IRB News June 2024

/in /by

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

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.

How do I get added to this incredible listserv?

Subscribe here.