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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