Renewing your human subjects research study

Federal regulations and IU policy require continuing review of non-exempt research that is subject to FDA regulations or research that requires review by the convened IRB. The IRB reviews the same factors at renewal as it did with the initial submission. While the IRB may require an alternate schedule depending on the risks and nature of the study, the review interval may not exceed one year. Minimal risk research, including Full Board studies that are now closed to enrollment with only clinical follow up or data analysis continuing, does not require annual renewal.

Renewal Notification

For studies that require renewal, a notification to submit a Renewal application will be sent from the Kuali Protocols IRB system at 45 days prior to expiration.  If a Renewal has not been submitted, additional reminder notifications will be sent to the study team at 30 days and 15 days prior to expiration.

Instructions for creating a Renewal in Kuali Protocols can be found in the Kuali Protocols instructional guides.

Failure to renew (study expiration)

Studies expire at 11:59 pm on the expiration date. If a renewal is not approved by the IRB prior to the expiration date, the investigator will receive a Study Expired notification from Kuali Protocols. Once a study expires, all research activities must stop, including enrollment of new participants, interaction with current participants, and analysis of identifiable data.

An expired study may be reopened with submission of a renewal in Kuali Protocols.