Institutional Animal CARe and use committee - IACUC Frank R. Moore – USM IACUC Chair

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. Occurred within the research lifespan of at least some of us, but most of you “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: Scientist conducting animal-based research Government through legislation/regulatory bodies Public Scientist 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 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.

IACUC Bit of History USM answers to two regulatory agencies viz. use of vertebrate animals in research and teaching. February 12th personnel affiliated with APHIS visited. Yesterday, USM submitted documents to renew our assurance of compliance under PHS policy

IACUC Bit of History PUBLIC INVOLVEMENT 1969 Greenpeace 1966 LIFE magazine article 1975 Animal Liberation, Peter Singer 2014 USM Examples Farm Animal Rights Movement on campus NIH statement on recent media coverage

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

IACUC Guide and Wildlife 59 active USM protocols in 2014, vast 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 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? Minimum of 5 members must be on a panel [USM: 8 member panel] Veterinarian familiar with the animals used in research Practicing scientist who works with animals in their research Member from institution whose concerns are non-scientific A member with no association to the institution What does IACUC do? Evaluate protocols that will involve animals in research and teaching Inspect facilities that house animals (twice/year) Responsible for animal care and use program IACUC reports to USDA and to OLAW/PHS Meets 2nd Thursday of each month in relation to protocol applications and ongoing development of University’s animal care and use program.

IACUC What does IACUC need to know from you? Identification of the species Number of individuals Description of the work – for a lay person Description of procedures Description of euthanasia

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. This year USM instituted continuing review of all protocols on annual basis. Everyone with active protocol did so.

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. See recent Webinar.

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. See Q from GCRL workshop presentation.

IACUC FAQs Are laparoscopic procedures considered major surgery? Response: Surgical procedures can be categorized as major or minor. Major survival surgery penetrates and exposes a body cavity, produces substantial impairment of physical or physiologic functions, or involves extensive tissue dissection or transection. Minor survival surgery does not expose a body cavity and causes little or no physical impairment. Regardless, IACUC will want a description of the procedure and the anticipated or actual consequences.

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