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ILAR The Guide

Laboratory animals are defined as any vertebrate animal (e.g., traditional lab animals, ag animals, wildlife, and aquatics) produced for or used in research, testing, or teaching.

Animal Use: “the proper care, use and humane treatment of laboratory animals produced for, or used in research or teaching”

ILAR establishes general principles and ethical considerations: Improvement in human or animal wellbeing. Animal use is a privilege. US Gov’t Principles

Replacement: Avoid using animals (i.e. computer programs (in silico; absolute) or lower species (related), Limulus amoebocyte assay test (horseshoe crabs).

Refinement: Modifications of husbandry/experimental procedures to enhance well-being and minimize/eliminate pain and distress (i.e. anesthesia, pain meds, better techniques, humane endpoints)

Reduction: Obtaining comparable levels of information from fewer animals or maximizing the information obtained so that in the long run fewer animals are needed to acquire the same scientific information (i.e. statistical methods/ power analysis). Discourages reuse of animals as reduction strategy.

Veterinary consultation must occur when pain or distress is beyond the level anticipated in the protocol description or when interventional control is not possible.

This edition of the Guide strongly affirms the principle that all who care for, use or produce animals for research, testing or teaching must assume responsibility for their well-being.

·       Engineering standard Prescriptive in nature - details a method, technology or technique for achieving a desired outcome. Does not provide for modification if acceptable alternative methods are available or unusual circumstances arise. Used to establish a baseline. Defined measuring parameter. Easy verification of compliance. Example: cage size, temperature/humidity range, photoperiod, perch length

·       Performance Standard While describing a desired outcome, provides flexibility in achieving this outcome by granting discretion to those with responsibility for Program, researcher, and the IACUC. Requires professional input, sound judgment, and team approach to specific goals. Example: cage height for normal postural adjustments, impervious walls and floors to allow for proper sanitation.

·       Practice Standard: Application of professional judgment by qualified individuals to a task or process over time (use in absence of published scientific literature or other definitive source). Example: Tree shrew hand rearing- apply techniques from scientific literature and consult with experts

·       Principles: broader in scope and application, endorsed by many organizations (US Gov’t Principles)

·       Policy: derived from a public agency or private entity. Practical statements of collective wisdom that are internal to the entity but can assume a broader force when they become how an implementing agency interprets existing statutes (PHS Policy).

·       Procedures: detailed, SOPs, can assist an institution in complying with regs., policies/principles & day-to-day operations.

●       ACU Program: composed of all activities conducted by and at an institution which have a direct impact on the well-being of animals including policies and procedures, animal and veterinary care, personnel and program management and oversight, occupational health and safety, IACUC functions, and animal facility design and management.

Each institution should establish and provide sufficient resources for a Program that is managed in accord with the Guide and in compliance with applicable regulations, policies and guidelines

Institutional Official (IO): bears ultimate responsibility for the Program; overall direction of the Program should be a shared responsibility among the IO, AV and IACUC. IO has authority to allocate resources and is responsible for resource planning and ensuring alignment of Program goals with the institution's mission.

The Attending veterinarian (AV) is responsible for the health and well-being of all laboratory animals used at the institution. The institution must provide the AV with sufficient authority, including access to all animals, and resources to manage the program of veterinary care. The AV should oversee other aspects of animal care and use (e.g., husbandry, housing) to ensure that the Program complies with the Guide.

If a full-time veterinarian is not available on site, visits by a consulting or part-time veterinarian should be at intervals appropriate to programmatic needs. In such instances, there must be an individual with assigned responsibility for daily animal care and use and facility management.

IACUC: responsible for assessment and oversight of the institution’s Program components and facilities and should have sufficient authority and resources to fulfill this responsibility

●       Participating institutions should have formal written understanding between participating institutions

All personnel involved with the care and use of animals must be adequately educated, trained and/or qualified in basic principles of laboratory animal science to help assure high quality science and animal well-being.

Veterinarians providing clinical and/or program oversight and support must have experience, training, and expertise necessary to appropriately evaluate the health and well-being of the species used, in the context of the animal use being carried out by the institution

Institutions: resources to support personnel training

IACUC: oversight and evaluating the effectiveness of training.

●       Personnel caring for animals should be appropriately trained to effectively implement the Program (beyond the basic Must), and the institution should provide for formal and/or on-the-job training

●       The institution should provide members of research teams appropriate education and training in the specific animal procedures proposed and with the species used.

●       It’s the institution’s responsibility to ensure that IACUC members are provided with training opportunities to understand their work and role. Should include formal orientation to the institution’s Program, relevant legislation, regulations, guidelines and policies, animal facilities and labs where animal use occurs, and the processes of animal protocol and program review.

Each institution must establish and maintain an Occupational Health and Safety Program (OHSP) as an essential part of the overall program of animal care and use.

The OHSP must be consistent with federal, state, and local regulations and should focus on maintaining a safe and healthy work place.

OHSP should identify potential hazards and conduct an assessment of risks

Participation of personnel in the OSHP should be based on: Hazards posed by the animals and materials used. Exposure intensity, duration, and frequency. Susceptibility of the personnel. History of the occupational illness and injury in the particular workplace

Equipment design should preferentially use engineering controls and equipment to minimize exposure to hazards

WF

ILAR The Guide

Laboratory animals are defined as any vertebrate animal (e.g., traditional lab animals, ag animals, wildlife, and aquatics) produced for or used in research, testing, or teaching.

Animal Use: “the proper care, use and humane treatment of laboratory animals produced for, or used in research or teaching”

ILAR establishes general principles and ethical considerations: Improvement in human or animal wellbeing. Animal use is a privilege. US Gov’t Principles

Replacement: Avoid using animals (i.e. computer programs (in silico; absolute) or lower species (related), Limulus amoebocyte assay test (horseshoe crabs).

Refinement: Modifications of husbandry/experimental procedures to enhance well-being and minimize/eliminate pain and distress (i.e. anesthesia, pain meds, better techniques, humane endpoints)

Reduction: Obtaining comparable levels of information from fewer animals or maximizing the information obtained so that in the long run fewer animals are needed to acquire the same scientific information (i.e. statistical methods/ power analysis). Discourages reuse of animals as reduction strategy.

Veterinary consultation must occur when pain or distress is beyond the level anticipated in the protocol description or when interventional control is not possible.

This edition of the Guide strongly affirms the principle that all who care for, use or produce animals for research, testing or teaching must assume responsibility for their well-being.

·       Engineering standard Prescriptive in nature - details a method, technology or technique for achieving a desired outcome. Does not provide for modification if acceptable alternative methods are available or unusual circumstances arise. Used to establish a baseline. Defined measuring parameter. Easy verification of compliance. Example: cage size, temperature/humidity range, photoperiod, perch length

·       Performance Standard While describing a desired outcome, provides flexibility in achieving this outcome by granting discretion to those with responsibility for Program, researcher, and the IACUC. Requires professional input, sound judgment, and team approach to specific goals. Example: cage height for normal postural adjustments, impervious walls and floors to allow for proper sanitation.

·       Practice Standard: Application of professional judgment by qualified individuals to a task or process over time (use in absence of published scientific literature or other definitive source). Example: Tree shrew hand rearing- apply techniques from scientific literature and consult with experts

·       Principles: broader in scope and application, endorsed by many organizations (US Gov’t Principles)

·       Policy: derived from a public agency or private entity. Practical statements of collective wisdom that are internal to the entity but can assume a broader force when they become how an implementing agency interprets existing statutes (PHS Policy).

·       Procedures: detailed, SOPs, can assist an institution in complying with regs., policies/principles & day-to-day operations.

●       ACU Program: composed of all activities conducted by and at an institution which have a direct impact on the well-being of animals including policies and procedures, animal and veterinary care, personnel and program management and oversight, occupational health and safety, IACUC functions, and animal facility design and management.

Each institution should establish and provide sufficient resources for a Program that is managed in accord with the Guide and in compliance with applicable regulations, policies and guidelines

Institutional Official (IO): bears ultimate responsibility for the Program; overall direction of the Program should be a shared responsibility among the IO, AV and IACUC. IO has authority to allocate resources and is responsible for resource planning and ensuring alignment of Program goals with the institution's mission.

The Attending veterinarian (AV) is responsible for the health and well-being of all laboratory animals used at the institution. The institution must provide the AV with sufficient authority, including access to all animals, and resources to manage the program of veterinary care. The AV should oversee other aspects of animal care and use (e.g., husbandry, housing) to ensure that the Program complies with the Guide.

If a full-time veterinarian is not available on site, visits by a consulting or part-time veterinarian should be at intervals appropriate to programmatic needs. In such instances, there must be an individual with assigned responsibility for daily animal care and use and facility management.

IACUC: responsible for assessment and oversight of the institution’s Program components and facilities and should have sufficient authority and resources to fulfill this responsibility

●       Participating institutions should have formal written understanding between participating institutions

All personnel involved with the care and use of animals must be adequately educated, trained and/or qualified in basic principles of laboratory animal science to help assure high quality science and animal well-being.

Veterinarians providing clinical and/or program oversight and support must have experience, training, and expertise necessary to appropriately evaluate the health and well-being of the species used, in the context of the animal use being carried out by the institution

Institutions: resources to support personnel training

IACUC: oversight and evaluating the effectiveness of training.

●       Personnel caring for animals should be appropriately trained to effectively implement the Program (beyond the basic Must), and the institution should provide for formal and/or on-the-job training

●       The institution should provide members of research teams appropriate education and training in the specific animal procedures proposed and with the species used.

●       It’s the institution’s responsibility to ensure that IACUC members are provided with training opportunities to understand their work and role. Should include formal orientation to the institution’s Program, relevant legislation, regulations, guidelines and policies, animal facilities and labs where animal use occurs, and the processes of animal protocol and program review.

Each institution must establish and maintain an Occupational Health and Safety Program (OHSP) as an essential part of the overall program of animal care and use.

The OHSP must be consistent with federal, state, and local regulations and should focus on maintaining a safe and healthy work place.

OHSP should identify potential hazards and conduct an assessment of risks

Participation of personnel in the OSHP should be based on: Hazards posed by the animals and materials used. Exposure intensity, duration, and frequency. Susceptibility of the personnel. History of the occupational illness and injury in the particular workplace

Equipment design should preferentially use engineering controls and equipment to minimize exposure to hazards