Renewing your human subjects research study

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.

Renewal Notification

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.

Failure to renew (study expiration)

If a renewal is not approved by the IRB prior to the expiration date, the investigator will receive notification via KC IRB. Studies expire at 11:59 pm on the expiration date. 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 within six months of expiration with submission of a renewal in the KC IRB and a memo from the principal investigator addressing these questions:

  • Were any research activities (e.g., recruitment, study-related activities, data analysis) conducted after the expiration date?
  • If activities were conducted, please state exactly what type of activity was performed.
  • Provide a corrective plan to assure that renewal requirements are met and a rationale for the conduct of this study past the approval date.

To reopen a study that has been expired or closed for more than six months, a new study submission is required.