Contents


Animal Welfare Concern Reports

How do I report an animal concern?

For details, go to the Reporting Animal Concerns web page and reference the ACUC Guideline on Reporting Suspected Deficiencies in Animal Care or Treatment . In short, any incidents, concerns, or questions regarding the inappropriate care and use of live vertebrate animals should be reported via telephone, electronic communication, or in-person to one or more of the following:

Telephone or in-person conversations must be followed by the submission of a written summary from the person to whom the incident was reported.


UC Berkeley’s Animal Care Program

What’s the difference between OLAC, ACUC and OACU?

The Office for Animal Care and Use (OLAC) is responsible for providing daily animal care, administering the animal health care program, maintaining animal facilities, providing training and veterinary research support services for investigators, overseeing animal transfers and shipments, and processing all animal acquisitions.

The Animal Care and Use Committee (ACUC) is a campus-wide compliance committee charged with ensuring the UC Berkeley animal care and use program complies with all federal and state regulates and university policies. All institutions using vertebrate animals for research or instruction must establish an Institutional Animal Care and Use Committee (IACUC) to oversee and evaluate the institution’s animal care and use program. This committee at UC Berkeley, known as the Animal Care and Use Committee (ACUC), falls under the purview of the Office of the Vice Chancellor for Research.

The Office for Animal Care and Use (OACU) is the administrative office that supports the functions of the ACUC. OACU is part of the Research Administration and Compliance Office and coordinates protocol submission and review, the semi-annual program review and inspection process, the post-approval monitoring program, ACUC meetings, etc.


Do I Need to Submit a Protocol

When do I need a research Animal Use Protocol (AUP)?

A faculty member needs to submit an AUP for review and approval by the ACUC anytime s/he proposes to use live vertebrate animals in research, research training, biological testing, and/or experimentation. This federally mandated requirement ensures the ethical use of animals by minimizing pain or distress and reducing the numbers of individuals needed.

“Use” refers to any activity that alters the health, wellbeing, or behavior of an animal. This includes alterations to the natural or lab environment in which the animal occurs if those changes will substantially impact any of the above attributes of the animal’s biology. Accordingly, “use” includes collection or manipulation of animals in the field as well as dissection of or collection of tissues from dead animals that were intentionally euthanized for said tissue collection or dissection. “Animal” refers to any vertebrate that has reached the developmental stage at which neural development may allow pain sensation. Although this life stage varies among species, investigators are referred to the ACUC policy on the Animal Care and Use Program, section III, A. (3), These requirements apply to all UC Berkeley employees who use vertebrates as part of their professional activities, regardless of the location at which these activities take place.

If you are uncertain as to whether your intended research activities require an AUP, please contact the OACU staff (email, phone number) to discuss your specific research plans.

When do I need a teaching Animal Use Protocol (AUP)?

An AUP is required to cover activities such as class projects, demonstrations, exhibitions, public outreach events, or field trips that involve any use of animals, including activities that alter their natural habitat and behavior. While this does not include strictly observational studies of free-living animals, it does include alterations to natural or lab environments that impact the behavior or other attributes of an individual. Accordingly, “use” includes collection or manipulation of animals in the field as well as dissection of or collection of tissues from dead animals that were intentionally euthanized for said tissue collection or dissection. This federally mandated requirement ensures the ethical use of animals by minimizing pain or distress and reducing the numbers of individuals needed.

“Animal” refers to any vertebrate that has reached the developmental stage at which neural development may allow pain sensation. Although this life stage varies among species, investigators are referred to the ACUC policy on the Animal Care and Use Program, section III, A. (3). These requirements apply to all UC Berkeley instructors, including lecturers and graduate student instructors, who use vertebrates as part of their educational activities, regardless of the location at which these activities take place.

If you are uncertain as to whether your intended teaching or outreach activities require an AUP, please contact the OACU staff (email, phone number) to discuss your specific plans.


Before Submitting an Animal Use Protocol (AUP)

What is eProtocol?

eProtocol is a research compliance management system which can be accessed from any desktop via CalNet Authentication. The system automates many aspects of workflow and operations for review committees, staff, and researchers, including electronic protocol preparation, submission, routing, review, tracking, approval, and closeout. Berkeley eProtocol is designed to support the administration of research involving human as well as animal subjects.

For more information about using eProtocol to submit an Animal Use Protocol (AUP), visit ACUC eProtocol, ACUC eProtocol Quick Guides, and ACUC eProtocol FAQs.

Who can submit an AUP?

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. For more information about using eProtocol to submit an Animal Use Protocol (AUP), visit ACUC eProtocol, ACUC eProtocol Quick Guides, and ACUC eProtocol FAQs.

What is the approval period for an AUP?

Protocols are approved for three (3) years. Throughout the three years, each AUP goes through a review once a year (annual continuing review) and then an in-depth review at the end of the three years (de novo review).

Is a separate AUP required for each teaching course involving animals?

In general, a separate AUP is needed for each course. 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.

Do I need ACUC approval for field research or teaching?

According to the PHS Policy (Frequently Asked Questions): “If the activities are PHS-supported and involve vertebrate animals then the IACUC 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), administered 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.

Who can I contact for advice about preparing an AUP?

For more information about using eProtocol to submit an Animal Use Protocol (AUP), visit ACUC eProtocol, ACUC eProtocol Quick Guides, and ACUC eProtocol FAQs.

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 acuc@berkeley.edu. The OACU staff are also available to meet with investigators to discuss any questions they might have.

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.

Who do I talk to about using hazardous agents or chemicals?

The use of many biological materials (e.g., infectious agents, viral vectors, human cell lines, recombinant DNA) and transgenic animals require a Biological Use Authorization (BUA). Please visit the Environment, Health & Safety (EH&S) Biosafety 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. CLEB approval must be obtained prior to ACUC approval.

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 visit the EH&S SOP website, for assistance developing SOPs.

Who do I talk to about using controlled substances?

Use of controlled substances must comply with federal (Drug Enforcement Administration or DEA), state, and UC Berkeley regulations. Please visit the Environment, Health and Safety (EH&S) Controlled Substances web page. For additional information, please contact Assistant Biosafety Officer Krystyna Kozakiewicz at 643-1397 or krystyna.kozakiewicz@berkeley.edu.

Who do I talk to about using radioactive material or radiation?

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 Officer (RSO) Carolyn Mac Kenzie at 643-7976 or cjmackenzie@berkeley.edu.


Personnel, Training, and Occupational Health and Safety

Who do I need to include in the Personnel section of my AUP?

Prior to starting any procedures, any individual who uses animals in instruction or research must be listed on the Principal Investigator (PI)’s approved Animal Use Protocol (AUP). This includes the PI(even those who 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.

What training is required?

Each individual on the AUP 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 ACUC Training for details regarding CITI and the other available training requirements.

Who is required to participate in the Occupational Health and Safety Program?

All individuals who are working or will come in contact with animals are required to complete a health questionnaire in the Occupational Health Surveillance System.

Please see the Occupational Health and Safety Program page for more details on the program.


Once an AUP is Submitted…

Who is permitted to respond to the ACUC/OACU during the protocol review?
(Paper protocols only - For information on post-submission and post-approval processes for electronic eProtocols, please see the ACUC eProtocol FAQs or Quick Guides)

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.


Once an AUP is Approved…

How can I modify an approved AUP?
(Paper protocols only - For information on post-submission and post-approval processes for electronic eProtocols, please see the ACUC eProtocol FAQs or Quick Guides)

To revise an approved MAUP, please submit a Revision Request Form and the AUP with the revisions incorporated into the document to acuc@berkeley.edu by 8am on the submission deadline. Please make sure the track changes are “on” when making the revisions.

When can I submit a revision?
(Paper protocols only - For information on post-submission and post-approval processes for electronic eProtocols, please see the ACUC eProtocol FAQs or Quick Guides)

You can submit a revision request at any time. Revisions will be triaged on alternating Mondays (see Protocol Submission and Review for submission deadlines).

What is the timetable for reviewing and approving an AUP or revision?
(Paper protocols only - For information on post-submission and post-approval processes for electronic eProtocols, please see the ACUC eProtocol FAQs or Quick Guides)

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.

Can I withdraw a revision once it has been submitted?
(Paper protocols only - For information on post-submission and post-approval processes for electronic eProtocols, please see the ACUC eProtocol FAQs or Quick Guides)

Yes, you can withdraw a revision at any point in the review process. To do this, please send an email to acuc@berkeley.edu as well as the OACU analyst handling the review of your protocol (if known) indicating that you would like to withdraw your revision.

Can I let my AUP expire?
(Paper protocols only - For information on post-submission and post-approval processes for electronic eProtocols, please see the ACUC eProtocol FAQs or Quick Guides)

Yes, you can let your AUP expire. To do this, please send an email to acuc@berkeley.edu 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.

What do I do if my protocol expires?

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.

If my protocol expires, can I reactivate it?

Expired protocol cannot be reactivated. A new AUP must be submitted for review.

Will my AUP be available to the public?

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.


Conflicts of Interest (COI)

What happens if there are potential conflicts of interest during the AUP review process?

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 acuc@berkeley.edu 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

How do I arrange for access to an OLAC animal facility?

Access to UC Berkeley animal facilities is requested through the Office for Laboratory Animal Care (OLAC). Visit the OLAC website (CalNet ID required) to download a Supplemental Application for Card Key Access. Prior to submitting a request for access to an OLAC Animal Facility, you must:

  • Obtain a Cal 1 ID Card and CalNet ID
  • Complete the required training:
  • Enroll in the Animal Occupational Health and Safety Program (AOHSP) by completing a health questionnaire in the Occupational Health Surveillance System.
  • Be listed on an approved Animal Use Protocol (AUP). Check with your PI or the Office for Animal Care and Use (OACU) at 510-642-8855 to verify that you have been added to an approved protocol.

For additional information, please contact OLAC at 642-9232 or the OACU at 642-8855 or acuc@berkeley.edu.

How do I arrange to acquire/purchase and transport live laboratory animals?

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). 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.

How do I arrange to acquire/purchase and transport live wild 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 Wildlife) 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 (“restricted 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, contact OLAC at 642-9232.

How is housing space for animals assigned?

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.

What happens when I have acquired the maximum number of animals but still need more?

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 an amendment to your protocol requesting additional animals. Please see Protocol Submission and Review and the ACUC Meeting and Deadline Calendar for information.

 

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