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COMING SOON - Expansion of Flexibility
New Exempt Categories and Changes to Renewal Requirements

March 6, 2018

Implementation of the new Common Rule has been delayed until at least July 19, 2018. While we await further information from the federal government regarding the new Common Rule, the IU IRB is moving forward with some of the changes outlined in the new rule.

Beginning March 29, 2018, research that is not federally funded and not FDA- or VA-regulated will be permitted to take advantage of certain burden-reducing provisions of the new Common Rule. Specifically, new exempt categories will be available to researchers, meaning that some research which previously required expedited review will now be eligible for exemption. In addition, the renewal requirement will be eliminated for expedited research and full board research which is in long-term follow-up or data analysis only. The changes will only impact research that is not federally funded and not subject to FDA or VA regulations.

Further information regarding these changes and KC IRB impacts will be available on the HSO website and will be sent via email announcement later this month.

HSO staff are available to answer questions about these upcoming changes. Please contact a member of the HSO staff or email with any questions.