Posted on November 2, 2020
The IRB’s Written Policies and Procedures (WPPs) were updated as of 10/30/2020 and are now available on the IRB’s website.
Links throughout the document were corrected and cross-linked.
Clarification was added to 3 WPPs about how the IRB reviews corrective actions or substantive changes that occur in response to an unanticipated problem – in particular changes to the research protocol that are initiated by the investigator prior to obtaining IRB approval to eliminate apparent immediate hazards to subjects.
For more information about Unanticipated Problems, see: Unanticipated Problems Involving Risks & Adverse Events Guidance (2007) and VCU IRB WPP VII-6