Protocol Submission and Review

Protocol Submission

Any individual with Principal Investigator (PI) status wishing to use live vertebrate animals in research or teaching must submit an Animal Use Protocol (AUP) for ACUC review and approval. An AUP describes all uses of live vertebrate animals proposed by an individual Principal Investigator for a three-year period. For investigators with multiple research projects, the AUP presents a cumulative description of all proposed animal species, numbers and procedures to be used during the next three years. The AUP must be fully approved by the ACUC before acquisition, housing or use of animals.

Below is a summary table of the necessary forms for each type of review. Links to the forms can be found below the table. Attachments should be submitted when necessary.

			Forms
			Annual Renewal Form	Personnel Sheet	Revision Request Form	AUP Form
Type of Reviews	Annual Reviews	No revisions	✔
		Personnel Changes Only	✔	✔
		Revisions to AUP and/or attachments (no personnel changes)	✔		✔	✔
		Revisions to personnel sheet, AUP and/or attachments	✔	✔	✔	✔
	Other	New		✔		✔
		Revisions that are not submitted during annual review			✔	✔
		De novo review		✔		✔
		Personnel Update Only		✔

Forms

AUP (Please make sure that the changes are made with the track changes “on”):

Attachments (Please make sure that the changes are made with the track changes “on”):

Attachment A: Numbers (required)
Attachment B: Alternatives (required for ALL painful procedures)
Attachment C: Non-Duplication (required)
Personnel Sheet (required)
Breeding Attachment (required if breeding animals)

Revision Request Form:

Revision Request Form

Annual Renewal Form (This form will be sent to the PI via email)

Protocol Review Process

According to federal regulations and the UC Berkeley PHS assurance, ACUC reviews new protocols and revisits all protocols annually (an Annual review) followed by a more extensive review on a triennial basis (a de novo review).

For instructions on how to complete the new research and teaching protocols, as well as the attachments, please contact the OACU (acuc@berkeley.edu or 642-8855).

For a de novo review, the protocol is reviewed “as new.” This process requires that the PIs ensure that 1) all procedures, number of animals, references, goals and experimental justifications used in their protocol are up-to-date; 2) the information outlined is accurate; 3) all procedures that have been completed are removed; and 4) all modifications are highlighted using track-changes prior to submitting their AUP. Once received by the OACU, track changes will be “accepted” in order for the reviewers to read the entire protocol “as new”. Please note that, although the protocol is reviewed as a “new” protocol, this does not mean that the PI must rewrite the protocol or copy and paste the AUP into a new document. However, the PI must ensure that all aspects of the protocol are current and reflects their plans for the next three years.

For the Annual review, the investigator must fill out and submit the Annual Renewal Form. This form asks a number of questions regarding progress of the research and any adverse events that have taken place during the past year. This form is sent to the PI via email.

Revisions to include new grant-related procedures, Material Transfer Agreements (MTAs), or other proposed vertebrate work can be made at any time during the year, including at the annual and/or de novo review. Please note that revisions made during the annual review will be processed separately from that of the annual review (i.e., separate approval letters if approved). In order to facilitate a more efficient review process for revisions, the PI must fill out and submit a Revision Request Form (see above) in addition to the protocol with the track-changes “on”.

Please contact the OACU (acuc@berkeley.edu) for a copy of your currently approved protocol and attachments.

IMPORTANT! Research or instruction using vertebrate animals cannot begin until the ACUC has approved the AUP and/or revision. Likewise, if an AUP approval lapses, research or teaching must cease immediately until approval is restored.