IRB News April & May 2024

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Unplugging Our Electronic Consent Language

Want to use an electronic platform to obtain consent? Great news! The UC Davis IRB no longer requires 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. You can now use an approved platform for electronic consent, even if your consent form does not include this section. We’re so serious about it that we even deleted this language from our consent templates. Don’t forget, there are additional requirements for electronic documentation of consent in HRP-091.

We’re Joining Forces with the VA

If you want to conduct research at UC Davis and the Northern California VA, the UC Davis IRB can now serve as the single reviewing IRB for both sites. Interested in learning more about teaming up with the VA? Contact John Tupin at [email protected] for more information.

P.S. We’ve made some changes to determination letters

You may have noticed that the UC Davis IRB has started issuing determination letters when we rely on an outside IRB. As part of this process change, we’ve added a new statement to these letters: “If there are contraceptive requirements for this study, provide information about acceptable contraceptive methods for the research participants and their partners. Use the Contraception Information Sheet, as needed.” Instructions for how to use the Contraception Information Sheet are located on our Contraception Requirements for Clinical Trials webpage.

Closing Time – Reliance Edition

I’m relying on an outside IRB

If UC Davis and/or all sites relying on an outside IRB close, all you have to do is submit the closure letter from the reviewing IRB on IRBNet. No other documents, including the Post-Approval Submission Form, should be submitted. Simple as that.

UC Davis is the single IRB for me (and a few of my friends)

When the UC Davis IRB is the reviewing IRB for a multi-site study, a study closure package must be submitted on IRBNet for each study site as it closes. Instructions for submitting a study closure package can be found on our Continuing Review/Study Closure webpage. Once each individual site is closed, the UC Davis reliance team will work with you to submit a study-wide closure package. Check out our Single IRB and Reliances webpage for a video that covers an overview of this process!

I have more reliance questions

Drop the reliance team a line at [email protected].

FAQs on our FWA

What is that expiration date at the bottom of my IRB determination or approval letter?

Spoiler alert! It is not the expiration date for your project. It’s the expiration date for our IRB’s federalwide assurance (FWA) at the time your project was reviewed. We always make sure to renew our FWA, so don’t worry about it expiring! To avoid confusion, we removed the FWA expiration date from letters in the beginning of 2024.

Okay, but where do I find the expiration date for my project on my IRB determination or approval letter?

Not every project submitted to the IRB has an expiration date. If there is no “Approval Period” section on your determination or approval letter, then your study does not expire and continuing review is not required. Otherwise, take a peek at the “Approval Period” section to ensure you submit a continuing review or study closure package at least 45 days prior to expiration.