1. Institutional Animal Care and Use 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? This workforce solution was funded by a grant awarded under the President’s Community-Based Job Training Grants as implemented by the U.S. Department of Labor’s Employment and Training Administration. The solution was created by the grantee and does not necessarily reflect the official position of the U.S. Department of Labor. The Department of Labor makes no guarantees, warranties, or assurances of any kind, express or implied, with respect to such information, including any information on linked sites and including, but not limited to, accuracy of the information or its completeness, timeliness, usefulness, adequacy, continued availability, or ownership. This solution is copyrighted by the institution that created it. Internal use by an organization and/or personal use by an individual for non-commercial purposes is permissible. All other uses require the prior authorization of the copyright owner.

2. IACUC Institutional Animal Care and Use Committee

3. Where Did IACUC Start? Where Did IACUC Start? The Animal Welfare Act The Animal Welfare Act First version passed August 24, 1966 First version passed August 24, 1966 Outlawed the theft of pet dog and cats Outlawed the theft of pet dog and cats Outlawed the sale of stolen pets Outlawed the sale of stolen pets Required certain animals used in research facilities to have humane care and treatment Required certain animals used in research facilities to have humane care and treatment

4. Amended in 1970 Amended in 1970 Now covered animals in exhibitions and sold at auction Now covered animals in exhibitions and sold at auction Protection for a broader range of animals (warmblooded) Protection for a broader range of animals (warmblooded) Definition of research facility was expanded to facilities that use all live animals, not just dogs and cats Definition of research facility was expanded to facilities that use all live animals, not just dogs and cats “Adequate veterinary care” now included pain management - the use of anesthetics, analgesics, and tranquilizers “Adequate veterinary care” now included pain management - the use of anesthetics, analgesics, and tranquilizers

5. Amended in 1976 Amended in 1976 Regulation of animals during shipping Regulation of animals during shipping Outlawed use of animals for fighting Outlawed use of animals for fighting Rats, mice, birds, horses and other farm animals excluded from coverage. This excluded at least 80% of the animals used in research. Rats, mice, birds, horses and other farm animals excluded from coverage. This excluded at least 80% of the animals used in research.

6. Amended in 1985 Amended in 1985 The Improved Standards for Laboratory Animal Act (Animal Welfare Act) The Improved Standards for Laboratory Animal Act (Animal Welfare Act) Strengthened the standards for providing laboratory animal care Strengthened the standards for providing laboratory animal care Developed standards for exercise of dogs, physical enrichment for primate, limitation of multiple survival surgeries, and pain management when warranted Developed standards for exercise of dogs, physical enrichment for primate, limitation of multiple survival surgeries, and pain management when warranted IACUC IACUC

7. Why is the Role of IACUC Important? Reduce Study Duplication Reduce Study Duplication Reduce Animal Discomfort Reduce Animal Discomfort Assure Veterinary Care Assure Veterinary Care Ethical Guidelines Ethical Guidelines Facility Inspections Facility Inspections Review and approve activities that involve the care and use of animals in research Review and approve activities that involve the care and use of animals in research Anonymous outlet for animal husbandry/handling concerns Anonymous outlet for animal husbandry/handling concerns

8. What Does IACUC Look Like? At least 3 members At least 3 members Veterinarian Veterinarian Community member that is not affiliated with the facility Community member that is not affiliated with the facility Act as agent of research facility in assuring compliance with the Animal Welfare Act. Act as agent of research facility in assuring compliance with the Animal Welfare Act. Meetings/Subcommittees Meetings/Subcommittees Semiannual Inspections/Program Reviews Semiannual Inspections/Program Reviews

9. IACUC and their role with Standard Operating Procedures (SOPs) Environmental Enrichment Environmental Enrichment Social Groupings Social Groupings Restraint Devices Restraint Devices Exercise Requirements Exercise Requirements Pain Management Pain Management Euthanasia Euthanasia Living conditions Living conditions Training of staff Training of staff

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

11. IACUC and Animal Welfare Laws and Guidelines Animal Welfare Act and its amendments Animal Welfare Act and its amendments Public Health Service Policy Public Health Service Policy Based on US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training Based on US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training All species of animals including birds, mice and rats All species of animals including birds, mice and rats All research funded by NIH All research funded by NIH

12. Guide for the Care and Use of Laboratory Animals Guide for the Care and Use of Laboratory Animals Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC)

13. Why Use Animals in Research? It’s the law It’s the law Almost every major medical advance in this century has been dependent on animal research and it remains critical to unlocking the cure to many diseases which still claim the lives of millions. Almost every major medical advance in this century has been dependent on animal research and it remains critical to unlocking the cure to many diseases which still claim the lives of millions. There are no real alternatives to animal research There are no real alternatives to animal research There are non-animal research models There are non-animal research models cell and tissue cultures cell and tissue cultures biochemical tests biochemical tests computer simulations computer simulations Eventually animal models must be used before the research can be tried on humans. Eventually animal models must be used before the research can be tried on humans.

14. What species are typically used? Rodents (Mice & Rats) Rodents (Mice & Rats) Drug treatments for hypertension, various kinds of cancer, and spinal cord injury Drug treatments for hypertension, various kinds of cancer, and spinal cord injury Antibiotic therapies Antibiotic therapies Toxicity and safety testing Toxicity and safety testing Nonrodents Nonrodents DOG DOG Cardiovascular and respiratory systems similar to human beings. Cardiovascular and respiratory systems similar to human beings. Heart disease research Heart disease research Surgical procedures, including coronary bypass surgery, pacemaker implantation, heart valve insertion, and angioplasty. Surgical procedures, including coronary bypass surgery, pacemaker implantation, heart valve insertion, and angioplasty. Transplant research Transplant research Immune system rejection research Immune system rejection research

15. What species are typically used (continued)? CAT CAT 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 brain Transmission of visual information from the eye to the brain Hearing disorders Hearing disorders Brain and spinal cord injuries Brain and spinal cord injuries NONHUMAN PRIMATES (MONKEYS) NONHUMAN PRIMATES (MONKEYS) Used to test drugs to combat: Used to test drugs to combat: Malaria Malaria Parkinson’s disease Parkinson’s disease HIV HIV Cancer therapies Cancer therapies Spinal cord injuries Spinal cord injuries Baboon research led to a new technique that allows cancerous bone marrow cells to be removed without destroying healthy ones Baboon research led to a new technique that allows cancerous bone marrow cells to be removed without destroying healthy ones

16. What species are typically used (continued)? RABBIT RABBIT Used in eye and skin irritation tests to develop appropriate procedures for handling certain chemicals and to predict the toxicity of accidental exposure. Used in eye and skin irritation tests to develop appropriate procedures for handling certain chemicals and to predict the toxicity of accidental exposure. Corneal transplants Corneal transplants

17. Other Advances Kidney, liver, heart, pancreas, and lung transplants developed using dogs, sheep, cows, and pigs. Kidney, liver, heart, pancreas, and lung transplants developed using dogs, sheep, cows, and pigs. Study of vitamin B deficiency, which causes heart and nerve impairment, using chickens. Study of vitamin B deficiency, which causes heart and nerve 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 strategies for teaching language to mentally retarded children. Research on the communicative abilities of primates has led to strategies for teaching language to mentally retarded children. Vaccines developed for polio, cholera, diphtheria, influenza, and plague. Vaccines developed for polio, cholera, diphtheria, influenza, and plague. Medical innovations including: artificial hearts, artificial limbs, CT scan, monoclonal antibodies, ultrasound, and x-rays. Medical innovations including: artificial hearts, artificial limbs, CT scan, monoclonal antibodies, ultrasound, and x-rays. Development of gene therapy/replacement which has a wide potential for future treatment for genetic disorders such as cystic fibrosis. Development of gene therapy/replacement which has a wide potential for future treatment for genetic disorders such as cystic fibrosis.

18. Name an animal model that is used in research Name an animal model that is used in research What medical advancements have come from using animals in research? What medical advancements have come from using animals in research?

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

20. 3 Types of Research Basic Research – increases knowledge about the basic processes of living organisms. This is the foundation for all other research. Basic Research – increases knowledge about the basic processes of living organisms. This is the foundation for all other research. Clinical Research – focuses on using humans. Builds on basic research. Clinical Research – focuses on using humans. Builds on basic research. Product Safety – in vitro, in vivo, and human testing using the compound that will be sold to and used by humans or animals. Product Safety – in vitro, in vivo, and human testing using the compound that will be sold to and used by humans or animals.

21. What is biomedical research? What is biomedical research? Biomedical research is an approach used towards solving medical problems. Biomedical research is an approach used towards solving medical problems. Almost every major medical advance in this century has been dependent on animal research and it remains critical to unlocking the cure to many diseases which still claim the lives of millions. Almost every major medical advance in this century has been dependent on animal research and it remains critical to unlocking the cure to many diseases which still claim the lives of millions.

22. What is the research process? Generally starts with an unanswered question or problem. Generally starts with an unanswered question or problem. All important information is collected and studied. All important information is collected and studied. The data is collected, organized, and the results interpreted. The data is collected, organized, and the results interpreted.

23. What does it mean to have ethics?

24. Nuremberg War Crimes Nuremberg War Crimes Tuskegee Syphilis Study Tuskegee Syphilis Study What was the outcome from these events? What was the outcome from these events?

25. Are these ethical? Omitting data that do not support your desired conclusions Omitting data that do not support your desired conclusions Making up data and reporting the fake data to be real Making up data and reporting the fake data to be real Deliberately changing data Deliberately changing data

26. What’s the Risk? Without a high standard of scientific integrity the scientific community and general public may become victims of scientific misconduct. Without a high standard of scientific integrity the scientific community and general public may become victims of scientific misconduct. Even when actual misconduct has not occurred, there are serious consequences of not maintaining a high level of scientific integrity, including undermining public confidence in the results of scientific research. Even when actual misconduct has not occurred, there are serious consequences of not maintaining a high level of scientific integrity, including undermining public confidence in the results of scientific research.

27. Example #1 A coworker knocks a feeder off a cage, spilling some of the feed. Instead of documenting it, they put it back on the cage. This study is monitoring food consumption.

28. Example #2 A coworker is supposed to go check environmental conditions on a particular room that has been having problems lately. Instead of going and reading the gauges, they go and sign the paperwork saying they checked and everything was fine.

29. Example #3 You see a coworker push an animal into a corner of a cage rougher than necessary. You’ve seen this coworker do this before.

30. Remember Carmen’s discussion about IBT and Searle? Remember Carmen’s discussion about 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 got through due to the fraudulent data? What were some negative study effects that got through due to the fraudulent data?

31. Remember: Remember: When using animals in research, our responsibilities include: When using animals in research, our responsibilities include: Humane treatment of animals Humane treatment of animals Conducting procedures as specified in the approved protocol Conducting procedures as specified in the approved protocol Following the general requirements for animal care and use Following the general requirements for animal care and use Reporting concerns related to the care and use of laboratory animals Reporting concerns related to the care and use of laboratory animals

32. Medical Advancements Medical Advancements 1796 – Smallpox vaccine 1796 – Smallpox vaccine 1881 – Anthrax vaccine 1881 – Anthrax vaccine 1885 – Rabies vaccine 1885 – Rabies vaccine 1921 – Insulin discovered 1921 – Insulin discovered 1956 – Open heart surgery & pacemaker development 1956 – Open heart surgery & pacemaker development 1990 – Organ transplant technique advancement 1990 – Organ transplant technique advancement Cow Cow Sheep Sheep Dog & rabbit Dog & rabbit Dog & fish Dog & fish Dog Dog Dog, pig, sheep, & cow Dog, pig, sheep, & cow

33. #1 - Truth or Myth? Research on animals is not relevant to people because animals are different from people. People and animals suffer from different illnesses. Research on animals is not relevant to people because animals are different from people. People and animals suffer from different illnesses.

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

35. #2 – Truth or Myth? Animal testing is unreliable, because drugs have different effects in people and animals. The result is that drugs passed as safe in animals are found to have serious side effects in people. Animal testing is unreliable, because drugs have different effects in people and animals. The result is that drugs passed as safe in animals are found to have serious side effects in people.

36. False - Animal research is important in understanding diseases and developing ways to prevent, treat or cure them. False - Animal research is important in understanding diseases and developing ways to prevent, treat or cure them. Animal tests are designed to reveal major undesirable effects such as liver damage, raised blood pressure, nerve damage, or damage to the fetus. The results of the animal studies will give a strong indication of what the effects in people are likely to be. Animal tests are designed to reveal major undesirable effects such as liver damage, raised blood pressure, nerve damage, or damage to the fetus. The results of the animal studies will give a strong indication of what the effects in people are likely to be.

37. #3 – Truth or Myth? The use of animals in biomedical research is necessary because equivalent information cannot be obtained by alternative methods The use of animals in biomedical research is necessary because equivalent information cannot be obtained by alternative methods

38. True - The living body is much more than just a collection of individual molecules, cells or tissues, and we need to understand how they interact, how they are controlled. True - The living body is much more than just a collection of individual molecules, cells or tissues, and we need to understand how they interact, how they are controlled. The process is not perfect, but testing in whole animals is by far the best way to protect people. Animal tests ensure that obviously toxic substances are not given to human beings and that doctors in charge of the human volunteer studies are made aware of possible serious side effects. The process is not perfect, but testing in whole animals is by far the best way to protect people. Animal tests ensure that obviously toxic substances are not given to human beings and that doctors in charge of the human volunteer studies are made aware of possible serious side effects.

39. #4 - Truth or Myth? Vaccines and antibiotics have achieved nothing. Public health measures such as clean water and good sanitation are the solution to the problem of infectious disease. Vaccines and antibiotics have achieved nothing. Public health measures such as clean water and good sanitation are the solution to the problem of infectious disease.

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

41. #5 – Truth or Myth? Many pointless, unnecessary animal experiments are carried out. Many pointless, unnecessary animal experiments are carried out.

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

43. #6 – Truth or Myth? Laboratory animals suffer great pain and distress. Laboratory animals suffer great pain and distress.

44. False – Most experiments do not cause significant pain or distress because they involve only mild procedures such as a single injection, taking a small blood sample, or a change of diet. In most of the remainder, anesthetics or pain- killing drugs are used to prevent discomfort and minimize distress. False – Most experiments do not cause significant pain or distress because they involve only mild procedures such as a single injection, taking a small blood sample, or a change of diet. In most of the remainder, anesthetics or pain- killing drugs are used to prevent discomfort and minimize distress. IACUC - weigh any distress involved in an experiment against the potential benefit for science and for humanity IACUC - weigh any distress involved in an experiment against the potential benefit for science and for humanity

45. #7- Truth or Myth Most research animals are cats, dogs or monkeys. Most research animals are cats, dogs or monkeys.

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

47. #8 – Truth or Myth? There are laws and regulations protecting laboratory animals. There are laws and regulations protecting laboratory animals.

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

49. #9 – Truth or Myth? There is no need to conduct product safety tests anymore because “cruelty free” products are available. There is no need to conduct product safety tests anymore because “cruelty free” products are available.

50. False - Companies that claim they conduct no animal testing either contract testing to an outside laboratory or use compounds known to be safe through previous animal testing. False - Companies that claim they conduct no animal testing either contract testing to an outside laboratory or use compounds known to be safe through previous animal testing. Product safety testing ensures that products are safe when used as directed and provides scientific data for poison control centers and emergency room physicians in the event a product is misused. Adequate testing of products is both a moral and legal obligation to the public. Product safety testing ensures that products are safe when used as directed and provides scientific data for poison control centers and emergency room physicians in the event a product is misused. Adequate testing of products is both a moral and legal obligation to the public.

51. Questions?