Human Subjects


Federal regulations and IU policy require non-exempt human subjects research studies to be reviewed on an ongoing basis throughout the life of the study. 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 for greater than minimal risk research and research that is federally funded or federally regulated (i.e., subject to FDA regulations or VA research regulations). Minimal risk research that is not federally funded or federally regulated, including Full Board studies that are now closed to enrollment with only long-term follow up or data analysis continuing, may be approved for up to two years. 

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 should also complete the Renewal Questionnaire in KC IRB.  For studies initially submitted and approved prior to the Phase IV KC IRB implementation (7/31/14), all forms should be reviewed with the renewal (Summary Safeguard Statement, Request Forms, HIPAA & Recruitment Checklist, etc.). Investigators should ensure that forms uploaded to KC IRB are up-to-date and accurate and should NOT attempt to replace the forms with the new KC IRB Questionnaires.

Renewal Notification
Renewal notification reminding the study team to submit a renewal to the HSO are sent via KC IRB 60 days prior to expiration, with additional reminders at 45 days and 15 days prior to expiration. For more information about receiving notifications, please see Notifications.

Failure to Renew (Study Expiration)

If a study does not receive approval from the IRB to continue the research prior to the expiration date, the investigator will receive notification via KC IRB. Studies expire at 11:59pm 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 reactivated within 6 months with submission of the renewal documents and a memo from the PI addressing the following questions:

  • Were any research activities (i.e., recruitment, study related activities, data analysis) conducted after the expiration date? Yes or No.
  • 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 reactivate a study that has been expired or closed for more than 6 months, a new application must be submitted.

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