IACUC POLICIES

EDUCATION AND TRAINING IN THE CARE AND USE OF LABORATORY ANIMALS (March 2002, rev May 2003, July 2008)

Background

The privilege of using animals in research is subject to three Congressional Acts: the Health Research Extension Act (Public Law 99-158), the Food Security Act (Public Law 99-198), and the Animal Welfare Act (AWA) [7 U.S.C. 2131-2156]. The AWA details requirements for the care and use of animals in research, testing and education. Specifically, Subpart C, Section 2.32, Personnel Qualification, requires that:

• It shall be the responsibility of the research facility to ensure that all scientists, research technicians, animal technicians, and other personnel involved in animal care, treatment and use are qualified to perform their duties. This responsibility shall be fulfilled in part through the provision of training and instruction to those personnel.



• Training and instruction shall be made available, and qualifications of personnel reviewed, with sufficient frequency to fulfill the research facility's responsibilities under this section.

Policy

Distribution of Responsibility

It is the Principal Investigator's responsibility to assure that his or her staff are trained and qualified. The Institutional Animal Care and Use Committee (IACUC) is responsible for the oversight and content of the UCSF Animal Use Training Program. The IACUC training staff conducts and documents training programs that meet federal requirements, and works with Laboratory Animal Resource Center and individual investigators to develop and document their own staff training.

Basis for Training Program

In 1991, the Committee on Education Programs in Laboratory Animal Science (Institute of Laboratory Animal Research, Commission of Life Sciences, National Research Council) published its report entitled, Education and Training in the Care and Use of Laboratory Animals - A Guide for Developing Institutional Programs. This document is the basis for UCSF's animal care training program.

UCSF Personnel Affected

The following UCSF personnel must complete the required training in the care and use of animals in research and instruction if they have contact with any living vertebrate animals:

• Scientists
• Research technicians and research animal technicians
• Medical students, fellows, and residents
• Summer students
• Visiting scholars
• Volunteers
• Other individuals involved in the care and handling of animals
• PIs and Co-PIs on Animal Use Protocols, even if those individuals will not have direct animal contact.

In addition, sufficiently detailed information on the experience and training of each individual involved must be included on the IACUC-approved protocol before any hands-on work may be done.

Implementation

The UCSF Animal Care and Use Training Program consists of six components:

1. Basic Ethical and Regulatory Requirements (BRER) ) (Core and Surgery / anesthesia modules)
2. Species-Specific Training
3. Laboratory-provided Training
4. Other IACUC-Mandated Training
5. Periodic Retraining
6. LARC Facility orientation
7. Exemptions

The IACUC staff, in conjunction with various individuals and user groups identified by the IACUC, has developed the content of each module. These programs will be periodically reviewed and updated to reflect any relevant changes in regulatory requirements and/or IACUC policies.

Proximity cards will not be activated nor keys issued for individual access to LARC animal facilities until IACUC-mandated training requirements and LARC facility orientation have been completed.

1. Basic Regulatory and Ethical Requirements

The revised BRER training comprises two on-line modules and replaces the previous training program that was effective January 1, 1999.

Effective June 1, 2003, ALL animal users must take one or both modules as appropriate, regardless of prior training,

The core module, BRER-I, is mandatory for all first time users named on animal care and use protocol capacity. It covers

• Ethical and scientific issues related to animal research;
• Laws, regulations, and policies related to animal research;
• Methods whereby animal care and treatment are reported;
• Responsibilities of the IACUC, research and veterinary staff;
• Alternatives to the use of animals and to the procedures planned;
• Pain and discomfort, anesthetics, and analgesics;
• Euthanasia;
• General safety, health and environmental considerations (Zoonoses).

BRER-II comprises of the Surgery / anesthesia module is required for anyone named on a protocol as conducting survival or non-survival surgery or anesthesia on laboratory animals.

Both modules include tests that must be passed to receive credit for the course.

2. Species-Specific Training

In addition to the basic training described above, effective January 1, 2000, species-specific training will be required for all personnel who will be in direct contact with animals, as follows:

• Any new user with less than 12 months of experience in the specific species must attend the appropriate species-specific course(s). Note that the safety component of sheep and primate species-specific training is UCSF-specific and is required of all new sheep or primate users regardless of prior experience with these species on other campuses.


• The IACUC will determine during the review process the need for, and extent of, training for others listed on the protocol, and for additional hands-on or similar training (e.g., observation by LARC staff), and include any requirement as a condition of IACUC approval of the protocol.

The specific content and degree of detail will vary depending on the knowledge, previous experience and expertise of the target audience. The modules will contain, as appropriate:

• Selection and procurement of animals;
• Husbandry and care;
• Handling and restraint;
• Anesthesia, analgesia, peri-operative monitoring, medications;
• Survival surgery and post-surgical care;
• Skill-building for selected procedures (hands-on sessions);
• Identification and records;
• Species-specific euthanasia;
• Species-specific safety, health and environmental considerations; and
• Other specific issues as needed.

3. Laboratory-provided Training

Individual PIs and/or their designates can apply to the IACUC training staff to conduct and document their own equivalent of the Species-Specific training sessions. For approval, such laboratories/investigators will work with the IACUC to develop the content of the training session and the method for documenting training. IACUC will maintain a database of individuals approved to provide introductory training in PIs' laboratories.

4. Other IACUC-Mandated Training

As stated above, the IACUC may mandate additional training for individuals or an entire group if:

• During the initial protocol review process, the need for more training is identified.



• The procedures in the protocol are changed or amended substantially enough to warrant additional training (e.g., changing from acute to survival surgery).



• The IACUC identifies violations of the protocol due to lack of understanding of procedures or insufficient training.

5. Periodic Retraining

Effective June 1, 2003 all individuals listed on an animal research protocol must undergo periodic retraining as prescribed by the IACUC every three years to retain their privilege to conduct research involving the use of animals. The retraining modules will be designed to address new, or changes in existing, regulatory or policy requirements.

6. LARC Facility Orientation

For most facilities where animals are housed, new individuals should meet with the relevant LARC area supervisor or principle technician to receive orientation for that particular facility.

7. Exemptions

The IACUC recognizes that UCSF research faculty are often involved in collaborative efforts with other institutions, which may include short-term visitors (a few days to a maximum of 30 days), and that at times these visitors may need to participate in a study involving animals. The IACUC will grant an exemption to these individuals if:

• The participant has a minimum of one year of prior animal use experience in the species involved.



• The UCSF PI/Co-PI forwards a completed Request for Exemption from IACUC Training form to IACUC office for review.



• A veterinarian reviews the form and approves the individual's exemption from training.



• The veterinarian informs the PI /Co-PI of training exemption approval.



• The veterinarian forwards a copy of the training exemption approval to the IACUC office to keep in the protocol file.



• The PI/Co-PI briefs the short-term participant in the details of the study and the procedures, and has the participant read and initial the relevant IACUC-approved protocol.
  
• The PI/Co-PI directly supervises the individual during the study, and this is documented by the PI/Co-PI signing the form and placing it in the PI's central LARC/IACUC Logbook.

Training Schedules

Basic Regulatory and Ethical Requirements. Core and Surgery / Anesthesia modules are available on-line at the user's convenience.

Rat and Mouse Basic Introductory Species-Specific training may also be scheduled on-line (class size is limited). Call 476-2197 for information or Email: traineriacuc@research.ucsf.edu

Species-Specific Courses for all other species and any other IACUC-Mandated Training are scheduled according to demand. Call 476-2197 for information or Email: traineriacuc@research.ucsf.edu