FDA EIR - Legacy Health IRB - December 17, 2021

A routine surveillance inspection was conducted at Legacy Health IRB in Portland, Oregon, from December 13 to December 17, 2021, under compliance program 7348.809 for Institutional Review Boards. The inspection identified several significant issues related to human subject protection and regulatory compliance, referencing sections of 21 CFR 50 and 56.

Main violations included critical deficiencies in informed consent documents, such as contradictory statements about study risks and misleading information regarding a subject's right to withdraw. The IRB also failed to update its registration information, including changes in the chairperson and inaccurate board member details, within the required 90-day period. Furthermore, the organization did not consistently follow its own written procedures, showing discrepancies in stated minimum board member counts and the designated signatory for final approvals. Additional concerns involved a study that potentially required an Investigational New Drug (IND) application but lacked one, and one emergency use not reported within the mandated five days.

In response to these findings, Legacy Health IRB management committed to corrective actions. These include revising problematic consent forms, promptly updating the IRB's registration for accuracy, and comprehensively reviewing and updating all written procedures to ensure alignment with both regulatory requirements and actual operational practices, thereby addressing the identified non-compliance.