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121 Cards in this Set

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Def: Program
Activities conducted by and at an institution that have a direct impact on the well-being of animals
What does a program include (6)
1. Andimal/vet care 2. Policies/procedures 3. Personnel/program management and oversite 4. Occupational health and safety 5. IACUC functions 6. Animal facility design and management
Guide principles (9)
1. Consider the 3-Rs 2. Procedures should be based on the relevance to human/animal health, advancement of knowledge, or good of society 3. Use appropriate species/quality/# 4. min/avoid discomfort/pain/distress 5. Use sedation, analgesia, and anesthesia 6. Establish humane endpoints 7. Provide vet care 8. Appropriate transportation/husbandry by a qualified person 9. Be trained/qualified for the experiment you are doing
US federal laws creates a statutory basis for (3)
IO, Attending vet, IACUC [Primary oversight responsibilty of the Program rest with these people and they should regularly communicate]
Institutional official (IO)
Representative of senior administration; ultimately responsible for the Program; Resource planning and alignment of Program goals with mission
Attending Veterinarian (AV)
Responsible for the health and well-being of all LA used at the institution. Needs sufficient authority, access and resources
Consulting or part-time vets
Should be available in visits at intervals appropriate to programmatic needs + someone assigned to daily animal care/use/management
Other documents the Guide endorses
1. PHS 2. AWA/AWR 3. US Principles 4. ACLAM "Guidelines for Adequate Vet Care"
Points of the ACLAM "Guidelines for Adequate Vet Care" mentioned in the Guide
1. Vet access to all animals and medial records 2. Regular vet visits to (potenital) animal facilities 3. Support for clinical, preventative, emergency vet care 4. System for legal animal procurement and transportation
IACUC
Responsible for assessment and oversight of the institution's Program componenets and facilities (authority and resources)
Interinstitutional collaboration: Institutions should have a formal written understanding that addresses (3)
1. Responsibility for off-site animal care and use 2. animal ownership 3. IACUC review and oversight
MUST: Training
All personnel invloved with the care and use of animal MUST be adequately educated, trained, and/or qualified in basic principles of LA science to ensure high-quality science and animal well-being
Factors that influcene the # and qualificaitons of personnel required to conduct and support a program:
1. institution type/size 2. administrative structure for providing animal care 3. Physical plant 4. Number and species of animals maintained 5. Nature of research, testing, teaching, and produciton
Who pays and who trains?
Institution responsible for providign resources to support AND IAUC is presonsible for providing oversight and evaluating effectiveness of training.
Training documentation
SHOULD: all personnel training should be documented
MUST: Training required of the vet and vet staff for animal care
Must have the experience, trainign, and expertise necessary to appropriately evaluate the health and well-being of the species used
Training of vets for administrative
Should be trained or have relevant experience in LA facility administration and management
Vet Continuting edu
Institution should provide opportunites and support for regular professional development and CE (enhance current knowledge and high-quality animal care)
Animal care personnel training
Should be appropriately trained and institution should provide for formal and/or on-the-job training to meet the Program and job duties
AC personnel CE
Encouraged (local national LAS meetings;Institutional (on-the-job, discussions, training programs)) for their job and the species they work with
References for training program coordinators
1. AWIC 2. Laboratory Animal Welfare and Training Exchange 3. AALAS 4. ILAR 5. "The Guide to the Care and Use of Experimental Animals" by the Canadian Council on Animal Care
Research team training (12)
That they have the knowledge and expertise needed for specific animal procedures and species used (lab specific) and general training on animal care and use legislation, IACUC function, ethics of animal use, 3-Rs, Methods for reporting animal concerns, Occupational health and safety, animal handling, aseptic surgical technique, anesthesia/analgesia, euthansia
Lab CE and Retraining
Offered; given PRN to ensure adequate training before animal work
IACUC member training (4)
Understand their work and role; Foral orientation to the Program, legislation/regulations/guidelines/policies, animal facilities/labs, and protocol/program review process
The nature of the OHSP will depend on what factors? (4)
1. facility 2. research activities 3. hazards 4. animal species involved
Reference given for OHSP
NRC "Occupational Health and Safety in the Care and Use of Research Animals"; BMBL; USDA standards
An effecitve OHSP requires coordination between: (5)
1. PI/Research program 2. Program (IO, AV, IACUC) 3. Environmental health and safety program 4. Occupational health services 5. Administration
How to accomplish OHSP
A safety committee may facilitate communiation and promote ongoing evaluation of health and safety (may be required by law); Lab and facility supervisor responsible for day-to-day workplace safety
OHSP control and prevention strategies
begins with the ID of hazardes and assessment of associated risk
OHSP: Steps to managing risk (3)
1. Engineering controls (facility) 2. Administrative controls (SOP) 3. Personal protective equipment
OHSP: Risk associated with animal use should be
identified and and reduced to minimal/acceptable levels for an effecive OHSP
OHSP: Risk assessment
ongoing processes; should involve health and safety specialist to implement ssafegaurds into the Program
OHSP: List some potential hazards: (10)
1. Biologic agents 2. Chemical 3. Radiation 4. Physical (needles) 5. Unusual (field studies) 6. Animal (Allergens/bites/zoonotic disease) 7. cleaning agents 8. wet floors 9. cage washers/equipments 10. lifting, ladder use
Basis for the extend and level of personnel particiaption in the OHSP
1. based on the hazard (severity/seriousness) 2. Exposure intensity/duration/frequency (prevalence) 3. Susceptibility (immune status) of personnel 4. History of occupational illness/injury of the workplace
OHSP: Because a high standard of personal cleanliness is esential what should be available in facilities
changing, washing and showering facilities and supplies
How should a facility that uses hazards (biologic, chemical, physical) be set up
Should be separatedf orm other animal housing and support areas, research and clinical laboratories, and patient care facilities. Identify them and limit access to authorized personnel
OHSP Engineering controls and equipment to consider
ergonomic, allergen, repetitive motion
OHSP: Animals should be house were contaminated food/bedding, feces, urine can be handled how?
In a controlled manner
OHSP: Testing safety equipment
properly mantian and validate function periodically
OHSP: Safety depends on ______
Trained personnel who rigorously follow safe practices
OHSP: What should personnel at risk be provided with (training)? (4)
1. clearly defined procedures 2. PPE to conduct their duties 3. Understanding of hazards involved 4. how to be proficient in implementing safegaruds
OHSP: What should personnel at risk be trained on? (7)
1. zoonoses 2. hazards (physical, chemical, biologic) 3. unusual conditions/agents that may be part of an experiement (human tissue) 4. handling of waste materials 5. personal hygine 6. Appropriate use of PPE 7. percautions to be taken during pregnancy, illness, immunosuppression PRN
OHSP: personal hygine policies should be __________and_________
Established and enforced
OHSP: Parts of a personal hygine program (4)
1. Soiled attire disposed of, laundered, or decontaminated by the institution 2. wash/disinfect hads and change clothing PRN 3. Garment worn in animal room should not be worn outside the animal facility (unless covered) 4. Don’t eat, drink, use tobacco products, apply cosmetics, or handle/apply contact lenese in lab or animal rooms
OHSP: Safeguard areas to consider with use of Hazards in animals (7)
1. Procedures for animal care and housing 2. storage and distribution of the hazardous agents 3. Dose preparation and administration 4. Body fluid and tissue handling 5. Waste and carcass disposal 6. Temporary items that may be removed from the site (witten records, exp. devices, sample vials) 7. Personal protection
Hazard use should have these 4 things to help the OHSP
1. Written policies and procedures 2. Oversight process (safety committee; review procedure and facility) 3. Formal safety programs (assess hazards, determine safegaurds, ensure trained staff) 4. Technical support to monitor/ensure compliace
OHSP: What to do with agents of uknown risk?
Contact the CDC about control and medical surveillance
OHSP: What should the institution develop if using highly pathogenic (select agents and toxins)?
Develop a program and procedures for procuring, maintaining, and disposing of these agents
OHSP: immunodeficient/GMAs mice given biologic hazards run the risk of what?
Be more susceptible to the hazard and increase the risk of shedding
OHSP: Hazardous agents should be contained in what?
The study environment (airflow, wast scavenging)
OHSP: PPE in general should be
1. Provided by the institution 2. appropriate for the work environment (primates, hazards, hearing, respiratory protection etc) 3. not worn beyond th eboundary of the hazardous agent work area or animal facility
OHSP: Fit test
Should have suitable resp. protection with respirator fit testing and training on the proper use and maintenance of the respirator
OHSP: Who should you consult when creating your program for medical evaulation and preventive medicine
trained helth professionals (occ health)
OHSP: What can you do per-employment to assess potential risk for individuals
A preemployment health evaluation and/or a health history evaluation; repeat PRN for specific risk categories
OHSP: Immunization
Tetanus and others people may be at risk to (rabies, hepatitis B, working on an infectious disease and a vaccination is available); a schedule should be adopted
OHSP: What should be considered if preemployment or preexposure serum collection is preformed (5)
ID, traceablility, retention, storage conditions, and the purpose for use consistent with laws
OHSP: What are some considerations for allergy prevention (3)
1. Evaluation of medical history for preexisting allergies 2. Training on allergies (prevention, recognition of symptoms, proper handling of animals) 3. PPE to supplement, no replace, engineering/processing controls
OHSP: Those who work with NHP should be:
1. Routinely screened for tuberculosis 2. have access and instruciton for use of bite or scratch emergency care stations 3. If exposed be evaluated and have appropriate postexposure treatment and follow-up
OHSP: Clear procedures shoud be established for reporting ___(4)____ with medical care available
accidents, bites, scratches, allergic reactions
Personnel Security: What criminal activities should you consider? (4)
Harassment and assault, trespassing, arson, vandalism
MUST regarding animal welfare concerns
the institution MUST develop methods for reporting and investigating animal welfare concerns (responsibility of the IO and IACUC)
Responses to animal welfare concerns should include:
1. communication of findings to the concerned employee 2. corrective actions PRN 3. Report to the IO of issue, findings, and actions taken. All should be documented
Mechanisms for reporting concerns
1. Post in facility and/or website with instructions and who to contact 2. Anonymity option 3. compliance with applicable whistleblower policies 4. Nondiscrimination against reporter 5. Protection from reprisal
IACUC: Institutions responsibility to provide __(4)__ to IACUC members to assist them in understanding their role
1. Orientation 2. Background material 3. Access to appropriate resources 4. Specific training PRN
IACUC membership:
1. DVM (certified or experience and training in LAM and species) 2. Practicing scientist experienced in animal research 3. Nonscientific member (inside or outside institution) 4. Public member (general community interest)
Certifications for DVMs
ACLAM, ECLAM, JCLAM, KCLAM
IACUC public member requirments (3)
1. Not a LA user 2. Not affiliated in any way with the institution 3. Not a immediate family member of a person affiliated with the institution
IACUC Compensation of public meber
allowed for participation and ancillary expenses but should be modest and not a substantial source of income
IACUC institution members
No more than 3 voting members per administrative unit (USDA as well)
IACUC member number and terms
Dependent on size/scope of institution
IACUC oversight functions (6)
1. Review and approval of protocols 2. Review and approval of significant changes to a protocol 3. Facility and animal use area inspections 4. Review of Program 5. Ongoing assessmetn of animal care and use 6. Establishing mechanism to receive and review of animal care and use concerns
When should IACUCs meet
as often as necessary to fulfill its responsibilities (record and maintain meetings and results)
IACUC review and inspections
Program review and facility inspections at least ANNUALLY (or more often as required by the PHS and AWA); results should be enclosed in a written report (including minority views) and given to the IO (status update)
Def: Animal use protocol
detailed description of the proposed use of laboratory animals
IACUC: Topics that should be considered during protocol prep and IACUC review (15)
1. Rationale and purpose 2. clear, concise, sequential procedure discription that is understandable 3. Availability and appropriateness of 3-Rs (where could they be used) 4. Justification of species and number (stats if possible) 5. unnecessary duplication of experiments 6. nonstandard housing/husbandry 7. impact on the animals' well-being 8. Appropriate sedation, analgesia, anesthesia 9. surgical procedures 10. Postprocedural care and observation (forms/records) 11. Description & rationale for anticipated or selected endpoints 12. Criteria and process for timely intervention, removal of animals ffom study, or euthanasia if painful or stressful outcomes are anticipated 13. method of euthanasia or disposition of animal (if not euthanised then long term plan for animal) 14. Training and experience of personnel and roles and responsibilities of those involved 15. Use of hazardouse materials and provisions for safe working environements
IACUC: What scientific elements should members review in a protocol?
Those that relate to the welfare and use of tha animals (hypothesis testing, sample size, group numbers, and adequacy of controls)
What can the IACUC do if there isn't evidence of a foraml scientific merit review?
Conduct or request a scientific merit review
MUST: What if the IACUC member is named in the protocol or has other conflicts?
They MUST crecuse themselves from decisions concerning these protocols
IACUC: IACUC's reviewing procedures that have not been previously encountered or have the potential to cause pain/distress that cannot be reliably predicted or controlled should (2)
1. Gather objective information on the procedures and study purpose from vets, PIs, literature, ect. about the effects on the animal 2. Request a limited pilot study under IACUC oversight (check effects on animal and skills of research team)
IACUC: What procedures, in general, require special considerations for review?
Those that have a potential for unrelieved pain or distress or other animal welfare concerns (stronger consideration of the 3-Rs)
Def: Experimental endpoint of a study
Occurs when the scientific aims and objectives have been reached
Def: Humane endpoint
the point at which pain or distress in an experimental animal is prevented, terminated, or relieved. Should be relevant and reliable.
IACUC: How do humane endpoints contribute to refinement?
provides an alternative to experimental end-points that result in urelieved or severe animal pain and distress, including death
IACUC: examples of studies that commonly require special consideration for humane endpoints (9)
1. Tumor models 2. infectious disease 3. vaccine challenge 4. pain modeling 5. trauma 6. production of monoclonal antibodies 7. assessment of toxicologic effects 8. organ system failure 9. models of CV shock
IACUC: Regarding humane endpoints what should the PI identify, explain, and include in the protocol?
a study endpoint that is humane and scientific; recommend that they are defined prior to the start of the experiment
IACUC: Dertermination of endpoints should invlove who?
PI, Vet, IACUC
What information is critical for the IACUC to have to assess appropriate end-points (4)
1. precise definition of the humane endpoint (assessment criteria) 2. Frequency of animal observation 3. Training or personnel responsible for assessment/recognition of the humane endpoint 4. response required after humane endpoint is met
IACUC: When would a pilot study be a good idea
1. little is know on the pain/distress a procedure may cause 2. to define end-points for a new procedure (need communicaiton with the IACUC during and after)
What clarifications between the PI and IACUC can aide in humane endpoint "understanding"
1. understanding preemptive euthanasia 2. behaviroal and physiologic definitions of moribund state 3. use of study specific animal assessment records
IACUC: Why should animals exposed to highly novel variables be monitored more frequently? Give one example.
Because there is an increase for unexpected outcomes that may affect the animals well-being; Example: GMAs with unanticipated phenotypes
Def: Leakiness (as it relates to GMAs)
the promoter sequences used to direct expression of transgenes to specific tussues have varying degrees of specificity (this can lead to unanticipated phenotypes)
IACUC: Monitoring of GMAs
The first offspring of a newly generated GMA line should be carefully observed from birth to adulthood
IACUC: What should the PI report back to the IACUC/add into protocol after monitoring a new GMAs phenotype (2)?
1. If revisions in animals numbers need to occur due to infertility/breeding issues 2. When a pheotype is noticed that negatively affects animal well-being (may need more extensive phenotype analysis to circumvent/alleviate the impact and/or establish humane-endpoints)
Def: Physical restraint
the use of manual or mechanical means to limit some or all of an animal's normal movement for the purpose of examination, collection of samples, drug administration, therapy, or exp. manipulation.
IACUC: What should restraint devices take into account to minimize discomfort, pain, distress and injury
Size, design, and operation
IACUC: Prolonged restraint should be avoided unless…
it is essential for achieving research objectives and is specifically approved by the IACUC
IACUC: Examples of systems that do not limit an animal's ability to make normal postural adjustments that are recommended in some cases over restraint
SQ osmotic minipumps, backpack-filled infusion pumps (dogs, NHP), free-stall housing for farm animals
IACUC: What should happen to animals that do not adapt to necessary restraint systems?
They should be removed from the study
IACUC: 2 reasons to use restraint devices
1. when it is impossible or impractical to accomplish research goals by other means 2. Prevent injury to animals or personnel
IACUC: 9 important guidelines for restraint
1. Should not be considered a normal method of housing and MUST be justified in protocol 2. Not used as a convenience 3. Consider alternatives to physical restraint 4. Period kept to minimum needed 5. Animals should be trained to restraint device/personnel with positive reinforcement 6. Animals that fail to adapt should be removed from the study 7. Provisions made for observations of the animal at appropriate invervals (as determined by the IACUC) 8. Vet care MUST be provided if lesions/illness assocated with restraint are observed (may need to be removed even with behaviroal changes) 9. Purpose and duration clarly explained to personnel involved in the study.
The MUST of restraint
Restraint must be justified in the animal use protocol; Vet care MUST be provided if lesions/illness assocated with restraint are observed
Who determines is a surgical procedure is major or minor?
Veterinarian and IACUC
Multiple major survival surgeries are acceptible only if…
1. essential to a single research project 2. Scientifically justified by investigator 3. Necessary for clinical reasons +/- 4. Conservation of scarce animal resources (seprate protocols discouraged)
What needs to be done for multiple major survival surgeries on different protocols (MUST)
IO MUST submit a request to the USDA and receive approval in order to allow a regulated animal to undergo MMSS in a seprate unrelated research protocol
What is the mentioned reason that MMSS would not be approved
Cost savings alone
Two types of food/water regulation
1. scheduled (give for a period of time) 2. restricted (total volume controlled)
3 factorsto evaluate with food/fluid regulation
1. Necessary level of regulation 2. Adverse consequences 3. Methods for assessing the health and welbeing of the animal
Factors that influence the amount of food/fluid regulation
Species, strain, stock, gender, age, thermoregulatory demand, type of housing, time of feeding, utritive value, fiber content of diet, prior exp. Manipulation.
food/fluid regulation for consistent behavioral performance influenced by
1. difficulty of task 2. individual 3. modivation 4. effectiveness of animal training
Animals on food/fluid regulation should be monitored for what?
meets nutritional needs, body weights at least weekly, records on daily consumption/hydration status/behavioral or clinical changes outlined in protocol for removal
Use of non-pharmaceutical-grade chemicals
should be described and justified in protocol. Consider grade, purity, sterility, pH, pyrogenicity, osmolality, stability, site/route of administration, formulation, compatibility, PK, animal welfare and scientific issues
Field studies
Consider international, federal, state, and local permits…merit/impact…OccHealth issues (zoonoses) and reviewed by OHS…PI should be up to date on these things and encouraged to consult
Ag study examples
food and fiber, feeding trials,
Categorizing Ag animals
IACUC should do and define standards for care (minimum wellfare, oversight, and minimize P&D)
Ag vs Biomedical housing differences
The protocol (not the category) should determine the setting
Guides def of PAM
In guide it consist of all types of protocol monitoring after the IACUC's initial protocol approval
continuing protocol review
Annual update/review and triennial review (PHS)
Facilities _____have a disaster plan
MUST
What should a disaster plan define
1. actions necessary to prevent animal pain/distress/death (HVAC, potable water), 2. preservation of critical or irreplaceable animals 3. essential trained personnel
What do you do with animals that cannot be protected from the disaster
MUST euthanise
Who should know about the disaster plan
IO/senior-level administrator and law enforcement and emergency personnel