Certain events and new information require reporting to the IRB. These events include, but are not limited to, reportable events, noncompliance, information that represents new risks and certain types of audits. The WU IRB Policies and Procedures and the HRPO Research Guide outline the reporting requirements in detail.
These tables provide a summary of what events require reporting to the IRB, details on how to submit the reportable events in myIRB and the reporting timeframes.
* When researchers rely on an IRB other than the WU IRB or NCI CIRB, the reporting requirements for the IRB being relied upon must be followed. However, there are a few circumstances where reporting to the WU IRB is also required. The WU Policy for use of a single IRB (SIRB) in multi-site research studies and the SIRB Research Guide outline the circumstances under which reporting to the WU IRB is required.
This memo provides clarification on the reporting requirements for IND safety reports. It may be helpful to provide this information to sponsors of research if there are questions about when IND safety reports should be submitted to the IRB.
This memo applies when WU or the NCI CIRB is the IRB of record. If you are relying on another IRB, refer to that IRB’s policies.
Content current as of 10/5/2022