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Amendments and Renewals - NHSR, Exempt, Flex Protocols

Dear Research Community:

On November 9, you should have received a notice that WVU Office of Human Research Protections (OHRP) will no longer accept amendments and/or renewals for NHSR or Flex protocols.

This change is now being extended to EXEMPT protocol submissions to reduce time submitting unnecessary amendments, renewals and/or submissions to “Notify to IRB” that are not federal requirements for these protocol types.

Summary Chart of Protocol Requirements

If you’re unsure if a change to your protocol impacts your approval ask, “Does this change increase risks to subjects and/or is it excluded from Flex or  EXEMPT ?” If your answer is “NO,” then changing your protocol type would most likely not be required. Regardless, if you question if a change to your protocol might disqualify your current approval,  please reach out to WVU OHRP staff. We’ll let you know if you need to take additional action, and we’ll walk you through the appropriate process.