Continuing Review

Guidelines for Continuing Review

For information on how to submit a continuing review, please navigate to our How to Submit's Continuing Review section.

The IRB will make a determination at the time of the initial review if a substantive continuing review of a protocol is required and document that determination in the meeting minutes. The IRB may require continuing review more frequently than annually for research conducted in settings subject to high degrees of volatility. For example, refugee camps, active duty military settings, nations experiencing major political/social upheaval, etc. Research projects reporting multiple adverse events and/or protocol deviations or multiple inquiries from potential and enrolled subjects may require verification that no substantial changes have been made to the research by the IRB chair, members, staff, appropriate third party at recruitment data collection sites or some combination of the above. 

Continuing review of research approved under the pre-2019 Common Rule that under the new Common Rule would not be subject to continuing review requirements will undergo a primary review by the Chair and voted upon at a convened IRB meeting. For research approved under the New Common Rule, effective January 19, 2019, where continuing review is no longer a requirement for all non-exempt research, the IRB will still require an annual “check-in” to confirm the research is still ongoing, to disclose any yet unreported protocol changes or adverse events, and to ensure the approved consent form is in use. 

Expedited review and approval of modifications in the protocol or consent form that are reviewed during an approved project period will not modify the original 365-day approval period granted to the project. If at the time of the initial review, it is determined by the IRB that a study needs to be reviewed more than once a year, it shall be included in writing to the primary investigator. The IRB Chairperson (or his/her designee) may, at his/her discretion, audit and/or review research records of individual protocols. Principal Investigators will receive a notice at least thirty (30) days before the approval expiration date that a continuing review report is due. If the form is not approved prior to the expiration date, the IRB may suspend enrollment of new subjects until approval is received.

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