Protocol Submission and Review
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. The AUP must be fully approved by the ACUC before acquisition, housing or use of animals.
The ACUC began transitioning from a paper-based protocol submission and review process to a web-based system called Berkeley eProtocol starting in July 2014. This is the same system that the UCB Office for Protection of Human Subjects (OPHS) has been using since 2009.
How does this impact you?
- Effective July, 2014, all new protocols must be submitted online via eProtocol.
- Protocols due for their de novo (three-year) review in October 2014 or later 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.
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.
Electronic Protocol Review Process (eProtocol)
For instructions on how to submit an eProtocol AUP and for information on the review process, please:
- Read the eProtocol Investigator Quick Guides,
- See the eProtocol FAQs,
- Contact the OACU (email@example.com or 642-8855).
Paper Protocol Review Process
According to federal regulations and the UC Berkeley PHS assurance, ACUC reviews new protocols and revisits all protocols annually (an Annual continuing review) followed by a more extensive review on a triennial basis (a de novo review).
De Novo Reviews
No longer done. All de novo reviews must be submitted via eProtocol.
Annual Continuing Review
For the Annual Continuing Review, the investigator must fill out and submit the Continuing Review 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 (firstname.lastname@example.org) for a copy of your currently approved protocol and attachments.
Below is a summary table of the necessary paper-based forms for each type of review. Links to the forms can be found below the table. Attachments should be submitted when necessary.
|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||Submit online eProtocol AUP|
|Revisions that are not submitted during annual review||✔||✔|
|De novo review||Submit online eProtocol AUP|
|Personnel Update Only||✔|
- To submit a new online protocol for either research or teaching, see eProtocol Instructions
Attachments to amend an existing protocol (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:
Annual Renewal Form (This form will be sent to the PI via email)
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