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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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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.

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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.

 

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In This Edition

• Baby, baby! New contraception language for clinical trials
• Want to use text messages to recruit study participants? U have 2 c our new recruitment SOP
• Translated short forms and HIPAA authorizations for research
• New number, who this? Update to the list of administrative modifications
• Show me the money! Reimbursing participants during the Aggie Enterprise transition
• Hot off the presses! Updated committee roster
• This one’s on us! No more review fees for K scholars
• Dear Researcher, we have new determination letters
• We want to hear from you
• FAQs

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:

• HRP-503 Drugs/Devices and/or Clinical Interventions protocol template
• HRP-502 General (2018 Common Rule Compliant) consent template
• Contraception Information Sheet template

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.”

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.

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)