Continuing Reviews & Closure

Continuing Review Overview

Continuing Review is a federally mandated re-evaluation of an approved study that must be conducted at least once per year. It is required until the Principal Investigator has completed all research-related interactions and interventions with participants, or when the collection and analysis of identifiable private information, as described in the IRB-approved protocol, has been completed.

This review allows the IRB to monitor the progress of the study and ensures that the study continues to meet the requirements for approval. The process begins when the Principal Investigator submits Continuing Review information through OneAegis.

To allow adequate processing time, Continuing Review information should be submitted no sooner than 60 days and no later than 30 days before the study’s expiration date. The expiration date can be found on the project page in OneAegis under the BYU IRB ID.

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Deadlines & Reminders

When To Submit

The Principal Investigator is responsible for submitting Continuing Review information within the 60–30 day window prior to the study’s expiration date.

Internal Reminders

Investigators are strongly encouraged to establish systems to track deadlines. Suggested methods include:

Setting reminders in electronic calendars
Holding regular meetings with study staff to review expiration dates

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Preparing the Continuing Review in OneAegis

Follow the instructions provided in the OneAegis site guide
Refer to an example of the OneAegis form

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Closing a Study

When To Close a Study

A study should be closed when all research-related interactions and interventions with participants are complete, and the collection and analysis of identifiable private data are finished.

How To Close a Study

To close a study, the investigator must submit a Closure Form through OneAegis. The IRB may request additional information to confirm the study is in good standing.

Once approved, the study will be marked as Closed and archived. If a study is closed in error or needs to resume, a new study submission is required.

After closure, investigators may retain collected data (including identifiable private data) if consistent with the approved protocol. All confidentiality protections and commitments must continue to be honored.

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Expired Studies

If IRB Approval Expires

If approval expires before Continuing Review is completed, all research activities must stop, unless continuation is necessary for the safety or best interest of current participants (typically in medical studies).

In such cases, the investigator must immediately notify the assigned IRB analyst.

If continuation is not approved, all activities must cease, including:

Interaction or intervention with participants
Collection or analysis of identifiable private information

How To Resume the Study

Research may resume only after Continuing Review has been completed and approved by the IRB.

Time Limits

Up to 60 days after expiration to obtain approval
After 60–90 days, the study will be permanently closed
A new study submission will be required after closure

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Continuing Reviews & Closure