AWP: FAQ

An IACUC is an Institutional Animal Care and Use Committee. IACUCs are required by Federal law to oversee the humane care and treatment of laboratory animals. At LLU, IACUC members are appointed by the Vice President for Research Affairs and confirmed by the President Council.

Ethical, regulatory, and policy mandates (including the USDA Animal Welfare Act, the USDA Animal Care Policies, the PHS Policy on Humane Care and Use of Laboratory Animals, the Guide for the Care and Use of Laboratory Animals, and Loma Linda University policies) require that approval by a duly appointed Institutional Animal Care and Use Committee (IACUC) be granted before any research project using vertebrate animal subjects can be initiated.

If you will conduct research on live vertebrate animals or on tissues collected from live animals, you must first submit an IACUC application for approval. All research conducted by LLU faculty, students, and staff that uses animal subjects, regardless of the source of funding or even when no funds are involved, must have prior approval from the LLU IACUC.

You are eligible to submit an IACUC application as a Principal Investigator if you have one of the following appointments in a clinical, teaching, or research track:

• Professor
• Associate Professor
• Assistant Professor

If you do not have Principal Investigator status according to the criteria listed above, you may still be listed as an Alternate Responsible Individual on an IACUC application.

If only blood and tissue are required, investigators are strongly encouraged to obtain them from animals euthanized by other laboratories through the LLU Tissue-Sharing Program. The Animal Care Facility (ACF) office has a database and can assist you in locating the tissues you need. Please contact the ACF office at x44316.

If tissue sharing is not possible, and animals must be euthanized for the project's purpose, an IACUC protocol must be submitted.

A protocol must also be submitted for the production of antibodies, whether they are generated by the investigator, by a LLU Core Facility, or by an outside facility.

Contact the IACUC Office at x44531 to schedule an orientation to the online system.

About 4 weeks. When a new application is submitted, it will first be pre-reviewed by an attending veterinarian, occupational health and safety personnel, and IACUC administrative staff. You will receive an e-mail with their comments for making revisions and instructions for resubmitting the application for a Full Committee Review. After the application has been reviewed by the full committee, you will either receive approval or another email requesting further revisions. The PI must respond to each of the committee's questions and make the relevant changes in the application form. This response is reviewed by the IACUC Designated Member (or by the Full Committee again if the changes are substantial) for final approval. No work may begin until the protocol has been approved.

For veterinary assistance, e.g., anesthesia, surgical procedures, analgesia, euthanasia, contact the Animal Care Facility at x44316.

For general assistance, e.g. policy and procedures, contact the IACUC office at x44531.

All warm and cold-blooded vertebrates, both in the field and the laboratory, e.g., fish, birds, mice, nonhuman primates, require IACUC protocol review.

All faculty, staff, students, and visiting scholars using animals must be listed on a protocol. New personnel must be added to a protocol prior to their use of laboratory animals. All personnel must have the required training as specified below.

Review the IACUC Training Webpage for all training information

• An Animal Care and Use Training (ACUT) course for all personnel on an IACUC protocol. (A refresher course is required every 3 years).
• A microsurgery course for all personnel involved with anesthesia, surgery, and/or post-surgical care.
• Occupational Health Service questionnaire and annual update
• Species-specific training (Use of Laboratory Animals in Research and Training module)
• Facility Orientation tour and the online CITI IACUC module for personnel access to animal facilities

Personnel who fail to complete these requirements may not work with or around experimental animals and are considered non-compliant. For further information about training, please email the ACF training group at [email protected].

Review and approval of scientific merit is required before the protocol can be assigned to an IACUC meeting agenda. The primary charge of the IACUC is to ensure the ethical and humane use of animals in research. Pursuant to that objective, all studies involving animals in research must be deemed scientifically meritorious. Several processes are in place to ensure this objective.

Scientific merit review may be conducted by the Principal Investigator's department. The Departmental Review process for scientific merit is determined by each department, center, or institute, or school. In any case, the PI must document this by submitting a signed application form to the IACUC which includes signatures from a department chair whose department for which the PI holds his faculty appointment.

The IACUC reserves the right to request additional review of scientific merit. In such cases, the IACUC forms an ad hoc committee. This committee may be composed of members of the IACUC and/or peers within the research community who have a particular area of expertise. Full Committee applications must include documentation of current scientific merit review and approval from one of the listed agencies or from the appropriate department chair. The IACUC will only consider the approval of applications that have been found to be scientifically meritorious by one of the described processes.

Federal regulations require comparison of IACUC protocols with the research grants that support them. If your protocol is new and federally funded, you must provide this documentation when you submit the protocol.

A3449-01

August 3, 1966

This is referred to as a continuing or annual review. Fill out a Research Report Form and send it to the IACUC office. Annual review applications (without concurrent modification) typically take less than 1 month to approve.

Note: A full committee application must be submitted every 3 years. After 2 consecutive Annual Reviews, a Full Committee application is required for the third renewal.

When a full committee renewal has been approved with a new approval number, you must transfer any existing animals to the new protocol (using ACF forms) and request new cage cards from the ACF Office.

• Revise all sections that are relevant to your modification. You might want to highlight the new information somehow, e.g., by italics or capital letters, to make it easier for the reviewers to see what has been modified.
• Be sure to address any potential adverse effects of your new procedures/agents, and for each adverse effect, describe management, monitoring, and the specific criteria you will use for early euthanasia.
• Describe your reasons for modifying the protocol, which sections you changed, and how you changed them.
• If the modifications are personnel changes only, use the form designed for personnel change (Personnel Change Form), and list the names of the personnel you added. (This form will be available on line soon)

The PI on an animal protocol must submit a modification to the relevant protocol and make the necessary changes to the Contacts and Personnel section in the application. Be sure to complete administrative and/or functional roles for all personnel added to the animal protocol. New personnel on an animal study must complete all of the required training, including the species specific training, Occupational and Safety Questionnaire, and related facility orientation/training, and be added to a protocol and approved by IACUC before beginning any live animal work.

Funding source and location additions and deletions are made by submitting a memo to IACUC.

Yes

The status of your protocol can be displayed in InfoEd. If you need assistance, please call the IACUC Office at x44531.

Under NO circumstances can you use expired drugs or fluids (including saline) on ANY live animals. If you would like to use expired medical materials (such as catheters) in terminal procedures you must fill out the request (amendment) form and submit it to the IACUC for review.

This certification is part of the application form and must be completed and signed by the Principal Investigator (PI) for new protocols, modifications, and the three-year renewal application. The PI's signature certifies that he or she has read and agrees to all items on the form. The signed form must be e-mailed, mailed, or faxed (x80131) to the IACUC office to be included in the protocol on file in the IACUC office.

No, not unless your protocol has listed the lab room number as "animal housing" AND the animal use area has been inspected and approved by IACUC. If you would like this designation for your lab, you must have scientific justification (not for convenience), and must submit a modification to an approved protocol so this space can be deemed "animal housing." IACUC will inspect the area and approve it for lab housing to ensure the space meets regulatory requirements.

Contact ACF at x44316.