Institutional Animal Care and Use Institutional Animal Care and Use Committee (IACUC)Committee (IACUC)

What is IACUC?What is IACUC?Where did it start?Where did it start?Why is IACUC important?Why is IACUC important?What does an IACUC look like?What does an IACUC look like?What are the IACUC’s responsibilities?What are the IACUC’s responsibilities?

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IACUCIACUC

Institutional Animal Care and Use Institutional Animal Care and Use CommitteeCommittee

Where Did IACUC Start?Where Did IACUC Start?The Animal Welfare ActThe Animal Welfare Act

First version passed August 24, 1966First version passed August 24, 1966 Outlawed the theft of pet dog and catsOutlawed the theft of pet dog and cats Outlawed the sale of stolen petsOutlawed the sale of stolen pets Required certain animals used in research facilities to Required certain animals used in research facilities to

have humane care and treatmenthave humane care and treatment

Amended in 1970Amended in 1970 Now covered animals in exhibitions and sold at Now covered animals in exhibitions and sold at

auctionauction Protection for a broader range of animals Protection for a broader range of animals

(warmblooded)(warmblooded) Definition of research facility was expanded to Definition of research facility was expanded to

facilities that use all live animals, not just dogs and facilities that use all live animals, not just dogs and catscats

““Adequate veterinary care” now included pain Adequate veterinary care” now included pain management - the use of anesthetics, analgesics, and management - the use of anesthetics, analgesics, and tranquilizerstranquilizers

Amended in 1976Amended in 1976Regulation of animals during shippingRegulation of animals during shippingOutlawed use of animals for fightingOutlawed use of animals for fightingRats, mice, birds, horses and other farm Rats, mice, birds, horses and other farm

animals excluded from coverage. This animals excluded from coverage. This excluded at least 80% of the animals used in excluded at least 80% of the animals used in research.research.

Amended in 1985Amended in 1985The Improved Standards for Laboratory The Improved Standards for Laboratory

Animal Act (Animal Welfare Act)Animal Act (Animal Welfare Act)Strengthened the standards for providing Strengthened the standards for providing

laboratory animal carelaboratory animal careDeveloped standards for exercise of dogs, Developed standards for exercise of dogs,

physical enrichment for primate, limitation of physical enrichment for primate, limitation of multiple survival surgeries, and pain multiple survival surgeries, and pain management when warrantedmanagement when warranted

IACUCIACUC

Why is the Role of IACUC Why is the Role of IACUC Important?Important?

Reduce Study DuplicationReduce Study Duplication Reduce Animal DiscomfortReduce Animal Discomfort Assure Veterinary CareAssure Veterinary Care Ethical GuidelinesEthical Guidelines Facility InspectionsFacility Inspections Review and approve activities that involve the Review and approve activities that involve the

care and use of animals in researchcare and use of animals in research Anonymous outlet for animal Anonymous outlet for animal

husbandry/handling concernshusbandry/handling concerns

What Does IACUC Look Like?What Does IACUC Look Like?

At least 3 membersAt least 3 membersVeterinarianVeterinarianCommunity member that is not affiliated with Community member that is not affiliated with

the facilitythe facilityAct as agent of research facility in Act as agent of research facility in

assuring compliance with the Animal assuring compliance with the Animal Welfare Act.Welfare Act.

Meetings/SubcommitteesMeetings/SubcommitteesSemiannual Inspections/Program ReviewsSemiannual Inspections/Program Reviews

IACUC and their role with Standard IACUC and their role with Standard Operating Procedures (SOPs)Operating Procedures (SOPs)

Environmental EnrichmentEnvironmental EnrichmentSocial GroupingsSocial GroupingsRestraint DevicesRestraint DevicesExercise RequirementsExercise RequirementsPain ManagementPain ManagementEuthanasiaEuthanasiaLiving conditionsLiving conditionsTraining of staffTraining of staff

What does IACUC stand for?What does IACUC stand for?Why is it important?Why is it important?

IACUC and Animal Welfare Laws IACUC and Animal Welfare Laws and Guidelinesand Guidelines

Animal Welfare Act and its amendmentsAnimal Welfare Act and its amendmentsPublic Health Service PolicyPublic Health Service Policy

Based on US Government Principles for the Based on US Government Principles for the Utilization and Care of Vertebrate Animals Utilization and Care of Vertebrate Animals Used in Testing, Research and TrainingUsed in Testing, Research and Training

All species of animals including birds, mice All species of animals including birds, mice and ratsand rats

All research funded by NIHAll research funded by NIH

Guide for the Care and Use of Laboratory Guide for the Care and Use of Laboratory Animals Animals

Association for the Assessment and Association for the Assessment and Accreditation of Laboratory Animal Care Accreditation of Laboratory Animal Care (AAALAC)(AAALAC)

Why Use Animals in Research?Why Use Animals in Research? It’s the lawIt’s the law Almost every major medical advance in this century has Almost every major medical advance in this century has

been dependent on animal research and it remains been dependent on animal research and it remains critical to unlocking the cure to many diseases which still critical to unlocking the cure to many diseases which still claim the lives of millions.claim the lives of millions.

There are no real alternatives to animal researchThere are no real alternatives to animal research There are non-animal research modelsThere are non-animal research models

cell and tissue culturescell and tissue cultures biochemical testsbiochemical tests computer simulationscomputer simulations

Eventually animal models must be used before the Eventually animal models must be used before the research can be tried on humans.research can be tried on humans.

What species are typically used?What species are typically used?

Rodents (Mice & Rats)Rodents (Mice & Rats) Drug treatments for hypertension, various kinds of cancer, and Drug treatments for hypertension, various kinds of cancer, and

spinal cord injuryspinal cord injury Antibiotic therapiesAntibiotic therapies Toxicity and safety testingToxicity and safety testing

NonrodentsNonrodents DOG DOG

Cardiovascular and respiratory systems similar to human beings. Cardiovascular and respiratory systems similar to human beings. Heart disease researchHeart disease research Surgical procedures, including coronary bypass surgery, pacemaker Surgical procedures, including coronary bypass surgery, pacemaker

implantation, heart valve insertion, and angioplasty. implantation, heart valve insertion, and angioplasty. Transplant researchTransplant research Immune system rejection researchImmune system rejection research

What species are typically used What species are typically used (continued)?(continued)?

CATCAT Neurological system is like human beings. Neurological system is like human beings. Research on:Research on:

Transmission of visual information from the eye to the brainTransmission of visual information from the eye to the brain Hearing disordersHearing disorders Brain and spinal cord injuriesBrain and spinal cord injuries

NONHUMAN PRIMATES (MONKEYS)NONHUMAN PRIMATES (MONKEYS) Used to test drugs to combat:Used to test drugs to combat:

MalariaMalaria Parkinson’s diseaseParkinson’s disease HIVHIV Cancer therapiesCancer therapies Spinal cord injuriesSpinal cord injuries Baboon research led to a new technique that allows cancerous bone Baboon research led to a new technique that allows cancerous bone

marrow cells to be removed without destroying healthy onesmarrow cells to be removed without destroying healthy ones

What species are typically used What species are typically used (continued)?(continued)?

RABBITRABBIT Used in eye and skin irritation tests to develop appropriate Used in eye and skin irritation tests to develop appropriate

procedures for handling certain chemicals and to predict the toxicity procedures for handling certain chemicals and to predict the toxicity of accidental exposure. of accidental exposure.

Corneal transplantsCorneal transplants

Other AdvancesOther Advances Kidney, liver, heart, pancreas, and lung transplants developed using Kidney, liver, heart, pancreas, and lung transplants developed using

dogs, sheep, cows, and pigs. dogs, sheep, cows, and pigs. Study of vitamin B deficiency, which causes heart and nerve Study of vitamin B deficiency, which causes heart and nerve

impairment, using chickens. impairment, using chickens. Leprosy research using monkeys and armadillos. Leprosy research using monkeys and armadillos. Bone fracture repairs using sheep.Bone fracture repairs using sheep. Research on the communicative abilities of primates has led to Research on the communicative abilities of primates has led to

strategies for teaching language to mentally retarded children. strategies for teaching language to mentally retarded children. Vaccines developed for polio, cholera, diphtheria, influenza, and Vaccines developed for polio, cholera, diphtheria, influenza, and

plague. plague. Medical innovations including: artificial hearts, artificial limbs, CT Medical innovations including: artificial hearts, artificial limbs, CT

scan, monoclonal antibodies, ultrasound, and x-rays. scan, monoclonal antibodies, ultrasound, and x-rays. Development of gene therapy/replacement which has a wide Development of gene therapy/replacement which has a wide

potential for future treatment for genetic disorders such as cystic potential for future treatment for genetic disorders such as cystic fibrosis. fibrosis.

Name an animal model that is used in Name an animal model that is used in researchresearch

What medical advancements have come What medical advancements have come from using animals in research?from using animals in research?

Science, Research, and EthicsScience, Research, and Ethics

The object of research is to extend human The object of research is to extend human knowledge of the physical, biological, or knowledge of the physical, biological, or social world beyond what is already social world beyond what is already known. known.

3 Types of Research3 Types of Research

Basic Research – increases knowledge about Basic Research – increases knowledge about the basic processes of living organisms. This is the basic processes of living organisms. This is the foundation for all other research. the foundation for all other research.

Clinical Research – focuses on using humans. Clinical Research – focuses on using humans. Builds on basic research.Builds on basic research.

Product Safety – in vitro, in vivo, and human Product Safety – in vitro, in vivo, and human testing using the compound that will be sold to testing using the compound that will be sold to and used by humans or animals.and used by humans or animals.

What is biomedical research?What is biomedical research?

Biomedical research is an approach used Biomedical research is an approach used towards solving medical problems. towards solving medical problems.

Almost every major medical advance in Almost every major medical advance in this century has been dependent on this century has been dependent on animal research and it remains critical to animal research and it remains critical to unlocking the cure to many diseases unlocking the cure to many diseases which still claim the lives of millions. which still claim the lives of millions.

What is the research process?What is the research process?

Generally starts with an unanswered Generally starts with an unanswered question or problem. question or problem.

All important information is collected and All important information is collected and studied. studied.

The data is collected, organized, and the The data is collected, organized, and the results interpreted. results interpreted.

What does it mean to have ethics?What does it mean to have ethics?

Nuremberg War CrimesNuremberg War CrimesTuskegee Syphilis StudyTuskegee Syphilis Study

What was the outcome from these events?What was the outcome from these events?

Are these ethical?Are these ethical?

Omitting data that do not support your Omitting data that do not support your desired conclusions desired conclusions

Making up data and reporting the fake Making up data and reporting the fake data to be real data to be real

Deliberately changing data Deliberately changing data

What’s the Risk?What’s the Risk?

Without a high standard of Without a high standard of scientific integrityscientific integrity the scientific community and general public may the scientific community and general public may become victims of become victims of scientific misconductscientific misconduct. .

Even when actual misconduct has not occurred, Even when actual misconduct has not occurred, there are serious consequences of not there are serious consequences of not maintaining a high level of scientific integrity, maintaining a high level of scientific integrity, including undermining public confidence in the including undermining public confidence in the results of scientific research.results of scientific research.

Example #1Example #1

A coworker knocks a feeder off a cage, A coworker knocks a feeder off a cage, spilling some of the feed. Instead of spilling some of the feed. Instead of

documenting it, they put it back on the cage. documenting it, they put it back on the cage. This study is monitoring food consumption.This study is monitoring food consumption.

Example #2Example #2

A coworker is supposed to go check environmental A coworker is supposed to go check environmental conditions on a particular room that has been having conditions on a particular room that has been having

problems lately. Instead of going and reading the problems lately. Instead of going and reading the gauges, they go and sign the paperwork saying they gauges, they go and sign the paperwork saying they

checked and everything was fine.checked and everything was fine.

Example #3Example #3

You see a coworker push an animal You see a coworker push an animal into a corner of a cage rougher than into a corner of a cage rougher than

necessary. You’ve seen this coworker necessary. You’ve seen this coworker do this before.do this before.

Remember Carmen’s discussion about Remember Carmen’s discussion about IBT and Searle?IBT and Searle?What prompted the investigation?What prompted the investigation?What was not ethical in this situation?What was not ethical in this situation?What were some negative study effects that What were some negative study effects that

got through due to the fraudulent data?got through due to the fraudulent data?

Remember:Remember:When using animals in research, our When using animals in research, our

responsibilities include: responsibilities include: Humane treatment of animals Humane treatment of animals Conducting procedures as specified in the Conducting procedures as specified in the

approved protocol approved protocol Following the general requirements for animal care Following the general requirements for animal care

and use and use Reporting concerns related to the care and use of Reporting concerns related to the care and use of

laboratory animalslaboratory animals

Medical AdvancementsMedical Advancements

1796 – Smallpox vaccine1796 – Smallpox vaccine 1881 – Anthrax vaccine1881 – Anthrax vaccine 1885 – Rabies vaccine1885 – Rabies vaccine 1921 – Insulin discovered1921 – Insulin discovered 1956 – Open heart 1956 – Open heart

surgery & pacemaker surgery & pacemaker developmentdevelopment

1990 – Organ transplant 1990 – Organ transplant technique advancementtechnique advancement

CowCow SheepSheep Dog & rabbitDog & rabbit Dog & fishDog & fish DogDog

Dog, pig, Dog, pig, sheep, & cowsheep, & cow

#1 - Truth or Myth?#1 - Truth or Myth?

Research on animals is not relevant to Research on animals is not relevant to people because animals are different from people because animals are different from people. People and animals suffer from people. People and animals suffer from different illnesses. different illnesses.

False - humans are biologically very False - humans are biologically very similar to other mammals. Most human similar to other mammals. Most human diseases exist in at least one other diseases exist in at least one other species. Illnesses such as cancer, heart species. Illnesses such as cancer, heart failure, asthma, rabies and malaria are failure, asthma, rabies and malaria are suffered by many species and can be suffered by many species and can be treated in much the same way. treated in much the same way.

#2 – Truth or Myth?#2 – Truth or Myth?

Animal testing is unreliable, because Animal testing is unreliable, because drugs have different effects in people and drugs have different effects in people and animals. The result is that drugs passed animals. The result is that drugs passed as safe in animals are found to have as safe in animals are found to have serious side effects in people. serious side effects in people.

False - Animal research is important in False - Animal research is important in understanding diseases and developing ways to understanding diseases and developing ways to prevent, treat or cure them. prevent, treat or cure them.

Animal tests are designed to reveal major Animal tests are designed to reveal major undesirable effects such as liver damage, raised undesirable effects such as liver damage, raised blood pressure, nerve damage, or damage to blood pressure, nerve damage, or damage to the fetus. The results of the animal studies will the fetus. The results of the animal studies will give a strong indication of what the effects in give a strong indication of what the effects in people are likely to be.people are likely to be.

#3 – Truth or Myth?#3 – Truth or Myth?

The use of animals in biomedical research The use of animals in biomedical research is necessary because equivalent is necessary because equivalent information cannot be obtained by information cannot be obtained by alternative methods alternative methods

True - The living body is much more than just a True - The living body is much more than just a collection of individual molecules, cells or collection of individual molecules, cells or tissues, and we need to understand how they tissues, and we need to understand how they interact, how they are controlled. interact, how they are controlled.

The process is not perfect, but testing in whole The process is not perfect, but testing in whole animals is by far the best way to protect people. animals is by far the best way to protect people. Animal tests ensure that obviously toxic Animal tests ensure that obviously toxic substances are not given to human beings and substances are not given to human beings and that doctors in charge of the human volunteer that doctors in charge of the human volunteer studies are made aware of possible serious side studies are made aware of possible serious side effects. effects.

#4 - Truth or Myth?#4 - Truth or Myth?

Vaccines and antibiotics have achieved Vaccines and antibiotics have achieved nothing. Public health measures such as nothing. Public health measures such as clean water and good sanitation are the clean water and good sanitation are the solution to the problem of infectious solution to the problem of infectious disease. disease.

False - Improvements such as clean water False - Improvements such as clean water and good sanitation were responsible for a and good sanitation were responsible for a dramatic drop in the great infectious dramatic drop in the great infectious diseases of the last century. However, the diseases of the last century. However, the introduction of vaccines to prevent introduction of vaccines to prevent diseases and antibiotics to treat them diseases and antibiotics to treat them when they did occur had a dramatic effect, when they did occur had a dramatic effect, virtually eradicating, and in some cases virtually eradicating, and in some cases totally eradicating, diseases such as TB, totally eradicating, diseases such as TB, diphtheria and cholera. diphtheria and cholera.

#5 – Truth or Myth?#5 – Truth or Myth?

Many pointless, unnecessary animal Many pointless, unnecessary animal experiments are carried out. experiments are carried out.

False - Strict controls on animal research False - Strict controls on animal research do not allow animals to be used to obtain do not allow animals to be used to obtain information that is obtainable by other information that is obtainable by other means. means.

#6 – Truth or Myth?#6 – Truth or Myth?

Laboratory animals suffer great pain and Laboratory animals suffer great pain and distress. distress.

False – Most experiments do not cause False – Most experiments do not cause significant pain or distress because they involve significant pain or distress because they involve only mild procedures such as a single injection, only mild procedures such as a single injection, taking a small blood sample, or a change of diet. taking a small blood sample, or a change of diet. In most of the remainder, anesthetics or pain-In most of the remainder, anesthetics or pain-killing drugs are used to prevent discomfort and killing drugs are used to prevent discomfort and minimize distress.minimize distress.

IACUC - weigh any distress involved in an IACUC - weigh any distress involved in an experiment against the potential benefit for experiment against the potential benefit for science and for humanity science and for humanity

#7- Truth or Myth#7- Truth or Myth

Most research animals are cats, dogs or Most research animals are cats, dogs or monkeys. monkeys.

False - More than 80 out of every 100 False - More than 80 out of every 100 animals used in research are mice, rats animals used in research are mice, rats and other rodents. Less than one in every and other rodents. Less than one in every 200 research animals is a cat or a dog 200 research animals is a cat or a dog

#8 – Truth or Myth?#8 – Truth or Myth?

There are laws and regulations protecting There are laws and regulations protecting laboratory animals. laboratory animals.

True - Around the world the welfare of True - Around the world the welfare of animals in research is protected by animals in research is protected by national and international legislation, by national and international legislation, by local laws or by ethical committees. In the local laws or by ethical committees. In the US, researchers must both comply with US, researchers must both comply with stringent national regulations and submit stringent national regulations and submit their research proposals to their local their research proposals to their local IACUC. IACUC.

#9 – Truth or Myth?#9 – Truth or Myth?

There is no need to conduct product safety There is no need to conduct product safety tests anymore because “cruelty free” tests anymore because “cruelty free” products are available.products are available.

False - Companies that claim they conduct no False - Companies that claim they conduct no animal testing either contract testing to an animal testing either contract testing to an outside laboratory or use compounds known to outside laboratory or use compounds known to be safe through previous animal testing. be safe through previous animal testing.

Product safety testing ensures that products are Product safety testing ensures that products are safe when used as directed and provides safe when used as directed and provides scientific data for poison control centers and scientific data for poison control centers and emergency room physicians in the event a emergency room physicians in the event a product is misused. Adequate testing of products product is misused. Adequate testing of products is both a moral and legal obligation to the public. is both a moral and legal obligation to the public.

Questions?Questions?