February 4, 2025
For the Record- February 4, 2025: PAVE Translation Audit, Consent Review for External Studies
In this Issue:
PAVE Translation Audit Findings
No Serious Noncompliance
A Post-approval Verification and Education (PAVE) quality assurance audit was conducted to examine the accuracy of translated consent forms approved by the UW IRB. The purpose of the audit was to gather information about the nature and frequency of errors in consent translations and identify the root causes to inform future HSD policy towards translated consent materials.
The review analyzed 48 unique IRB approved translated consent documents from 41 studies across 10 academic departments and representing 19 different languages. A third-party translation company was used to provide back-translations of the consent forms. HSD reviewed these back-translations and compared them to the IRB-approved English consent forms to identify any discrepancies.
The results indicate that the majority of consent forms (62.5%) had no issues and the rest (37.5%) contained only minor errors. There were no findings of serious noncompliance. Translator error accounted for the majority of the issues found. There was no difference in the error rate between consent forms translated by a professional versus non-professional translator.
The findings from the audit suggest that, generally, HSD’s current researcher requirements for translating consent materials are sufficient in ensuring study participants with a non-English language preference are receiving accurate consent information.
Consent Review Process for Externally Reviewed Studies
Minor Change
As part of its post IRB approval audit of consent forms for industry research and research reviewed by Advarra, HSD has required researchers to either provide separate attestation that study participants or their insurers will not be billed for research procedures or include specific language about the potential for billing in the consent form.
The change: Researchers no longer need to provide a separate attestation. Instead, information about whether study participants or their insurance will be billed will be collected as a new question in the initial REQUEST External IRB form. This minor change should improve clarity and reduce delay during HSD’s audit process.
No change: Studies for which participants or their insurers might be billed must still include UW required consent language as describe in HSD’s GUIDANCE Consent Elements for Externally Reviewed Studies.
In order to facilitate this and other process changes, researchers requesting authorization to use an external (non-UW) IRB should always use the most current version of the REQUEST External IRB form when submitting in Zipline.
For questions, contact hsdrely@uw.edu.
2025 NWABR IRB, IBC, & IACUC Conference
Discounted Registration Available
The Northwest Association for Biomedical Research (NWABR) annual IRB, IBC and IACUC conference will be held March 3-5, 2025. UW affiliates qualify for a 65% discount on conference attendance. The conference will take place at Seattle Children’s Research Institute in downtown Seattle, and there is a virtual attendance option. You can register to attend, one, two or all three days. For more information, including the offered sessions and how to register, review the NWABR conference webpage.