1. Institutional Animal Care and Use Committee (IACUC) General Information

2. UMCES IACUC Members:
Christopher L. Rowe, Chesapeake Biological Laboratory, Chair and Scientist Member
John L. Hoogland, Appalachian Laboratory, Scientist Member
Elizabeth North, Horn Point Laboratory, Scientist Member
Erica Kropp, Center Administration, Non-scientist Member
Kirk Mantay, South River Federation, Community Representative
Janet E. Whaley, USDA/APHIS, Veterinarian

3. General Information I. Ethics of Animal Use in Research The use of animals in scientific research is a controversial issue. Animals have been used throughout history for anatomical and physiological research as well as for testing toxic substances. Many medical advances, including vaccines for polio and rabies, the development of certain antibiotics and cancer treating agents and transplant medicine, have been developed thanks to the use of animals in research. But the question arises as to whether it is right or wrong to use animals for these purposes.

4. 18th century Utilitarian philosophers believed that pain and suffering should be minimized and that animals deserved moral protection. Great Britain was a leader in the animal welfare movement and founded the Society for Prevention of Cruelty to Animals in The Cruelty to Animals Act was passed in Great Britain in 1876 and regulated animal experimentation.

5. There are, however, other views of the moral value (or status) of animals that influence the question of if and how animals are used in research. Animal rights theorists equate the lives of animals (or some animals more than others) with those of human beings and believe that humans do not have the right to use animals solely as a means to a human end. Others have taken political and social action to draw attention to their views.

6. Those who espouse an animal welfare point of view, however, may believe that while humans and animals are not necessarily morally equivalent, animals do have a 'right' not to suffer needlessly.

7. Even those who do not believe that animals have any moral standing in relation to humans may believe that it is harmful for a human being to inflict needless pain and distress on a sentient being. And from a scientific point of view, pain and distress can add an uncontrollable variable into an experiment and so it is in the interest of good science to control pain and distress whenever possible.

8. A research institution that receives money and support from the public is responsible for conducting research according to the limits set by society. In this instance, the use of animals in research is a privilege and not a right. The consensus at this time in the United States is that animals should be treated humanely and that pain and distress should be minimized when animals are used for research or teaching purposes. This is evident in the laws and regulations that have been developed by democratic processes.

9. Laws and Regulations i. Animal Welfare Act (AWA) In the 1960's, there was public concern over the conditions experienced by research animals and fears of pet animals being stolen and sold into research. These concerns led to the passage of the Animal Welfare Act (AWA) in This act licenses dealers, exhibitors and breeders of animals, regulates research facilities that use animals, lists standards for the humane care and treatment of animals and regulates the transportation of animals. The Act was amended in 1970, 1976, 1985, and

10. The AWA specifically exempts birds, mice and rats used in research as well as agricultural animals that are used for agricultural production. The Act also exempts horses that are not used for research purposes. The protection for these animals is covered by other regulations and inclusion under the AWA was considered to be redundant. The United States Department of Agriculture (USDA) is the government agency that is responsible for the enforcement of this act.

11. Public Health Service (PHS) Policy The Public Health Service Policy on the Humane Care and Use of Laboratory Animals is based on the 9 United States Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training This policy covers all species of animals including birds, mice and rats and it covers all research that is funded by the National Institutes of Health (NIH).

12. Institutions covered by this policy, must annually submit a written document called an Assurance to NIH, which documents how the institution is complying with all the regulations covering animals used in research. The Office of Laboratory Animal Welfare (OLAW) at NIH is the agency that is responsible for enforcement of this policy.

13. B. Other Guidelines i. Guide for the Care and Use of Laboratory Animals The Guide for the Care and Use of Laboratory Animals ("The Guide") was first developed in 1963 as a manual for research facilities receiving public funding for research using animals. The latest version of the Guide sets specific standards for the care and use of laboratory animals. It addresses institutional responsibilities, husbandry and housing standards, veterinary care and physical plant specifications. It is written by experts in laboratory animal care and is published by the National Research Council.

14. UMCES Policy Our policy on animal care and use follows federal and other laws and regulations. It addresses the roles and responsibilities of the Institutional Official (President Don Boesch), the Institutional Animal Care and Use Committee (IACUC), and the UMCES Community. President Boesch appoints all IACUC members. Note that our assurance with the PHS restricts laboratory housing and manipulative experiments on vertebrates to fish, amphibians, and reptiles only. However, non-invasive field studies on mammals and birds are permitted.

15. The IACUC, which is a committee mandated by the AWA and the PHS policy, reviews and must approve all activities involving vertebrates at UMCES. The AWA and PHS policy state membership requirements for the committee:
1 veterinarian (with laboratory animal background and responsibility at the institution),
1 member of the community (to represent the public interest),
1 scientist who uses animals in research, and
1 non-scientist member. University policy states that the committee should have at least 5 members, currently our committee has 6 members.

16. The committee reviews all animal usage protocols
The committee reviews all animal usage protocols. In addition, the committee ensures:
that the use of animals is necessary to answer a scientific question,
a search for alternatives to the pain and distress is conducted and that pain and distress experienced by the animals is minimized, and
that all the laws and policies for the use of laboratory animals are followed, including environmental safety

17. The committee also ensures the humane care of animals through the inspection of animal housing and use facilities twice a year and by investigating any complaints made regarding animal use. The committee is also responsible for reporting any instances of non-compliance and recommending corrective action.

18. C. Pain and Distress i. Pain It is difficult to know how animals experience pain and distress. The AWA defines a painful procedure in an animal as: "any procedure that would reasonably be expected to cause more than slight or momentary pain or distress in a human being to which that procedure was applied, that is, pain in excess of that caused by injections or other minor procedures."

19. Distress Distress is harder to define
Distress Distress is harder to define. Distress differs from stress, which is a physiological reaction that can lead to an adaptive response. Distress is currently defined as "a state in which an animal cannot escape from or adapt to the external or internal stressors or conditions it experiences resulting in negative effects upon its well being…" Principle IV of the US Government Principles states that unless the contrary is established, the assumption must be made that a procedure that causes pain or distress in a human being will cause pain and distress in an animal.

20. iii. Alternatives Current regulations stress the need to search for and develop alternatives to procedures on animals that cause more than momentary pain or distress. The concept of the 3 "R"s has been used when thinking about alternatives to animal use. This concept was developed in 1959 by Russell and Burch in their book: The Principles of Humane Animal Experimental Techniques. The 3 "R"s are Replacement, Reduction, and Refinement. Investigators at UMCES, who use animals that may undergo more than momentary pain or distress, must consider the 3 "R"s in the design of their experiments or teaching protocols and must demonstrate their search for alternatives.

21. Replacement of animals with other systems may be an option
Replacement of animals with other systems may be an option. Computer modeling or in vitro testing may be a substitute for animal models. "Lower" or non-vertebrate animals may be used in some situations rather than a higher order animal.

22. Reduction of the number of animals used for research is also an important concept. This is done mostly through experimental design and the use of statistics.

23. Refinement refers to methods that decrease the amount of pain and distress experienced by the animals that are actually needed to perform an experiment. This is done through the use of pain relieving measures such as anesthetics and analgesics whenever possible.

24. II. Use of Animals in Research and Teaching
A. To use animals at UMCES you must:
Have an approved and up to date (active) animal use protocol
Be certified by the IACUC to use animals in research or teaching
Complete any additional training needed
Occupational health, be up-to-date in vaccinations/testing, etc.
Ensure the humane care and treatment of animals

25. Hints on Animal Use Protocols i
Hints on Animal Use Protocols i. Always download the most recent version of the animal use protocol from the IACUC web site ii. Answer all the questions completely and attach relevant appendices, etc., to protocol form as new end pages. iii. Once the protocol is completed, the file as a single attachment to the IACUC Office Assistant, Gail Canaday, Submit it well in advance of your starting date, at least 2 months.

26. iv. Also, mail a hardcopy with your signature and that of your Laboratory Director to Gail. v. Gail will then post the electronic copy to Moodle and notify the IACUC members that a new protocol is available for review. vi. IACUC members generally review the protocol in 1 month, adding their comments, if any, for all members to read.

27. C. IACUC will Recommend One of the Following: i
C. IACUC will Recommend One of the Following: i. Approve the protocol, as is. IACUC will send you a letter saying that the protocol has been approved and you may begin work.

28. ii. Approve with stipulations
ii. Approve with stipulations. This means that IACUC had a few minor questions that needed clarification before final approval. If this is the case, you will receive a letter outlining the questions that need clarification, or steps that need to be taken before final approval is granted. You respond to the committee in writing and once the stipulations have been met, you will receive a final approval letter. You may not begin work or order animals until you receive final approval.

29. iii. Defer the protocol. If your protocol is deferred, this means that IACUC did not have enough information to approve or not approve your protocol. Again, IACUC will write you a letter outlining the questions they had and request further information. iv. Not approve the protocol. While this is rare, if a protocol is not approved, IACUC will require you to submit an entirely new protocol. IACUC will identify animal welfare concerns and provide policy requirements for a new submission.

30. D. Protocol Number (example) F-AL Once your protocol is approved, that approval is valid for 3 years pending annual renewal. The protocol will receive a number. The first letter, F or S, designates faculty or student, the next 2-3 letters the laboratory (AL, CBL, or HPL), the next 2 digits the year (04, 05, etc.), and the last several digits the number of protocols approved in that year. Faculty and student protocols are numbered separately. The protocol number is also used to identify animals. It should be on the aquarium/cage cards for all animals. A copy of the protocol, or the protocol number should be available in any areas where animals are taken or used.

31. E. Continuing Review Once your protocol is approved, the IACUC will request a brief report for an annual continuing review and renewal of approval. You will receive correspondence from the IACUC office regarding this continuing review and your response is required in order for your animal use protocol to remain active. F. Three-year Re-review Based on federal regulations, the protocol approval is valid for 3 years. If needed beyond 3 years, you will need to submit well in advance of its termination date a new, updated protocol for a “de novo” review by the IACUC.

32. G. Changes to Protocols All changes to animal use protocols must be approved by the IACUC before they are initiated. Submit all changes in protocol to the IACUC office in writing. i. Very minor changes may be handled administratively by the IACUC office. ii. Major changes, such as a change in animal numbers, a change in animal species, or changes in objectives or procedures, will be reviewed by the full committee.

33. H. Closing a Study If you are closing your study, inform the IACUC of this action by requesting a change memo.

34. I. Certification for Animal Use Everyone who uses animals in research or teaching must be certified by the IACUC. This certification is accomplished through attendance at an IACUC Training Seminar offered in October of each year. All personnel must obtain this certification at the earliest date following their employment at UMCES. A Letter of Certification will be mailed to you stating that you have completed IACUC training and when.

35. J. Occupational Health i
J. Occupational Health i. Be aware of occupational health issues related to your work (see laboratory safety officer). For example, zoonoses are diseases that can be passed between humans and other animals. You should be aware of some of the zoonotic diseases carried by the species that you are working with. Check out: Center for Disease Control and Prevention

36. ii. Tetanus vaccination It is required that all personnel who work with animals be vaccinated for tetanus. iii. Rabies vaccination If you are working with bats or other carnivores, it is recommended that you receive the pre-exposure rabies vaccination.

37. Other Training We expect that only trained, experienced personnel will capture, mark, track, transport, take tissue or fluid samples, perform surgery, or euthanize laboratory or wild animals. If this training is not obvious to the IACUC or is insufficient, we may stipulate that such training be completed to our satisfaction before beginning the research.

38. An additional note: Semi-annual facility inspections: Representatives of the IACUC conduct site visits every 6 months to ensure that approved protocols are being followed. Some issues we are particularly stringent about: 1. Labels on holding tanks/cages (as appropriate) must be present listing the approved protocol number, species, numbers, etc. Blank forms are available on the IACUC web site. 2. Husbandry logs must be available showing feeding, cleaning, water quality check histories. 3. Food must be properly stored and labeled.