USDA-APHIS Animal Care Resource Policy #12 "Considerations of Alternatives to Painful/Distressful Procedures" states that when a database search is the primary means of considerations to alternatives of painful and distressful procedures, that a narrative should include all of the following except: |
C. The specific field of study |
Which of the following should be considered a significant change to an animal use proposal? |
C. change in anesthetic agent |
Which of the following entities are required to release information per the Freedom of Information Act? |
A. OLAW |
Training and instruction of personnel must include guidance in which of the following areas? |
D. Research or testing methods that limit the use of animals |
Which of the following procedures may correctly be applied to Designated Member Review? |
A. The IACUC Chair appoints one member to do the Designated Member Review. |
In which of the following circumstances may animal work begin before receipt of IACUC approval? |
D. There are no circumstances in which animal work may begin before IACUC approval. |
Which of the statements below about the responsibility and authority of the Institutional Official (IO) is false? |
C. The IO may reinstate an animal activity that was previously suspended by the IACUC. |
With regard to conducting official IACUC business, the definition of a quorum is: |
A. More than fifty percent (a majority) of voting members |
The proper sequence for a designated member review by the IACUC is: |
A. Review materials are sent to all voting members, full committee review is not requested by any member, the chairperson assigns one or more IACUC members as designated reviewers. |
Notifying investigators of IACUC protocol review outcomes in writing is: |
C. Required by both the USDA Animal Welfare Act Regulations and PHS Policy. |
According to the Animal Welfare Act Regulations of the USDA, when conducting a semi-annual evaluation, the IACUC must conduct the evaluation: |
B. With at least 2 IACUC members and allow participation by any member who wishes to do so. |
Who is given the authority to decide if a deficiency identified during a semi-annual IACUC evaluation is significant or minor? |
A. The IACUC and IO together. |
What information must be provided in the report for deficiencies identified during the IACUC semi-annual self-evaluation? |
B. A reasonable and specific plan for correcting significant and minor deficiencies and a schedule for completing the corrective actions. |
Which of the following institutions must follow the PHS Policy? |
D. Institutions that accept PHS funding. |
The three Rs of Russell and Burch stand for what? |
C. Replacement, reduction, and refinement. |
What is a primary mission of the Animal Welfare Information Center (AWIC)? |
B. Provides assistance with alternatives and database searches. |
Which agency requires an annual report of the number of animals used by pain/distress category? |
D. United States Department of Agriculture |
Regarding studies with infectious agents in animals, as the BSL and ABSL number increases from 1 to 4, what happens to the containment and safeguard practices? |
D. They become more stringent. |
U.S. Government Principles on the Use of Animals in Research state that: |
D. Procedures that are painful to humans should be assumed to cause pain in animals unless there is evidence to the contrary. |
Which of the statements below about the responsibility and authority of the Institutional Official (IO) is false? |
C. The IO may reinstate an animal activity that was previously suspended by the IACUC. |
PHS policy states that the OLAW requires assurance renewal every: |
b) up to five years |
The guide incorporated two must to Diaster Planning and Emergency Prepardness which involved: |
3. c and e |
For the VA semiannual program review and facility inspection report, which of the following need not be included: |
c. The signatures of the majority of the voting members |
According to the Guide, who can conduct Post-Approval Monitoring (PAM)? |
e) all the above |
According to PHS, awardee institutions shall maintain good recordkeeping. Which one is not a recordkeeping requirement? |
e) none of the above |
The 8th addition of the guide incorporated new additions to the guide: IACUC, IACUC Training, Personnel Security, Investigating and Reporting Animal Welfare Concerns, Veterinary Clinical Care Management, Drug Storage and Control. According to the Guide, what item not a requirement for IACUC members: |
b) Training by a certified veterinarian on all procedures involving animals |
Which of the following is not required for IACUC membership according to the Ag Guide: |
a. veterinarian with training or experience in laboratory animal science and medicine |
USDA Regulations require the following IACUC members: |
1. Veterinarian, chair, nonaffiliated |
PHS Policy requires the following IACUC members: |
3. Veterinarian, nonaffiliated, scientist, nonscientist |
PHS and AWRs state that all records should be kept for a minimum of: |
c) 3 years |
PHS institutional Assurance is approve up to ___ years where as USDA registration is updated every ___ years: |
b) up to 5 years for PHS and 3 years FOR USDA |
Which is not required when filing a PHS Institutional Assurance: |
c) Number of covered species used annually |
If the institution is PHS assured and is not AAALAC accredited, what must be included in the annual report to OLAW? |
c) Semiannual IACUC report |
What are the two circumstances that you would submit a semiannual report to OLAW? |
At the request of OLAW or if your institutional is not assured by a accrediting body such as AAALAC |
What line of authority submits the annual report to OLAW? |
The IO |
Where do you send the USDA annual report? |
APHIS AC Regional Director. |
When there is a change in name of institution, or ownership or operation for the research facility how many days do you have to notify the APHIS AC Regional Director of the change? |
Notify within 10 days of change in operation. |
According to USDA, failure to correct a significant deficiency in accordance to a specific schedule and plan must be reported to APHIS and any other federal agency within ____days by who_____? |
Notify within 15 days by the IACUC through the IO. |
There are three main circumstances for prompt report to PHS, which one of the three circumstances below must be reported promptly to USDA: |
d) none of the above |
When there are allegations of concerns on animal care and use, what are recommended steps for the IACUC when investigating the concern: |
e) all the above |
True or False. If a facility that receives DoD funds is under USDA investigation, the facility must notify DoD and have a site visit within 30 days of notification. |
True |
True or False. The Secretary of the Army as Executive Agent develops and issues joint service regulations to implement the Department of Defense Directive number 3216.1. |
True |
True or False. DoD Activities performed or sponsored in foreign countries shall follow all applicable US requirements, as well as regulations and standards of the host country. |
True |
True or False. The non-affiliated member(s) on a DoD IACUC may be a federal employee with demonstrated commitment to the community. |
True |
True or False. DoD organizations/facilities are not required to apply for AAALAC accreditation. |
False |
True or False. Violation complaints within the DoD can only be reported to the Inspector General. |
False |
True or False. The Department of Defense directive indicates that any species may be purchased or used for inflicting wounds from any type of weapon to conduct training in surgical/medical treatment procedures. |
False |
True or False. The Joint Technical Working Group (JTWG) acts as a central advisory committee to the Armed Services Biomedical Research Evaluation and Management (ASBREM) Committee. |
True |
The Executive Agent designates the Commander of the US Army Veterinary Command, the Director of Veterinary Services Activity, the Director of Defense Research and Engineering and: |
d. None of the above |
Which of the following are applicable to the Department of Defense: |
e. All of the above |
The Executive Agent for the Department of Defense Directive number 3216.1 is the _____ |
b. Secretary of the Army |
According to the 8th edition of the Guide each institution must or should have an occupational health program in place consistent with federal, state and local regulations? |
a) must |
True or False: Institution procuring animal must have lawful procedures in place as well as procedures for compliance with animal transportation regulations to include international requirements. |
True |
Programs for medical evaluation preventative medicine include all the following except: |
g) Nove of the above |
Which of the following is not typically a function of the IACUC? |
C. Review and score scientific value for animal protocols submitted. |
Which of the following is a required member of the IACUC? |
C. Individual not otherwise affiliated with the institution |
According to USDA Regulations, an IACUC may have no more than how many members from any one administrative unit? |
B. 3 |
Which of the following statements concerning confidentiality of IACUC business is false? |
D. Confidentiality requirements prohibit IACUC members from reporting violations of the Animal Welfare Act Regulations or PHS Policy. |
What do the Animal Welfare Act Regulations state about IACUC members who report violations to USDA? |
C. It is against the law for anyone to discriminate against them or subject them to reprisals. |
OLAW recommends which of the following reporting lines within an animal care and use program? |
B. Attending Veterinarian reports to the Institutional Official |
Which of the following statements about OLAW’s guidance on the use of carbon dioxide as a euthanasia agent is false? |
A. Carbon dioxide must be supplied only from compressed gas cylinders. |
Which of the following statements about IACUC suspensions of animal activities is false? |
A. USDA Animal Welfare Act Regulations and PHS Policy allow the chairperson or another IACUC member to suspend an animal activity on behalf of the IACUC. |
When reporting an IACUC suspension of an animal activity, the IACUC should: |
B. Report the suspension as soon as possible to the regulatory authorities. |
Which of the following statements regarding the process of polling IACUC members via email is true? |
D. Polling via email can be used to allow the IACUC members to call for full committee review when using the designated reviewer system. |
Which of the following statements about the use of "alternate" IACUC members is false? |
C. Alternate members may vote on an issue even when the regular member is present and votes on the same issue. |
Which of these IACUC protocol review outcomes are recognized in the USDA Animal Welfare Act Regulations and PHS Policy? |
C. Approve, require modifications in (to secure approval), and withhold approval |
Although opinions vary about the level of detail needed in IACUC minutes, a typical standard is that IACUC minutes: |
B. Should allow an outside observer to verify that deliberations occurred, and understand the outcomes of those deliberations. |
When conducting the facilities inspection portion of the semi-annual evaluation in compliance with both the USDA Animal Welfare Act Regulations and PHS Policy, the IACUC must include: |
D. All areas housing animals for more than 12 hours, and laboratories where animal procedures are performed with the exception of laboratories performing only non-survival surgical procedures. |
To comply with the USDA Animal Welfare Act Regulations, what is the proper IACUC course of action to follow if a significant deficiency is not corrected according to the plan set forth in the IACUC semi-annual evaluation report? |
D. Report the situation through the IO to USDA within 15 business days. |
Which of these statements is true concerning the USDA Animal Welfare Act? |
D. The Animal Welfare Act regulations take precedence over guidelines produced by the Public Health Service, Department of Veterans Affairs, and other government agencies. |
Which of the following is not an example of replacement? |
C. The use of a new analgesic that provides better postoperative pain relief. |
Which of the following is not an example of reduction? |
A. The use of a new anesthetic that provides better induction and a shorter recovery period. |
Which of the following is not an example of refinement? |
C. The use of computer modeling software to substitute for animal experiments. |
What is required, of the IACUC, by the USDA AWA Regulations regarding alternatives? |
D. Ensure that the principal investigator has considered alternatives to painful or distressing procedures, and review a written assurance that alternatives are not available. |
What is the basis for the pain/distress classification system used by most institutions? |
C. USDA pain/distress categories. |
Which of the following activities would disqualify an animal from USDA category B? |
A. Blood collection. |
Which of the following activities would disqualify an animal from USDA category D? |
D. Studies in which animals are allowed to die without pain relief. |
An investigator wishes to use animals in an experiment that involves category B, C, and D activities performed on the same animal. How should the animal be categorized? |
D. Category D. |
Which of the following activities would place an animal in category E? |
A. Lethal dose experiments in which animals are allowed to die without intervention. |
All personnel performing animal procedures must be properly trained to do so when? |
B. Before any procedures are performed. |
Which statement about the Occupational Health and Safety Program is false? |
C. You may not decline medical treatments provided as part of the Occupational Health and Safety Program. |
Which of the following is false concerning prolonged restraint of animals? |
B. It can be justified as a convenience for the research staff. |
Which of the following is true of the dog exercise program mandated by the USDA Animal Welfare Act regulations? |
B. The IACUC can exempt an animal for scientific |
Great Southern Agricultural and Technical University has an Animal Welfare Assurance Statement on file with OLAW that covers all PHS funded projects. The University’s policy states that all use of live vertebrate animals for teaching and research requires IACUC review and approval. A faculty member contacts the IACUC Chair to report that he demonstrated a blood sampling procedure on a live chicken for a teaching lab, but it was not the blood sampling method described in the IACUC approved protocol for the lab. The IACUC must report this noncompliance to: |
3) The University’s IO |
The institution’s PHS Assurance applies to PHS-funded projects only. An investigator has two IACUC protocols using mice. Protocol A (NIH funded) stipulates that animals will be killed by barbiturate overdose while decapitation would be the method used in Protocol B (private foundation funds). The investigator informs the IACUC Office that his staff mistakenly euthanized a few animals assigned to Protocol B with barbiturate overdose. How should the IACUC respond? a) Suspend the investigator. |
a) you could suspend, but it’s not required, and would probably make people mad at the IACUC. b) reporting noncompliance to the USDA is not required. c) this institution’s Assurance applies to PHS funded activities only therefore reporting noncompliance on a project not funded by the PHS is not required. d) probably the best practice to prevent future noncompliance. Source: Certified Professional IACUC Administrator (CPIA) Study Group – Facebook Post by Molly Greene Haywood on February 8, 2013 |
Which entity does not require the IACUC to have a scientific member? |
USDA Source: Certified Professional IACUC Administrator (CPIA) Study Group – Facebook Post by Molly Greene Haywood on March 6, 2013 |
Which of the following statements is true about routes of administration for injectable agents? a. When performing an IP injection, the drug must also contain a neuromuscular blocking agent. |
c. IC injection is acceptable when the animal is either heavily sedated, anesthetized, or comatose. Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines |
What is the recommended concentration of carbon monoxide used for euthanasia of small mammals? a) Over 10% |
d) 4-6% Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines |
Under what circumstance is the IV or IC injection of potassium chloride an acceptable euthanasia method? a) When other methods have failed |
d) If the animal is anesthetized Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines |
For which species is an adjunctive method of euthanasia is recommended to make sure that the animal is dead because detection of heartbeat is difficult in these animals? a) Fish |
c) Small rodents Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines" |
Physical methods of euthanasia cause death through destruction of: a) muscular activity in the body. |
d) midbrain centers controlling respiratory and cardiac activity. Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines |
A reflex movement during the euthanasia procedure indicates that the unconscious animal is still experiencing pain. a) True |
b) False Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines" |
Which of the following statements is true of barbiturates? a) Barbiturates cause the animal to gasp for air before becoming unconscious indicating some pain and distress. |
b) These drugs are extremely painful when administered outside the vein. Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines |
Which of the following statements regarding physical methods of euthanasia is true? a) There are few aesthetic considerations for this form of euthanasia. |
b) Physical methods of euthanasia may be the most humane method for relieving pain and suffering in some instances. Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines" |
In special circumstances that may indicate a need to deviate from the AVMA guidelines, what should be the deciding factor? a) The cost of the procedure |
b) The best interest of the animal Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines" |
Cervical dislocation should not be performed in rabbits weighing more than: a) 500 g. |
d) 1 kg. Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines |
Which of the following statements is true about the use of carbon monoxide for euthanasia? a) Acceptable for individual or mass euthanasia of cattle, horses, and other large mammals. |
c) Death occurs rapidly at concentrations of 4 to 6%. Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines |
Confirmation of death is determined by: a) Lack of movement |
c) Cessation of vital signs Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines" |
What is the mode of euthanasia action for an overdose of barbiturates? a) Depresses the CNS leading to cardiac arrest |
a) Depresses the CNS leading to cardiac arrest Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines" |
Which of the following is a definition of euthanasia as described in the AVMA Guidelines? a) The act of killing animals by methods that preserve physiologic function after death |
b) The act of killing animals by methods that induce rapid unconsciousness and death with minimal pain or distress Feedback: Euthanasia as defined by the Animal Welfare Act (AWA): ""The humane destruction of an animal must be accomplished by a method that produces rapid unconsciousness and subsequent death without evidence of pain or distress, or a method that utilizes anesthesia produced by an agent that causes painless loss of consciousness and subsequent death."" Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines |
Euthanasia agents that act by way of hypoxia are not recommended for which of the following groups of animals? a) Warm-blooded neonates |
a) Warm-blooded neonates Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines" |
Which of the following statements is true about inhalant agents used for euthanasia? a) Since inhalant anesthetic effects are specific to the animal species being euthanized, no special precautions for personnel are required. |
d) Animals should be protected from contact with the liquid form of the anesthetic agent. Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines" |
Which of the following statements is true when using CO2 for euthanasia? a) It is best to combine carbon dioxide with oxygen for euthanasia. |
d) Gas flow should be maintained for at least 1 minute after apparent death to make sure the animal does not recover. Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines |
Immersing aquatic species in a bath saturated with carbon dioxide is an acceptable euthanasia method. a) True |
a) True Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines" |
Which of the following statements concerning euthanasia is incorrect? a) Physical methods of euthanasia are most desirable when used on conscious animals. |
a) Physical methods of euthanasia are most desirable when used on conscious animals. Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines |
Chloral hydrate is conditionally acceptable for use in large animals that: a) are already sedated. |
a) are already sedated. Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines" |
Which of the following mandates require the provision of occupational health services for employees who work in animal facilities? a) Occupational Health and Safety Act |
d) PHS Policy Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Occupational Health and Safety in the Care and Use of Research Animals" |
Serum collection and storage may be of value in which of the following situations? a) A veterinary technician is providing medical care to rabbits in safety assessment studies. |
b) Employees have a substantial possibility of acquiring an infection that can be detected serologically. Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Occupational Health and Safety in the Care and Use of Research Animals" |
Which person is primarily responsible for developing and sustaining a useful occupational health and safety program? a) IACUC chairperson |
b) Senior institutional official Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Occupational Health and Safety in the Care and Use of Research Animal" |
Which of the following statements is false concerning shigellosis? a) Very large numbers of organisms are required to produce an infection. |
a) Very large numbers of organisms are required to produce an infection Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Occupational Health and Safety in the Care and Use of Research Animals" |
The effectiveness of the autoclave can be monitored by using: a) Paper strips or vials containing bacterial spores |
a) Paper strips or vials containing bacterial spores Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Occupational Health and Safety in the Care and Use of Research Animals |
Which of the following are in a unique position to monitor the daily effectiveness of and compliance with health and safety procedures in a laboratory animal program? a) Principal investigators |
b) Animal care staff Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Occupational Health and Safety in the Care and Use of Research Animals" |
Which of the following statements is true concerning dermatomycosis? a) Infected animals usually have several obvious lesions. |
d) None of the above Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Occupational Health and Safety in the Care and Use of Research Animals" |
Which of the following is not an effective means of identifying hazards? a) Consulting personnel from governmental agencies (e.g., NIH, CDC, OSHA) |
b) Considering only those hazards that previously caused obvious illness or injury Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Occupational Health and Safety in the Care and Use of Research Animals |
How often should biological safety cabinets be certified? a) At the time of the IACUC inspection |
d) At least once a year Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Occupational Health and Safety in the Care and Use of Research Animals |
Which of the following is not considered to be a major mode of transmission of the herpes B-virus? a) Needle stick |
c) Aerosol Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Occupational Health and Safety in the Care and Use of Research Animals" |
Which of the following viruses causes a disease similar to smallpox but much less severe? a) Measles |
b) Benign epidermal monkeypox Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Occupational Health and Safety in the Care and Use of Research Animals |
Which of the following infections is particularly hazardous to a human fetus? |
b) Toxoplasmosis |
Which disease is not readily transmitted to humans through animal bites? |
a) Measles |
What are allergic reactions seen within 10 to 15 minutes of exposure called? |
b) Immediate hypersensitivity |
Occupational health and safety programs intended to protect employees in animal facilities should be the same at all institutions where research animals are housed. |
b) False |
Which of the following is not a hazardous property of a chemical? |
b) Hardness |
The use of radioisotopes is regulated by what agency? |
a) US Nuclear Regulatory Commission |
Which of the following should not be a consideration when selecting proper equipment for facilities? |
d) Lease expensive |
Which of the following statements is true? a) Female mice excrete four times as much allergen as males. |
c) Sensitivity to mouse allergen is common |
Which of the following is not a good method to prevent Q fever infection in laboratory workers? |
a) Rely on serology in sheep to detect shedding of the organism. |
What is included in Animal Welfare Regulations for housing guinea pigs and/or hamsters? |
b) Cages for hamsters must be at least 5 inches high. |
Who has the legal authority to sign the USDA registration form of a research institution? |
b) The Institutional Official |
How frequently does the USDA conduct inspections of research facilities? |
a) Once a year |
Dogs obtained from a Class B dealer may originate from what source? |
d) All of the above |
What is one objective of the annual report to the USDA/APHIS? |
a) Assure that the facility complies with the AWA standards and regulations. |
Record-keeping requirements of the Animal Welfare Regulations state that: |
d) IACUC records for meeting minutes, protocols and semiannual reports must be available to USDA inspection. |
What determines cage space requirements for nonhuman primates as outlined in the Animal Welfare Regulations? |
c) Weight group of the nonhuman primates |
The AWA Regulations require that the attending veterinarian must: a) Approve animal use protocols. |
b) Have authority to ensure adequate veterinary care. |
What is not required by Animal Welfare Regulations for transport cages? |
b) An elevated screened bottom to keep animals off the floor of the cage |
Which statement is TRUE about exercise plans for dogs? |
d) Exercise plans are required for all facilities housing dogs. |
What type of identification is not acceptable for dogs or cats at acquisition? |
d) Distinctive color markings |
Which statement is TRUE regarding health requirements for shipping animals: |
b) Health certificates must accompany any dog, cat or nonhuman primate transported by a research facility. |
Animal Welfare Regulations for rabbits require: |
b) Cages to be sanitized once every 30 days. |
What change was made to the Animal Welfare Act by the 1990 pet protection amendment? |
c) Cats and dogs must undergo a 5-day holding period before being acquired by a dealer. |
Which of the following information need not be present on an official tag? |
c) Date of birth |
What requirement does the Animal Welfare Act place on multiple survival surgery? |
a) Multiple survival surgeries are permitted when scientifically justified. |
Which of the following is NOT a responsibility of the IACUC? |
d) Specifying veterinary treatments to be administered to facility animals. |
A person supplying dogs to research is exempted from licensing with the USDA under which of the following conditions? |
b) Fewer than 25 dogs born on their premises are sold within a one-year period. |
What space requirements for cats are included in the Animal Welfare Regulations? |
a) If clean and sanitized, the litter box can be counted as floor space. |
Record-keeping requirements of the Animal Welfare Regulations state that: |
c) Acquisition records must be maintained for dogs and cats that are received by the facility. |
Reports prepared by the IACUC during semiannual facilities inspections must distinguish between minor and significant deficiencies. Which of the following best describes a significant deficiency? |
a) Poses a threat to the health and safety of the animals |
On behalf of an institution, which individual is ultimately responsible for compliance with PHS Policy? |
d) Institutional Official |
Which of the following statements is TRUE? |
b) Sheep used in a study testing different ways to improve the quality of wool for use in clothing would NOT be covered by the Animal Welfare Act. |
According to the PHS policy, any building, room, or area used for confinement, transport, or experiments including surgery is considered an animal facility if the animals are maintained there for more than ______ hours. a) 48 |
c) 24 |
According to the PHS Policy, can the non-affiliated member and the nonscientific member of the IACUC be the same person? |
c) Yes, but the committee still must consist of no less than five members. |
Which of the following is an example of a record that is NOT required by the IACUC to maintain? |
b) Minutes of veterinary rounds meetings |
What does the PHS Policy state about the use of the Guide for the Care and Use of Laboratory Animals by institutions receiving federal funding for research? |
b) It requires that they use the Guide as a basis to develop and implement their animal care and use program. |
What are three components that must be described in the Animal Welfare Assurance? |
d) Animal Care and Use Program description, Institutional Status, and IACUC membership |
According to the PHS Policy, the definition of animal includes which of the following? |
b) Any live vertebrate animal |
Which of the following is not an IACUC activity? |
c) Administering the employee health service |
Which US agency requires placing animals used in research into pain/distress categories? |
c) USDA |
What is the organization whose guidelines on euthanasia are required by the PHS Policy? |
b) American Veterinary Medical Association |
Who appoints the IACUC members? |
c) The CEO of the institution |
Several types of records must be maintained by research institutions (i.e., minutes of IACUC meetings, etc.). How long must these records be retained by the institution for possible review after the completion of the project? |
c) 3 years |
What best describes the required composition of a 5-member IACUC? |
c) a veterinarian, a scientist, a nonscientist, and a public member not affiliated with the institution |
PHS Policy ______________ an occupational health and safety program for PHS-assured institutions. |
b) requires |
Which federal law mandates the PHS Policy? |
c) Health Research Extension Act (1985) |
Which of the following is NOT a component of the veterinary care program? |
e) Training of husbandry personnel on changing cages |
What is a quorum of a committee? |
b) More than half of the members |
The institution’s program for the care and use of animals should include which of the following information? |
e) All of the above |
Which is NOT a main objective of the Guide? |
a) To provide institutional policies |
Which is an example of appropriate enrichment for a guinea pig? |
d) Shelter |
What does the term primary enclosure mean? |
c) A cage, pen, or stall |
Which of the following statements about an HVAC system is FALSE? a) Air intakes that remove air from the outside should be located away from vehicles and equipment that generate exhaust fumes. |
d) Each institution’s HVAC system should maintain each room’s temperature by +/- 5° C. |
Which of the following is NOT a role of the attending veterinarian? |
b) Approving animal use protocols |
What type of drug must be used with neuromuscular blocking agents? |
b) General anesthetic |
Areas for quarantine, hazardous substance studies, and nonhuman primate rooms should be kept at ______________ pressure. |
b) negative |
Feed and bedding should be: |
b) protected from vermin and toxic substances. |
Which of the following types of drugs relieve pain? |
d) Analgesics |
What is the shelf life for feed that is fortified with non-stabilized vitamin C? |
d) 3 months |
Which term is defined in the Guide as "an aversive state in which an animal fails to cope or adjust to various stressors with which it is presented"? |
c) Distress |
What is the main problem caused by algae growth in an aquatic system? |
c) Blocks ability to easily observe animals |
Life support systems are usually one of three types: re-circulating, flow-through, or ____________________. |
d) static |
Which hazard is addressed with the use of bite and scratch emergency kits? |
b) Macacine herpesvirus 1 |
Which of the following is the best definition of a laboratory animal as defined by the Guide? |
d) Any vertebrate animal produced for or used in research, testing, or teaching. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – US Mandates and Guidelines – 8th Edition of the Guide for the Care and Use of Laboratory Animals (2011) |
In the Guide, which term means the physical structure that contains the water and the animals, and the equipment used to move and/or treat the water? |
c) Life support system Source: AALAS Learning Library Regulatory and IACUC Compliance Track – US Mandates and Guidelines – 8th Edition of the Guide for the Care and Use of Laboratory Animals (2011) |
Which of the following statements is TRUE regarding the Guide’s discussion of the use of non-pharmaceutical grade chemicals? |
a) The use of non-pharmaceutical grade chemicals should be described and justified in the IACUC-approved protocol. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – US Mandates and Guidelines – 8th Edition of the Guide for the Care and Use of Laboratory Animals (2011) |
Which of the following animals require the same minimum cage height recommendations in the Guide? |
b) Rats and guinea pigs Source: AALAS Learning Library Regulatory and IACUC Compliance Track – US Mandates and Guidelines – 8th Edition of the Guide for the Care and Use of Laboratory Animals (2011) |
Who has the responsibility to ensure that all personnel working with live animals have been properly and appropriately trained? |
d) IACUC Source: AALAS Learning Library Regulatory and IACUC Compliance Track – US Mandates and Guidelines – 8th Edition of the Guide for the Care and Use of Laboratory Animals (2011) |
Which are used to standardize the method for performing specific institutional practices and procedures? |
c) Procedures Source: AALAS Learning Library Regulatory and IACUC Compliance Track – US Mandates and Guidelines – 8th Edition of the Guide for the Care and Use of Laboratory Animals (2011) |
Which is true about the effects of anesthetics? |
b) Consciousness is lost before the perception of pain is lost. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – US Mandates and Guidelines – 8th Edition of the Guide for the Care and Use of Laboratory Animals (2011) |
Which term is defined in the Guide as "all measures to control known or unknown infections in laboratory animals." a) Biosafety |
b) Biosecurity Source: AALAS Learning Library Regulatory and IACUC Compliance Track – US Mandates and Guidelines – 8th Edition of the Guide for the Care and Use of Laboratory Animals (2011) |
Which of the following statements regarding floor drains is TRUE?? |
b) Floor drains are not necessary in all animal rooms; but if they are used, they should be at least 4 inches in diameter. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – US Mandates and Guidelines – 8th Edition of the Guide for the Care and Use of Laboratory Animals (2011) |
Which of the following serves as a biological filter in the life support systems of aquatic animals? |
b) Denitrifying bacteria Source: AALAS Learning Library Regulatory and IACUC Compliance Track – US Mandates and Guidelines – 8th Edition of the Guide for the Care and Use of Laboratory Animals (2011) |
Which of the following is FALSE regarding performance standards? |
d) Performance standards define the methods in detail to be used to achieve the outcome. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – US Mandates and Guidelines – 8th Edition of the Guide for the Care and Use of Laboratory Animals (2011) |
When a federal employee licenses an invention to a private company, the employee cannot continue to work on the invention while on government duty because of the disqualifying interest represented by the employee’s financial stake in the invention. |
a) True Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Conflict of Interest |
As a VA employee, you are required to disclose intellectual property to the VA so that the VA can determine if it has a claim on that property. |
a) True Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Conflict of Interest |
When should you get agency advice regarding activities that may create a conflict of interest? |
d) Before you engage in that activity. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Conflict of Interest |
To protect yourself from potentially severe penalties, you should discuss and fully disclose potential outside payment and royalty opportunities with whom? |
d) An agency ethics official. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Conflict of Interest |
To violate Section 208, the employee’s disqualifying financial interest must be a party to the matter in which he/she is making a recommendation. |
b) False Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Conflict of Interest |
If a VA researcher is conducting research "after-hours", A VA non-profit research corporation may supplement this employee’s salary for the work although he is performing the same research project during his official tour of duty. |
b) False Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Conflict of Interest |
Stocks held by a sector fund outside of the main business or sector concentration do not usually represent a disqualifying financial interest under 18 U.S.C. § 208. a) True |
a) True Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Conflict of Interest |
A federal researcher or clinician who receives royalty payments or compensation from a company licensing an invention can represent that company in matters in which the U.S. is a party or in which the U.S. government has a direct and substantial interest. a) True |
b) False Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Conflict of Interest |
A federal physician is asked to speak about his federal research on AIDS after work to a non-profit organization. He can probably accept a payment or honorarium for the presentation without violating ethics statutes or regulations. a) True |
b) False Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Conflict of Interest |
A part-time federal physician wishes to recruit VA patients for a privately-funded clinical study, but she is not sure if this will violate one or more ethics statutes. Her best course of action would be to consult with VA ethics legal counsel: |
d) Before proceeding with VA patient recruitment. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Conflict of Interest |
A "regulation" is written by an agency to provide more specific information on complying with statutes, and to help ensure uniform application of the statutes. Administrative penalties such as job termination can result from violating regulations. a) True |
a) True Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Conflict of Interest |
If a federal employee assigns intellectual property rights for an invention to the Government, the Federal Technology Transfer Act allows royalty payments to the employee in excess of their official pay up to a $150,000 maximum per year. a) True |
a) True Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Conflict of Interest |
The VA may decide to give a waiver to an employee to participate in a particular matter if the disqualifying financial interest is not so substantial as to be deemed likely to affect the integrity of the employee’s government service. a) True |
a) True Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Conflict of Interest |
A recent ruling would allow federal employees to recommend purchasing drugs produced by a pharmaceutical company held by a sector mutual fund so as long as the employee, his/her spouse and dependent child did not own more than what amount of the sector fund? a) $10,000. |
d) $50,000 |
"Statute" is another term for a law passed by Congress as part of the legislative process. Violations of certain statutes can result in civil fines and even imprisonment. a) True |
a) True |
Which federal agency decides if an employee has violated conflict of interest statutes? a) Department of Veterans Affairs. |
e) Department of Justice |
Federal employees may use their Government position or title to endorse a product or service. a) True |
b) False Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Conflict of Interest |
WOC (Without Compensation) employees are not covered by ethics statutes because they are not receiving a federal salary. a) True |
b) False Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Conflict of Interest |
VA non-profit research corporation (foundation) employees are subject to the same federal criminal conflict of interest statutes and ethics regulations governing conduct of federal employees. a) True |
a) True Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Conflict of Interest |
Minority opinions in IACUC minutes are not directly addressed in the language of the USDA Animal Welfare Act Regulations or PHS Policy. Which of the following statements best reflects the operation of an effective IACUC? a) It is very damaging to IACUC harmony for minority opinions to be expressed, and they should be allowed only in exceptional circumstances. |
d) It is a best practice to include them whenever an IACUC member requests to do so. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
The two IACUC review methods recognized by the USDA Animal Welfare Act Regulations and PHS Policy are: |
b) full committee review and designated review. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
The Animal Welfare Regulations and PHS policy do NOT allow the IO to do which of the following? |
d) Approve an activity involving animals Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
Which of the following statements is TRUE regarding review outcomes in full committee review versus designated review of animal protocols? |
b) The "withhold approval" option is available in full committee review, but not designated review. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
Which of the following statements about modifications or amendments to animal protocols after IACUC approval is TRUE? |
a) Significant changes must be reviewed and approved by the IACUC before they are implemented. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
Regarding IACUC use of review outcomes such as "approval pending," "conditional approval," or "deferred," which of the following is TRUE: |
a) These terms mistakenly imply that IACUC approval for an animal activity has been given, and that work may proceed as soon as formal notification has been given in writing. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
When reporting an IACUC suspension of an animal activity, the IACUC should: |
b) report the suspension as soon as possible to the IO, who must then notify regulatory authorities. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
It is particularly important for IACUC members who are serving as the lay member or the non-affiliated member to do what? |
a) Ask questions if they do not understand so they can effectively fulfill their roles on the IACUC Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
To comply with the law, after the IACUC semi-annual self-evaluation report has been written, a majority of: |
a) A majoriity of all voting members must review and sign it, then it is submitted to the CEO. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
To comply with the Animal Welfare Regulations, what is the proper IACUC course of action to follow if a significant deficiency is NOT corrected according to the plan set forth in the IACUC semi-annual evaluation report? |
c) Report the situation through the IO to USDA within 15 business days. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
The regulatory entities that enforce the Animal Welfare Act and Regulations and PHS Policy, respectively, are: |
d) USDA/APHIS/Animal Care and OLAW. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
Although opinions vary about the level of detail needed in IACUC minutes, a typical standard is that IACUC minutes: |
d) should allow an outside observer to verify that deliberations occurred, and understand the outcomes of those deliberations. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
If an IACUC member has a conflict of interest in reviewing a certain protocol, they may not vote on that proposal, and it is a best practice for them to: |
b) remove themselves completely from the IACUC meeting room during IACUC deliberations on that protocol. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
According to the law, when conducting a semi-annual self-evaluation, the IACUC must conduct the evaluation with: |
b) at least 2 IACUC members, and allow participation by any member who wishes to do so. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
The proper sequence for a designated review by the IACUC is: |
a) Review materials are sent to all voting members; full committee review is not requested by any member; the Chairperson assigns one or more IACUC members as designated reviewers. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
Which of these IACUC protocol review outcomes are recognized in the Animal Welfare Regulations and PHS Policy? |
d) Approve, require modifications (to secure approval), and withhold approval. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
Which of the following do NOT facilitate an effective IACUC protocol review? |
d) Members who are reluctant to express differing opinions Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
The CEO is the highest ranking administrative official at an institution whereas the IO is the official with authority to commit institutional resources to ensure that the animal care and use program is in compliance. Which of the following statements is FALSE? |
d) The CEO must also be the IO. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
Which of the following statements regarding the process of polling IACUC members is TRUE? |
d) Polling can be used to allow the IACUC members to call for full committee review before using the designated reviewer system. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
Which of the following lists the required members of an IACUC constituted to comply with both Animal Welfare Regulations and PHS Policy? |
d) 5 members- Chair, veterinarian, scientist, non-scientific member, and non-affiliated member Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
Regarding investigations of complaints, which of the following statements is TRUE? |
d) There is no required process for investigating concerns expressed about animal care and use; however, investigations must be quick and complete. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
Which of the following statements about IACUC suspensions of an animal activity is FALSE? |
c) Once notified of an IACUC suspension by the IACUC, the IO must convene an advisory committee to decide if it should be reported to regulatory authorities. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
When conducting the facilities inspection portion of the semi-annual evaluation in compliance with both the Animal Welfare Regulations and PHS Policy, the IACUC must include all areas housing animals for more than: |
c) 12 hours, and all investigator laboratory and study areas where surgery is performed. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
Which of the following statements about IACUC membership is FALSE? |
b) Compensation may not be paid to the non-affiliated member for expenses such as travel, parking, meals, and participation because any payment could influence votes on the IACUC. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
Both the USDA Animal Welfare Regulations and PHS Policy emphasize that the IACUC semi-annual self-evaluation of the animal care and use program must include two review components. What are they? |
d) Facility inspection and program review Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Essentials for IACUC Members |
What is Post Approval Monitoring? |
b) Comparing the actual activities that are occurring against the written protocol document Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Post-Approval Monitoring |
The PAM program is required by PHS Policy and the Animal Welfare Regulations to investigate any animal welfare concerns reported to them. |
b) False Feedback: A formal PAM program is not required by PHS Policy or the Animal Welfare Regulations. However, the IACUC IS required to investigate any reports of concerns for animal welfare. Many institutions use PAM staff to investigate these concerns and then report directly to the IACUC so the Committee may adjudicate. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Post-Approval Monitoring |
Which of the following statements is FALSE? |
d) Investigators are usually allowed to house animals in the laboratory if it is only for a couple of days. Feedback: Animals should not be housed in the laboratory without special permission or oversight. Institutions should have policies regarding laboratory animal housing; refer to these specific policies or guidelines for details. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Post-Approval Monitoring |
Which of the following would occur if a PAM staff member finds a serious noncompliance? |
b) The staff member should report the issue to the IACUC. Feedback: The staff member should report the issue to the IACUC, and the IACUC should decide the consequences. The IACUC or IACUC Coordinator should contact OLAW, if it is determined that this is necessary. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Post-Approval Monitoring |
What factors should you consider when designing a PAM program for your institution? |
e) All of the above Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Post-Approval Monitoring |
All of the following are good reasons to formalize a PAM program EXCEPT: |
c) It provides instructions for veterinary staff on the latest advances in veterinary care. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Post-Approval Monitoring |
Which statement is TRUE about an ACTIVE PAM program? |
a) Staff may or may not be dedicated to performing post-approval monitoring; however, some of their time is spent actively monitoring compliance with approved protocols. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Post-Approval Monitoring |
What is the main disadvantage of a passive PAM program? |
b) A whistleblower atmosphere may be created. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Post-Approval Monitoring |
Why are inspections, or assessments of animal use areas, an important part of a PAM program? |
d) Inspections enable PAM staff to see what is actually being done in an area, including the drugs and agents being used on the animals. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Post-Approval Monitoring |
If USDA-covered animals are involved in a compliance incident, what must the institution report to the USDA? |
c) Only suspensions of animal activity by the IACUC should be reported to the USDA. Feedback: Institutions are only required to report suspensions of activity by the IACUC to the USDA (if USDA-covered species are involved). Source: AALAS Learning Library Regulatory and IACUC Compliance Track – IACUC Members and Administration – Post-Approval Monitoring |
What is the procedure for removing soiled cages from a procedure room? |
d) Take them to the cagewash room yourself at the end of the day. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Facilities, Supplies, and Materials |
How much extra caging can be stored in the procedure room at one time? |
d) Enough for short term use (less than 2 days) Feedback: The purpose is to keep only what is necessary for short-term use. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Facilities, Supplies, and Materials |
What area has the same level of standards and care as animal procedure rooms? |
a) Animal rooms Feedback: Procedure rooms should be more controlled than this area. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Facilities, Supplies, and Materials |
How does one know there is a hazard in a room? |
c) The appropriate signage is posted on the outside door. Feedback: Look for the posting outside the room to see what hazards, if any, may be encountered when entering that room. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Facilities, Supplies, and Materials |
How often should the people who use the procedure room clean it? |
d) After each use Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Facilities, Supplies, and Materials |
Under which circumstances is it acceptable to store food and chemicals in the same refrigerator? |
b) It is never acceptable. Feedback: Never put food and chemicals in the same refrigerator. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Facilities, Supplies, and Materials |
It is acceptable to hold excess equipment in a procedure room as long as the equipment is covered. |
b) False Feedback: This is not a good practice. Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Facilities, Supplies, and Materials |
Who is responsible for monitoring the expiration date of drugs stored in a procedure room? |
b) The owner of the drug Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Facilities, Supplies, and Materials |
When should you stop using a sharps container? |
d) When it is 2/3 full Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Facilities, Supplies, and Materials |
Which group monitors the conditions of procedure rooms? |
d) All of the above Source: AALAS Learning Library Regulatory and IACUC Compliance Track – Facilities, Supplies, and Materials |
Which of the following offers a voluntary accreditation program of institutional animal care and use programs? |
D. AAALAC Source: CPIA Handbook Sample Examination Questions |
Which of the following is a required member of the IACUC? |
C. Individual not otherwise affiliated with the institution Source: CPIA Handbook Sample Examination Questions |
According to USDA Regulations, an IACUC may have no more than how many members from any one administrative unit? |
A. 3 Source: CPIA Handbook Sample Examination Questions |
Which of the following does NOT need to be maintained by the IACUC? |
C. Logs of laboratory records Source: CPIA Handbook Sample Examination Questions |
The IACUC may suspend an activity only after |
A. a vote of a majority at a convened meeting. Source: CPIA Handbook Sample Examination Questions |
Training and instruction of personnel must include guidance in which of the following areas? |
D. Research or testing methods that limit the use of animals Source: CPIA Handbook Sample Examination Questions |
APHIS |
Animal and Plant Health Inspection Service (part of USDA) |
Which regulatory body does NOT require that the IACUC have a scientific member? |
USDA – APHIS |
Which organization confers CPIA certification? |
The Council for CPIAs (CCPIA), an affiliate of PRIM&R. |
Which of the following offers a voluntary accreditation program of institutional animal care and use programs? |
D. AAALAC |
Which of the following is a required member of the IACUC? |
C. Individual not otherwise affiliated with the institution |
USDA limit on how many IACUC members can be from the same administrative unit. |
3 (usually implemented at a departmental level) |
What limits the number of IACUC members from any one administrative unit to 3? |
USDA Regulations (but also found in the Guide) |
Which of the following does NOT need to be maintained by the IACUC? |
C. The IACUC must maintain copies of the PHS Assurance, semiannual reports, and meeting minutes, but does NOT have to maintain copies of laboratory records. |
The IACUC may suspend an activity only after |
A. The IACUC may suspend an activity only after a majority vote of a convened meeting. |
Training and instruction of personnel must include guidance in which of the following areas? |
D. Training and instruction of personnel must include guidance in research or testing methods that limit the use of animals. |
AAALAC (International) |
Association for Assessment and Accreditation of Laboratory Animal Care International (voluntary, accreditation) |
AALAS |
American Association for Laboratory Animal Science |
AC |
Animal Care Section (USDA -APHIS – AC; enforces AWA through AWAR) |
ACLAM |
American College of Laboratory Animal Medicine |
AWA |
Animal Welfare Act (enforced by USDA-APHIS-AC; includes warm blooded animals aside from birds, Rattus, Mus, and farm animals) |
Which entity enforces the AWA? |
USDA-APHIS-Animal Care Section |
Which animals are covered by USDA/AWA? |
Most warm blooded animals. |
Which animals are specifically excluded from the AWA? |
Birds, Rattus, Mus, farm animals, cold blooded animals |
AWAR/AWR |
Animal Welfare Act Regulations |
AWIC |
Animal Welfare Information Center (mandated by AWA to provide animal welfare info) |
CDC |
Centers for Disease Control and Prevention |
DHHS |
Department of Health and Human Services |
DOD |
Department of Defense |
EPA |
Environmental Protection Agency |
FDA |
Food and Drug Administration |
GLP |
Good Laboratory Practice |
IACUC |
Institutional Animal Care and Use Committee |
ILAR |
Institute for Laboratory Animal Research |
IO |
Institutional Official |
IRAC |
Interagency Research Animal Committee |
NIH |
National Institutes of Health |
NRC |
National Research Council |
NSF |
National Science Foundation |
OHSP |
Occupational Health and Safety Program |
OLAW |
Office of Laboratory Animal Welfare (PHS-NIH; enforces Health Research Extension Act public law through PHS Policy) |
Which entity enforces the Health Research Extension Act? |
PHS-NIH-OLAW (through PHS Policy) |
OSHA |
Occupational Safety and Health Administration |
PHS |
Public Health Service |
PI |
Principal Investigator |
PRIM&R |
Public Responsibility in Medicine and Research |
USDA |
United States Department of Agriculture |
VA |
Department of Veterans Affairs |
VMO |
Veterinary Medical Officer |
PHS Policy is enforced by |
OLAW |
AWA and AWAR are enforced by |
Animal Care Section of APHIS (USDA) |
AWA is to AWAR as ______ is to _______ |
Health Research Extension Act is to PHS Policy |
PHS Policy consists of |
1. Primary document "PHS Policy on Humane Care and Use of Laboratory Animals", which incorporates the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training" 2. The Guide (incorporated into primary document by reference) |
What are the three categories of regulatory documents used by USDA and PHS? |
1. Public law 2. The Regulations (carry force of law) 3. Guidance (interpretive rules) Note: Institutions must comply with ALL of them. |
Where is most USDA Guidance published? |
Animal Care Policy Manual (online and downloadable PDF) |
List the five most important IACUC responsibilities |
1. Review and approve animal activities (both new proposals and significant changes) 2. Evaluate animal care and use program and facility at least every 6 months 3. Review concerns about animal care and use 4. Suspend activity not being performed in accordance with IACUC-approved protocol, or not in compliance with regulations 5. Report to IO |
How frequently must the IACUC review the animal program and facilities? |
At least every 6 months. |
List the five most important responsibilities of individual IACUC members |
1. Attend meetings 2. Be prepared 3. Understand animal issues affecting protocols 4. Attend semiannual review of program and facilities 5. Participate in discussions |
Who is responsible for the animal care and use program? |
1. the vet and their staff 2. the IACUC 3. the IO |
Which document provides fines for IACUC members who violate confidentiality regulations? |
B: AWA (intended to protect institutions; AWAR states that reports of violations to regulatory agencies do NOT violate confidentiality) |
True or False: The AWAR provide ‘whistleblower’ protections for people (including IACUC members) who report AWA or AWAR violations to regulatory agencies. |
True |
True or False: The AWAR state that IACUC members may not participate in IACUC review or approval of an activity in which they are personally involved. |
True (with the exception that they may provide information requested by the IACUC) |
Which policy states that IACUC members may not contribute to a quorum for purposes of reviewing their own protocols? |
PHS Policy |
Which policy states that IACUC members may not vote on their own proposals? |
USDA/APHIS Policy #15 in the Animal Care Policy Manual |
Which IACUC roles are specified by USDA AWAR? |
1. IO 2. Chairperson 3. Attending Vet 4. Nonaffiliated Member |
What is the best practice when discussing proposals for which IACUC members have conflicts of interest? |
Member(s) should remove themselves completely from the room for the duration of the deliberation, and this should be specifically noted in the minutes. (Conflicted members may summarize the proposal for the other members, but should not be present during deliberations.) |
Which of the following is not typically a function of the IACUC? |
C. The IACUC does NOT typically review and and score the scientific value of submitted animal protocols. |
Which of the following does NOT facilitate an effective IACUC protocol review? |
B. All members should feel encouraged to participate in discussions and voice differing opinions. |
It is particularly important for IACUC members who are serving as the non-scientist member or the non-affiliated member to do what? |
C. Jargon should not get in the way of discussion or discourage any member from participating fully in the meeting. |
Which of the following statements concerning confidentiality of IACUC business is false? |
D. The AWAR specifically state that reporting violations to regulatory agencies is NOT a violation of the IACUC confidentiality provided by AWA. |
What do the Animal Welfare Act Regulations state about IACUC members who report violations to USDA? |
D. The AWAR provide ‘whistleblower’ protections for IACUC members who report violations to the USDA. |
If IACUC members have conflicts of interest in reviewing a certain protocol, they may not vote on that proposal, and it is a best practice for them to: |
C. The member should remove themselves from the room during BOTH deliberations AND voting. |
How many voting IACUC members are required, and who are they? |
Five 1. Chairperson 2. Veterinarian (with program responsibility and authority) 3. Scientist (practicing, with animal experience) 4. Non-scientific Member (primary concernis in non-scientific area) 5. Non-affiliated Member (not affiliated with institution in any way other than IACUC membership) (This list assumes no use of agricultural animals) |
True or False: The 2011 Guide does NOT list Chair as essential member. |
True (but still must have Chair to be in compliance with USDA or if receiving federal research funds, because AWAR lists Chair as necessary member and PHS Policy frequently lists duties of the Chair, such as appointing designated reviewers) |
Ag Guide |
Guide for the Care and Use of Agricultural Animals in Research and Teaching (published by FASS) |
FASS |
Federation of Animal Science Societies; publishes Ag Guide |
If institution uses agricultural animals, what additional requirements are there for the membership of the IACUC? |
Must have 2 scientific members, one with ag animal research or teaching experience and one with ag animal management training and experience. |
Which regulatory body requires that the IACUC have a Chairperson? |
USDA/APHIS (Policy #15 in AC Policy Manual) |
What are the required credentials and skills of the IACUC Chairperson? |
There are none, officially. However, it is best practice for them to have 1) familiarity with animal research and regs, 2) working knowledge of basic parliamentary procedure, 3) maturity and group leadership skills, and 4) relatively secure institutional position. |
Can just any vet serve on the IACUC? |
No. The vet must have authority in the animal care and use program. USDA uses the term Attending Vet, and OLAW sometimes uses the term Institutional Vet. |
Who is the only member that serves on the IACUC on the basis of employment (ex officio)? |
The Attending Vet. |
What are the best practice credentials for an Attending Vet? |
1. DVM or equivalent 2. Certification by ACLAM or equivalent (or equivalent training and experience) 3. Authority and responsibility for institutional animal activities. |
What additional authorities and responsibilities are given to the Attending Vet by AWAR? |
1. AV or designee must approve details of surgical proposals 2. Make recommendations (in health records) of activity level or restrictions 3. Decide when necropsies should be performed (APHIS can also require necropsies) 4. AV or designee must consult (pre-review) in planning procedures that involve more than momentary pain or distress 5. Determine specifics of dog exercise program in consultation with and approval by IACUC 6. Direct environmental enrichment program for primates |
For which animals must health records be kept? |
USDA covered species |
Can the non-affiliated member be a scientist? |
Yes, but they should NOT utilize laboratory animals (Guide, p. 24). |
Can the non-affiliated member be compensated for participation on the IACUC? |
Yes, as long as it is not a significant source of income, does not influence voting, and does not qualify them as an employee |
Can the non-affiliated member be a veterinarian? |
Yes (but they CANNOT be the Attending Veterinarian). |
Can members of the IACUC fulfill more than one role (for example, an non-affiliated non-scientist)? |
While nothing prohibits this practice, it is discouraged. PHS Policy specifically states that the IACUC must have at least 5 members, and USDA APHIS AC Policy Manual specifically discourages the practice. |
Must the non-affiliated member attend in order for the IACUC to conduct business? |
No. That is an IRB rule, and no equivalent rule exists for the IACUC. |
Must the Attending Vet attend in order for the IACUC to conduct business? |
No, but remember that there must have been a vet consultation prior to approval of any procedure that involves more that temporary pain or distress. |
How frequently must the IACUC meet? |
Guide: "…as often as necessary to fulfill its responsibilities…" (p. 25). This would appear to place the lower limit at twice per year in order to perform the semiannual review. |
True or False: The required members of the IACUC must all be voting members. |
True |
An IACUC that is not properly constituted: |
C. An IACUC cannot conduct official business unless it is properly constituted (must have all 5 required members appointed). |
Which of the following lists the required members of an IACUC constituted to comply with both USDA Animal Welfare Act Regulations and PHS Policy? |
D. 5 members-chair, veterinarian, scientist, non-scientific member, and non-affiliated member. |
The attending veterinarian must meet all of the criteria except which of the following? |
A. Being the Attending Vet has nothing to do with being the Chair. |
All of the following are responsibilities of the attending veterinarian or designee except: |
B. Determine when emergency IACUC meetings must be scheduled. |
Which of the following statements about IACUC members is true? |
C. Non-affiliated members must not be affiliated with the institution, but they must also not utilize laboratory animals elsewhere. |
Which of the following statements about IACUC membership is false? |
C. In fact, the IACUC can reimburse the non-affiliated member for their time and expenses, provided it is not a substantial source of income, does not influence their voting, and does not qualify them as employees of the institution. |
Which of the following statements about attendance at IACUC meetings is false? |
B. The IACUC can meet and conduct official business regardless of whether or not the non-affiliated member is present, so long as they are properly constituted (all 5 required members appointed) and there is a quorum. |
Which two institutional administrators are specifically dealt with in the regulations? |
The IO and the CEO. |
Who is the CEO? |
The highest operating official of the institution, such as the president of a university (PHS Policy). |
Who appoints members to serve on the IACUC? |
The CEO, although they can delegate this responsibility in writing (HREA and PHS Policy). |
Can the CEO and the IO be the same person? |
Yes (PHS Policy specifically allows) |
Who is the IO? |
The Institutional Official is the person in the organization having the administrative and operational authority to commit institutional resources to ensure that the animal care and use program complies with AWAR and PHS Policy. |
Who signs the Assurance? |
The IO. |
Who does the IACUC notify of deficiencies found during semiannual self-evaluation? |
The IO. |
Who does the IACUC inform its progress toward correcting significant program and facility deficiencies falls short? |
The IO. |
If the IACUC suspends an activity, what is the role of the IO? |
The IO must in consultation with the IACUC review the reasons for suspension and take appropriate corrective action. In addition they must (together) report the suspension to OLAW and/or APHIS and the federal funding agency, and maybe also AAALAC. |
To whom does the IACUC make recommendations regarding the animal program, facilities, or personnel training? |
The IO (AWAR). |
Who signs the USDA/APHIS Annual Report? |
The CEO or IO (AWAR). |
What is best practice regarding institutional reporting practices? |
The Attending Vet and the IACUC report directly to the IO. Also the IO should clearly define and assign responsibilities and reporting channels for other program elements such as training, occ health, and facility maintenance. |
Can the IO (or other administrator) suspend IACUC approved activities? |
Yes |
Can the IO (or other administrator) approve animal activities in the absence of IACUC approval or reverse and IACUC suspension? |
No |
The CEO is the highest ranking administrative official at an institution whereas the IO is the official with authority to commit institutional resources to ensure that the animal care and use program is in compliance. Which of the following statements is false? |
A. In fact, the CEO and the IO may or may not be the same person. |
Which of the following is NOT a duty assigned to the IO by the Animal Welfare Act Regulations or PHS Policy? |
A. The IO can NOT approve animal activities in the absence of IACUC approval, nor can he or she reverse an IACUC suspension. |
The USDA Animal Welfare Act Regulations and PHS Policy do NOT allow the IO to do which of the following? |
C. The IO can NOT approve an animal activity that the IACUC has witheld approval of. |
Aside from the IACUC, can any other body or official approve an animal protocol? |
Not in the absence of IACUC approval. (AWAR and PHS Policy) |
True of False: The IACUC has no real authority to suspend animal activities. |
False. The IACUC must have institutional authority to suspend any animal activities. (AWAR and PHS Policy) |
Can the IACUC suspend animal activities that it never reviewed in the first place? |
Yes. (Although it is not explicitly stated in the regs or guidance, this authority is implied, as all animal activities that are ongoing should have been first reviewed and approved by the IACUC.) |
Who can stop animal activities? |
The institution can give any number of people the right to stop animal activities. Notably, the IO’s authority to do so is specified in the regs. The CEO and the AV usually also have these authorities. Note that the IACUC can only do so based on a majority vote of a quorum at a convened meeting, and this is a suspension. |
Is suspension synonymous with stopping animal activities? |
No. Suspension (as defined by OLAW) is when the IACUC votes at a convened meeting to stop an activity. When others with the right to stop animal activities do so, it is not necessarily a suspension. In many cases, the person stopping the activity is acting for the institution, not the IACUC. And sometimes, the activity is stopped to give the IACUC a chance to investigate and determine whether or not to suspend. |
What steps are necessary for the IACUC to suspend an activity? |
1. Convene a meeting of a quorum to review the activity. Criteria are a) is it being conducted as described in the approved protocol?, and b) is it being conducted in accordance with AWAR and PHS Policy? 2. Vote to suspend by a majority vote of the quorum present at the meeting. 3. Notify the IO of the suspension. (Note that the IO and IACUC must then review reasons for suspension, take appropriate corrective action, and report the suspension to the appropriate federal bodies and maybe AAALAC.) |
What are the criteria the IACUC should use in determining whether or not to suspend an animal activity? |
1. Is the activity being carried out according to the originally approved protocol? 2. Is the activity being carried out in accordance with AWAR and PHS Policy? |
Do the individual members of the IACUC have authority to stop animal activities? |
Only if specifically conferred by the institution (usually no). |
When should the IACUC and IO report a suspension? |
As a best practice, immediately by phone and letting them know that written correspondence will be forthcoming. |
Under what circumstances does USDA/APHIS need to be informed of a suspension? |
If the activity involves USDA covered species or if the PHS Assurance requires it. |
What has to be reported to AAALAC? |
An annual report, plus prompt notification of any adverse event relating to the animal care and use program. These include USDA or OLAW investigations, and presumably also IACUC suspensions. |
Are even temporary holds considered suspensions? |
Yes, according to OLAW, if they result from a majority vote of a convened quorum of the IACUC. |
Once the IO (or other individual with authority) has stopped an activity, can they reinstate the activity without IACUC action? |
Yes, unless the IACUC voted to suspend–in that case, only the IACUC can lift the suspension. |
Which of the following statements about IACUC suspensions (use the PHS definition) of animal activities is <b>false</b>? |
D. Although individual IACUC member may be empowered by the institution to stop animal activities, they can NOT suspend activities on behalf of the IACUC. According to OLAW definitions, suspensions are temporary or permanent actions taken by the IACUC by majority vote of a convened quorum; anything less is not a suspension by OLAW definitions. |
Which of the following statements about IACUC suspensions of an animal activity is <b>false</b>? |
A. In fact, once the IO is notified of a suspension, they must (with the IACUC) promptly report the suspension to federal regulatory bodies (and maybe AAALAC). |
When reporting an IACUC suspension of an animal activity, the IACUC should: |
C. Report to the IO right away, and then with the IO report right away to regulatory authorities. |
What is a quorum? |
More than 50% (50% plus one) of the voting members are present. |
Can the IACUC conduct formal business without a quorum? |
No |
If a quorum is present, then is lost when members have to leave or recuse themselves, can business continue? |
No. A quorum must be present for each issue that is before the committee. |
Is it better for the IACUC to have an odd number of members or an even number of members? |
Odd is better, because it does not increase the quorum requirement. |
Are alternate members discussed in AWAR or PHS Policy? |
No, but there is Guidance on the issue from OLAW and USDA. |
Can a pool of alternates be used? |
No, they must be appointed in a one-to-one correspondence with regular members. |
Do alternates need to be appointed by the CEO or his or her designee? |
Yes, just like regular members. |
Should alternates be listed on IACUC rosters submitted to OLAW with Assurances and annual reports? |
Yes |
Can a member and his or her alternate contribute to a quorum at the same time? |
No |
What kind of training do IACUC alternates need? |
They should receive training similar or identical to that provided for regular members. |
Are alternates supposed to represent the position of their regular members? |
No, they are supposed to vote their conscience. |
Can alternate members attend meetings and participate in activities even when their regular members are present? |
Yes, at the discretion of the institution, but they cannot vote or contribute to a quorum at the same time as their regular member. |
Can alternates serve for more than one regular member? |
Yes, but they can only stand in at the meeting for one absent member per issue. |
Can one regular member have more than one alternate? |
Yes, but only one of them can stand in at the meeting for the regular member per issue. |
What is polling? |
According to OLAW, it is sequential, one-on-one communication. It is OK for some things, but as it does not allow real time direct communications within a group, it is not suitable for activities that require a convened quorum. |
Can teleconferencing (even phone) be used to convene a quorum? |
Yes, as long as there is direct real time communication among the group and everyone has full opportunity to participate. However, face-to-face meetings are best practice, and if an IACUC has routine need of teleconferencing, they should contact OLAW and the USDA for the latest Guidance. |
Which of the following statements regarding the process of polling IACUC members is <b>true</b>? |
C. Because all of the other actions require a convened quorum, and polling can never be used to contribute to a convened quorum, as it does not allow for direct real time communication. |
Which of the following statements about the use of "alternate" IACUC members is <b>false</b>? |
C. Alternates cannot vote on or contribute to a quorum for the same issue as their primary member(s). |
With regard to conducting IACUC business, the definition of a quorum is: |
D. A quorum is 50% plus one of voting members. |
In order to conduct official business throughout a convened meeting, a quorum of voting members must: |
B. No official business can be conducted any time a quorum not present. |
Which regulations require the use of prepared, fillable forms for animal protocols? |
None, it is just the most common practice. |
Which regulations require pre-review? |
None. Remember, though, that a vet or designee must be involved in planning procedures that cause more than slight or momentary pain or distress. It is best practice to pre-review all protocols and to have a vet involved in the process. |
Do IACUC members have to be provided with actual protocols before the meeting? |
A literal interpretation of the AWAR and PHS Policy indicates that they must receive a list of activities and that the descriptions have to be available. However, it is generally deemed necessary to provide full protocols to the committee prior to review in order to ensure that they are adequately prepared. |
Should IACUC members have access to grant documents? |
It is not required, but it is best practice to make these available |
What are the review methods allowed by USDA and PHS? |
1. Full committee review (FCR) 2. Designated member review (DMR) |
Can designated-member review be used for new submissions? |
Yes |
Who assigns designated reviewers when DMR is used? |
The Chairperson. |
What is the minimum number of designated reviewers for a protocol when DMR is used? |
One. |
What is the process for DMR of new submissions? |
1. All members sent (at least) a list of protocols to be reviewed. 2. Any member may call for FCR. If no one does, then the protocol is eligible for DMR. 3. One or more designated reviewers, assigned by the Chair, review the protocol. |
What options do designated reviewers have? |
1. Approve 2. Require modifications to secure approval 3. Request FCR. |
Can designated members withhold approval? |
No (although they can require modifications or call for FCR). |
What happens if there are more than one designated reviewer, and one of them calls for FCR? |
FCR, no matter what the other(s) want. |
If 3 or more designated reviewers are used, does the majority decide the outcome. |
Only if they all agree. A majority of designated reviewers can NOT overrule a minority, as they must all agree on the outcome or refer to FCR. Designated members must all agree to approve or all agree to require (the same) modifications; otherwise, the protocol goes to FCR. |
Which regulations call for the use of primary reviewers? |
None |
True or False: Designated reviewers are the same thing as primary reviewers. |
False, the two things have nothing to do with one another. In fact, the concept of primary reviewers is not even codified; it is just a system used by some IACUCs for convenience. |
Can the Chair initiate DMR during the waiting period for calling for FCR? |
Only if all members have replied that DMR is fine. Silence can be considered assent, but only after the end of the pre-determined window. (There is no reason the potential designated member shouldn’t receive the protocol, and they can even begin work, but they cannot officially be a designated reviewer until after the end of the waiting period.) |
Who determines the time frame for when members must call for FCR before the DMR process can begin? |
The Committee (not the Chair). |
What is expedited review? |
This term has no official meaning for IACUCs. Rather, it is a term associated with a certain kind of IRB review. It is NOT the same thing as DMR, and the colloquial use of the term should be avoided as a best practice. |
The best-practice sequence of events for a designated review by the IACUC is: |
C. Send to all members – no member calls for FCR within time frame – initiate DMR. |
The two IACUC review methods recognized by the USDA Animal Welfare Act Regulations and PHS Policy are: |
D. FCR and DMR are the only forms of review recognized by AWAR and PHS Policy. |
What are the possible outcomes of FCR? |
1. Approve 2. Require modifications to secure approval 3. Withhold approval |
What is conditional approval? |
It does not exist. Protocols are either approved or not. A protocol that requires modifications is not yet approved. |
How long is approval ‘good’ for? |
One year for USDA covered species, or up to three years for other species. |
Who must be notified of IACUC decisions to approve, withhold approval, or require modifications? |
The PI and the institution. |
If the IACUC withholds approval, what must be included in the notification? |
The reasons for the decision, and an opportunity to respond in person or in writing. |
If the IACUC votes to withhold approval, can it reconsider its decision? |
Yes, in light of additional information provided by the PI, and there must be documentation in the minutes. |
Notifying investigators of IACUC protocol review outcomes in writing is: |
A. Notifying the the PI in writing of protocol review outcomes is required. |
Which of the following statements is true regarding review outcomes in full committee review versus designated review of animal protocols? |
A. Designated reviewers can call for FCR, but they can NOT withhold approval. |
Which of these IACUC protocol review outcomes is recognized in the USDA Animal Welfare Act Regulations and PHS Policy? |
A. The only possible outcomes are Approve, Require modifications to secure approval, or Withhold approval. |
Regarding IACUC use of review outcomes such as "approval pending," "conditional approval," or "deferred," which of the following is false? |
A. These terms have not codified meaning, and are best avoided. |
What are the four categories of protocol reviews? |
1. Initial review 2. Annual review 3. Three-year review 4. Review of proposed significant changes to already approved protocols ("modifications" or "amendments") |
Which regulatory body requires annual reviews? |
USDA (AWAR; continuing review, not less than annually) |
How detailed should the USDA-required annual review be? |
It is not stipulated in the regs, but can be less detailed than initial review. |
Which regulatory body requires detailed three-year (triennial) reviews? |
PHS |
How detailed should the PHS-required three-year review be? |
It is a de novo review, with the same level of detail as an initial review. |
How frequently does the PI need to reconsider alternatives? |
According to USDA AC Policy Manual, every 3 years, which is consistent with PHS Policy triennial review. It is best practice for the IACUC to require documentation of new searches. |
How strict are the annual and triennial deadlines? |
OLAW has indicated that the triennial deadline is extremely strict. Approval expires on that deadline, and cannot be extended expect by a full de novo review. There is no official Guidance on the annual review deadline, but it is best practice to treat it the same as the triennial deadline. |
Do new forms have to be used for the triennial review? |
Forms are not mandated at all. However, it is best practice to use them and to require new forms for the triennial review, as regulations and their interpretations can change between reviews, and the forms help to ensure that the IACUC is reviewing the activity according to the most up-to-date standards, as required. |
Does every project have to undergo both annual and triennial reviews? |
It depends on the species, the source of funding, and the contents of the Assurance. Annual review is required by USDA, triennial review is required by PHS, and many institutions’ Assurances are written in such a way that annual review is required regardless of species. |
If a grant is for longer than 3 years, can the triennial review period be extended? |
No, the activity must receive a de novo review at least once every three years (PHS), regardless of length of funding. |
Can amendments just wait until the annual review? |
No, the IACUC must review and approve significant changes to the approved protocol before they take effect. |
What are considered "significant changes" in terms of requiring a review of an amendment? |
There is no definitive list. However, OLAW has said that they include, but are not limited to: -changes in study objectives -switching from non-survival to survival surgery -changes in degree of invasiveness or discomfort -change in species -change in approximate number of animals used -changes in animal personnel -changes in anesthetic, analgesia, or euthanasia -changes in duration, frequency, or number of procedures The IACUC should develop guidelines and inform the PIs |
Which of the following statements is true regarding the IACUC-performed three-year (triennial) review of animal activities (protocols)? |
B. But it is best practice for the IACUC to require new forms. |
Which of the following statements is true about modifications or amendments to animal protocols after IACUC approval? |
B. Significant changes must be reviewed and approved by the IACUC before they are implemented. |
To comply with both the USDA Animal Welfare Act Regulations and PHS Policy, the IACUC must do which of the following after the initial review and approval of a protocol? |
D. Perform an annual review prior to the first and second approval anniversaries, and perform a triennial review prior to the third anniversary. |
True or False: The IACUC may administratively extend approval (without using full committee or designated review) of a protocol past the date when the triennial review is due. |
False |
What level of detail must there be in the minutes? |
Opinions differ but the basic concepts are that they must contain enough detail so that an outsider can understand what deliberations took place and verify that the IACUC is meeting its legal mandates. |
Do minority opinions have to be recorded? |
By regs, only for semi-annual review (and these must be reported to OLAW in the annual report). However, it is definitely best practice to allow any member to voice minority opinions at any time and have these recorded in the minutes. |
Although opinions vary about the level of detail needed in IACUC minutes, a typical standard is that IACUC minutes: |
C. Should allow an outside observer to verify that deliberations occurred and to understand the outcomes of those deliberations. |
Minority opinions in IACUC minutes are not directly addressed in the language of the USDA Animal Welfare Act Regulations or PHS Policy. Which of the following statements best reflects the operation of an effective IACUC? |
C. Although they are only required for the semi-annual evaluation, it is best practice to allow any member the chance to voice and record a minority opinion on any issue. |
Which body requires the semi-annual evaluation? |
Both USDA and PHS. |
What are the 3 main goals of the semi-annual evaluation? |
1. Monitor facilities and program to ensure they meet standards of AWAR and PHS Policy. 2. Identify deficiencies, create plan and schedule for corrections and make sure corrections are made. 3. Communicate results and suggestions to the IO. |
What are the two components of the semi-annual evaluation? |
1. Facility inspection 2. Program review |
What is to be used as the basis of the semi-annual evaluation? |
1. USDA requires use of AWAR 2. PHS requires use of PHS Policy (including Guide) |
Is a quorum necessary to carry out the semi-annual evaluation? |
No. Although AWA appears to say this, AWAR only requires 2 members to be present, and PHS Policy sets no limit at all. Note that AWAR requires a majority of all IACUC members to review and sign the report. |
Can any members be denied the ability to participate in the semi-annual evaluation? |
No (AWAR) |
According to AWAR and PHS Policy, what 3 elements are required to be in the semi-annual report? |
1. a description of facility’s adherence to AWAR and PHS Policy 2. the identification of departures, and the reason for each 3. any minority views |
Who must review and sign the semi-annual report? |
A majority of all IACUC members (NOT just a quorum). (AWAR only) |
To whom is the semi-annual report submitted? |
The IO (both AWAR and PHS Policy) |
Both the USDA Animal Welfare Regulations and PHS Policy emphasize that the IACUC semi-annual evaluation of the animal care and use program must include two review components. What are they? |
A. The two elements are facility inspection and program review. |
Taken together, the USDA Animal Welfare Act Regulations and PHS Policy mandate the use of which documents as a basis for the IACUC semi-annual evaluation? |
A. The USDA Animal Welfare Act Regulations (AWAR) and PHS Policy, which includes the Guide. |
According to the Animal Welfare Act Regulations of the USDA, when conducting a semi-annual evaluation, the IACUC must conduct the evaluation: |
C. With at least 2 IACUC members, and allow participation by any member who wishes to do so. |
To comply with the Animal Welfare Act Regulations (AWAR), after the IACUC semi-annual evaluation report has been written: |
B. A majority of all IACUC members (not just those who conducted the evaluation) must review and sign it, then it is submitted to the IO. |
What animal areas have to be inspected? |
Any areas where animals are kept more than 12 hours (AWAR; PHS Policy says 24). And any areas used for confinement, transport, maintenance, breeding, or experiments (including investigator labs where animals are used). |
The program review portion of the semi-annual IACUC evaluation includes all of the following except: |
C. It is basically everything about IACUC and animal use other than the physical facility. |
When conducting the facilities inspection portion of the semi-annual evaluation in compliance with both the USDA Animal Welfare Act Regulations and the PHS Policy, the IACUC must include: |
D. All areas housing animals for more than 12 hours, and all investigator laboratory and study areas where animal procedures are performed. |
What 2 categories are used for deficiencies described in the semi-annual report? |
1. Significant 2. Minor (non-significant) |
What is a significant deficiency in the semi-annual report? |
One that in the view of the IACUC and IO is or may be a threat to the health or safety of the animals. |
Do significant deficiencies found in the semi-annual evaluation have to be reported to regulatory bodies? |
Not necessarily. The USDA requires a report if the significant deficiency is not corrected within the time period defined by the IO and IACUC. Note, though, that PHS Policy requires notifying PHS of any serious or continuing non-compliance or any suspension. |
What are the reporting rules if a significant deficiency identified during the semi-annual evaluation is not corrected according to the timeline set forth by the IACUC and IO? |
This must be reported within 15 days, through the IO, to the USDA and the federal funding agency. |
Which of the following is the regulatory definition of a significant deficiency that should be used by the IACUC during a semi-annual self-evaluation? |
A. A significant deficiency is one which is or may be a threat to the health or safety of the animals. |
Who is given the authority to decide if a deficiency identified during a semi-annual IACUC evaluation is significant or minor? |
A. The IACUC and IO together. |
What information must be provided in the report for deficiencies identified during the IACUC semi-annual self-evaluation? |
B. A reasonable and specific plan for correcting significant and minor deficiencies and a schedule for completing the corrective actions. |
To comply with the USDA Animal Welfare Act Regulations, what is the proper IACUC course of action to follow if a significant deficiency is not corrected according to the plan set forth in the IACUC semi-annual evaluation report? |
B. Report the situation through the IO to USDA within 15 business days. |
What are the responsibilities of the IACUC if a concern is raised from the public or a member of the institution regarding animal care? |
Review (both AWAR and PHS Policy) and if warranted investigate (AWAR) the concern. |
What is the process for reviewing (and investigating) concerns about animal care? |
Neither AWAR nor PHS Policy have specific requirements. Best practice is for the IACUC to discuss the collected facts during a convened meeting, approve a course of action by a majority vote of a quorum, and prepare a report to the IO with recommendations. Many IACUCs use a subcommittee. Best practice is to notify IO as soon as allegations are made. |
Which regs make it illegal for an institution to take reprisal against an individual that reports a violation? |
AWAR |
Which of the following statements regarding the USDA Animal Welfare Regulations and PHS Policy and allegations of improper animal care and use is false? |
A. In fact, it is the responsibility of the IACUC. |
Which codes and policies call for animal research as a moral imperative? |
Principle 3 of the Nuremburg Code, and PHS regulations. |
ACLAM |
American College of Laboratory Animal Medicine |
What official is responsible for the oversight of the DoD animal use program? |
Director of Defense Research and Engineering (DDRE) |
Can DoD researchers inflict wounds with weapons to train in surgical or medical treatments for these wounds. |
Yes, but they can’t use dogs, cats, primates, or marine mammals. |
DoD rules apply to which animals? |
Living or dead vertebrates, used on DoD facilities or in research supported by DoD. |
Which law/regs does DoD specifically require researchers to follow? |
AWA/AWAR |
Do DoD researchers have to follow foreign rules and regulations when working outside the US? |
Yes |
IRAC |
Interagency Research Animal Committee. |
In DoD research, who reports infractions to DDR&E? |
DoD Component heads. |
How long does DoD require records be kept? |
At least three years after the end of the activity. |
DoD Veterinary Services Program is under control of which military branch? |
Army |
True or False?: |
True |
How many members does DoD require? |
At least 5. Vet, non-affiliated (with mandatory alternate), non-scientist, plus enough others to make at least 5. |
Which body requires that vet and non-affiliated member be present for IACUC to conduct business? |
Only DoD. |
According to DoD regs, what must be administratively reviewed & approved at the Component headquarters level? |
Protocols using primates, cats, dogs, or marine mammals. Amendments to such protocols. The semiannual review report (and be responsible for oversight of any corrective actions needed). |
According to DoD regs, what events require an institution to notify the Component headquarters? |
1. Being notified by USDA that the institution is under investigation. 2. Being notified by AAALAC that accreditation status has been lost. 3. Institution experiences any "adverse events" relating to animal program. (In each case, notification must be made within 5 business days.) |
True or False: |
False. VA rules mandate that the Director serve as the IO. |
Does the VA VMO have to be full-time? |
No. |
Does the AV have to <b>pre</b>-review protocols <b>before</b> IACUC submission? |
Only at VAs. For other institutions, it is acceptable for the FCR to be the first time the AV sees the protocol (note that in this case, though, the AV must be present at the meeting for review to occur). |
Does the AV have to participate in the semiannual review? |
Only in the VA system. |
Does the VA <b>require</b> AAALAC accreditation? |
Yes. |
VA reciprocity rules. |
A VA can use an affiliate IACUC as its IACUC. However, VA IACUC cannot serve as the IACUC of record for any non-VA institution. |
VA IACUC appointment process. |
IACUC (in consultation with RDC) forwards names of nominees to director, who appoints. |
What are the VA IACUC membership requirements? |
Must meet AWA and PHS Policy requirements. |
According to VA rules, who must take part in the semiannual review? |
At least three members, two of whom must be voting members, and one of whom must be the Vet. |
To which animals do VA rules apply? |
Live vertebrates. |
True or False: |
True. This is more strict than USDA/PHS rules. |
True or False: |
True. This is more strict than USDA |
This edition of the Guide for the Care and Use of Laboratory Animals (the Guide) strongly affirms the principle that all who care for, use, or produce animals for research, testing, or teaching ______ assume responsibility for |
a. Must |
Institutions ______ use the recommendations in the Guide as a foundation for the development of a comprehensive animal care and use program and a process for continually improving this program. |
b. Should |
Veterinary consultation ______occur when pain or distress is beyond the level anticipated in the protocol descrip-tion or when interventional control is not possible. |
a. Must |
a. ACURO will ONLY review protocols that have been approved by an IACUC. |
b. Animal work may be initiated once the awardee receives IACUC approval, but ACURO funds are only released upon ACURO approval. |
Principal investigators are strongly discouraged from advocating ani¬mal reuse as a reduction strategy, and reduction ______ not be a rationale for reusing an animal or animals that have already undergone experimental procedures especially if the well-being of the animals would be compro¬mised. |
b. Should |
The Attending Veterinarian |
a. Must |
The IACUC ______ have sufficient authority and resources (e.g., staff, training, comput¬ers and related equipment) to fulfill this responsibility. |
b. Should |
All personnel involved with the care and use of animals ______ be ade¬quately educated, trained, and/or qualified in basic principles of laboratory animal science to help ensure high-quality science and animal well-being. |
a. Must |
All Program personnel training _____ be documented. |
b. Should |
In cases of collaboration involving animal use (beyond animal transport), the participating institutions ______ have a formal written understanding (e.g., a contract, memorandum of understanding, or agreement) that addresses the responsibility for offsite animal care and use, animal ownership, and IACUC review and oversight (AAALAC 2003). |
b. Should |
Veterinarians providing clinical and/or Program oversight and support _____ have the experience, training, and expertise necessary to appropriately evaluate the health and well-being of the species used in the context of the animal use at the institu¬tion. |
a. Must |
The extent and level of participation of personnel in the OHSP ______ be based on the hazards posed by the animals and materials used (the severity or seriousness of the hazard); the exposure intensity, duration, and frequency (prevalence of the hazard); to some extent, the susceptibility (e.g., immune status) of the personnel; and the history of occupational illness and injury in the particular workplace (Newcomer 2002; NRC 1997). |
b. Should |
Regarding Medical Evaluation and Preventative Medicine for Personnel. Confidentiality and other medi¬cal and legal factors ______ be considered in the context of appropriate fed¬eral, state, and local regulations. |
a. Must |
The institution ______ develop methods for reporting and investigating animal welfare concerns. |
a. Must |
Animal technicians, veterinarians, investigators, students, research technicians, maintenance workers, and others who have contact with nonhuman primates or their tissues and body fluids or who have duties in nonhuman primate housing areas should be routinely screened for tuber¬culosis. |
a. True |
The identification of humane endpoints is often challenging, however, because multiple factors _____ be weighed, including the model, species animal health status, study objectives, institutional policy, regulatory requirements, and occasionally conflicting scientific literature. |
b. Must |
Studies that commonly require special consideration include those that involve tumor models, infectious diseases, vaccine challenge, pain modeling, trauma, production of monoclonal antibodies, assess¬ment of toxicologic effects, organ or system failure, and models of cardio-vascular shock. |
a. True |
When the initial characterization of a GMA reveals a condition that negatively affects animal well-being, this ______ be reported to the IACUC, becaue more extensive analysis may be required to better define the phenotype. |
b. Should |
Restraint devices should not be considered a normal method of housing, and should be justified in the animal use protocol. |
b. False Restraint devices MUST not be considered a normal method of housing |
When applicable, the IO MUST submit a request to the USDA/APHIS and receive approval in order to allow a regulated animal to undergo multiple major survival surgical procedures in separate unrelated research protocols. |
a. True |
Facilities must therefore have a disaster plan and animals that cannot be relocated or protected from the consequences of the disaster should be humanely euthanized. |
b. False Facilities must therefore have a disaster plan and animals that cannot be relocated or protected from the consequences of the disaster must be humanely euthanized. |
Room temperature settings for rodents are typically set below the animals’ LCT (Lower Critical Temperature) |
a. True |
The immediate physical environment surrounding the animal in the primary enclosure? |
Microenvironment |
The physical environment of the secondary enclosure i.e. room. |
Microenvironment |
The ambient temperature range in which thermoregulation occurs without the need to increase metabolic heat production or activate evaporative heat loss mechanisms. |
TNZ Thermoneutral Zone. |
Sheltered or Outdoor Housing |
a. Must |
At a minimum, animals should have enough space to express their natural postures and postural adjustments without touching the enclosure walls or ceiling, be able to turn around, and have ready access to food and water. In addition, there must be sufficient space to comfortably rest away from areas soiled by urine and feces. |
b. False At a minimum, animals must have enough space to express their natural postures and postural adjustments without touching the enclosure walls or ceiling, be able to turn around, and have ready access to food and water. In addition, there must be sufficient space to comfortably rest away from areas soiled by urine and feces. |
Floor space taken up by food bowls, water containers, litter boxes, and enrichment devices (e.g., novel objects, toys, foraging devices) can considered part of the floor space. |
b. False |
When selecting a suitable social environment, attention should be given to whether the animals are naturally ______ or _______ and whether they should be housed singly, in pairs, or in groups. |
territorial or communal |
Single housing of social species ______ be the exception and justified based on experimental requirements or veterinary-related concerns about animal well-being. |
b. Should |
Animals ______ have access to potable, uncontaminated drinking water according to their particular requirements. |
b. Should |
In general, enclosures and accessories, such as tops, should be sanitized at least once every ______. |
c. 2 weeks |
Agents designed to mask animal odors should not be used in animal housing facilities. |
a. True |
Hazardous wastes ______ be rendered safe by sterilization, containment, or other appropriate means before their removal from the facility (DHHS 2009 or most recent edition; NRC 1989, 1995b). |
a. Must |
Emergency veterinary care should be available after work hours, on weekends, and on holidays. |
b. False. Emergency, Weekend, and Holiday Care Emergency veterinary care must be available after work hours, on weekends, and on holidays. |
Use of pesticides ______ be recorded and coordinated with the animal care management staff and be in compliance with federal, state, or local regulations. |
b. Should |
Chlorine and chloramines used to disinfect water for human consumption or to disinfect equipment are toxic to fish and amphibians and should be removed or neutralized before use in aquatic systems |
b. False Chlorine and chloramines used to disinfect water for human consumption or to disinfect equipment are toxic to fish and amphibians and must be removedor neutralized before use in aquatic systems |
The biofilter must be of sufficient size (i.e., contain a sufficient quantity of bacteria) to be capable of processing the bioload |
a. True |
Chlo¬rine and most chemical disinfectants are inappropriate for aquatic systems containing animals as they are toxic at low concentrations; when used to disinfect an entire system or system components, extreme care ______ be taken to ensure that residual chlorine, chemical, and reactive byproducts are neutralized or removed. |
a. Must |
The veterinary medical staff ______ implement procedures for evaluating the health and, if appropriate, the pathogen status of newly received animals, and the procedures should reflect acceptable veterinary medical practice and federal and state regu¬lations applicable to zoonoses. |
b. Should |
Squirrel monkeys and tamarins may be latently infected with herpesviruses, which could be transmitted to and cause a fatal epizootic disease in owl monkeys. |
a. True |
Researchers conducting surgical procedures must have appropriate train¬ing to ensure that good surgical technique is practiced—that is, asepsis, gentle tissue handling, minimal dissection of tissue, appropriate use of instruments, effective hemostasis, and correct use of suture materials and patterns |
a. True |
The selection of appropriate analgesics and anesthetics should reflect professional PI judgment as to which best meets clinical and humane requirements as well as the needs of the research protocol. |
b. False The selection of appropriate analgesics and anesthetics should reflect professional veterinary judgment as to which best meets clinical and humane requirements as well as the needs of the research protocol. |
Stress |
An aversive state in which an animal fails to cope or adjust to various stressors with which it is presented. |
Distress induces an immediate and observable pathologic or behavioral alteration. |
b. False. Distress may not induce an immediate and observable pathologic or behavioral alteration, making it difficult to monitor and evaluate the animal’s state when it is present. |
Antinociception occurs at a surgical plane of anes¬thesia and must be ascertained before surgery. |
a. True |
Animals can be maintained in a laboratory to satisfy the scientific aims of a protocol until the protocol expires or the animals are euthanized? |
b. False If animals must be maintained in a laboratory to satisfy the scientific aims of a protocol, that space should be appropriate to house and care for the animals and its use limited to the period during which it is required. |
Decentralization provides a greater opportunity for exposure to disease agents special consideration should be given to biosecu¬rity, including transportation to and from the site, quarantine before or after use of the specialized research area, and environmental and equip¬ment decontamination. |
b. False Centralization provides a greater opportunity for exposure to disease. |
Areas for surgery or clean equipment storage should be kept under negative pressure? |
b. False Areas for surgery or clean equipment storage should be kept under relative positive pressure. |
HVAC should be capable of adjustments in and ideally maintain dry-bulb temperatures of _____. |
b. ±1°C (±2°F) |
Valves controlling reheat coils should fail in the open position? |
b. False Valves controlling reheat coils should fail in the closed position. |
Aquatic Life Support System |
The Physical structure that contains the water and animals and the ancillary equipment to move or treat the water |
The three general categoris of aquatic life support systems |
1. Recurculating 2. Flow Through 3. Static |
CPIA Exam Study Questions
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