New Administrative Review Process Incorporates Veterinary Verification and Consultation (VVC)
Attention Investigators! ACUC, OACU and OLAC are very pleased to announce that in keeping with new regulatory guidance on how some significant protocol changes may be reviewed, we are implementing a new administrative review process that incorporates Veterinary Verification and Consultation (VVC). Please see the revised Policy and Procedures on Protocol Review and our Guidance on Administrative Review, ACUC - DMR/FCR for more information and examples of how to utilize this new process for your revisions. If you have any questions, please call the OACU or send us an email at ACUC@berkeley.edu.
OACU/ACUC Launched eProtocol August 2014
The UC Berkeley Office for Animal Care and Use (OACU) and the Animal Care and Use Committee (ACUC) are transitioning from a paper-based protocol submission and review process to a web-based system called Berkeley eProtocol in August 2014. This is the same system that has been in use by the UCB Office for Protection of Human Subjects (OPHS) and the Committee for Protection Human Subjects (CPHS) since 2009. Within eProtocol, the two different protocol systems are designated as eProtocol IACUC (animals) and eProtocol IRB (humans subjects).
eProtocol is a proven system that has not only been in place at Berkeley since 2009, it’s also in use at many other academic institutions, including Stanford University, University of Texas (Austin), Colorado State University, Harvard University, and University of Minnesota, to name a few.
How does this impact you?
- Effective July 1, 2014, all new protocols must be submitted online via eProtocol.
- eProtocol will be available for submissions starting August 5, 2014.
- New submission received prior to August 25, 2014, will be reviewed at the October 8th ACUC meeting. See the ACUC web site for submission deadlines.
- Protocols due for their de novo (three-year) review in October 2014 must be submitted online via eProtocol.
- Revisions to existing “electronic” protocols (“eProtocols”) will be made using the eProtocol system.
- Annual reviews and revisions to existing “paper” protocols can continue to use the paper-based process up until the protocol’s de novo submission.
- Investigators may opt to submit a revision as a new electronic eProtocol and they are strongly encouraged to contact the OACU Director at email@example.com regarding this possibility.
What are the benefits of eProtocol?
- eProtocol will be a “one-stop shop” for investigators submitting both human and animal research protocols (one PI dashboard to navigate from).
- PIs can designate up to two other people to have “editing” access to the protocol.
- Protocols will be readily accessible online for all team members through “view only” access.
- eProtocol sends automatic email reminders to the PI, Lab Contact and third designated individual on protocol for protocol annual renewals and three-year de novo reviews.
- eProtocol sends automated emails acknowledging receipt of submission, when review questions from ACUC/OACU have been sent to the PI, and when the protocol action has been approved.
- PIs can “clone” (i.e. copy) a protocol and edit from that point or they can choose to cut and paste from a Word document into the text fields in answering questions. Or, both strategies can be used when writing/developing a new protocol submission.
- eProtocol provides secure, worldwide access (where the internet is available) for the PI to work on documents and even submit them.
- Because documents (animal use protocols, review questions, attachments) reside within the web-based system, there are no version control issues.
- After initial protocol submission, annual reviews and subsequent de novo submissions will be greatly simplified.
- eProtocol simplifies the process of revision submission and we anticipate it will speed the approval process along.
- eProtocol will help the PI and ACUC ensure compliance more efficiently and effectively, particularly for USDA-regulated species.
Please contact the OACU office at 642-8855 or firstname.lastname@example.org if you have any questions.