Annual protocol review

First and second year review

PHS policy requires all approved IACUC protocols be reviewed on an annual basis. The annual reviews include full contact protocols, not sample or observational. These 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 updates should be submitted at least one month prior to the anniversary date of approved research. For example, if your protocol was originally approved on May 1, 2013, your annual update should be received by the Office of Research Compliance by April 1, 2014.

The Annual Protocol Update Form will arrive via email three months, two months and one month prior to the expiration date of the protocol. Annual reviews are submitted to the IACUC analyst at iacuc@ucsc.edu

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 be submitted by either the protocol's principal investigator or the co-respondent. The Office of Research Compliance strives to send the Annual Protocol Update 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, the IACUC requires that all animal research protocols get re-submitted as new protocols every three years. These de novo protocol application forms need to be submitted by the protocol's principal investigator or co-respondent to iacuc@ucsc.edu as a Word doc.

Applications should be submitted early enough so that they may be reviewed and approved before the expiration date of the protocol (expiration date calculated from the date of initial IACUC approval.) If the de novo review is not completed before a protocol's expiration date, the research protocol will expire and the research must shut down. Research may not resume until the de novo application has been reviewed and approved by the IACUC.