Institutional Animal Care and Use Committee

IACUC  Required by AWA, PHS, AAALAC  Is appointed by the President of the UA  The Institutional Official for Animal Welfare at UA is the Vice President for Research

IACUC Membership Required by law to have at least 5 members including: –Veterinarian –Animal Research Scientist –Non-scientist –Community Member UA Has: –Four Veterinarians –Two community members –Two non-scientists –Scientist representatives from all Colleges using animals

IACUC Functions  Review and approve all activities involving animals  Inspect animal housing areas and laboratories (at least twice a year)  Ensure adequate veterinary care and oversight  Keep records to verify compliance with all regulations  Supervise the training required by the law

IACUC Functions  Prepare and submit Reports to IO regarding program  Make Recommendations to IO  Review Concerns  Suspend Activities

PROTOTOCOL REVIEW

Justification for the Use of Animals  What are the scientific aims of the research?  What procedure(s) will be applied to animals?  What is the potential relevance and value of the research?

CONSIDERATIONS IN PROTOCOL REVIEW  SCIENTIFIC MERIT  DUPLICATION  3 R’S  SELECTION OF SPECIES  PROPER USE OF ANALGESICS, ANESTHETICS, AND OTHER PAIN/DISTRESS RELIEF, EUTHANASIA  QUALIFICATIONS OF RESEARCHERS  WHERE RESEARCH IS TO BE PERFORMED

IACUC Approval Criteria: Scientific Merit “Procedures involving animals should be designed and performed with due consideration given to their relevance to human or animal health, the advancement of knowledge, or the good of society.” US Government Principles # II

USDA Regulations on Scientific Value/Merit  Rationale for… and… appropriateness of the species and numbers of animals  Activities do not unnecessarily duplicate previous experiments  Procedures… for the conduct of scientifically valuable research 9 CFR 2.31

Scientific “Merit” Sound Research Design Relevance Valid Results Scientifically Valuable

The 3 R’s  Replace  Reduce  Refine

First R: Replace  Utilize alternative methods: –Non-animal models –In vitro methods –Invertebrates –Lower species first

The 2 nd R: Reduce  Reduction in animal numbers –Must show statistical significance

The 3 rd R: Refine  Refinement –Reduce pain and distress –Provide relief from pain and distress

Application of the Principles of Replacement, Reduction and Refinement (3 R’s)  How much animal pain, discomfort, distress, morbidity, and mortality is associated with the research (ethical cost)?  How can ethical cost be minimized?

Ethical Cost Benefit Relationship  What is an acceptable ethical cost-benefit relationship in animal research?

IACUC Approval Criteria Projects involving animals should be designed and performed in a way which minimizes the ethical costs as much as possible by applying the 3 R’s within justifiable scientific constraints. Based on PHS Policy and USDA Rules

Ethical Cost Benefit Relationship  The ethical cost of the research must be outweighed or balanced by the potential value of research to human or animal health, the advancement of knowledge or the good of society.

Ethical Cost Benefit Relationship Acceptable Scientific Value Ethical Cost To humans To animals To science To society Pain Discomfort Distress Morbidity Mortality

Ethical Cost Benefit Relationship Not Acceptable Ethical Cost To humans To animals To science To society Pain Discomfort Distress Morbidity Mortality Scientific Value

Ethical Cost Benefit Relationship Very Acceptable Scientific Value Ethical Cost To humans To animals To science To society Pain Discomfort Distress Morbidity Mortality

Ethical Cost Benefit Relationship Problematic Scientific Value Ethical Cost

Selection and Justification of Species What species will be used in the project and what is the rationale?

IACUC Approval Criteria The investigator should choose the most appropriate species for the project based upon anatomical, physiological or other characteristics in consideration of the scientific objectives and the need to obtain valid results Based on USGP III; USDA 9 CFR 2.31

Treatment of Pain & Discomfort  Will any intervention(s) potentially cause pain, discomfort or distress?  What is the estimated magnitude and duration of pain, discomfort or distress requiring treatment?  What is the regimen for relief of pain, discomfort or distress including the agent, dose, route and duration of administration?

IACUC Approval Criteria Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in animals. USGP IV; USDA Policy 11, 4/17/97

IACUC Approval Criteria Procedures that may cause more than momentary or slight pain or distress to the animals will be performed with state of the art sedation, analgesic, or anesthesia unless withholding is justified for scientific reasons… PHS Policy at IV.C.1.b; USDA 9 CFR 2.31

IACUC Approval Criteria  No animal will be used in more than one major operative procedure from which it is allowed to recover unless justified for scientific reasons or is required to protect the health of the animal. USDA 9 CFR 2.31; The Guide p. 12

IACUC Approval Criteria  During monitoring, animals should be evaluated for the presence of pain, discomfort or distress. In assessing animal welfare, the monitor should use criteria based upon the normal behavioral pattern of the species. Simple observation can reveal a great deal of information. Based on PHS Policy and USDA Rules

IACUC Approval Criteria Pain alleviating agents should be administered as part of a continuum, when appropriate, e.g. pre-surgery, immediately post- surgery, during recovery (hrs to days). This is based upon the premise that where pain is concerned, the animal should always be given the benefit of the doubt. Based on PHS Policy and USDA rules

IACUC Approval Criteria  The method of euthanasia should be based upon the species, size of the animal, the scientific objectives of the experiment and its ability to quickly and painlessly produce a loss of consciousness and death. Euthanasia must comply with current AVMA guidelines. Based on the PHS Policy at IV.C.1.g; The Guide, p. 65; USDA 9 CFR 2.31

Qualification of Research Personnel  Who are the scientists, research technicians and other study personnel?  What are their assigned responsibilities?  Are they qualified by experience and training?

IACUC Approval Criteria  Personnel who perform procedures involving live animals must be knowledgeable about the biology of the species under study and must be fully qualified by training and experience to carry out the surgical and non-surgical procedures assigned to him/her and responsibilities related to the care of animals. Any individual who lacks the prerequisite qualifications must be trained before they interact with the animals. Based on PHS Policy at IV.c.1.f; USGP VIII; USDA 9 CFR 2.31

Suspension of Protocols  If the IACUC finds that an investigator is violating the approved protocol, or if the committee determines that any procedures being conducted in the study are not in compliance with federal laws, the IACUC is required by law to suspend the activity.

Suspension of Protocols  Both the Animal Welfare Act and the Public Health Service Policy require the IACUC to report any suspensions. The federal agencies will then conduct their own investigation and may choose to apply penalties to the institution.

OTHER IACUC RESPONSIBILITIES  Facilities inspections: 12 and 24 hours

Investigation of Complaints  Required by the Animal Welfare Act and the Public Health Service Policy  Concerning suspected animal abuse or noncompliance  For any serious or life-threatening complaint, the results of the investigation must be forwarded to Federal authorities.

Whistle Blower Protection  Any person (student or employee) who reports an alleged violation is protected from retaliatory action be Federal and State laws

Shared Responsibilities  Follow the laws, regulations and policies  Ensure proper training for all using or working with animals  Practice humane standards at all times