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Preparing for the Revised Common Rule:
New Exempt Categories & Changes to Renewal Requirements

December 15, 2017

Final revisions to the Federal Policy for the Protection of Human Subjects (Common Rule) go into effect on January 19, 2018. At that time, new exempt categories will be available to researchers, meaning that some research which previously required expedited approval will now be eligible for exemption. In addition, the revised Common Rule removes the renewal requirement for expedited research and full Board research which has progressed to the point where research procedures are limited to accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care (i.e. long-term follow-up) or data analysis only.

Detailed information about these changes and their impact is available on the Human Subjects Office Homepage. Please visit this page and view the Preparing for the New Common Rule section in red, specifically the sections concerning Changes to Exempt Research and Removal of Renewal Requirements to learn more.

Spanish versions of the revised informed consent templates published last month, are now available on the HSO Forms & Templates webpage as well.

HSO staff are available to answer questions about the revised Common Rule. Please contact a member of the HSO staff or email irb@iu.edu. If you would like to request a departmental-specific training session on the revised Common Rule, please complete the Revised Common Rule Training Request.