Important IRB notice regarding direct sponsor submissions

Message from the WVU IRB Office:

It has come to light that sponsors are submitting protocols on WVU’s behalf directly to commercial (Central) IRBs. While WVU IRB understands this process accelerates approvals and reduces site submission workloads, going forward any direct sponsor submissions must stop as this process is not approved by WVU IRB.

For anyone utilizing direct sponsor submissions, this news is understandably disappointing. However, until a well-defined process is in place that ensures human subjects, investigators, and all of WVU are properly protected the risks associated with direct sponsor submissions eclipse any benefits.

Our office is reaching out to other institutions that use this process to evaluate its use. Once our evaluation is complete, a determination will be made regarding any future changes concerning the acceptance of direct sponsor submissions.

If you have any questions or concerns, please don’t hesitate to contact WVU IRB office.