Ongoing IACUC Projects
Amendments and Modifications
In order to make changes to an already approved IACUC protocol, the PI needs to submit an Amendment Form to the IACUC Coordinator as a Word/doc attachment.
If the proposed modifications are significant, the IACUC may require the researcher to submit an entirely new application. If you have questions about whether the changes you want to incorporate will necessitate a new application, contact the IACUC Coordinator, iacuc@ucsc.edu.
Proposed research modifications may not be implemented before receiving IACUC approval.
Annual Reviews
All approved IACUC protocols require review on an annual basis. These annual reviews need to include a list of any and all changes to the protocol and must be approved before the protocol's expiration date. Annual reviews should be submitted as Word/doc files to the IACUC Coordinator.
The annual review expiration date is calculated from the date of initial IACUC review approval. This may be of significance for protocols where an approval could not be issued as soon as IACUC approval was granted (often because training requirements had not been met).
Annual Updates may only be submitted by either the protocol's Principal Investigator or the Co-Respondent. The Office of Research Compliance strives to send the Annual Review Form to the PI and Co-Res at least three months before research is set to expire, but ultimate responsibility for submitting the Annual Review on time lies with the researchers. Therefore, it is of the utmost importance that researchers maintain awareness of the initial approval and expiration dates of all their research protocols.
If an annual review is not completed before a protocol's expiration date, the research protocol will expire and the research must shut down. In order to continue the research after a lapsed annual review, the PI will need to submit an entirely new application. Research may not resume until the new application has been reviewed and approved by the IACUC.
De Novo Review/Three-Year Renewal
In compliance with PHS policy, UCSC's IACUC requires that all animal research protocols get re-submitted as new protocols every three years. These De Novo applications need to be submitted to the IACUC Coordinator as a Word/doc file of the most recent, updated version of the application. Applications should be submitted early enough so that they may be reviewed and approved before the expiration date of the protocol (please note that a protocol's expiration date is calculated from the date of initial IACUC approval).
De Novo applications may only be submitted by either the protocol's Principal Investigator or the Co-Respondent. The IACUC Coordinator strives to send a reminder email to the PI and Co-Res at least three months before research is to expire, but the ultimate responsibility for submitting the De Novo application on time lies with the researchers. Therefore, it is of the utmost importance that researchers maintain awareness of the initial approval and expiration dates of all their research protocols.
PHS policy does not allow the IACUC to extend the expiration date of a protocol. If a De Novo review is not completed before a protocol's expiration date, the research protocol will expire and the research must shut down. The research may not resume until the De Novo application has been reviewed and approved by the IACUC.
