IRB News March 2024

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Step up your game

Want your next consent form to be a slam dunk? The Office of Human Research Protections (OHRP) just released an interactive training on writing “participant-centered” informed consent forms. We love this training and so will you!

Click here to access.

We want to hear from you

Starting in March, we will be sending out surveys to some submitters who had studies recently reviewed. This is your chance to give the IRB feedback that we can use in our never-ending quest of process improvement.

ChatGPT cordially invites you to the 2024 UC Davis Research Expo

Interested in the learning more about the use of AI in research? Want to hear about the latest research-related insights, resources, opportunities, and tools to help you advance your research? Come to the 2024 UC Davis Research Expo on April 18, from 10:00 AM to 3:00 PM. This free event includes exhibits, presentations, and workshops, including breakout sessions and a keynote address specifically focused on AI in research.

Register here.

Don’t be surprised

The FDA has released a final rule on waivers or alterations of consent for minimal risk clinical investigations.

Cool, but what does this mean to me?

If you tell the IRB that you do not plan to obtain consent for participants for a minimal risk FDA regulated study—for example, you plan to test leftover samples on an investigational device without obtaining consent—the new regulations require us to ask about why you couldn’t use de-identified data or samples instead. While we’re working on updating our forms to match the new regulations, we just don’t want you to be surprised by these new questions!

FAQs

Do I need to submit a modification to the IRB if…?

We get a lot of questions about which modifications need to be submitted to our IRB. To save yourself the headache of submitting unnecessary modifications, check out our list of administrative modifications that can be implemented without IRB approval.

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