IRB News October + November 2024

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Reinstalling required electronic consent language

At the end of April 2024, we announced on this listserv that the UC Davis IRB no longer required the What are my rights when signing this consent electronically? section for studies where DocuSign or any other IT-approved electronic consent platform is used to document consent. However, it has come to our attention that many researchers are using electronic consent platforms that do not meet the requirements of California state law for electronic signatures. As a result, we have reinserted this required language into our consent templates and updated our SOP HRP-091 Written Documentation of Consent to be consistent with our reinstated requirements.

How can researchers add this language to consent forms approved between April 2024 and today?

As long as changes are not made to the boilerplate language in the What are my rights when signing this consent electronically? section, researchers can add this section to their approved consent forms without further IRB approval. We have added this to our list of administrative modifications that do not require IRB review and approval prior to implementation.

‘Tis the season for our holiday closure reminder

IRB Administration will be operating with limited staff Tuesday, December 24, 2024, through Wednesday, January 1, 2025. We will resume normal operations on Thursday, January 2, 2025. We historically see a large influx of submissions in January. As such, you may experience longer than typical processing times for IRB submissions.

If you require a determination from the IRB during the winter holidays or early 2025, please plan ahead and submit early.

Certified Fresh! The UC Davis IRB has earned CARE-Q Certification

After a months-long evaluation, the UC Davis IRB has earned certification through the Consortium for Applied Research Ethics Quality (CARE-Q). CARE-Q is a quality assurance program developed at the University of California and Stanford University to provide external, independent evaluation of IRB offices.

Speaking of fresh… We have uploaded a new IRB roster

Our latest IRB roster can always be found on our About IRB webpage, but here is a link to our latest IRB roster for your convenience.

FAQs

The industry sponsor for my clinical trial told me the FDA now requires single IRB review. Is that true?

Not yet! The FDA is expected to issue an updated rule in 2025 to align with the 2018 Common Rule. Some researchers have asked if current multi-site clinical trials under FDA oversight are now required to use a central IRB, but this is not yet mandatory. For questions about single IRB and reliance agreements, please visit our Single IRB and Reliances webpage. If you still have questions after reviewing the webpage, feel free to contact our IRB Reliance Team at [email protected].

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