THE OFFICE OF RESEARCH

NEW INVESTIGATORS: A QUICK GUIDE TO STARTING YOUR RESEARCH AT UCSF

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Obtaining Regulatory Committee Approvals - Other Topics:
| Making Sense of the Regulations | What is Research Online? | Working with Biologicals | Working with Chemicals | Working with Radioactive Materials | Working with Radioactive Materials in Humans | Working with Controlled Substances at UCSF | Involving Human Subjects in Research | Serving on the Committees | Working with UCSF's UCSF's Affiliates |

OBTAINING REGULATORY COMMITTEE APPROVALS

Working with Animals

• What kinds of animals can I use in my research at UCSF?
• Who do I contact?
• What approvals do I need?
• What resources and training are available?
• What auditing is required?
• Top tips to speed up approval and prevent problems
• Relevant policies and procedures

What kinds of animals can I use in my research at UCSF?

At UCSF, the kinds of animals that can be used in research depends upon adequate justification for use of animals in the proposed study. Before you submit research protocols to funding agencies or commit to collaborative agreements, you must contact the Laboratory Animal Research Center (LARC) to discuss any specific requirements to house your research animals.

The Institutional Animal Care and Use Committee (IACUC) is responsible for institutional compliance with all applicable Federal regulations, State laws and University policies governing the humane care and use of animals. At UCSF, this includes education and training in the care and use of animals in research and the regulatory oversight of all vertebrate animals research at UCSF.

Who do I contact?

Contact the IACUC at (415) 476-2197. You can call this number for help with the application and approval class, class scheduling, and general information. You can also refer to the Contacts portion of the IACUC website for additional contact information. The Laboratory Animal Resource Center (LARC), provides veterinary services and support for all animal research at UCSF; contact LARC at 476-2204.

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What approvals do I need?

Approvals: Before you undertake any type of vertebrate animal research at UCSF, you must submit a protocol on a Full Committee Application to the IACUC for review and approval. IACUC applications must be submitted at least six weeks in advance of initiating the animal research. Consult the IACUC office to determine how long the review process will take for your type of animal research as the committee meets only twice a month.

Before you are allowed to start research, you must have met UCSF training requirements. All new users must take the on-line Basic Regulatory and Ethical Requirements (BRER I) course and obtain certification, which must be renewed every three years. In addition, all personnel with direct animal contact must also take species-specific training, and all personnel authorized to conduct surgery, anesthesia and post-procedural care must take the BRER II course.

Expiration Date: IACUC approval must be renewed every year – no extensions are allowed. If your study expires, you must stop all work on animals and you will not be allowed to order any animals until your approval has been renewed.

Modifications: Submit all modifications to the IACUC for review before you implement them.

Additional Approvals: You must also obtain the appropriate Use Authorization (for the use of biohazardous materials, radioactive materials, and controlled substances) that may apply to your research. If you are inserting any human tissues or cells into animals, then approval from the Committee on Human Research may also be required unless you are using established cell lines as defined by the CHR. Forms can be found at the IACUC web site.

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What resources and training are available?

•	Bloodborne Pathogens training;
•	For New Users
•	Good Laboratory Practices Guidelines;
•	Hotline for monkey bites (same as Needlestick Hotline) (719-3898);
•	IACUC forms (i.e., for committee applications, purchasing and housing animals);
•	Phone support: IACUC: 476-2197; LARC: 476-2204;
•	Species and Procedures Training online;
•	Working Safely With Animals; and
•	Veterinary services.

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What auditing is required?

Ask the Principal Investigator you are responsible for ensuring that all laboratory staff conduct animal research in accordance with all applicable regulations, laws, and policies, and follow the approved IACUC protocol exactly as written.

Federal law requires the IACUC to conduct biannual inspections of animal procedure and housing areas to verify that they are in compliance with animal welfare regulations. In addition, your laboratory may be audited by the IACUC at any time, either as part of UCSF’s routine post-approval monitoring program, or as a result of concern expressed about animal welfare. These audits include site visits, review of all records and procedures, adequacy of personnel training, and compliance with all provisions of IACUC approved protocols, and animal welfare concerns as appropriate.

The US Dept of Agriculture (USDA) also conducts bi-annual animal facility inspections, and their findings, including any citations issued to UCSF become part of the public record, e.g. available to the public on the USDA website.

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Top Tips to speed up the approval process and prevent problems:

•	Read and follow all directions supplied with the form when completing an IACUC application.
•	Read and follow all IACUC Guidelines and Standard Procedures that pertain to your protocol.
•	Be sure that all attachments are complete and included in your application.
•	Allow enough time (at least six weeks for a new application) to respond to IACUC questions or concerns.
•	Do not let your IACUC approval expire before you submit a renewal application.
•	Do not change any protocol procedures, including drugs, dosages, animal numbers, and new personnel without prior IACUC approval
•	Do not overcrowd cages.
•	Do not use drugs past their expiration date.
•	Do not share your proximity card or key.

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Relevant policies and procedures:

The principal investigator has the overall responsibility for the conduct of the study in accordance with the applicable regulatory and UCSF Policy requirements.

Ethical, regulatory, and policy mandates 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. These mandates include:

•	The USDA Animal Welfare Act (AWA),
•	The USDA Animal Care Policies,
•	The PHS Policy on Humane Care and Use of Laboratory Animals, and
•	The NAS Guide for the Care and Use of Laboratory Animals,
•	All of the above policies are encompassed in University policies and procedures posted on the IACUC website.

Failure to comply with animal welfare and safety regulations is taken seriously at UCSF. The IACUC has the authority to shut down your animal research and revoke your animal research privileges at UCSF. Furthermore, if NIH funds your research, the IACUC must notify them of any animal research suspensions, which could potentially affect research funding. In order to prevent any noncompliance, you must make sure that:

•	Appropriate approvals are obtained,
•	Your personnel are properly trained,
•	Your personnel understand and know the provisions of the approved protocols,
•	You can freely call upon the expertise of the IACUC and LARC.