Researchers or study personnel who are not affiliated with WVU or associated health systems* and are engaged in human subjects research should not be added to the personnel section of any WVU+kc IRB protocol.
Requirements for working with non-affiliated personnel are based on IRB review type:
Not Human Subjects Research, FLEX, Exempt: Requirements for these review types depend on your collaborators’ affiliations, and whether they are associated with an organization with its own IRB.
- Organizations with an IRB (universities, medical systems, or other institutions): Each non-affiliated researcher must seek guidance from their organization for review requirements. These individuals should not be listed on the WVU+kc protocol and are not covered by WVU IRB review and oversight. In this circumstance, each institution is responsible for its own IRB review and oversight.
- Organizations without an IRB and community members: If the non-affiliated researcher is not associated with an institution with its own IRB, then the PI may choose to include an attachment listing non-affiliated personnel to note their involvement. WVU Principal investigators are responsible for ensuring all personnel, including non-affiliates, have appropriate training/oversight.
Expedited/Full Board
Non-affiliated researchers are only covered by WVU IRB when a reliance agreement is in place. In general, WVU IRB will only serve as the IRB of Record for other institutions in limited circumstances and/or when required by a federal single IRB mandate.
If reliance does not apply:
- Each institution/organization involved will be responsible for IRB review and oversight.
- If unfunded and working with community members or organization without an IRB, WVU Principal investigators are generally responsible for ensuring all personnel, including non-affiliates, have appropriate training/oversight but this will be evaluated on a case by case basis.
*WVU Health System Only Employees must follow specific instructions to access WVU+kc/Kuali Build.