ALAT Chapter 2 - The Animal Research Environment

When was the earliest animal cruelty law passed in America?

1641

When were anti-cruelty laws extended to include the humane treatment of lab animals?

20th century

How many members does IACUC require the AWR committee to have?

3 members, including: - Chairperson - vet with training or lab animal medicine - public member

What animals are covered under GLP's?

No specific animals, but is directed to the type of research conducted.

What do the Animal Welfare Act (AWA) and Animal Welfare Regulations (AWR) do?

- Create general and species specific standards; AWR provide more specific details on how to achieve compliance. - Require that all research facilities establish an IACUC, which must submit an annual report to USDA-APHIS. - Require licensing and registration. - USDA-APHIS inspectors perform unannounced visits at least once a year. Violations can result in penalties

AWR's are published each year in the code of Federal Regulations. They outline...

- Define roles of different individuals in the animal facility - Provide more specific standards than the AWA itself - Describes what facility must do in order to comply with AWA - These are the MINIMUM acceptable standards in areas of housing, feeding, watering, handling, sanitation, ventilation, transportation, separation, and vet care.

USDA APHIS (Animal and Plant Health Inspection Service)

Administers and enforces the AWR - APHIS inspector conducts unscheduled site visits at least annually to look at animals covered under AWA and relevant records. Reviews IACUC's semi-annual report. Any violation noted on report must be corrected (inspector has authority to stop the research from being conducted). APHIS reports are public in accordance with the Freedom of Information Act (FOIA)

What animals are covered under the US Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research and Training? (US Gov. Principles)

All vertebrates. Includes rats, mice, birds, farm animals, wildlife, and aquatics

Guide for the Care and Use of Laboratory Animals

Primary source of the standards and guidelines for laboratory animal care and use in the United States

The Office of Laboratory Animal Welfare (OLAW) at NIH is responsible for...

general administration and coordination of PHS policy. IO must submit a document called the Animal Welfare Assurance of Compliance Statement (AKA: PHS Assurance) to OLAW

What agency enforces PHS policy?

Office of Laboratory Animal Welfare (OLAW)

Institutional SOP

"the way things are done here" Ex. general housekeeping and husbandry, washing cages or feed storage

US Government Principles for the Utilization and Care of Vertebrate Animals in Testing, Research, and Training. (incorporated into PHS policy in 1986)

1. The transportation, care and use of animals should be in accordance with the AWA 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 appropriate species and quality, and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered 4. Proper use of animals, including the avoidance of minimization of discomfort, stress, and pain when consistent with sound scientific practices, is imperative. Until the contrary is established, investigators should consider that procedures 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 anaesthetized animals paralyzed by chemical agents 6. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relived 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 and 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 lab animals 9. Where exceptions are required in relation to the provisions of these principles, the decision should not rest with the investigator directly concerned but should be made, with due regard to Principle II, by an appropriate review group such as an IACUC - such exceptions should not be made solely for teaching or demonstration

When was the first federal anti-cruelty law enacted?

1873 - specifically directed at meat packing industry to limit confined shipment time. Also required food, water, and rest during shipment.

When did the ACP publish the first edition of The Guide?

1963

When was IACUC created?

1985 in amendment to AWA

AAALAC International

A private non-profit organization that promotes the humane treatment of laboratory animals and accredits lab animal research programs - voluntary accreditation

Which organization accredits laboratory animal facilities that demonstrate that they are meeting the standards outlined in the guide and all federal and local regulations?

AAALAC International

According to the Guide and PHS policy, what document must institutions comply with when animals are euthanized?

AVMA Guidelines for Euthanasia

What animals are covered in the Guide for the care and Use of Laboratory Animals (The Guide)?

All vertebrates. Includes rats, mice, birds, farm animals, wildlife, and aquatic animals

What federal agency is responsible for enforcing and administering the Animal Welfare regulations?

Animal and Plant Health Inspection Service

What was the first federal law for lab animal welfare and when was it passed?

Animal Welfare Act 1966 - Established standards for lab animal care and use - Requires that minimum standards of care be provided for covered animals bred for commercial sale, used in research, transported commercially, or exhibited to the public.

What is not a requirement of the AWA/AWR a researcher much comply with if they house a covered species?

Appoint an unaffiliated member to the IACUC

What is the term for the field of study concerned with the philosophical issues raised by some medical procedures and treatments?

Bioethics

According the the AWA, list the three types of members who must sit on the IACUC

Chair, Veterinarian, Non-affiliated member

Who enforces/governs GLP's?

FDA and EPA

What agency enforces US Government Principles?

Office of Laboratory Animal Welfare (OLAW)

If an incident of animal misuse is not resolved after contacting your supervisor, you can submit your concerns to whom?

IACUC Chair

American Veterinary Medical Association (AVMA) Guidelines for Euthanasia of Animals

Lists acceptable, acceptable with conditions, and unaccepted methods per species - The Guide and PHS policy require that these guidelines are followed - Must be as painless and distress-free as possible

What animals are covered under the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS)?

Live vertebrates used or intended for use in research, research training, experimentation, biological testing, or related purposes. Includes mice, rats, and birds.

When did New York pass a law for "more effectual prevention of animal cruelty"?

Mid 19th Century

What agency oversees The Guide?

National Research Council (NRC) and Institute of Laboratory Animal Research

Are genotyping procedures a component of an animal care and use program described in the guide?

Nope

What is not stated as a requirement for compliance with the US Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training?

PI should determine where exceptions to these principles are required and may ignore them if they decide it is a scientific necessity

Beyond food, water, shelter, and healthcare requirements, the AWA and AWR require that dogs have the opportunity for ___ and nonhuman primates have ___ enrichment

Physical exercise and phycological enrichment

Using the minimum number of animals that will serve a useful purpose, yet yeild statistically sound data and produce scientific benefit demonstrates which 3R's principle?

Reduction

The appropriate use of analgesics in postsurgical animals would apply to which of the 3R's?

Refinement

Good Laboratory Practices

Regulations developed by the FDA and the EPA to validate and document the process of safety testing

Bioethics, the study of...

Social and moral issues concerning work with live animals for research, and the applications of the research (most common issue is maintaining balance of animal use in research and the benefits that may be derived from that)

Who does the AWA cover?

Those who sell, auction, exhibit, transport, breed, or conduct research with animals

What agency enforces the Animal Welfare Act (AWA) and Animal Welfare Regulations (AWR)

USDA-APHIS

GLP Purpose

Validation and documentation of process by which safety tests are conducted in such a way that the processes can be reconstructed if needed.

IACUC requirement of members of The Guide

Vet with training or experience in lab animal med. - scientist using animals -nonscientist -public member

What animals are covered under the Animal Welfare Act (AWA) and Animal Welfare Regulations (AWR)

Warm blooded animals, live or dead, EXCEPT: birds, rats, mice, and agricultural animals used for food or fiber, horses

Standard Operating Procedure

Written instructions approved by management and used to perform a routine activity

Would these animals be covered by the AWA? Guinea pigs, rabbits, hamsters, ferrets, wild mice, horses, gerbils, goats, and sheep.

Yes

How to report a concern

immidetly to animal care supervisor, vet, director, or IACUC

The 3 Rs Principle - Developed in 1959 by Russell & Burch

replacement, reduction, and refinement

Are hamsters covered by the AWA?

Nope

Which agency is responsible for enforcing the PHS on Humane Care and Use of Laboratory Animals?

Office of Laboratory Animal Welfare (OLAW)

Good Laboratory Practices Regulations (GLP'S)

- Applies to non-clinical studies (safety data) in support of applications to the FDA for food or drug research or marketing permits fir pesticides and toxic products - Requires staff training and SOPs and the establishment of a QA unit

The Public Health and Service Policy (PHS) oversees...

- CDC - FDA - Indian Health Service (IHS) - National Institutes of Health (NIH) - Substance Abuse and Mental Health Services Administration (SAMHSA)

List two common alternatives to using animals in research studies

- Mathematical model - Cell cultures

What must a facility do to meet GLP standards?

- Meet basic guidelines on animal care and welfare - Adequately train personnel and maintain a current training file for each individual, including: technical training documentation, current job description, and any relevant training certificates - Establish a QA unit (QA members should not be involved in the study, only ensure compliance with GLP, SOP, and Protocol) - Write SOPs for all husbandry and scientific purposes

List three differences between the PHS policy and the AWA

- PHS policy covers all vertebrates used in research (AWA does not cover birds, rats, and mice bred for research) - PHS policy has some administrative differences in its IACUC requirements - PHS policy requires an Occupational health and safety program

List five components of an animal care and use program for which the Guide describes standards

- Personnel qualifications and training - Occupational health and safety - Veterinary care - Animal environment (including housing) - Animal procurement and transportation - Surgical and postsurgical care - alleviation of pain and distress - Euthanasia - Physical plant design and construction

What do the US Gov. Principles do?

- Presents overarching principles for the humane care of animals in theses activities and in the relevance of animal use to the good of society - Covers humane transportation, minimization of discomfort, appropriate husbandry, and methods of euthanasia

What does The Guide outline?

- Primary source of guidelines and standards for lab animal care and use in the US. Describes standards such as justification for species and number used, availability of less-invasive alternatives, training of personnel, occupational health and safety, Vet care, anesthesia and analgesia, euthanasia, physical plant design, alleviation of pain and distress, disposal of animals, and the safety of the working environment for personnel. - The Guide identified the outcomes that need to be achieved but does not specify how to achieve them

What are five requirements of the AWA and AWR?

- Register with the USDA - Appoint an IACUC - Provide training for all animal users - Maintain individual animal records - Provide adequate veterinary care

What does PHS policy require?

- Requires all federal grant recipients to comply with the US Principles, the AWA, and the Guide. - Requires an IACUC and an occupational health safety program

The Institutional Animal Care and Use Committee (IACUC)

- Responsible for ensuring compliance with all applicable laws, regulations, policies, and guidelines - Reports to senior administrator known as the Institutional Official (IO) - often the CEO - Must perform semi annual inspections and report findings to IO

PHS requirement of IACUC

- Some administrative differences in structure - Requires occ. health program - Federal grant recipients must comply with US Gov. Principles, AWA, The Guide and AVMA guidelines for euthanasia

Some institutions may have to comply with the PHS policy but not the AWA/AWR and vice versa. Other institutions must comply with both. list two factors that help determine which regulations are relevant to a particular research study.

- Species of animal used - Funding sources

Animal Use Protocol

A document written by the Principal Investigator and approved by the IACUC, that describes and justifies the use of animals for a project

Procedural SOP

Address procedures specific to each study

IACUC requirement of PHS Policy

At least 5 members, including: -scientist - Vet with training or experience - nonscientist - unaffiliated member

How does PHS affect Humane Care and Use of Lab Animals?

Federal mandate that applies to federally funded research projects. Requires appropriate care and use of animals

PHS Policy

Federal mandate that covers all live vertebrates used or intended for use in research, research training, experimentation, biological testing, or for related purposes

What would be considered a GLP study?

Human or veterinary drug testing, food coloring additives for human or animal use, medical devices, or biologics