ALAT Chapter 2 Notes

"Animal protocol" can also be referred to as?

"Animal Study Protocol"

Define ombudsman

This term defines that many institutions can submit anonymously concerns by a hotline.

True or False Some institutions must comply with the AWA and AWR, but not with the PHS Policy. While others may comply only with the PHS Policy alone.

True

True or False The USDA requires that animal suppliers and research facilities maintain records of animal acquisition and disposal. Also, these areas must submit an annual report to the USDA.

True

According to protocol numbers, what should animal care technicians be aware of?

They should be aware that each animal is counted on a specific protocol number.

Approved protocols are typically assigned with what?

An ID number based on a numbering scheme of the institution. All animals on the protocol are identified with that protocol's number. Then, the protocol number is typically displayed on cage cards and other animal documents, such as health records.

Which federal mandate requires that institutions have an occupational health and safety program for all personnel working with animals, and requires all federal grant recipients to comply with the US Government Principles?

The Public Health Service Policy (PHS)

Who has authority to stop the research being conducted at the facility if the violations are not corrected in a timely fashion?

The USDA

According to the chapter, what happened in 1966?

The United States Congress enacted the first federal law for laboratory animal welfare called the Animal Welfare Act (AWA). The purpose of this law was to establish legal standards for laboratory animal care and use.

The IO must submit a type of document to the OLAW, what is the name and purpose of this document?

The document is called the Animal Welfare Assurance of Compliance Statement. It can also be referred to as the PHS Assurance, and it describes the institution's program for the care and use of animals.

Companies or institutions that sell, auction, exhibit, transport, breed, or conduct research with animals are subject to the regulations contained in which documents and what are their minimum regulations?

The documents are AWA and AWR, and their minimum regulations describe acceptable standards in areas such as housing, feeding, watering, handling, sanitization, ventilation, transportation, separation of species, and veterinary care.

According to this chapter, what happened in 1641?

The earliest law to protect animals from cruelty in America were passed in 1641 in the Massachusetts colony.

According to this chapter, what is the 1985 amendment?

This amendment to the AWA requires that each registered institution have an Institutional Animal Care and Use Committee (IACUC). It also states that this committee is responsible for ensuring that animal care at any facility conforms to the AWR.

What was the AALAS called before?

The Animal Care Panel (ACP)

What is the name of something that most institutions have that protects anyone reporting incidents?

"Whistleblower Policy"

What are the 3 general IACUC members?

1. AWR 2. The Guide 3. PHS Policy

Which 5 agencies does the Public Health Service (PHS) oversees?

1. Center for Disease Control and prevention (CDC) 2. Food and Drug Administration (FDA) 3. Indian Health Service (IHS) 4. National Institutes of Health (NIH) 5. Substance Abuse and Mental Health Services Administration (SAMHSA)

In the Guide, what are the 9 standards for the following components of an animal care and use program?

1. Personnel qualifications and training 2. Occupational health and safety 3. Animal environment, housing, and management 4. Veterinary care 5. Animal procurement and transportation 6. Surgical and post-surgical care 7. Alleviation of pain and distress 8. Euthanasia 9. Physical plant design and construction

What are the 10 requirements of the AWA and AWR if a laboratory animal research facility houses covered species?

1. Register with the USDA. 2. Appoint an Institutional Animal Care and Use Committee to oversee the animal care and use program. 3. Provide training for all animal technicians and other animal users. 4. Maintain individual animal records, including their source and use. 5. Show that they provide adequate housing for each species and meet requirements for housing dimensions and environmental controls. 6. Meet or exceed the sanitization standards for the cages and the facility. 7. Provide adequate veterinary care. 8. Provide dogs with the opportunity to exercise. 9. Provide psychological enrichment to nonhuman primates. 10. Provide for the relief of animal pain and distress. 11. Consider alternatives to experiments likely to cause pain or distress. 12. Perform no more than one major surgery on an animal unless scientifically justified or medically necessary. 13. Submit an annual report that includes the number of covered species used and the animals under the "pain category."

What were Russell's and Brunch's 3 concepts that served their "3Rs Principle" and describe them?

1. Replacement: Before using animals in research, non-animal alternatives should be considered, such as using cell cultures or mathematical and computer models. If not, lower forms of vertebrate or invertebrate models when possible. 2. Reduction: If there are no alternatives to using animals, then the study should require only the minimum number of animals needed to obtain valid information. 3. Refinement: When laboratory animals are involved, follow the guiding principles and procedures to reduce pain and distress in their care. When judging the potential effect of any procedure, it should be assumed how painful it feels if it were done to a human.

According to the AWA, which three roles of the different individuals in the animal facility do they define?

1. The Attending Veterinarian 2. The Institutional Official 3. The Institutional Animal Care and Use Committee

What are the 5 most important mandates or guidelines that affect a laboratory animal's technican's daily duties?

1. The Guide for the Care and Use of Laboratory Animals 2. Animal Welfare Act and the Animal Welfare Regulations 3. Public Health Service Policy on Humane Care and Use of Laboratory Animals 4. US Government Principals for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training 5. American Veterinary Medical Association Guidelines for the Euthanasia of Animals

If you encountered an animal welfare issue and followed the procedures and submitted the concern to the hierarchy and the IACUC chair, but the situation is still unresolved after sufficient time, which departments can you notify?

1. The United States Department of Agriculture (USDA) Animal Care Section. 2. Office of Laboratory Animal Welfare (OLAW) at NIH.

Under the US Government Principles, what are the 9 principals that responsible institutional official must follow?

1. The transportation, care, and use of animals should be by the Animal Welfare Act and other applicable federal laws, guidelines, and policies. 2. Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society. 3. The animals selected for a procedure should be of an appropriate species and quality, and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulations, and in vitro biological systems should be considered. 4. Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Until the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals. 5. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents. 6. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedure. 7. The living conditions of animals should be appropriate for their species and contribute to their health and comfort. Normally, the housing, feeding, and care of all animals used for biomedical purposes 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. In any case, veterinary care shall be provided as indicated. 8. 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. 9. Where exceptions are required about the provisions of these Principles, the decisions should not rest with the investigators directly concerned b

According to bioethics, what should biomedical researchers abide to in order to maintain a certain balance?

1. Work with animals in research should be scientifically relevant and appropriate. 2. Animals in research studies should be maintained in a way that provides them with as much physical and psychological well-being as possible. 3. Animals in research studies should not be submitted to unnecessary pain and distress. If these effects are unavoidable, efforts should be made to minimize the extend and duration of the pain and distress. 4. If an animal's severe pain cannot be relieved, the animal should humanely be euthanized in order to end its suffering.

What year was the first edition of the Guide published?

1963

What century did anti-cruelty laws were extended to include the humane treatment of laboratory animals?

20th Century

Expand on Bioethics

A study that includes social and moral issues concerning work with live laboratory animals and the applications of that research. An issue in bioethics is how to maintain a balance between using animals for research and the benefits that may be derived from their experimentation.

Expand on the Guide for the Care and Use of Laboratory Animals (the Guide) by providing what animals they cover, their agency, and general comments.

Animals Covered 1. All vertebrates such as rats, mice, birds, farm animals, wildlife, and aquatic animals. Agency 1. National Research Council (NRC); Institute of Laboratory Animal Research (ILAR). Comments 1. Applies to nonclinical studies in support of applications to the FDA for food or drug research or marketing permits, or to EPA for research or marketing permits for pesticides and toxic products. 2. Requires staff training and SOPs and the establishment of a QA unit.

Expand on the US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training (US Government Principles) by providing what animals they cover, their agency, and general comments.

Animals Covered 1. This document covers all vertebrates such as rats, mice, birds, farm animals, wildlife, and aquatic animals. Agency 1. OLAW Comments 1. Presents humane care of animals in use or research to the good of society. 2. Covers humane transportation, minimization of discomfort, appropriate husbandry, and methods of euthanasia.

Expand on the Good Laboratory Practice Regulations (GLPS) by providing what animals they cover, their agency, and general comments.

Animals Covered 1. Does not cover specific species but it is directed to the type of research conducted. Agency 1. FDA and EPA Comments 1. Applies to nonclinical studies in support of applications to the FDA for food or drug research or marketing permits or EPA for research or marketing permits for pesticides and toxic products. 2. Requires staff training and SOPs and the establishment of a QA unit.

Expand on the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) by providing what animals they cover, their agency, and general comments.

Animals Covered 1. The animals that are covered under this document are mice, rats, and birds. 2. Live vertebrates used or intended for use in research, research training, experimentation, biological testing, or related purposes. Agency 1. OLAW Comments 1. Require all federal grant recipients to comply with US Principles, the AWA, and the Guide. 2. Requires an IACUC and an occupational health and saftey program.

True or False It is optional for the IACUC membership to include a practicing scientist experienced in research involving animals.

False The IACUC membership must include a practicing scientist with experience in animal research.

Which government principle is incorporated into the PHS Policy and what year?

In 1986, the "US Government Principles" that were incorporated into the PHS Policy is the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training.

Who and what year published the eighth edition of the Guide?

In 2011, the Institute of Laboratory Animal Research (ILAR) published the Guide.

What are the two types of SOPs and describe them.

Institutional SOPs 1. This type describes "the way things are done here." 2. Institutional SOP mentions general housekeeping and husbandry chores in the animal rooms. a. An SOP for washing cages or how to load the cage washer, settings, and checking to see if the equipment works. b. A feed storage SOP that provides instructions for storing and rotating food to ensure freshness. Procedural SOPs 1. They address procedures for specific studies a. A mouse breeding SOP shows how and when to plug check on female mice to determine if copulation took place between breeding pairs. b. A blood collection SOP describes the steps to follow and the precision for obtaining samples from experimental animals. The SOP includes information on what blood vessels can be used, how much blood can be collected safely, how the animal should be restrained and handled, and how to care for them after the procedure. Finally, the SOP informs how often the blood collection can be repeated.

What is the purpose of the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching?

It applies to research and teaching that have agricultural rather than biomedical objectives.

What is the Freedom of Information Act (FOIA)?

It is a federal law that allows public access to APHIS inspector's reports.

What are the Good Laboratory Practices (GLPs) and what is their purpose?

It is a group of regulations that apply to animal and non-animal research and safety studies funded or reviewed by the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA). The purpose of GLPs is to validate and document the processes by which safety tests are conducted in such a way that the processes can be reconstructed if needed.

According to this chapter, what is a protocol?

It is a standard form developed by the institution and provides information required for regulatory compliance.

The AWR is administered by what?

It is administered by the Animal and Plant Inspection Service (APHIS) of the United States Department of Agriculture (USADA).

Why was the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) created?

It was created because the ACP recognized that they needed to form a committee to evaluate how well individual institutions followed the guidelines. Therefore, the AAALAC took place as a private, nonprofit organization that promotes humane treatment of laboratory animals and accredits laboratory animal research programs.

Who created the 3Rs Principle and why?

It was published in 1959 by two English scientists, a zoologist named William Russell and a microbiologist called Rex Brunch. They hoped to promote the practice and methods of humane experimental techniques and reduce distress inflicted upon laboratory animals.

Who is responsible for the general administration and coordination of the PHS Policy?

The Office of Laboratory Animal Welfare (OLAW)

To meet GLP standards, what are the 3 basic guidelines that an animal facility must comply with?

The 3 basic guidelines are: 1. Adequately train personnel and maintain a current training file for each individual. The file should include technical training documentation, a current job description, and any relevant training certificates. 2. Establish a Quality Assurance (QA) unit. The individuals who are in the QA unit should not be involved in the study. Their role is to independently monitor all phases of the research process to ensure compliance with the GLPs, SOPs, and the study protocol. 3. Write SOPs for all husbandry and scientific procedures. SOPs are written instructions that explain in detail how procedures such as equipment use, sanitization methods, feed and bedding storage, cage cleaning methods, and blood collection methods are performed. The staff must read and understand the SOPs and must have easy access to them.

What are the 4 specific members inside the Guide?

The 4 members are: 1. Veterinarian with training or experience in lab animal medicine 2. Scientists using animals 3. Nonscientist 4. Public Member

What are the 5 specific members inside the PHS policy?

The 5 members are: 1. Scientists experienced in animal research 2. Veterinarian with training or experience in lab animal medicine 3. Nonscientist 4. Nonaffiliated Member

Who approves all work with vertebrate animals at the institution by reviewing each animal use protocol?

The IACUC

If you encountered animal welfare issues in the facility and reported the situation within the hierarchy, but the allegation was not resolved after sufficient time, who can you submit your concern to?

The IACUC Chair

According to the AWR, how many chairmans and members must the IACUC have?

The IACUC must have 1 chairperson and at least two other members.

Who does the IACUC report to and who are they?

The IACUC must report to a senior administrator known as the Institutional Office (IO), who is often the Chief Executive Officer (CEO). The IO must have the authority to provide resources to ensure compliance.

Expand on these two documents by providing what animals they cover, their agency, and general comments. 1. Animal Welfare Act (AWA) and amendments 2. Animal Welfare Regulations (AWR)

The information below applies to both of these documents! Slight differences and similarities between these two will be discussed in the comments. Animals Covered 1. Warm-blooded animals that are either live or dead. 2. Animals not covered under these documents are birds, rats, mice bred for research, and agricultural animals used for food or fiber. Agency 1. USDA-APHIS Comments 1. AWR provides more specific details on how to achieve compliance with the AWA. 2. The AWA requires that minimum standards of care and treatment be provided for covered animals bred for commercial sale or transport, used in research, or exhibited to the public. 3. These documents require that all research facilities establish an IACUC, and submit an annual report to the USDA-APHIS. 4. These documents support licensing and registration for all staff. 5. USDA-APHIS inspectors will visit unannounced at least once a year. Any violation will result in penalties.

Who established the guidelines of what is acceptable and unacceptable methods or conditions for the euthanasia of different species of laboratory animals?

The one who accomplished this are The American Veterinary Medical Association.

What is the purpose of the Guide for the Care and Use of Laboratory Animals?

The purpose of this book is to assist institutions in caring for and using animals in research in the United States. It sets standards and guidelines to support good science through the humane use of animals in animal facilities.

What law was enacted in 1873 and why?

The regulation that was enacted in 1873 was the first federal anti-cruelty law. This law was enacted because it was directed at the meat packing industry to limit the amount of time the animals could be confined during shipment. This law also included that the animals were provided food, water, and a place to rest during their transportation.

According to this chapter, what happened in the mid 19th century?

The state of NY passed a law for the "more effectual prevention of animal cruelty."

What are the studies that are regulated by the FDA GLP?

The studies are veterinary drug testing, food coloring additives for human or animal use, medical devices, or biologics.

What are the 3 specific members inside the AWR?

The three members are: 1. Chairperson 2. Veterinarian with training or experience in lab animal medicine 3. Nonaffiliated member No more than three of the members may be from the same administrative unit.

According to this chapter, how many members and chairmans must The Public Health Service Policy on Humane Care and Use of Laboratory Animals must have?

They must have at least 1 chairperson and 5 members. Then, they shall have a nonaffiliated member and represent their community.

What is the IACUC's responsibility?

They oversee and evaluate animal care and use program at institution. They also review the methods of animal care in all animal study protocols, and verifies that the methods are appropriate and in compliance with federal regulations and institutional policies.