January 9, 2024
For the Record- January 9, 2024: FDA Inspection, Advarra Consent Form Audit
In this Issue:
FDA Inspection
No Findings
The Human Subjects Division recently underwent a surveillance inspection by the Food and Drug Administration (FDA). FDA routinely reviews IRBs approximately every 5 years. Our last inspection was in 2017. Consistent with our prior review, there were no findings by the inspector.
This positive outcome provides assurance to our research community and partners that HSD is fully compliant with FDA regulations and provides high quality review and oversight of human subjects research. It is also a reflection of the hard work and dedication of our UW staff, faculty, and community members who serve on our IRBs. Thank you for contributing to this successful outcome
Consent Form Audit for Studies Reviewed by Advarra
Reminder
As announced in our December 5th newsletter, this is a reminder that effective January 1, 2024, Advarra will no longer ensure that UW’s required elements of consent are present in all consent forms it reviews for UW research.
Research teams are responsible for ensuring that UW’s institutionally required consent elements are added to consent forms (including sponsor provided templates) prior to review by Advarra (and any non-UW IRB).
As a result of this change, HSD will now perform a post-approval audit of all consent forms approved by Advarra in initial submissions to ensure that they meet UW institutional requirements. If consent materials are not consistent with these requirements, HSD will contact the UW research team to describe the inconsistencies. Inconsistent consent materials may need to be re-reviewed by the external IRB at the sponsor and/or PI’s expense, and subjects who have already been enrolled in the study may need to sign the new consent materials.
Information about this new requirement has been added to HSD’s guidance documents, including the Checklist of Responsibilities for Researchers using a non-UW IRB. For questions about this new requirement, contact HSD’s Reliance Team at hsdrely@uw.edu.