IRB News April 2025

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It’s Been a While… and We Have a Lot to Cover!

You haven’t missed anything since our October + November 2024 newsletter. But buckle up, because we’ve got plenty of IRB updates coming your way!

End of an Era, Start of a New One

After 25 years of dedicated service to the UC Davis IRB, Dr. John Anderson, MD stepped down as Chair of Committee B at the end of 2024. Dr. Anderson’s leadership, clinical expertise, and mentorship have been foundational to our human research protection program. We extend our heartfelt thanks to Dr. Anderson for his invaluable contributions in guiding researchers while safeguarding the rights and welfare of research participants.

We’re excited to announce Dr. Lisa Mills, MD as the new Chair of Committee B, effective January 2025. With extensive experience as both a researcher and IRB leader, Dr. Mills has served as Co-Vice Chair of Committee A and is eager to continue supporting UC Davis researchers. Her vision includes fostering greater collaboration between the two biomedical committees for a more unified approach to research review and a continued focus on facilitating research.

Doesn’t That Mean There’s a New IRB Roster?

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

Wednesdays are the New Mondays

All IRB committee meetings will now take place on Wednesdays. This includes Committee B, which has moved from its usual Monday slot to the second and fourth Wednesday of every month. You can always find the list of IRB meeting dates for the year on our About IRB webpage, but here is a link to our 2025 meeting dates for reference.

Ouch! New Injury Language

Following updated UCOP guidance on subject injury language for informed consent forms, 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.

P.S. We also edited the UC Davis Required Consent Language for studies where the UC Davis IRB will rely on an external IRB to reflect this new language!

Making Cents of Participant Payments

In collaboration with research staff in the Department of Neurology, IRB Administration has created a Candex Participant Information Sheet to help research participants understand how to use the new Candex software to receive study payments. 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.

Say Hello to Your Friendly Neighborhood IRB at the 2025 Research Expo

Want to hear about the latest research-related insight, resources, opportunities, and tools to help you advance your research? Come to the 2025 UC Davis Research Expo on April 30 at the UC Davis Conference Center.

This free event includes exhibits, presentations, workshops, and opportunities to network with potential collaborators. You’ll even get a chance to say hello to your favorite UC Davis IRB staff members! For more information and event registration, visit the 2025 Research Expo Event webpage.

FAQs

Why do IRB staff always remind me to “Mark Revisions Complete” to re-lock my submission when they ask for changes?

Contrary to popular belief, IRB staff and committee members are not automatically notified when changes are made to a submission. To let us know you’ve addressed any requested revisions, you must click “Mark Revisions Complete” at the top of the Designer page for that submission. If your submission still shows a red open lock, it tells us that you are still working on the revisions and are not yet ready for re-review.

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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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IRB News September 2024

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MythBusters: IRB Edition

The UC Davis IRB Education, Training, and Outreach team will be conducting an interactive training where we take on the myths and misconceptions surrounding the IRB. Just like the TV show MythBusters, we will examine commonly held beliefs about IRB requirements and procedures to uncover the truth. Attendees will learn the purpose of the IRB, how to navigate the submission process, and what ethical considerations must be accounted for in human subjects research. Whether you’re a seasoned researcher or just starting out, this course will debunk the myths that create confusion and empower you with practical knowledge for conducting ethical research with confidence.

Date: Thursday, September 19, 2024

Time: 12:00 PM – 1:30 PM

Location: Zoom (Advance LMS Registration Required)

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)

You Shall Not Pass… Without a Post-Approval Submission Form Wizard!

We have noticed an uptick in the number of post-approval submissions missing the Post-Approval Submission Form, which is a software wizard to be completed in IRBNet. It is required for all submissions to the IRB after a project has been issued an approval, including:

FAQs

Does your website have some sort of FAQ webpage?

We thought you’d never ask! But actually we did, so here is our Frequently Asked Questions webpage.

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Subscribe here.

 

IRB News July + August 2024

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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.

IRB News June 2024

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This just in: Time your NIH submissions

For Just-In Time requests, NIH is no longer accepting placeholder letters from the IRB instead of an IRB exemption or approval letter. Considering this, if you are applying for an NIH grant, please make sure to submit your IRB application early to allow ample review time!

Stay safe with these consent changes

In keeping with our recent change to remove electronic consent language from our consent forms, we updated our SOP on Written Documentation of Consent (HRP-091) and our UC Davis Required Consent Language (for studies where we cede review to another IRB). In addition, we updated our injury language in these documents as well as our consent forms. As always, please make sure to use the most updated versions of our forms!

What’s new on the IRB website?

We recently made the following changes to our website:

  • To support our friends at the Clinical Trials Office, we added a section to the Ancillary Reviews page on our website to provide information about clinicaltrials.gov posting requirements. Please reach out to the Clinical Trials Office if you have any questions about these requirements.
  • We updated our definition of Cognitively Impaired Adult to include the word “may.” It now reads: “Cognitively Impaired Adult means a person who has reached the legal age of consent but may lack the decision making capacity to comprehend the consent process and voluntarily choose to participate in research.” This change acknowledges that there are many cases where a potential research participant may have a cognitive impairment that does not affect their ability to consent to participate in research.

Roll call: New committee roster

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.

The mystery of the yellow edit button

In case you have been searching in vain for a yellow “Edit” button at the top of the Project Overview page in IRBNet, allow us to end the search. It has been replaced with a blue “Update” button and shifted to the right (And our directions have been updated accordingly). As a reminder, the Project Overview page is where you can update basic study information, including the title, principal investigator information, and sponsor. Mystery solved!

FAQs (Commonly misused terms edition)

“One expedited review, please”

We commonly see submitters use the term “expedited review” to refer to a request to speed up the review process. In the federal regulations, expedited review is an official category of review that refers to applications that can be reviewed by a single reviewer instead of a full committee. This is unrelated to the amount of time that it takes to review the package. Because of this, when submitters “request an expedited review,” it can cause some confusion. If you need to speed up the review timeline to meet an urgent research need, we would refer to this as a request for a rush review.

Unlock, or submit a modification?

We often receive requests to unlock IRBNet packages, and sometimes these requests come in for projects with no pending packages. The lock feature in IRBNet is a tool used to make revisions to pending submissions before a final determination is issued. If you need to make changes to a project after a package has received a determination, however, these changes would need to be submitted in a separate modification package.

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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.

 

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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IRB News February 2024

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In This Edition

Baby, baby! New contraception language for clinical trials

We are excited to announce that we have released simplified language for any clinical trial that requires participants to use contraception. The new language can be found in the following documents:

Not so sure about how to use this new language? Check out our new Contraception Requirements for Clinical Trials webpage and a recording of our recent Baby-Proofing Your Clinical Trial: Navigating Contraception Compliance Without Going Goo Goo Ga Ga training in the Clinical Research Guidebook.

Want to use text messages to recruit study participants? U have 2 c our new recruitment SOP

We have added HRP-094 Subject Recruitment to our list of Standard Operating Procedures (SOPs) to provide researchers with our policies for recruiting participants using text messages, email, MyChart, mail, or carrier pigeon (just kidding on that last one!).

Translated short forms and HIPAA authorizations for research

Don’t see a short form or HIPAA authorization for research in the language you need on our Forms webpage? As long as references to UCSF are changed to UC Davis, we now allow the use of the short forms and HIPAA authorizations from UCSF to be used at UC Davis. The translated short forms, which UCSF refers to as the Experimental Participants Bill of Rights Form, may be found here. Note: You must use the version with a signature! The HIPAA authorizations for research may be found by clicking the Translated versions of the form drop-down here.

Remember to reference our Overcoming Language Barriers guidance and consent SOPs, HRP-090 Informed Consent Process for Research and HRP-091 Written Documentation of Consent, when you’re looking to enroll a potential participant who has limited English proficiency.

New number, who this? Update to the list of administrative modifications

Our list of administrative modifications–those modifications that can be implemented without IRB review—has been expanded to include any “changes to revise phone numbers, physical addresses, or email addresses associated with a study.” This administrative modification was previously limited to contact information participants should use if they have questions during a study. Participants who are receiving study-related interactions or interventions must still be provided with updated information as soon as feasible but in no case later than their next study-related interaction or intervention.

Show me the money! Reimbursing participants during the Aggie Enterprise transition

As UC Davis transitions to a new financial system, Aggie Enterprise, we are temporarily allowing researchers experiencing issues with payment processing to reimburse participants with gift cards instead of cash or check. No need to submit a modification to the IRB to make this change, but make sure to ask your study participants if receiving gift cards is preferable to waiting for cash or checks.

Hot off the presses! Updated committee roster

A new roster has been posted to our About IRB webpage.

This one’s on us! No more review fees for K scholars

We have updated our fee schedule to exclude review fees for Career Development (K) scholars, even when the study involves a reliance agreement. Confused about our fees? Check out our IRB fees calculator.

Dear Researcher, we have new determination letters

We have updated our determination letters on IRBNet. What does this mean for you? It’s going to be a whole lot easier to understand things like what vulnerable populations you are approved to enroll and how to communicate modifications to participants.

We want to hear from you

Starting in February, 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.

FAQs

What do the IRBNet agenda dates mean?

If your study is on the…

  • Unassigned agenda, it has not yet been screened by our intake analysts.
  • 01/01/2024 agenda, it has been routed for review by one of our IRB analysts.
  • 02/01/2024 agenda, it has been routed for review by one of our committees. Be on the lookout for a more specific agenda date when you receive an IRBNet notification that this package has been forwarded!
  • 03/01/2024 agenda, it has been identified as a response to one of our committee’s questions or requested revisions from a previous package.
  • 04/01/2024 agenda, it has been routed to our reliance team.
  • 05/01/2024 agenda, it has been identified as either a medical record review or a project that may not meet the definition of human subjects research.
  • 12/31/2024 agenda, it has been assigned to one of our IRB analysts or the review has been completed. Remember, you will receive an IRBNet notification when a package has been issued a determination!

When can I request a rush review?

All rush review requests are considered on a case-by-case basis. Participant safety concerns or finances, such as a grant deadline, are the most common reasons rush requests are approved. If you do request a rush review, include the reason for your request and a deadline for review in the comments box that appears on the final screen when you click “Submit this Package.”

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IRB News December 2023

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In This Edition

  • UC Reliance Registry Update
  • Holiday Closure
  • Weekly Virtual IRB Office Hours

UC Reliance Registry Update

The UC Reliance Registry is being phased out and will no longer be used for new studies requiring a reliance between UC campuses. Pending reliance requests submitted through the UC Reliance Registry will be withdrawn. If you have a study that is pending on the Reliance Registry, please contact the reliance team at [email protected] for more information.

Information about reliance agreements can be found on our Single IRB and Reliances webpage.

Holiday Closure

IRB Administration will be operating with limited staff Monday, December 25, 2023 through Monday, January 1, 2024. We will re-open Tuesday, January 2, 2024. Additionally, 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 2024, please plan ahead and submit early. In addition, make sure to include any relevant deadlines for research activities, so that reviews may be prioritized appropriately.

During the holiday closure, please call (530) 219-7951 or email [email protected] for any urgent issues.

Weekly Virtual IRB Office Hours

The IRB holds weekly drop-in office hours every Friday from 12:00 PM – 1:00 PM. To join virtual office hours at the following times, please use this LINK:

December 08 | 12:00 PM–1:00 PM
December 15 | 12:00 PM–1:00 PM
December 22 | 12:00 PM–1:00 PM
December 29 | No Office Hours (UC Holiday)

IRB News November 2023

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In This Edition

  • Employment Opportunity
  • Holiday Closure
  • Don’t Let Your IRB Approval Expire!
  • New IRB Roster and 2024 Committee Meeting Dates
  • Training Corner
  • Weekly Virtual IRB Office Hours

Employment Opportunity

Do you dream of IRB trainings? Can you navigate IRBNet with your ears closed? Is your reading comprehension sharp enough that you caught the mistake in the last sentence? If you answered yes to these questions, come join us at the IRB!

IRB Administration is recruiting a Research Compliance Analyst 3 to support our Systems and Education team. The last day to apply is November 10!

Research Compliance Analyst 3

Requisition Number: 60815

Payroll Title: RSCH CMPLNC ANL 3

Percentage of Time: 60% Variable

LINK to posting

Holiday Closure

IRB Administration will be operating with limited staff Monday, December 25, 2023 through Monday, January 1, 2023. We will re-open Tuesday, January 2, 2024. Additionally, 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 2024, please plan ahead and submit early. In addition, make sure to include any relevant deadlines for research activities, so that reviews may be prioritized appropriately.

During the holiday closure, please call (530) 219-7951 or email [email protected]for any urgent issues.

Don’t Let Your IRB Approval Expire!

In response to an increase in the number of studies missing the administrative due date for continuing review of approved research, we have asked IRBNet to reconfigure the settings for automated continuing review reminders. All studies requiring continuing review will now be sent an automated reminder to submit a Continuing Review package, regardless of whether or not there is a package (e.g., reportable event or modification) pending review. If you receive an automated reminder after you have submitted a continuing review package, then you may ignore this message.

Nonetheless, we encourage researchers not to rely on automated messages. You may look up the expiration date for any study by navigating to the “Project Overview” for your study (see below). The administrative due date to submit a Continuing Review is 45 days prior to expiration. For example, the administrative due date for the study below is 11/04/2023.

New IRB Roster and 2024 Committee Dates

In addition to our 2024 committee meeting dates, a new roster of IRB reviewers has been posted on our About IRB webpage. This document is oftentimes requested by sponsors of research regulated by the FDA.

Training Corner

Diversity, Equity, and Inclusion in Clinical Research Recruitment

Date: Thursday, November 30, 2023

Time: 10:00 AM – 12:00 PM

Description: This course explores the importance of diversity, equity, and inclusion in clinical research recruitment. Participants will learn practical skills to engage diverse communities, develop inclusive outreach strategies, and foster a more representative research environment.

LINK to enroll

Weekly Virtual IRB Office Hours

The IRB holds weekly drop-in office hours every Friday from 12:00 PM – 1:00 PM. To join virtual office hours at the following times, please use this LINK:

  • November 10 | No Office Hours (UC Holiday)
  • November 17 | 12:00 PM–1:00 PM
  • November 24 | No Office Hours (UC Holiday)