Dear Research Community:
In an effort to continue to reduce investigator burden, the WVU+kc system will no longer accept amendments and/or renewals for NHSR or Flex protocols.
This change is being implemented in order to reduce time spent by investigators submitting unnecessary amendments, renewals and/or submissions to “Notify to IRB” that are not required for these protocol types.
- NHSR and Flex protocols will be approved for a single, 5-year term.
- Flex protocols still active after five (5) years will need to be resubmitted as new protocols. However, most Flex studies end before this time so this change should have minimal impact on researchers.
- NHSR projects active after five (5) years do not need to reapply. If your NHSR project is still active after this time it may continue if no changes are made that increase risks or change the study’s protocol type.
If you’re unsure if a change to your protocol impacts your approval ask yourself,
“Does this change increase risks to study subjects and/or is it excluded from Flex?”
If your answer is “NO,” then an amendment is most likely not required.