Institutional Animal CARe and use committee - IACUC Frank R. Moore & Paula Smithka

IACUC What is IACUC? Why is it a part of my academic life? Why do we need it? Who needs to deal with IACUC? Who will be on an IACUC panel? What can I expect? Animals in research – “Any vertebrate animal (traditional laboratory animals, agricultural animals, wildlife, and aquatic species) produced for or used in research, testing, or teaching” From: Guide for the Care and Use of Laboratory Animals

IACUC Regulatory body that oversees the employment of policies regarding animal research/use Every institution that uses federally derived funds for research involving animals must have an IACUC Many private funding sources now require IACUC review Many journals require IACUC review of work they might publish IACUC established in 1985 by amendment to the Animal Welfare Act. Most of us “grew up/growing up” with IACUC.

IACUC Bit of History Mid-1800s saw increased use of animals in research, and that spawned efforts in the area of animal welfare. For example, British Cruelty to Animals Act of 1876. Since mid-1900s, three entities involved in development of animal care standards: Scientists conducting animal-based research Government through legislation/regulatory bodies Public Scientists Ethical/animal welfare considerations Non-uniform care can result in variable outcomes and poor research 1963 the first Guide for the Care and Use of Laboratory Animals. Now in 8th edition. National Research Council of the National Academy of Sciences

IACUC Bit of History 1966 – Animal Welfare Act USDA is regulator. Original intent regulate animal care in laboratory setting. Regulates the treatment of warm-blooded animals in research, exhibition, transport, and by dealers. Act enforced by Animal and Plant Health Inspection Service (APHIS).

IACUC Bit of History 1979 – Public Health Service developed policy covering animal research OLAW oversees implementation of policy NIH, CDC, FDA – to name a few agencies NSF follows OLAW regulations/recommendations Requires an IACUC and expands to all vertebrates OLAW – Division within the Public Health Service that oversees animal research and use. PHS Policy on Humane Care and Use of Laboratory Animals. Visit OLAW.nih.gov

IACUC Bit of History USM answers to two regulatory agencies viz. use of vertebrate animals in research and teaching. Last year, OLAW reviewed/approved our Animal Welfare Assurance under PHS policy. This August USDA/APHIS Veterinarian visited our facilities – do so unannounced and on regular basis. Responsive to other responsible organizations. Example: This past March received/answered Public Records Request from The Humane Society. Received announcement from NSF this year making explicit compliance with PHS policy.

IACUC The Guide Key Concepts Animal Care and Use Program Environment, Housing, and Management Veterinary Care Physical Plant Three Rs Replacement Absolute Relative (lower vertebrates) Refinement Improve husbandry Improve experimental procedures Minimize pain, distress Reduction Fewest number used to maximize information viz. design

IACUC Guide and Wildlife 70 active USM protocols in 2015, the majority of which are for research with non-laboratory animals. Title: Laboratory animals; but animal care and use program outlined in guide applies to all vertebrate animals, laboratory housed or free-ranging, used in teaching and research. Those of us working with “wildlife” must rely heavily on the organizations/societies that have developed guidelines for capture, handling, housing of our animals.

IACUC Who is on the IACUC? What does IACUC do? What does IACUC need to know from you?

Composition of the IACUC Committee A Doctor of Veterinary Medicine. At least one practicing scientist experienced in research involving animals. At least one member from a nonscientific background, from inside or outside the institution (the University, in this case). At least one public member to represent general community interests in the proper care and use of animals. Public members should not: be laboratory animal users be affiliated with the institution be members of the immediate family of a person who is affiliated with the institution See: Guide for the Care and Use of Laboratory Animals, 8th edition

Size of the IACUC Committee The size of the institution and the nature & extent of the Animal Care and Use Program determines the number of members and their terms of appointments. Large institutions with many administrative units or departments should have no more than 3 members from any unit/department. Scientists on the committee should be from different disciplines. USM’s IACUC currently has 7 members: 4 scientists, a veterinarian, 1 non-science member (myself), and 1 community member.

Protocol Requirements Your protocol should provide a detailed description of the proposed use for laboratory animals. The description needs to be clear and understandable to all members of the committee. Remember: you have scientists from areas other than your own, a non-science member, and a community member, so you must make your ideas clear. You should avoid overly technical terminology—no jargon! Where technical terms or procedures must be incorporated in your protocol, explain them.

Protocol Requirements, continued Your Protocol Should Provide: The rationale and purpose of the use of animals (including a justification why non-animal alternatives won’t suffice). A sequential description of all procedures involving animals, including catching/trapping. The justification of your use of a particular species and the number of animals involved. Specific housing requirements, if needed. If intend to use the University’s Animal Research Facility, must see the manager of the ARF. Details about the training and expertise of personnel involved. An explanation of the impact your research procedures will have on the animals’ well-being.

Protocol Requirements, continued Your Protocol Should Provide: Details concerning any surgical procedures and post- procedural observation and care for the animals, including anesthesia, analgesics, etc. Criteria and processes for intervention, removal of animals from the study, or euthanasia if the stress or pain becomes too intense for the animal. The means and method of euthanasia, if that is the endpoint, or disposition of animals, including long-term animal care after the conclusion of the study. Provisions for a safe working environment if hazardous materials are involved. See: Guide for the Care and Use of Laboratory Animals, 8th edition

Some Helpful Hints Proofread your protocol carefully. Spelling and grammatical errors mar the presentation of your work, but more importantly, ambiguities can cause confusion and raise questions on the part of the committee. Inconsistencies can delay approval if the committee has to send it back for clarification. Have someone else read your protocol, preferably a non- specialist in your area, and have them explain it to you. We are all “close to our own work.” Another set of eyes can help identify potential problems/issues where you may have assumed too much on the part of your reader. Remember: Clarity is the goal in the presentation of your proposed research.

IACUC FAQs How frequently does IACUC review research protocols? The PHS Policy requires that de novo IACUC reviews of all PHS-supported protocols be conducted on a triennial basis. Additional work within a protocol can be added via an amendment/modification. To be compliant with the USDA's Animal Welfare Regulations, the IACUC must review those protocols involving dogs, cats, nonhuman primates, rabbits, guinea pigs, and hamsters each year to assure active status and to identify significant changes. Last year USM instituted continuing review of all protocols on annual basis.

IACUC FAQs Does the PHS Policy apply to live embryonated eggs? For example, graduate student asked about zebrafish viz. research project.  Response: It is not necessary to have an approved IACUC protocol for work with fish embryos.  If you were working with larval fish or larval amphibians, you would need an IACUC. Although avian and other egg-laying vertebrate species develop backbones prior to hatching, OLAW interprets the PHS Policy as applicable to their offspring only after hatching. 

IACUC FAQs What is meant by “Death as End Point”? Fish taking study (see section 2.6 of protocol application form).  Response: No need to check “Death as an Endpoint” in section 2.6.  Terminology can be confusing – after all you are taking the fish.  “Death as an Endpoint" is the natural death of an animal as a direct result of the experimental procedures that are performed on them and considered to be necessary to meet the scientific objectives of the experiment.  Euthanasia of animals is NOT a death as an endpoint activity.

IACUC FAQs Is an approved IACUC protocol necessary for field studies? Response: If the activities are PHS-supported and involve vertebrate animals, IACUCs must know where field studies will be located, what procedures will be involved, and be sufficiently familiar with the nature of the habitat to assess the potential impact on the animal subjects. If the activity alters or influences the activities of the animal(s) that are being studied, the activity must be reviewed and approved by the IACUC (e.g., capture and release, banding). A study on free-living/ranging vertebrate species that involves invasive procedures, harms or materially alters the behavior of an animal under study is covered by USDA animal welfare regulations and requires IACUC review and approval.

IACUC FAQs Field studies continued ... . If the activity does not alter or influence the activity of the animal(s), IACUC review and approval is not required (observational, photographs, collection of feces). However, studies with the potential to impact the health or safety of personnel or the animal’s environment may need IACUC oversight, even if described as purely observational or behavioral.  The IACUC must also ensure compliance with the regulations and permit requirements of pertinent local, state, national, and international wildlife regulations.

IACUC FAQs Does the PHS Policy apply to use of animal tissue or materials obtained from dead animals? Response: The use of dead animals or parts of animals is not covered by the PHS Policy unless the activity involves: (1) killing animals for the purpose of obtaining or using their tissues or other materials, or (2) project-specific antemortem manipulation of animals prior to killing them. If either circumstance is applicable to the acquisition of dead animals, body parts or tissues, prior IACUC protocol review and approval are required.

IACUC FAQs May the IACUC administratively extend approval of a project that has expired? Response: No. IACUCs do not have authority to administratively extend approval beyond three years. When IACUC approval expires the protocol lacks valid approval. Continuation of animal activities in the absence of valid approval is a serious and reportable violation of PHS Policy. Earlier this month, reviewed protocols scheduled for expiration. If new protocol not submitted, continuation of animal activities is not allowed.

IACUC Q & A Regardless of what people think, we are not here to slow or stop research. We are here to make sure we all follow the rules – rules essential to ethical, humane treatment of animals and good science