Using AAALAC Program Description Sections in the OLAW Domestic Assurance

The U.S. Government Principles¹, Health Research Extension Act of 1985² and the PHS Policy³ repeatedly state that personnel must be appropriately trained, qualified, and experienced, and that proper instruction and training must be provided. Training should be documented. Institutions are responsible for providing appropriate resources to support personnel training (Guide, pg.15). As the size and nature of institutional research programs vary significantly, there is corresponding variation in the scope and depth of instructional programs and the frequency at which they are offered.

As part of their review of animal activities, IACUCs are responsible for verifying that individuals listed in animal activities will be appropriately qualified and trained prior to engaging in animal activities (see PHS Policy IV.C.1e.-f., and 9CFR 1, chapter 1, Part 2, 2.31). This may be accomplished by staff, such as IACUC administrators, using an administrative review mechanism to determine if personnel meet all institutional training requirements.

While training is an institutional responsibility, IACUCs are required to evaluate the effectiveness of the institutional training program as it relates to the care and use of animals as part of the semiannual program review.

Discussion of appropriate training is found throughout the Guide. At a minimum, the PHS Policy and the Guide (page 15) require institutions to:

• Ensure that individuals using or caring for animals are trained and qualified in the appropriate species-specific housing methods, husbandry procedures, and handling techniques;
• Ensure that researchers performing experimental manipulation, including anesthesia and surgery, are qualified through training or experience to accomplish the procedures humanely and in a scientifically acceptable fashion;
• Provide training or instruction in research and testing methods that minimize the number of animals required to obtain valid results and minimize animal distress;
• Ensure that professional staff whose work involves hazardous biological, chemical, or physical agents have training or experience to assess potential dangers, and select and oversee the implementation of appropriate safeguards; and
• Ensure compliance with any initial and continuing education regarding local, regional, and national requirements licensing veterinarians, veterinary technicians, and animal health technicians.  

¹ The U.S. Government Principles state that, “…housing, care, and feeding…must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied” (VII) and that, “Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals” (VIII).

² The Health Research Extension Act of 1985 requires that, “scientists, animal technicians, and other personnel involved with animal care, treatment, and use…have available to them instruction or training in the humane practice of animal maintenance and experimentation…” (Sec. 495.(c) (1) (B)).

³ The PHS Policy requires that institutions seeking an Assurance provide “a synopsis of training or instruction in the humane practice of animal care and use, as well as training or instruction in research or testing methods that minimize the number of animals required to obtain valid results and minimize animal distress, offered to scientists, animal technicians, and other personnel involved in animal care, treatment or use” (IV.A.1.g.); that medical care for animals will be provided by “qualified” veterinarians (IV.C.1.e.) and that, “Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures” (IV.C.1.f.).

The PHS Policy requires a “health program for personnel who work in laboratory animal facilities or have frequent contact with animals” (IV.A.1.f.). The Guide states that, “Each institution must establish and maintain an occupational health and safety program as an essential part of the overall Program of animal care and use…The nature of the OHSP will depend on the facility, research activities, hazards, and animal species involved.” (Guide pages 17-23)

“A comprehensive OHSP should include a hierarchy of control and prevention strategies that begins with the identification of hazards and the assessment of risk associated with those hazards.” (Guide page 18) An effective occupational health and safety program must encompass all personnel that have contact with animals. Depending on the species of animal or the amount of animal exposure, the program may not affect all personnel equally. Minimally, the program must include:

• pre-placement medical evaluation;
• identification of hazards to personnel and safeguards appropriate to the risks associated with the hazards;
• appropriate testing and vaccinations;
• training of personnel regarding their duties, any hazards, and necessary safeguards;
• policies and facilities that promote cleanliness;
• provisions for treating and documenting job-related injuries and illnesses;
• facilities, equipment, and procedures should be designed, selected, and developed to reduce the possibility of physical injury or health risk to personnel;
• good personal hygiene practices, prohibiting eating and drinking, use of tobacco products, and application of cosmetics and/or contact lenses in animal rooms and laboratories; and
• personal protective equipment (PPE).

Occupational Health and Safety in the Care and Use of Research Animals, published in 1997 by the National Research Council, includes helpful guidelines and references for establishing and maintaining an effective and comprehensive program.

Continuing IACUC oversight of animal activities is required and can be accomplished through a variety of mechanisms. (Guide pages 33-34) Monitoring animal care and use is required by the PHS Policy, but the Policy does not explicitly require specific post approval monitoring (PAM) procedures to compare the practices described in approved protocols and SOPs against the manner in which they are actually conducted. IACUCs are charged, however, with program oversight and as such are responsible for program evaluations, reviews of protocols, reporting noncompliance, ensuring that individuals who work with animals are appropriately trained and qualified, and addressing concerns involving the care and use of animals at the institution. The veterinarian with program authority and responsibility for animal activities along with the animal care and technical staff, add another important level of program supervision.

Related components of institutional programs provide monitoring by a multi-disciplinary team of individuals.  Examples of such components include daily observation of animals by trained animal care personnel and communication to the veterinary staff for follow-up, facility monitoring by facility maintenance personnel, post operative care by trained personnel, evaluation of outcomes of animal procedures by investigators and staff, hands-on training in animal procedures, and appropriate reporting of incidents involving occupational health and safety.  All of these functions and responsibilities imply a level of monitoring. Ultimately the institution has flexibility in how it achieves compliance. 

Some institutions have developed PAM programs with dedicated staff that physically monitor procedures and practices associated with animal use protocols. This is one acceptable method that institutions may elect to adopt, but it is not a federally mandated requirement. Whatever methods an institution incorporates, it is important that the authority and responsibility of the IACUC not be contravened by a PAM program, institutional compliance officials, or other mechanism established to monitor animal care and use.