Want to stay informed of the latest UC Davis Institutional Review Board news? Subscribe to the IRB listserv.

Fun-Size Initial Review Application Update

A few bite-sized changes to the Initial Review Application (IRA) are live on IRBNet as of Friday, October 31, 2025. If you submitted an Initial Review Application before this date, your existing responses will carry forward. However, you’ll need to answer any new required questions that have been added.

The next time you make changes to an Initial Review Application, pay special attention to the following pages:

• Ancillary Reviews
• Special Populations
• Children Participant Information (for studies involving neonates, if applicable)
• Data Confidentiality

No Tricks, Only a Treat for Working with the UC Davis IRB

We’ve brewed up a new resource to make collaboration smoother for sponsors, lead sites, and external IRBs. The Working with the UC Davis IRB: Guidance for Sponsors, Lead Sites, and External IRBs highlights key considerations that often arise when partnering with UC Davis, including information about our Federalwide Assurance (FWA) and standard consent form language.

This resource is available on our Forms and Single IRB and Reliances webpages.

Roster Re-Boo-t

We recently posted a new IRB committee roster. This roster, as well as all our historical rosters, can be found on our About IRB webpage.

Too Soon for Tinsel?

IRB Administration will operate with limited staffing from Monday, December 22, 2025, through Friday, January 2, 2026. We’ll resume normal operations on Monday, January 5, 2026.

We also tend to see a high volume of submissions in January, which may extend processing times. If you’ll need a determination during the winter holidays or early in the new year, please plan ahead and submit early.

FAQs

Does the IRB have office hours?

Yes! We host drop-in office hours on Zoom every Friday from 12:00 PM to 1:00 PM (except UC holidays). We have already helped 205 researchers in office hours just this calendar year, so stop by to get your burning IRB questions answered. Registration is not required—simply use this Zoom link.

What email should I use to contact the IRB? What about the Reliance Team?

For general questions, please email [email protected]. To contact the Reliance Team, please email [email protected]. We did not migrate to the @health.ucdavis.edu domains.

How do I get added to this incredible listserv?

Subscribe here.

Want to stay informed of the latest UC Davis Institutional Review Board news? Subscribe to the IRB listserv.

Extra! Extra! Read All About It on the New IRB News Webpage!

Introducing the new IRB News webpage. This is your one-stop shop for our full archive of listserv announcements, dating back to January 2013—more than a decade of updates, announcements, and reminders, all in one place.

New Injury Language 2: Judgment Day

This is your second (and final) newsletter reminder that we have edited the What happens if I believe I am injured or get sick because of this study? section of our General Consent Template. Beginning June 1, 2025, the updated language in this section will be required for all greater than minimal risk research. This requirement does not apply to studies submitted before June 1, 2025.

Redeem Now! The Candex Participant Information Sheet Just Got a Can’t-Miss Update

We have updated the FAQs in the Candex Participant Information Sheet to let participants know that study payments issued through Candex may expire if not accepted within 30 days of issuance. As a reminder, this information sheet is available on our IRB Forms webpage and does not need to be submitted to the UC Davis IRB for approval prior to use.

Previously on IRB Forms…

Our new Forms Archive webpage is now live. Starting with forms updated in March 2025—such as the General Consent Template with new injury language and the updated Candex Participant Information Sheet mentioned above—this webpage includes archived versions of our protocol templates, consent form templates, and consent form resources showing tracked changes. No subscription required.

New Decision-Making Capacity Assessment Tool

In alignment with UCOP guidance, we have uploaded a new Decision-Making Capacity Assessment Tool to assist researchers in determining whether a participant has the capacity to consent to a research study. You can find the tool, along with our IRB’s guidance on informed consent and participants with diminished capacity, on our Surrogate Consent webpage.

Make Waves, Not Delays! Submit Your Summer Research Now

Looking to enjoy a hot research summer? Submit your research to the IRB now so you can dive into your study without delay.

FAQs

Can I Trust AI-Generated Answers to My IRB Questions?

No. AI-generated answers from tools like Google’s AI Overviews or ChatGPT may be inaccurate when it comes to UC Davis IRB policies, guidance, and requirements. For the most reliable information, always visit our official IRB website or email us at [email protected].

How do I get added to this incredible listserv?

Subscribe here.

Want to stay informed of the latest UC Davis Institutional Review Board news? Subscribe to the IRB listserv.

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].

How do I get added to this incredible listserv?

Subscribe here.

Want to stay informed of the latest UC Davis Institutional Review Board news? Subscribe to the IRB listserv.

Let’s Get Down to Brass Tacks with WCG IRB

The UC Davis IRB will be hosting a virtual Q & A session with a representative from the WCG IRB, formerly the Western Institutional Review Board (WIRB), for researchers who are already conducting a study where the UC Davis IRB relies on the WCG IRB for review or plan to do so in the near future.

Date: Thursday, September 12, 2024

Time: 10:00 AM – 11: 00 AM

Location: Zoom (Registration Link)

Stronger Together

Research collaboration and funding opportunities are available with Veterans Affairs Northern California Health Care System (VANCHCS). Interested in learning more about teaming up with VANCHCS? Check out this announcement on the new Office of Research website.

FAQs

Does my project need IRB review?

Lucky you! We have an entire Does My Project Need IRB Review? webpage dedicated to answering this very question.

How do I get added to this incredible listserv?

Subscribe here.

Want to stay informed of the latest UC Davis Institutional Review Board news? Subscribe to the IRB listserv.

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.