New Consent Templates

Institutional Review Board

Human Research Protections (HRP)

 

New Consent Templates

Version September 5, 2024

Drawing of two hands working on document together (decorative)New consent templates have been added to the HRP webpage, on the IRB Forms page.  The updated templates are for immediate implementation.  Researchers should revise their consent forms, as necessary, considering the current state of their research.

 

Existing studies that are still enrolling subjects should transition to the new template / add the new template text at their next IRB submission. Similarly, for those studies where procedures are ongoing, it may be appropriate to add in the new template text, as part of the next IRB submission.

——What has changed?——

e-Consent
Rights

Email letter icon

The Federal Electronic Signatures in Global and National Commerce Act (“eSIGN”) and California’s adoption of the Uniform Electronic Transactions Act (“UETA”) were both intended to facilitate the use of electronic systems to document legal transactions and other activities. Under these acts, and others that describe requirements for electronic signatures, there are specific rights that must be stated in the electronic consent form.  These rights have been added to the new consent template. If a human research study will definitively not use electronic consent, the additional language does not need to be included in the consent template.

New Mailing Address

//services-web.research.uci.edu/zotmail/hrp/mailbox-icon@2x.png” alt=”Mailbox icon”>

The HRP has been 100% remote since March 2020.  We maintain a mailing address, which includes space for the Vice Chancellor for Research’s office. That physical office is moving.  To avoid future changes, we are simplifying the mailing address to exclude the street address.  We have confirmed with UCI Mail Services that this address, without a street number or name, will be functional for delivery:

University of California, Irvine,

Office of Research

Irvine, CA 92697-7600

Stay informed! Sign up for our HRP / IRB Listserv: To subscribe to HRP News & Announcements, send a blank email to: or-irb-hrp+subscribe@uci.edu