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

General InformationGeneral Information

J. Edward Gates, Ph.D.J. Edward Gates, Ph.D.Committee ChairCommittee Chair

Appalachian LaboratoryAppalachian LaboratoryUniversity of Maryland Center for University of Maryland Center for

Environmental ScienceEnvironmental Science

Current UMCES IACUC Members:Current UMCES IACUC Members:

• J. Edward Gates, Appalachian Laboratory, Chair and Scientist Member

• John L. Hoogland, Appalachian Laboratory, Scientist Member

• Christopher L. Rowe, Chesapeake Biological Laboratory, Scientist Member• Elizabeth North, Horn Point Laboratory, Scientist Member• Erica Kropp, Center Administration, Non-scientist Member• Kirk Mantay, Wetlands Ecologist, Chesapeake Bay

Trust, Non-affiliated Member

• Janet E. Whaley, Aquaculture Program Manager, USDA,Veterinarian

General InformationGeneral InformationI. Ethics of Animal Use in ResearchI. Ethics of Animal Use in Research

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

18th century Utilitarian philosophers believed that pain 18th century Utilitarian philosophers believed that pain and suffering should be minimized and that animals and suffering should be minimized and that animals deserved moral protection.deserved moral protection. Great Britain was a leader in the animal welfare Great Britain was a leader in the animal welfare movement and founded the Society for Prevention of movement and founded the Society for Prevention of Cruelty to Animals (SPCA) in 1824. The Cruelty to Cruelty to Animals (SPCA) in 1824. The Cruelty to Animals Act was passed in Great Britain in 1876 and Animals Act was passed in Great Britain in 1876 and regulated animal experimentation.regulated animal experimentation.

There are, however, other views of the moral value (or There are, however, other views of the moral value (or status) of animals that influence the question of if and status) of animals that influence the question of if and how animals are used in research.how animals are used in research.

Animal rightsAnimal rights theorists equate the lives of animals (or theorists equate the lives of animals (or some animals more than others) with those of human some animals more than others) with those of human beings and believe that humans do not have the right to beings and believe that humans do not have the right to use animals solely as a means to a human end. Others use animals solely as a means to a human end. Others have taken political and social action to draw attention have taken political and social action to draw attention to their views.to their views.

Those who espouse an Those who espouse an animal welfareanimal welfare point of view, point of view, however, may believe that while humans and animals however, may believe that while humans and animals are not necessarily morally equivalent, animals do have are not necessarily morally equivalent, animals do have a 'right' not to suffer needlessly. For a discussion about a 'right' not to suffer needlessly. For a discussion about the differences between the differences between animal rightsanimal rights and and animal animal welfarewelfare, please see:, please see:

http://www.sover.net/~lsudlow/ARvsAW.htmhttp://www.sover.net/~lsudlow/ARvsAW.htm

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

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

A.A. Laws and RegulationsLaws and Regulations

i. Animal Welfare Act (AWA)i. Animal Welfare Act (AWA)

In the 1960's, there was public concern over the conditions In the 1960's, there was public concern over the conditions experienced by research animals and fears of pet animals being experienced by research animals and fears of pet animals being stolen and sold into research. These concerns led to the stolen and sold into research. These concerns led to the passage of the Animal Welfare Act (AWA) in 1966.passage of the Animal Welfare Act (AWA) in 1966. This act licenses dealers, exhibitors and breeders of animals, This act licenses dealers, exhibitors and breeders of animals, regulates research facilities that use animals, lists standards for regulates research facilities that use animals, lists standards for the humane care and treatment of animals and regulates the the humane care and treatment of animals and regulates the transportation of animals. The Act was amended in 1970, 1976, transportation of animals. The Act was amended in 1970, 1976, 1985, 1990, 2002, 2007, and 2008.1985, 1990, 2002, 2007, and 2008.

http://www.nal.usda.gov/awic/legislat/usdaleg1.htmhttp://www.nal.usda.gov/awic/legislat/usdaleg1.htm

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

ii.ii. Public Health Service (PHS) PolicyPublic Health Service (PHS) Policy

The Public Health Service Policy on the Humane Care The Public Health Service Policy on the Humane Care and Use of Laboratory Animals is based on the 9 United and Use of Laboratory Animals is based on the 9 United States Government Principles for the Utilization and States Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research Care of Vertebrate Animals Used in Testing, Research and Training.and Training. http://grants.nih.gov/grants/olaw/references/phspol.htm#http://grants.nih.gov/grants/olaw/references/phspol.htm#USGovPrinciplesUSGovPrinciples

This policy covers all species of animals including birds, This policy covers all species of animals including birds, mice and rats and it covers all research that is funded by mice and rats and it covers all research that is funded by the National Institutes of Health (NIH).the National Institutes of Health (NIH).

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

B. Other GuidelinesB. Other Guidelines

i. Guide for the Care and Use of Laboratory Animalsi. Guide for the Care and Use of Laboratory Animals

The Guide for the Care and Use of Laboratory Animals The Guide for the Care and Use of Laboratory Animals (("The Guide""The Guide") was first developed in 1963 as a manual for ) was first developed in 1963 as a manual for research facilities receiving public funding for research research facilities receiving public funding for research using animals. using animals. The latest (2011) version of the GuideThe latest (2011) version of the Guide, sets , sets specific standards for the care and use of laboratory specific standards for the care and use of laboratory animals.animals.

It addresses institutional responsibilities, husbandry and It addresses institutional responsibilities, husbandry and housing standards, veterinary care and physical plant housing standards, veterinary care and physical plant specifications. It is written by experts in laboratory animal specifications. It is written by experts in laboratory animal care and is published by the National Research Council.care and is published by the National Research Council.

ii. UMCES Policyii. UMCES Policy

Our policy on animal care and use follows federal and Our policy on animal care and use follows federal and other laws and regulations. It addresses the roles and other laws and regulations. It addresses the roles and responsibilities of the Institutional Official (President responsibilities of the Institutional Official (President Don Boesch), the Institutional Animal Care and Use Don Boesch), the Institutional Animal Care and Use Committee (IACUC), and the UMCES Community. Committee (IACUC), and the UMCES Community. President Boesch appoints all IACUC members.President Boesch appoints all IACUC members.

The The IACUCIACUC, which is a committee mandated by the AWA , which is a committee mandated by the AWA and the PHS policy, reviews and must approve all and the PHS policy, reviews and must approve all activities involving vertebrates at UMCES. The AWA and activities involving vertebrates at UMCES. The AWA and PHS policy state membership requirements for the PHS policy state membership requirements for the committee: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 7 members. All UMCES laboratories are represented.

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

The committee also ensures the humane care of animals The committee also ensures the humane care of animals through the inspection of animal housing and use facilities through the inspection of animal housing and use facilities twice a year and by investigating any complaints made twice a year and by investigating any complaints made regarding animal use.regarding animal use.

The committee is also responsible for reporting any The committee is also responsible for reporting any instances of non-compliance and recommending instances of non-compliance and recommending corrective action.corrective action.

C. Pain and DistressC. Pain and Distress

i. Paini. Pain

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

Pain can be acute, short lived, or chronic. The signs Pain can be acute, short lived, or chronic. The signs manifesting acute or chronic pain may differ and may be manifesting acute or chronic pain may differ and may be different in different species.different in different species.

ii. Distressii. Distress

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

iii. Alternativesiii. Alternatives

Current regulations stress the need to search for and Current regulations stress the need to search for and develop alternatives to procedures on animals that cause develop alternatives to procedures on animals that cause more than momentary pain or distress. The concept of the more than momentary pain or distress. The concept of the 3 "R"s3 "R"s has been used when thinking about alternatives to has been used when thinking about alternatives to animal use. This concept was developed in 1959 by animal use. This concept was developed in 1959 by Russell and Burch in their book: Russell and Burch in their book: The Principles of Humane The Principles of Humane Animal Experimental TechniquesAnimal Experimental Techniques.. The The 3 "R"s3 "R"s are are ReplacementReplacement, , ReductionReduction, and , and RefinementRefinement. . Investigators at UMCES, who use animals that may Investigators at UMCES, who use animals that may undergo more than momentary pain or distress, must undergo more than momentary pain or distress, must consider the consider the 3 "R"s3 "R"s in the design of their experiments or in the design of their experiments or teaching protocols and must demonstrate their search for teaching protocols and must demonstrate their search for alternatives.alternatives.

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

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

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

II. Use of Animals in Research and TeachingII. Use of Animals in Research and Teaching

A. Animal Use Form

To use animals at UMCES you must:

i. Have an approved and up to date (active) animal use protocol

ii. Be certified by the IACUC to use animals in research or teaching

iii. Complete any additional training needediv. Occupational health, be up-to-date in

vaccinations/testing, etc.v. Ensure the humane care and treatment of animals

B.B. Hints on Animal Use ProtocolsHints on Animal Use Protocols

i. Always download the most recent version of the animal i. Always download the most recent version of the animal use protocol from the IACUC web site in either Adobe use protocol from the IACUC web site in either Adobe Acrobat (pdf) format, go to UMCES home page, ABOUT Acrobat (pdf) format, go to UMCES home page, ABOUT UMCES, MY UMCES, and then IACUC to get the latest UMCES, MY UMCES, and then IACUC to get the latest form. form. http://www.umces.edu/about/iacuchttp://www.umces.edu/about/iacuc

ii. Answer all the questions in Part A and Part B completely ii. Answer all the questions in Part A and Part B completely and attach relevant appendices, etc., to protocol form as and attach relevant appendices, etc., to protocol form as new end pages.new end pages. iii. Once the protocol is completed, email the file as a single iii. Once the protocol is completed, email the file as a single attachment to the IACUC Office Assistant, Paulette Orndorff, attachment to the IACUC Office Assistant, Paulette Orndorff, orndorff@al.umces.eduorndorff@al.umces.edu. Submit it well in advance of your . Submit it well in advance of your

starting date, at least 2 months.starting date, at least 2 months.

iv. Also, mail a hardcopy with your signature and that of iv. Also, mail a hardcopy with your signature and that of your Laboratory Director to Paulette.your Laboratory Director to Paulette.

v. Paulette will then post the electronic copy to Moodle v. Paulette will then post the electronic copy to Moodle and notify the and notify the IACUCIACUC members that a new protocol is members that a new protocol is available for review.available for review.

vi. vi. IACUCIACUC members generally review the protocol in 1 members generally review the protocol in 1 month, adding their comments, if any, for all members to month, adding their comments, if any, for all members to read.read.

C. IACUC will Recommend One of the Following:C. IACUC will Recommend One of the Following:

i.i. Approve the protocol, as isApprove the protocol, as is..IACUC will send you a letter saying that the protocol has IACUC will send you a letter saying that the protocol has been approved and you may begin work.been approved and you may begin work.

ii. ii. Require modifications to secure approvalRequire modifications to secure approval.. This means that IACUC had a few minor questions that This means that IACUC had a few minor questions that needed clarification before approval. If this is the case, needed clarification before approval. If this is the case, you will receive a letter outlining the questions that need you will receive a letter outlining the questions that need clarification, or steps that need to be taken before clarification, or steps that need to be taken before approval is granted. You respond to the committee in approval is granted. You respond to the committee in writing and once the stipulations have been met and writing and once the stipulations have been met and approved by the IACUC, you will receive a final approval approved by the IACUC, you will receive a final approval letter.letter.

You may not begin work or order animals until you You may not begin work or order animals until you

receive final approvalreceive final approval..

iii. iii. Defer the protocolDefer the protocol. . If your protocol is deferred, this means that IACUC did not If your protocol is deferred, this means that IACUC did not have enough information to approve or not approve your have enough information to approve or not approve your protocol. Again, IACUC will write you a letter outlining the protocol. Again, IACUC will write you a letter outlining the questions they had and request further information.questions they had and request further information.

iv.iv. Not approve the protocol.Not approve the protocol. This is rare and requires a full IACUC meeting via IVN. If This is rare and requires a full IACUC meeting via IVN. If a protocol is not approved, IACUC will require you to a protocol is not approved, IACUC will require you to submit an entirely new protocol. IACUC will identify submit an entirely new protocol. IACUC will identify animal welfare concerns and provide policy requirements animal welfare concerns and provide policy requirements for a new submission.for a new submission.

D. Protocol Number (example) F-AL-11-07D. Protocol Number (example) F-AL-11-07

Once your protocol is approved, that approval is valid for Once your protocol is approved, that approval is valid for 3 years pending annual renewal. The protocol will 3 years pending annual renewal. The protocol will receive a number. The first letter, F or S, designates receive a number. The first letter, F or S, designates faculty or student, the next 2-3 letters the laboratory (AL, faculty or student, the next 2-3 letters the laboratory (AL, CBL, or HPL), the next 2 digits the year (10, 11, etc.), CBL, or HPL), the next 2 digits the year (10, 11, etc.), and the last several digits the number of protocols and the last several digits the number of protocols approved in that year. Faculty and student protocols are approved in that year. Faculty and student protocols are numbered separately.numbered separately. The protocol number is also used to identify animals. It The protocol number is also used to identify animals. It should be on the aquarium/cage cards for all animals. A should be on the aquarium/cage cards for all animals. A copy of the protocol, or the protocol number, should be copy of the protocol, or the protocol number, should be available in any areas where animals are taken or used.available in any areas where animals are taken or used.

E. Continuing ReviewE. Continuing Review

Once your protocol is approved, the IACUC will request a Once your protocol is approved, the IACUC will request a brief report for an annual continuing review and renewal brief report for an annual continuing review and renewal of approval. You will receive correspondence from the of approval. You will receive correspondence from the IACUC office regarding this continuing review and your IACUC office regarding this continuing review and your response is required in order for your animal use protocol response is required in order for your animal use protocol to remain active.to remain active.

F.F. Three-year Re-reviewThree-year Re-review

Based on federal regulations, the protocol approval is Based on federal regulations, the protocol approval is valid for 3 years. If needed beyond 3 years, you will valid for 3 years. If needed beyond 3 years, you will need to submit well in advance of its termination date a need to submit well in advance of its termination date a new, updated protocol for a “new, updated protocol for a “de novode novo” review by the ” review by the IACUC, along with a brief summary of accomplishments.IACUC, along with a brief summary of accomplishments.

G. Changes to ProtocolsG. Changes to Protocols

All changes to animal use protocols must be approved by All changes to animal use protocols must be approved by the the IACUCIACUC before they are initiated. Submit all changes before they are initiated. Submit all changes in protocol to the in protocol to the IACUCIACUC office in writing. office in writing.

i. Very i. Very minorminor changes may be handled administratively changes may be handled administratively by the by the IACUCIACUC office. office.

ii. ii. MajorMajor changes, such as a change in animal numbers, changes, such as a change in animal numbers, a change in animal species, or changes in objectives or a change in animal species, or changes in objectives or procedures, will be reviewed by the full committee, and procedures, will be reviewed by the full committee, and may require a new submission.may require a new submission.

H. Closing a StudyH. Closing a Study

If you are closing your study, inform the If you are closing your study, inform the IACUCIACUC of this of this action by requesting a change memo.action by requesting a change memo.

I. Certification for Animal UseI. Certification for Animal Use

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

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 Preventionhttp://www.cdc.govhttp://www.cdc.gov/DiseasesConditions/

ii. ii. Tetanus vaccinationTetanus vaccinationIt is required that all personnel who work with animals be It is required that all personnel who work with animals be vaccinated for tetanus.vaccinated for tetanus.

iii. iii. Rabies vaccinationRabies vaccinationIf you are working with bats or other carnivores, it is If you are working with bats or other carnivores, it is recommended that you receive the pre-exposure rabies recommended that you receive the pre-exposure rabies vaccination.vaccination.

K. Other TrainingK. Other Training

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

A Good Source for Information on Euthanasia:A Good Source for Information on Euthanasia:AVMA Guidelines on Euthanasia (American VeterinaryAVMA Guidelines on Euthanasia (American Veterinary Medical Association 2007) Medical Association 2007)http://www.avma.org/issues/animal_welfare/euthanasia.pdfhttp://www.avma.org/issues/animal_welfare/euthanasia.pdf