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Research Administrators Management Program

Use of Animal Subjects (IACUC) Judy Lassiter, Regulatory Compliance Administrator

Objectives

• A Brief History of Animal
• A Brief History of Animal

Research O i i f R l ti

• Origin of Regulations
• Legal Requirements
• Ethical Responsibilities
• IACUC Oversight

IACUC Oversight

A Brief History of Animal Research

Rome, 150 C.E. - Galen studied animal physiology to better animal physiology to better understand human physiology

1600 C.E. - William Harvey

• Through study
• f both animal

and human cadavers, , explains the circulation of blood

Advances against lethal Advances against lethal diseases: Smallpox

Anthrax and Rabies

Malaria

Management of Diabetes

1940’s, 1950’s

• Post WWII, revelations from

Nuremberg trials, Nuremberg Code g , g

• 1950 – The Animal Care Panel (now

AALAS) AALAS)

• Development of Polio vaccine

1960’s

• 1961: Animal Care Technician Certification

Board of the Animal Care Panel

• 1962-1963: Development of the first Guide

for Laboratory Animal Facilities and Care

• 1964:The Animal Facilities Accreditation

Board of the Animal Care Panel becomes th A i A i ti f A dit ti the American Association for Accreditation

• f Laboratory Animal Care (AAALAC).

1965: Pet Theft & Regulations

In 1965, a pet Dalmatian (Pepper) owned by a New York family was missing.

• The owner recognized his dog in a news photograph of a group of

dogs being transported for eventual resale to biomedical research institutions.

• The dog owner was refused entry to the holding facility by the dealer

A l b hi l f d th d

• Appeals by his congressman were also refused; the dog was

sacrificed as part of an experiment by a NYC hospital

• Unhappy, the congressman introduced a bill to regulate the trade of

dogs A similar bill was introduced in the Senate simultaneously

• dogs. A similar bill was introduced in the Senate simultaneously.
• Both bills had only marginal support and might have died in

committee except for a supporting event…

February 1966 Life Magazine February 1966 Life Magazine “Concentration Camps for Dogs”

A raid on a dog dealer's premises by a Humane Society of the United States agent and the Maryland State Police plays a significant role in creating public pressure for the enactment of the federal L b t A i l W lf A t f 1966 Laboratory Animal Welfare Act of 1966

Legal Obligations

Animal Welfare Act

• A series of laws regulating animal use activities.
• The enforcing body of the animal welfare act is the United

States Department of Agriculture.

• Violation of the Act is punishable under federal law and

could lead to research program suspensions fines and/or could lead to research program suspensions, fines and/or imprisonment.

Public Health Service (PHS) Policy on Humane Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals

• Any time The Public Health Service funds research

involving animals the PHS Policy is applicable.

• The Office of Laboratory Animal Welfare, National Institutes
• f Health administers the PHS Policy through the Research

Extension Act.

• Deviation from the PHS Policy could result in loss of funding

from Public Health Service organizations.

What do these regulations What do these regulations and policies ensure?

• That animals are used in research
• nly when it’s absolutely necessary.

y y y

• That when animals are used in

research they are humanely treated.

When can animals be used?

1. When there are no other alternatives. 2 When confirmation has been made that research 2. When confirmation has been made that research activities are not unnecessarily duplicating previously conducted experiments. 3. Experiments involving animals are relevant to human or animal health, will advance scientific k l d ill b f th d f i t knowledge, or will be for the good of society.

Ethical responsibilities when using Ethical responsibilities when using animals

• Animal users have an ethical responsibility to

respect and treat animals humanely

• They also have an ethical responsibility to avoid
• r minimize the pain and distress animals may

endure when used in research or teaching endure when used in research or teaching

• The Regulations and Policies help to ensure

i l t t d h l animals are treated humanely.

How? The law specifically How? The law specifically states:

1. When animals are used for research a scientist must avoid or minimize discomfort, distress, and painful situations. 2. If a procedure involves more than momentary or slight pain or 2. If a procedure involves more than momentary or slight pain or distress, it must be performed using appropriate pain relieving drugs (e.g. sedatives, analgesia or anesthesia). 3. If animals are to be transported, appropriate arrangements must 3. If animals are to be transported, appropriate arrangements must be made to ensure the process is comfortable and occurs with as little stress as possible. 4. The living conditions of animals must be clean and appropriate for 4. The living conditions of animals must be clean and appropriate for the species.

Guidelines and Regulations used to ensure Guidelines and Regulations used to ensure animals are humanely treated

1. Guide for Care and Use of Laboratory Animals 2. The Guide for Care and Use of Agriculture Animals in A i lt l R h d T hi Agricultural Research and Teaching 3. Report of the AVMA Panel on Euthanasia 4. Guidelines for the Use of Fish in Research 5. USDA Animal Care and Use Policies 6. Animal Welfare Act Regulations 7. Public Health Services Policy

Example: Recommended Space for Commonly Used Group-Housed Laboratory Rodents

TABLE 2.1 (Guide for Care and Use of Laboratory Animals, page 27)

Animals Weight, g Floor Area/Animal, in2 Height, in Mi <10 6 5 Mice <10 6 5 Up to 15 8 5 Up to 25 12 5 >25d >15 5 Rats <100 17 7 Rats <100 17 7 Up to 200 23 7 Up to 300 29 7 Up to 400 40 7 Up to 500 60 7 >500d >70 7

Regulatory Oversight

How do federal and state agencies ensure the regulatory requirements g y q are satisfied?

Institutional Animal Care and Institutional Animal Care and Use Committees (IACUCs)

• A committee comprised of faculty and staff and empowered by law to

ensure all research activities involving animals satisfy federal, state and local regulations & policies governing the use of animals in research.

• The committee is comprised of at least 5 members:

The committee is comprised of at least 5 members:

• Chairperson
• Veterinarian
• Scientist - Must be experienced in using research animals.
• Non-Scientific Member – Conducts protocol evaluations not

based on the science.

• Nonaffiliated Member – Represents the general interests
• f the community.

What is the Charge of the What is the Charge of the IACUC?

The IACUC is a “University Governance” committee, legally , g y required to oversee all animal care and use activities conducted at their institution.

How does the committee How does the committee satisfy its responsibilities?

The IACUC reviews and approves all research, teaching or testing activities that involve animals before scientists begin their experiments to ensure: there are no alternatives to using animals, that research is not being unnecessarily duplicated, and th t th i t i l t t h that the experiment is relevant to human or animal health and will be for the good of society.

IACUC Oversight

• Review of animal use procedures:

Reviews and approves all procedures to be conducted on animals. Identify potentially painful and stressful procedures and ensure medications are being used to eliminate or minimize the pain/distress. Monitor the research acti ities to ens re onl IACUC re ie ed & appro ed proced res Monitor the research activities to ensure only IACUC reviewed & approved procedures are being conducted on animals.

• Inspect the living quarters of animals at least twice a year to ensure:

Animals are checked daily that , their housing facilities are clean and that they regularly f f & receive fresh food & water. They are appropriate for the species being housed. Animals are receiving appropriate veterinary care.

• The IACUC also ensures:

The number of animals used for the research will yield statistically valid results. The appropriate specie of animal is being used for the project. Humane experimental endpoints have been established. Appropriate methods of euthanasia are being utilized.

Peers Providing Oversight at Peers Providing Oversight at their Own Institution?

Does this sound like the fox guarding the hen house?

External Oversight – of IACUCs

• Remember – one IACUC member is a non-

affiliated member and is acting on behalf of the community. community.

• Reports made to federal agencies are available to

the public for review. p

• Opponents of animal research will do everything

in their power to hold research institutions t bl t f d l l ti d li i accountable to federal regulations and policies

The Bottom Line

1. Using animals for research activities is a privilege, not a right. 2. It is a privilege that a scientist or an instit tion can lose if the ethical (e g institution can lose if the ethical (e.g. legal and moral) responsibilities are not satisfied satisfied.

We are here to help you

• It is best to defer to the IACUC office for a

determination on whether or not review is required We’re here to assist you and the

• required. We re here to assist you and the
• investigators. If we don’t know the

answers, we probably know who does! , p y Don’t hesitate to contact us with your questions.

Online Informational Resources Online Informational Resources Available through NCSU

• NCSU Animal Subjects Tutorial

(http://www.ncsu.edu/iacuc/training.html)

• http://www.ncsu.edu/iacuc/

Questions?

• Judy Lassiter, Certified Professional IACUC Administrator,

919.515.7507, judy_lassiter@ncsu.edu

• Paula DeLong, AALAS Certified Laboratory Animal

Technologist, 919.515.9532, paula_delong@ncsu.edu

• Dr. Steve Dempsey, Assistant Vice Chancellor & University

Attending Veterinarian, 919.513.8142, steve_dempsey@ncsu.edu