Institutional Animal Care and Use Committee (IACUC)

Activities Requiring an IACUC Protocol

Before any vertebrate animal can be used in research, training or teaching, the proposed animal use must be reviewed and approved by the IACUC, regardless of the funding source. The animal-use regulations require the IACUC to consider a number of specific aspects of animal use in the context of a particular research or teaching project. For this reason, an approved “protocol” covering a particular procedure cannot be used for another project with a different objective even if the animal procedure is the same, although reference to approved standard operating procedures may simplify the process. Protocols must be approved before any work can commence, and work must cease if a protocol is determined to be out of compliance.

The PI of an IACUC protocol must be a CSUF faculty member.

A completed Application for Animal Care and Use must be submitted for all on-campus or off-campus research or instructional activities involving vertebrate animals and involving CSUF faculty, students, or staff. This requirement includes both funded and unfunded projects. Off-campus work done at another institution must have approval from that institution's IACUC, which must then be sent to CSUF IACUC.

Any activity that will affect animals in CSUF’s care (e.g., remodeling, public display of animals) should also be brought to the IACUC’s attention and may also be subject to review.

Exceptions

The following activities are exempt from the requirement for a completed protocol for Animal Care and Use, but still require a formal exemption letter. A request for exemption can be done through a memo, which is reviewed and approved by the IACUC Chair. It is recommended that the PI contact the IACUC Chair before submitting an exemption request.

• Use of dead animals or tissue from dead animals. However, persons collecting carcasses must have the appropriate state or local permits, and persons using dead lab animals must verify that the animals were not sacrificed for their project.
• Non-invasive observational studies of wild animals in their natural habitat that do not materially affect the behavior of the animals. Field studies that involve killing, trapping, banding, darting or implantation of telemetry devices, or that involve procedures designed to habituate the animals to the presence of humans, are NOT exempt. Field studies of threatened or endangered species are also NOT exempt.
• Work done by a CSUF investigator at another institution, not using funds procured or managed by CSUF, and not doing the work for CSUF credit or thesis.
• Procurement of custom antibody or tissue products from USDA-approved commercial sources. However, the contractor must have a current NIH Assurance and be USDA-registered as a research facility. The contractor must also provide certify and provide evidence (e.g., approved protocol) that all procedures will be done in compliance with federal regulations governing the ethical care and use of animals, and that CSUF IACUC will be notified promptly of any problems related to animal care and use for the project.

IACUC Protocol Application and Review Process

1. The Principal Investigator (PI) should establish the need for an IACUC protocol by reviewing relevant policies and guidelines (see IACUC Guidelines and Policy Statementslink opens in a new window) and then obtain any required federal or state permits. PIs using animals on campus must consult with the Animal Care Facility Manager regarding available facilities and procedures before submitting an application. Animals cannot be used or procured for a project until the protocol has been approved by the IACUC. PIs who are proposing animal work that also involves potential biohazards or zoonotic diseases, controlled substances, radiation or radioactive isotopes should consult with the appropriate safety officer before completing their application and if necessary, submit a Cayuse IACUClink opens in a new window request.
2. All individuals (PIs/staff/students) who handle or directly assist with the care of vertebrate animals must be screened for potential health risks associated with working with animals. The PI must complete the Job Duty portion of the Animal Handler Referral Formlink opens in a new window describing any biological (e.g., infectious agents, toxins, recombinant materials, tissue cultures), chemical, physical, or radiation animal-use related risks to the health and safety of personnel involved. The PI will then email a copy of the form to all individuals who will handle animals or be exposed to these risks. Each worker will then complete the first page of the form and then email it to EHS (EHSMedical@fullerton.edu). EHS will email the form to our contracted medical provider (Kaiser), who will then contact each worker to assess potential risks and if necessary, schedule a health visit. In addition, all workers must complete an online CITI training course on using animals in research. All personnel must provide evidence of CITI training and be medically cleared to handle animals before a protocol can be approved. Because this process can take several weeks, PIs must ensure that worker begin training and submit the Medical Referral form immediately after the protocol application is submitted, to avoid delays in beginning work.
3. To begin the protocol application process, the PI should log on to the Cayuse IACUC online application system and gather the necessary information. Staff or students involved in a project must be listed in the Personnel section. Be sure that all sections are completed and that, for all literature reviews, the database(s) searched, key words used, the date the search was done and dates covered by the search are all provided. PIs are urged to use the Excel template provided for the initial submission or for the continuation submission to construct the table describing the number of animals to be used. Moreover, it is the responsibility of the PI to ensure that all personnel receive appropriate protocol-specific training and to maintain documentation of that training in their research laboratories. All individuals planning to work in the CSUF vivarium rooms must be trained by the Animal Facility Specialist prior to entering those facilities.
4. PIs are strongly encouraged to contact the IACUC chair for pre-review of their completed Draft application prior to submitting it through Cayuse. The chair will provide feedback to the PI and suggest changes before it is submitted for formal IACUC review. After the PI has modified the application in response to the chair’s comments, the PI will digitally sign the assurance in Cayuse and submit the application.
5. The coordinator will distribute the application to the IACUC for review. IACUC review and approval normally takes about 6 weeks. If approval is needed sooner, the PI should notify the IACUC chair at the time of pre-review.
6. Based on the review, the chair will inform the PI of the changes that are needed for the application to be approved. The PI must address the committee’s comments in Cayuse by re-submitting the application with changes that address these comments. The PI’s response and changes will then be re-routed to IACUC, which must approve of all the changes before the protocol can be approved.
7. Once the application is approved and all certifications received, an automated email notification will be sent to the PI. The PI’s department chair will also be notified by the IACUC office.
8. Approvals are valid for three years, but protocols must be reviewed annually by submitting a Continuing Review request through Cayuse. After three years, work that is ongoing must be renewed by submitting a De Novo protocol application through Cayuse. When all work on a project is completed, PIs must close the protocol in Cayuse.
9. If a protocol needs to be modified, the proposed changes must be submitted as an Amendment request in Cayuse. Amendment requests must be reviewed and approved by the IACUC prior to beginning work. The PI must describe the Reason for the Change in detail in the online application. Minor changes, i.e., that are not considered significant as defined by NIH-OLAW and USDA, such as personnel changes, may be approved solely by the IACUC Chair, but must still be submitted via Cayuse IACUC.

IACUC Guidelines and Policy Statements

Linked below are guidelines on animal use from scientific societies, state and federal government agencies, and CSUF.

Important notice to Principal Investigators
All PIs listed on an IACUC protocol must thoroughly review the CSUF IACUC Handbook.link opens in a new windowpdf file

• IACUC Animal Care and Use Occupational Health Program link opens in a new window
• IACUC AVMA Panel on Euthanasia 2020 link opens in a new windowpdf file
• IACUC California Department of Fish and Wildlife link opens in a new window
• IACUC California Department of Public Health link opens in a new window
• IACUC Cal/OSHA link opens in a new window
• IACUC CSUF Handbook link opens in a new windowpdf file
• IACUC Federal Animal Welfare Act link opens in a new windowpdf file
• IACUC Guidelines for Use of Amphibs Reptiles 2004 link opens in a new windowpdf file
• IACUC Guidelines for Care and Use of Lab Animals NIH 8th ed 2011 link opens in a new windowpdf file
• IACUC Guidelines for Use of Fishes 2014 link opens in a new windowpdf file
• IACUC Guidelines for Use of Mammals 2016 link opens in a new windowpdf file
• IACUC Guidelines for Use of Wild Birds 2023link opens in a new windowpdf file
• IACUC Guidelines for Hantavirus 2010 link opens in a new windowpdf file
• IACUC Office of Laboratory Animal Welfare (OLAW) link opens in a new window
• IACUC US Department of Agriculture link opens in a new window
• IACUC US Fish and Wildlife Service link opens in a new window
• IACUC US Public Health Service (PHS) link opens in a new window

IACUC CITI Training

Because of the intimate and highly individualized nature of most research projects involving animals, the most important training will necessarily be hands-on, and conducted by an experienced investigator, the Animal Care Facility Manager, or the Campus Veterinarian. However, it is essential that all researchers and instructors working with animals understand the key principles, policies, and responsibilities that are involved with animal-related research and teaching.

Toward that end, all investigators listed on an IACUC protocol must complete the online Collaborative Institutional Training Initiative (CITI) link opens in a new windowtraining module entitled “Using Animal Subjects in Research” (ID: 13301). CITI trainings are designed to meet U.S. Department of Agriculture (USDA) and Office of Laboratory Animal Welfare (OLAW) requirements for basic training in the humane care and use of animals.

Furthermore, students and postdoctoral researchers working on NIH and NSF grants must also complete the "Required" modules in the Responsible Conduct of Research (RCR) Basic Course. All researchers would benefit from completing the RCR-Basic Course at least once during their career at CSUF and are urged to do so.

Step-by-step instructions on how to create a CITI Programlink opens in a new window account and register for the correct course for the use of animal subjects can be downloaded below.

• CITI RCR Animal Use Instructions link opens in a new windowpdf file

At its discretion, the IACUC may require additional online or hands-on training, depending on the project.

Evidence of successful completion of the appropriate training modules (normally, a Completion Record or Certificate available from CITI) must be submitted to the coordinator for all listed investigators, including students and staff, at the time of submission of a new or continuing IACUC protocol application. Training must be renewed every five years. The Principal Investigator on a project or course is responsible for ensuring that all researchers working with animals under his/her supervision have the appropriate and updated training.

Contact IACUC

Questions about the IACUC and CSUF policies and procedures regarding the use of animals in teaching, training and research can be directed to:

CSUF IACUC Chair
Dr. Paul Stapp, Professor
Department of Biological Science
(657) 278-2849
pstapp@fullerton.edu

Animal Care Facility Specialist
Esther Escobar
(657) 278-5543
(657) 767-3315 (cell)
elescobar@fullerton.edu

Campus Veterinarian
Dr. Scott Weldy
(949) 855-9744

Research Compliance Coordinator
Mandie Claussen
Office of Research and Sponsored Programs
(657) 278-7719
Animal Use: iacuc@fullerton.edu