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  • Study Expiration and Processing Guidance - DEADLINE - AUGUST 15, 2021

Study Expiration and Processing Guidance - DEADLINE - AUGUST 15, 2021

To remain compliant with FDA and DHHS Common Rule regulations and to protect the integrity of WVU’s AAHRPP Accreditation status and Federalwide Assurance (FWA), WVU OHRP will be making changes regarding protocol expiration policies.

As you are aware, our WVU+kc electronic IRB system provides reminders for protocols requiring Continuing Renewal at 90, 60, 45 and 30 days prior to the expiration date of the currently approved protocol.

 Effective August 15, 2021, any protocol in the WVU+kc system that reaches its expiration date prior to Continuing Review and approval will no longer be eligible for renewal. Researchers with protocols whose approval has expired will need to submit a new Initial Review application in the system.

 To ensure your Expedited protocol does not expire before it is reviewed and approved by the IRB, please submit your renewal no less than 30 calendar days prior to the expiration date.

 If your study is a Full Board protocol, you should submit your renewal 45 days prior to expiration to allow time for your study to be pre-reviewed and submitted to the agenda for processing.

 Please note: If your protocol expires prior to renewal, no research activities may be conducted until a new Initial Review application is submitted and approved by the WVU IRB to continue the research.

 If you have questions regarding this policy change, please contact WVU OHRP at