Healthcare Inspection Patient Care, IRB, and Research Oversight Issues at a VA Medical Center

The purpose of this review was to evaluate allegations related to inadequate oversight of human subjects’ research and improper Institutional Review Board (IRB) actions that resulted in patient harm at a VA medical center. We found no evidence that the index patient was harmed as a result of his removal from Protocol X, nor did we find that an oncologist made medical decisions that negatively impacted the patient’s life. We also determined that the IRB acted within its authority to question the tumor staging of the index patient, and notified the appropriate individuals of needed actions. The IRB notified the principal investigator (PI) of Protocol X’s suspension in a timely manner and engaged in ongoing communication with the PI about the status of the study and the participants. We substantiated that responsible managers did not assure adequate oversight of human subjects’ research activities. We noted that some deficiencies identified by external review groups still existed at the time of our review, and we found that documentation of PI annual reports and IRB continuing reviews was inadequate. We also questioned some management decisions related to peer review, study audits, and provider reprivileging. We recommended that the PI annual report and continuing review documentation is completed in accordance with VHA Handbook 1200.5, and that Professional Standards Board members receive training on the options available when reprivileging employees. The VISN and Medical Center Directors agreed with our findings and recommendations and provided acceptable improvement plans.