Frequently Asked Questions
- Animal Welfare Concern Reports
- Before Submitting an AUP
- What is a “Master” Animal Use Protocol (AUP)?
- Who can submit an AUP?
- What is the approval period for an AUP?
- Is a separate AUP required for each teaching course involving animals?
- How does field research fit with the ACUC?
- Whom can I contact for advice about preparing an AUP?
- Who do I talk to about using hazardous agents or chemicals?
- Who do I talk to about using controlled substances?
- Who do I talk to about using radioactive material or radiation?
- Personnel and Training
- Once an AUP is Submitted
- Once an AUP is Approved
- How can I modify an approved AUP?
- When can I submit a revision?
- What is the timetable for reviewing and approving an AUP or revision?
- Can I withdraw a revision once it has been submitted?
- Can I let my AUP expire?
- What do I do if my protocol expires?
- If my protocol expires, can I reactivate it?
- Will my AUP be available to the public?
- Conflicts of Interest (COI)
For details, go to the Reporting Animal Concerns page. In short, any incidents, concerns, or questions regarding the inappropriate care and use of live vertebrate animals should be reported via telephone or in-person conversation to 1) the Animal Resources Manager followed by OLAC’s Attending Veterinarian; 2) the ACUC Chair; or, 3) the OACU Director. These communications should be followed up by written documentation via email or fax.
A “Master” AUP describes the use of live vertebrate animals proposed by an individual Principal Investigator (PI) for a three-year period. For investigators with multiple research projects, the Master AUP presents a cumulative description of all proposed animal species, numbers and procedures to be used during the next 12 months. The Master Protocol must be fully approved by the ACUC before acquisition, housing or use of animals.
In the past, Principal Investigators usually submitted an AUP for each of their animal research projects. The advantage of the Master AUP is that only one protocol form must be prepared, reviewed and approved each year for investigators involved in multiple projects. Once an AUP is approved, proposed changes (i.e., modifications for ongoing procedures) can be added to it by submitting a revised protocol and the Revision Request form. Under the Master Protocol system, each investigator is assigned a single AUP number that can be used when ordering animals and certifying new grant applications. The term AUP will mean a document that describes all proposed uses of animal for a three-year period.
All forms and instructions for the Research and Instruction AUP are available on the Protocol Submission and Review page.
Only individuals with Principal Investigator status at UC Berkeley can submit a new AUP. With regard to teaching protocols, only the Course Instructor can submit an AUP, therefore becoming the Principal Investigator.
Protocols are approved for three (3) years. Throughout the three years, each AUP goes through a less arduous review once a year (annual review) and then an in-depth review at the end of the three years (de novo review).
A single AUP may be submitted for closely related courses or individual research projects (e.g., 199’s) provided that the AUP lists all animal species, procedures, and numbers to be used in the instructional activities.
If the course is not related, a separate AUP is needed to cover the course.
According to the PHS Policy (Frequently Asked Questions): “If the activities are PHS-supported and involve vertebrate animals then theIACUC is responsible for oversight in accord with PHS Policy. IACUCs must know where field studies will be located, what procedures will be involved, and be sufficiently familiar with the nature of the habitat to assess the potential impact on the animal subjects. Studies with the potential to impact the health or safety of personnel or the animal’s environment may need IACUC oversight, even if described as purely observational or behavioral. When capture, handling, confinement, transportation, anesthesia, euthanasia, or invasive procedures are involved, the IACUC must ensure that proposed studies are in accord with the Guide. The IACUC must also ensure compliance with the requirements of pertinent state, national and international wildlife regulations.”
According to the Animal Welfare Act (9CFR §2.31,1.1) through the USDA, a field study is defined as “any study conducted on free-living wild animals in their natural habitat, which does not involve an invasive procedure, and which does not harm or materially alter the behavior of the animals under study…however, if the animals are confined in any way, an invasive procedure is involved, or the behavior of the animal is harmed or materially altered, then they are regulated and must comply with the regulations and standards”.
Because the definition of a field study is ambiguous, please contact the OACU if you are concerned about whether your field research should be reviewed by the ACUC.
For help in preparing an AUP, or for advice about the laws, regulations and policies that may affect your proposed use of animals, please contact the OACU at 642-8855 or email@example.com.
For assistance in planning specific animal care or use procedures (e.g., use of anesthetics or analgesics, surgical procedures, special animal care requirements, transportation, etc.), please contact OLAC veterinary staff at 642-9232.
Many biological materials (e.g., infectious agents, viral vectors, human cell lines) require a Biological Use Authorization (BUA). Please visit the Environment, Health & Safety (EH&S) BUA web page for a list of what agents require a BUA, application and amendment forms, as well as details regarding submission, approval, duration, and termination of a BUA. Allow 30 days for the processing of a BUA with animal subject usage to ensure that the Committee for Laboratory and Environmental Biosafety (CLEB) can resolve containment-related issues prior to a convened Animal Care and Use Committee (ACUC) meeting.Additionally, in consultation with the Office for Environment, Health & Safety (EH&S), Standard Operating Procedures (SOPs) must be developed for the safe handling of hazardous materials (e.g., carcinogens, reproductive hazards, highly toxic materials). Some examples of hazardous materials that require a SOP for use in animal research include formaldehyde, urethane, BrDU, ENU, DMBA, and acute toxins (e.g., TTX, diptheria toxin). Please contact firstname.lastname@example.org for assistance developing SOPs.
Use of controlled substances must comply with federal (Drug Enforcement Administration or DEA), state, and UC Berkeley regulations. Please visit the Controlled Substances Used in Research page of the Office for Environment, Health and Safety (EH&S) website. For additional information, please contact Assistant Biosafety Officer Krystyna Kozakiewicz at 643-1397 or email@example.com.
Use of radioactive materials and/or radiation requires a Radiation Use Authorization (RUA). Please visit the Environment, Health & Safety Radiation Safety Programs page for information regarding forms, training and safety. For assistance, please contact Radiation Safety Specialist Kathleen Dinnel-Jones at firstname.lastname@example.org or 643-9242.
Prior to starting any procedures, any individual who uses animals in instruction or research must be included on the Principal Investigator (PI)’s personnel sheet. These individuals must include the Principal Investigator (PI), including those that are only in supervisory role for the laboratory, laboratory personnel (i.e., undergraduate, graduate and post-doctoral students), technicians, research assistants/associates, rotation students, students taking a course that involves direct interaction with live or freshly euthanized vertebrate animals, visiting scientists, and volunteers.
Each individual on the personnel sheet is required to complete the Collaborative Institutional Training Initiative (CITI) web-based training.
Depending on the nature of the research, additional training may be required. Please see the Training page for details regarding CITI and the other available training requirements.
All individuals who are working or will come in contact with animals are required to complete the Animal Exposure Questionnaire.
Please see the Occupational Health and Safety Program page for more details on the program.
Once the AUP has been approved, only the PI on the AUP can submit and respond to emails during the review process. If a PI is absent during the review process, an individual from the lab can send answers to the reviewers’ questions but only if there is a confirmation email from PI indicating that the changes inserted are appropriate and what they wanted.
To revise an approved MAUP, please submit a Revision Request Form and the AUP with the revisions incorporated into the document to email@example.com by 8am on the submission deadline. Please make sure the track changes are “on” when making the revisions.Protocol Submission and Review for submission deadlines).
Submission deadlines for full committee meetings are set six (6) weeks in advance of the meeting. All new protocols and AUPs undergoing de novo review are always reviewed at the ACUC meetings. The ACUC meets a maximum of eleven times a year with no meeting in July. Please note that the December meeting is tentative and, if it happens, is only used for reviewing revisions.
Revisions are initially triaged for Designated Member Review (DMR) or Full Committee Review (FCR) every other Monday. The timeline for review and approval of revisions that go DMR is variable, as it depends on the response time of the PI and reviewers; however the time frame can be as short as two (2) weeks. Depending on the date at which the revision is submitted, revisions that go FCR can be reviewed and approved in a minimum of six (6) weeks.
Review and approval of annual renewals and personnel updates are variable.Please refer to the ACUC Meeting and Deadline Calendar for submission deadlines and meeting dates.
Yes, you can withdraw a revision at any point in the review process. To do this, please send an email to firstname.lastname@example.org as well as the OACU analyst handling the review of your protocol (if known) indicating that you would like to withdraw your revision.
Yes, you can let your AUP expire. To do this, please send an email to email@example.com and the Attending Veterinarian indicating that 1) the date you will cease animal work, and 2) what should happen to any remaining animals that are still in the animal facility under your protocol.
If your protocol expires, all work with vertebrate animals must stop immediately. The funding agency for any grants associated with your protocol must be notified that your protocol has expired. You are no longer allowed to do any vertebrate animal work nor will you (or your lab personnel) be permitted in the animal facilities.
Expired protocol cannot be reactivated. A new AUP must be submitted for review.
Under State law and campus policy, an approved AUP for research or instruction is available on written request to members of the public once activity has begun.
Because most of the scientists serving on the ACUC are Berkeley faculty members who are engaged in animal research funded by competitively awarded research grants, it is possible for potential conflicts of interest to arise during the AUP review process. If you feel you have a potential conflict of interest with other UCB investigators who may be members of the ACUC (i.e., are a competitor for extramural research awards), please send a written request to firstname.lastname@example.org to the attention of the ACUC Chair requesting one or more faculty/staff be excluded from your AUP review. If this individual is a member of the ACUC, the Chair will ensure that this individual will not have access to your AUP or funding application. When your protocol is discussed at the meeting, the ACUC member with a conflict will be asked to leave the room and the remaining members of the committee will discuss and vote on your AUP.
Animals can be acquired through an OLAC-approved vendor (e.g., Jackson Laboratories), through another investigator or institution (e.g., through a Material Transfer Agreement), transportation of animals between campus facilities, or obtained from the wild. Regardless of the method of acquisition, live vertebrate animals cannot be purchased or otherwise acquired without an approved AUP.
Plans to acquire, transport, and house animals is reviewed and approved by OLAC as part of the AUP review process.
Once approved, all arrangements for the acquisition and transportation of live vertebrates from any source must be made through OLAC. Forms for animal purchase/acquisition and transfers can be found on the OLAC website (under Forms & Publications). Please be aware that some animals may be quarantined upon arrival, a decision that is dependent on the source of the animals. Please discuss this potential requirement with OLAC prior to acquiring/purchasing the animals.
Arrangements for any necessary quarantine must be made through OLAC before animals are obtained. The investigator also is responsible for determining if permits (e.g., U.S. Fish and Wildlife or California Fish and Game) are required. All applicable permits must be obtained before trapping, importing, or otherwise, obtaining wild, protected and/or endangered species. If the animals are illegal to possess in the state of California (“detrimental species”), OLAC must apply for the permits. All other permits, such as those for importation and collection, are the responsibility of the Principal Investigator to obtain; although, OLAC may be contacted for advice or assistance in procuring them.
For further information about acquisition/purchase, transportation and quarantine of animals, call OLAC at 642-9232.
Animals cannot be housed without an approved AUP. However, approval of an AUP does not guarantee that animal housing space will be available for the proposed project. OLAC is responsible for the management of animal housing space on campus and assigns space when it is available. If appropriate and adequate space is not available, the request for space is forwarded to the Committee on Animal Research Space Assignment (CARSA), which reviews and recommends plans for accommodating space requests. CARSA is composed of academic senate members who are animal users and non-animal users, the OLAC Director, ACUC Chair, and the Associate Vice Chancellor for Research. CARSA is advisory to the Vice Chancellor for Research, who has final authority to make animal research space assignments.
If you have acquired the maximum number of animals allowed under your approved AUP but are still in need of more, you will need to submit a revision request for additional animals. Please see Protocol Submission and Review and the ACUC Meeting and Deadline Calendar for information.