December 5, 2023
For the Record- December 5, 2023: Advarra Studies Consent Audit
In this Issue:
Consent Form Audit for Studies Reviewed by Advarra
New Requirement
For the past several years, Advarra has agreed to ensure that UW’s institutionally required elements of consent are present in all consent forms it reviews for UW research. Although UW researchers should be adding these elements to consent forms before they are submitted to Advarra, this assessment by Advarra has served as an important double check to ensure that UW’s institutional requirements are met.
Advarra has notified HSD that it will cease assessing consent forms for UW institutionally required elements beginning January 1, 2024.
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. HSD already performs this audit for all industry-initiated clinical trials reviewed by Advarra. There will be no change to that process for those studies.
For all other studies reviewed by Advarra, HSD will now audit all consent forms approved at the time of initial review by Advarra to ensure that:
- UW’s institutionally required elements of consent are present, and
- Any compensation for injury language is consistent with any Clinical Trial Agreement (CTA) applicable to the study.
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.
HSD’s audit will begin when HSD is in receipt of the initial approval and consent forms and any CTA being negotiated by Office of Sponsored Programs is complete. Advarra typically includes HSD in its notification of approval, and HSD will begin its audit upon receipt of this notification, however it is the responsibility of the UW study team to provide a copy of the initial approval and consent forms to HSD if it is not included in Advarra’s notification email. Researchers may begin recruitment and consenting prior to the conclusion of HSD’s audit but should be prepared to re-consent subjects if consent elements are found to be missing during the audit.
HSD will not audit new consent forms for existing IRB-approved studies or modifications to already approved consent forms.
Research teams can prepare for this change by familiarizing themselves with UW’s institutionally required elements of consent and developing processes to ensure that they are added to all consent forms submitted to Advarra (and any non-UW IRB).
During the next year, HSD will be evaluating this post-approval consent audit and may make changes to the process. Any changes will be announced in a future newsletter prior to being implemented.
Information about this new requirement will be added to HSD’s guidance documents in January. For questions about this new requirement, contact HSD’s Reliance Team at hsdrely@uw.edu.
Guidance on Research Involving Valley Medical Center
Now Easier to Find
HSD has moved and refreshed its guidance on research involving Valley Medical Center (Valley). The guidance is now easier to find on HSD’s website and easier to read. There are no changes to HSD’s policies for research involving Valley. Researchers planning research involving Valley should review the guidance and can contact HSD’s Reliance Team at hsdrely@uw.edu for questions.