRB office will send reminder notices approximately 90, 60, and 30 days prior to the expiration date of each protocol detailing whether full board or expedited review is required. The same continuing application is used for both expedited or full board review. Once received in the IRB office, a notice of receipt is sent to the principal investigator indicating the type of review, date of meeting if applicable, and listing any documents missing from the submission.

If approval for continuation is not granted prior to the expiration date of the protocol, all recruitment and subject enrollment must stop. Currently enrolled subjects should continue to receive treatment and follow-up that is in their best interest. Consistent failure to submit timely requests for continuing review is reportable to the FDA, OHRP, and the study sponsor.

Please complete a Final Study Report / Study Closure Form if all study related activities are complete - do not complete a Continuation Review Application.

Expedited continuation requests are assigned to reviewers on a rolling basis. Continuation requests which require full board review are assigned to a full board meeting based upon date and time of submission to the IRB office.

The following must be included in an expedited continuing review submission:

1 original and 3 copies of the Continuing Review Application

1 original and 3 copies of the current protocol (updated to reflect any approved modifications)

1 original and 3 copies of the Investigator Financial and Other Interests Disclosure Forms for all study personnel

4 copies of current consent forms to be approved with the continuation, and

4 copies of the most recently stamped and approved consent and/or assent forms.

Continuation applications for expired protocols must include 1 original and 2 copies of the Expired Study Report Form.

The following must be included in a full board protocol submission, collated into 1 original packet, 3 full packets including the current protocol and Financial and Other Interests Disclosure Forms, and 17 packets containing just the Continuing Review Application, current and previously approved consent documents:

1 original and 20 copies of the Continuing Review Application,

1 original and 3 copies of the current protocol (updated to reflect any approved modifications),

4 copies of Investigator Financial and Other Interests Disclosure Forms for all study personnel,

1 original and 20 copies of current consent forms to be approved with the continuation, and

21 copies of the most recently stamped and approved consent and/or assent forms.

Continuation applications for expired protocols must include 1 original and 20 copies of the Expired Study Report Form.

Following continuing review, your protocol will receive one of the following status determinations: Approved, Approvable pending re-review by the chair or his/her designee, Approvable pending re-review by the subcommittee, or Approvable pending re-review by the full board.

*Exempt protocols and protocols which have been determined to be Non Human Subjects Research do not require submission of continuing review applications.