institutional animal care and use committee. iacuc required by awa, phs, aaalac is appointed by...

Institutional Animal Care and Use Institutional Animal Care and Use CommitteeCommittee

IACUCIACUC

Required by AWA, Required by AWA, PHS, AAALACPHS, AAALAC

Is appointed by the Is appointed by the President of the UAPresident of the UA

The Institutional The Institutional Official for Animal Official for Animal Welfare at UA is Welfare at UA is the Vice President the Vice President for Researchfor Research

IACUC MembershipIACUC Membership

Required by law to Required by law to have at least 5 have at least 5 members members including:including:– VeterinarianVeterinarian– Animal Research Animal Research

ScientistScientist– Non-scientistNon-scientist– Community Community

MemberMember

UA Has:UA Has:– Four VeterinariansFour Veterinarians– Two community Two community

membersmembers– Two non-scientistsTwo non-scientists– Scientist Scientist

representatives representatives from all Colleges from all Colleges using animalsusing animals

IACUC FunctionsIACUC Functions

Review and approveReview and approve all activities involving all activities involving animalsanimals

Inspect animal housing areas and Inspect animal housing areas and laboratorieslaboratories (at least twice a year) (at least twice a year)

Ensure Ensure adequate veterinary careadequate veterinary care and and oversightoversight

Keep Keep recordsrecords to verify compliance with all to verify compliance with all regulationsregulations

Supervise the Supervise the trainingtraining required by the law required by the law

IACUC FunctionsIACUC Functions

Prepare and submit Prepare and submit Reports to IO regarding Reports to IO regarding programprogram

Make Recommendations Make Recommendations to IOto IO

Review ConcernsReview Concerns Suspend ActivitiesSuspend Activities

PROTOTOCOL REVIEWPROTOTOCOL REVIEW

Justification for the Use of Justification for the Use of AnimalsAnimals

What are the scientific aims of the What are the scientific aims of the research?research?

What procedure(s) will be applied to What procedure(s) will be applied to animals?animals?

What is the potential relevance and value What is the potential relevance and value of the research? of the research?

CONSIDERATIONS IN CONSIDERATIONS IN PROTOCOL REVIEWPROTOCOL REVIEW

SCIENTIFIC MERITSCIENTIFIC MERIT DUPLICATIONDUPLICATION 3 R’S3 R’S SELECTION OF SPECIESSELECTION OF SPECIES PROPER USE OF ANALGESICS, PROPER USE OF ANALGESICS,

ANESTHETICS, AND OTHER PAIN/DISTRESS ANESTHETICS, AND OTHER PAIN/DISTRESS RELIEF, EUTHANASIARELIEF, EUTHANASIA

QUALIFICATIONS OF RESEARCHERSQUALIFICATIONS OF RESEARCHERS WHERE RESEARCH IS TO BE PERFORMEDWHERE RESEARCH IS TO BE PERFORMED

IACUC Approval Criteria: Scientific IACUC Approval Criteria: Scientific MeritMerit

““Procedures involving animals Procedures involving animals should be designed and performed should be designed and performed with due consideration given to their with due consideration given to their relevance to human or animal relevance to human or animal health, the advancement of health, the advancement of knowledge, or the good of society.”knowledge, or the good of society.”

US Government Principles # IIUS Government Principles # II

USDA Regulations on Scientific USDA Regulations on Scientific Value/Merit Value/Merit

RationaleRationale for… and… for… and… appropriateness of the species and appropriateness of the species and numbers of animalsnumbers of animals

Activities do Activities do not unnecessarily not unnecessarily duplicateduplicate previous experiments previous experiments

Procedures… for the conduct of Procedures… for the conduct of scientifically valuablescientifically valuable research research

9 CFR 2.319 CFR 2.31

Scientific “Merit”Scientific “Merit”

Sound Research Design

Relevance

Valid Results

Scientifically Valuable

The 3 R’sThe 3 R’s

ReplaceReplace ReduceReduce RefineRefine

First R: ReplaceFirst R: Replace

Utilize alternative Utilize alternative methods:methods:– Non-animal modelsNon-animal models– In vitro methodsIn vitro methods– InvertebratesInvertebrates– Lower species firstLower species first

The 2The 2ndnd R: Reduce R: Reduce

Reduction in Reduction in animal numbersanimal numbers– Must show Must show

statistical statistical significancesignificance

The 3The 3rdrd R: Refine R: Refine

RefinementRefinement– Reduce pain and Reduce pain and

distressdistress– Provide relief from Provide relief from

pain and distresspain and distress

Application of the Principles of Application of the Principles of Replacement, Reduction and Replacement, Reduction and

Refinement (3 R’s)Refinement (3 R’s) How much animal pain, discomfort, How much animal pain, discomfort,

distress, morbidity, and mortality is distress, morbidity, and mortality is associated with the research (ethical associated with the research (ethical cost)?cost)?

How can ethical cost be minimized?How can ethical cost be minimized?

Ethical Cost Benefit Ethical Cost Benefit RelationshipRelationship

What is an What is an acceptable ethical acceptable ethical cost-benefit cost-benefit relationship in relationship in animal research?animal research?

IACUC Approval CriteriaIACUC Approval Criteria

Projects involving animals should be Projects involving animals should be designed and performed in a way designed and performed in a way which minimizes the ethical costs as which minimizes the ethical costs as much as possible by applying the 3 much as possible by applying the 3 R’s within R’s within justifiablejustifiable scientific scientific constraints.constraints.

Based on PHS Policy and USDA RulesBased on PHS Policy and USDA Rules


The The ethicalethical cost of the research cost of the research must be must be outweighed or balancedoutweighed or balanced by by the the potential valuepotential value of research to of research to human or animal health, the human or animal health, the advancement of knowledge or the advancement of knowledge or the good of society.good of society.


AcceptableAcceptable

Scientific Value

Ethical Cost

To humans To animals To science To society

Pain Discomfort Distress Morbidity Mortality


Not AcceptableNot Acceptable

Ethical Cost



Scientific Value


Very AcceptableVery Acceptable

Scientific Value

Ethical Cost




ProblematicProblematic

Scientific Value

Ethical Cost

Selection and Justification of Selection and Justification of SpeciesSpecies

What species will be What species will be used in the project used in the project and what is the and what is the rationale?rationale?


The investigator should choose the The investigator should choose the most appropriate species for the most appropriate species for the project based upon anatomical, project based upon anatomical, physiological or other characteristics physiological or other characteristics in consideration of the scientific in consideration of the scientific objectives and the need to obtain objectives and the need to obtain valid resultsvalid results

Based on USGP III; USDA 9 CFR 2.31Based on USGP III; USDA 9 CFR 2.31

Treatment of Pain & DiscomfortTreatment of Pain & Discomfort Will any intervention(s) Will any intervention(s)

potentially cause pain, potentially cause pain, discomfort or distress?discomfort or distress?

What is the estimated What is the estimated magnitude and duration magnitude and duration of pain, discomfort or of pain, discomfort or distress requiring distress requiring treatment?treatment?

What is the regimen for What is the regimen for relief of pain, discomfort relief of pain, discomfort or distress including the or distress including the agent, dose, route and agent, dose, route and duration of duration of administration?administration?


Unless the contrary is established, Unless the contrary is established, investigators should consider that investigators should consider that procedures that cause pain or procedures that cause pain or distress in human beings may cause distress in human beings may cause pain or distress in animals.pain or distress in animals.

USGP IV; USDA Policy 11, 4/17/97USGP IV; USDA Policy 11, 4/17/97


Procedures that may cause more Procedures that may cause more than momentary or slight pain or than momentary or slight pain or distress to the animals will be distress to the animals will be performed with state of the art performed with state of the art sedation, analgesic, or anesthesia sedation, analgesic, or anesthesia unless withholding is justified for unless withholding is justified for scientific reasonsscientific reasons……

PHS Policy at IV.C.1.b; USDA 9 CFR PHS Policy at IV.C.1.b; USDA 9 CFR 2.312.31


No animal will be used in more than No animal will be used in more than one major operative procedure from one major operative procedure from which it is allowed to recover unless which it is allowed to recover unless justified for scientific reasons or is justified for scientific reasons or is required to protect the health of the required to protect the health of the animal.animal.

USDA 9 CFR 2.31; The Guide p. 12USDA 9 CFR 2.31; The Guide p. 12


During monitoring, animals should be During monitoring, animals should be evaluated for the presence of pain, evaluated for the presence of pain, discomfort or distress. In assessing discomfort or distress. In assessing animal welfare, the monitor should animal welfare, the monitor should use criteria based upon the normal use criteria based upon the normal behavioral pattern of the species. behavioral pattern of the species. Simple observation can reveal a Simple observation can reveal a great deal of information.great deal of information.

Based on PHS Policy and USDA RulesBased on PHS Policy and USDA Rules


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

Based on PHS Policy and USDA rulesBased on PHS Policy and USDA rules


The method of euthanasia should be The method of euthanasia should be based upon the species, size of the based upon the species, size of the animal, the scientific objectives of animal, the scientific objectives of the experiment and its ability to the experiment and its ability to quickly and painlessly produce a loss quickly and painlessly produce a loss of consciousness and death. of consciousness and death. Euthanasia must comply with Euthanasia must comply with current AVMA guidelines.current AVMA guidelines.

Based on the PHS Policy at IV.C.1.g; Based on the PHS Policy at IV.C.1.g; The Guide, p. 65; USDA 9 CFR 2.31The Guide, p. 65; USDA 9 CFR 2.31

Qualification of Research Qualification of Research PersonnelPersonnel

Who are the Who are the scientists, research scientists, research technicians and other technicians and other study personnel?study personnel?

What are their What are their assigned assigned responsibilities?responsibilities?

Are they qualified by Are they qualified by experience and experience and training?training?


Personnel who perform procedures Personnel who perform procedures involving live animals must be involving live animals must be knowledgeable about the biology of the knowledgeable about the biology of the species under study and must be fully species under study and must be fully qualified by training and experience to qualified by training and experience to carry out the surgical and non-surgical carry out the surgical and non-surgical procedures assigned to him/her and procedures assigned to him/her and responsibilities related to the care of responsibilities related to the care of animals. Any individual who lacks the animals. Any individual who lacks the prerequisite qualifications must be trained prerequisite qualifications must be trained before they interact with the animals.before they interact with the animals.

Based on PHS Policy at IV.c.1.f; USGP VIII; USDA 9 CFR 2.31Based on PHS Policy at IV.c.1.f; USGP VIII; USDA 9 CFR 2.31

Suspension of ProtocolsSuspension of Protocols

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

Suspension of ProtocolsSuspension of Protocols

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

OTHER IACUC OTHER IACUC RESPONSIBILITIESRESPONSIBILITIES

Facilities inspections: 12 and 24 hoursFacilities inspections: 12 and 24 hours

Investigation of ComplaintsInvestigation of Complaints

Required by the Animal Welfare Act Required by the Animal Welfare Act and the Public Health Service Policyand the Public Health Service Policy

Concerning suspected animal abuse Concerning suspected animal abuse or noncomplianceor noncompliance

For any serious or life-threatening For any serious or life-threatening complaint, the results of the complaint, the results of the investigation must be forwarded to investigation must be forwarded to Federal authoritiesFederal authorities..

Whistle Blower ProtectionWhistle Blower Protection

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

Shared ResponsibilitiesShared Responsibilities

Follow the laws, Follow the laws, regulations and regulations and policiespolicies

Ensure proper training Ensure proper training for all using or working for all using or working with animalswith animals

Practice humane Practice humane standards at all timesstandards at all times

institutional animal care and use committee. iacuc required by awa, phs, aaalac is appointed by...

Documents

research ethical cost

animal pain

animal health

animal welfare

animal numbersmust

institutional animal

potential value of research

ethical costs