Federal regulations and IU policy require non-exempt human subjects research studies that are greater than minimal risk or federally funded or FDA- or VA-regulated to be reviewed at least on an annual basis so long as research procedures continue. 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 that is not federally funded or FDA- or VA-regulated, including Full Board studies that are now closed to enrollment with only clinical follow up or data analysis continuing, does not require annual renewal.
The IRB reviews the same factors at renewal as it did with the initial submission, and all current study documents are required to accompany the renewal submission. Investigators complete the Renewal Questionnaire in KC IRB to request annual review.
For studies that do require renewal, notifications will be sent through the Kuali Coeus IRB system to remind the study team at 60 days prior to expiration, and at 45 days and 15 days prior to expiration.
To request an annual review, you should complete the Renewal Questionnaire in the KC IRB.