Continuing Review of Studies

Continuing Review of Expedited & Full Board Studies

All full board research studies and expedited studies that do not have an “NCR” prefix before the IRB number require continuing review. Under the new common rule (NCR), expedited studies are not required to obtain continuing review approval, although continuing review can be assigned by the IRB Designee reviewing the study if s/he believes it is warranted. If your study does require continuing review there will be an expiration data assigned on the IRB approval letter and you will receive a continuing review notification in GW iRIS. Principal investigators (PI) are responsible for submitting the Continuing Review form containing sufficient information. In addition to this form, the Research Team Personnel Form (available within GW iRIS) must be submitted.

Continuing review of an IRB approved study must be submitted at least 30-60 days prior to study expiration date.

In cases where a Continuing Review form application is not submitted prior to the expiration date, or in cases where the continuing review form is significantly incomplete and the PI has not responded to a request for information, the study will expire. At the time of expiration, all research activity must stop and the consent form (if applicable) is no longer valid.

When study approval expires, the PI has 90 days to submit a continuing review and obtain IRB approval to re-initiate the study. We recommend including a progress note on activity that occurred prior to expiration. If the study expired more than 90 days ago, please contact our office at [email protected].

For research studies that have been completed, a closure form should be submitted.

Referenced forms can be accessed and completed by logging into GW iRIS.

 

Exempt studies

Exempt studies DO NOT require a renewal.

 

Resources:

• IRB Forms
• Research Tools