The ONE BIG CPIA set

How long must records be maintained under PHS policy?

"All records shall be maintained for at least 3 years; records that relate directly to...ongoing activities reviewed and approved by the IACUC shall be maintained for the duration of the activity and for an additional three years after completion of the activity." (p17)

How long must dealers (including research facilities) and exhibitors maintain records? What must these records include?

"reasonable period of time"- prior owner, transport, animal ID. Research facilities only required to do this for dogs and cats. (p3)

Name the group that wrote/administers each: 1. Animal Welfare Act 2. PHS Policy 3. The Guide 4. Ag Guide 5. Directive 3216.1 6. Handbook 1200.07

1 USDA 2 OLAW 3 National Research Council 4. Federation of Animal Science Societies 5. DOD 6. VA

Describe the minimum IACUC makeup under each set of regulations? 1. USDA 2. PHS Policy 3. The Guide 4. Ag Guide 5. DoD 6. VA

1. 3 members, 3 roles (Chair, AV, unaffiliated) 2. 5 members, 4 roles (AV, practicing scientist with animal research experience, nonscientist, unaffiliated) 3. 4 members, 4 roles (Lab animal vet, practicing scientist with animal research experience, nonscientist, unaffiliated), *no more than 3 from the same department* 4. 5 members, 5 roles (Large animal vet, scientist with ag research/teaching experience, animal/dairy/poultry scientist, nonscientist, unaffiliated) 5. 5 members, 4 roles (chair, DVM, nonscientist, nonaffiliated) 6. 5 members, 5 roles (Chair, AV, scientist with research experience, unaffiliated, lay member) *unaffiliated cannot be lay member, Senior admins can't be on IACUC, need 1 member from R&D committee*

Name the law that provides authority for the following: 1. AWA 2. PHS Policy 3. The Guide 4. Ag Guide

1. 9 CFR, Statute 7 USC 2131-2156 2. Health Research Extension Act of 1985 3. Required by PHS Policy 4. Endorsed by PHS policy

What is a quorum as defined by each set of regulations?

1. A majority of voting members

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

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 must be reported to OLAW?

1. Any change in the program or facilities that would change the institution's assurance category (i.e. lost of AAALACi accreditation) 2. date of semiannual inspections and IO report 3. Changes in IACUC membership 4. Changes in program description 5. Serious or continuing noncompliance with the PHS policy 6. serious deviation from the Guide 7. any suspensions OR an annual notice stating that no changes happened shall be filed along with the inspection findings and IO report (p17-18)

Name the animals covered by each: 1. AWA 2. PHS policy 3. The Guide 4. Ag Guide 5. DoD 6 VA

1. Any live or dead warm-blooded animals used in research, teaching, testing, experimentation, except birds, rats of the genus "Rattus", mice of the genus "Mus", bred for use in research. 9 CFR 1.1 2. Any live, vertebrate animal used or intended for use in research, research training, experimentation or biological testing or for related purposes. Policy III.A. 3. Any vertebrate animals, ag animal, wildlife, aquatic species, produced or used for research, testing, or teaching Ch. 2 4.Ag animals NOT used for research, testing, or teaching (food/fiber) 5. Any live vertebrate animal including larvae; eggs after hatching; any dead animal that is killed for the purpose of conducting research development testing evaluation, etc 3216.01 Part II 6. Same as PHS Policy. 1200.07 .3.c

What options do designated reviewers have?

1. Approve 2. Require modifications to secure approval 3. Request FCR.

What are the possible outcomes of FCR?

1. Approve 2. Require modifications to secure approval 3. Withhold approval

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

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.)

Who appoints the IACUC members under each set of regulations? 1. USDA 2. PHS Policy 3. The Guide 4. Ag Guide 5. DoD 6. VA

1. CEO 2. CEO; may delegate (per FAQ) 3. Not stated 4. CEO or responsible administrative official of IACUC 5. Most senior official (CEO/commander) 6. Medical Director

PHS policy requires what actions of the IACUC?

1. Conduct Semiannual Inspections, 2. Perform Semiannual Program Review, 3. Provide Semiannual IO reports (p11) 4. Review Protocols and have authority to suspend as necessary 5. Make Recommendations to IO as needed (p12-13)

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 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 are the two components of the semi-annual evaluation?

1. Facility inspection 2. Program review

What are the review methods allowed by USDA and PHS?

1. Full committee review (FCR) 2. Designated member review (DMR)

What guidelines govern IACUC review of protocols?

1. Guide and AWA 2. Minimization or elimination of pain/distress/discomort) within sound research design (includes anesthesia/sedation, etc as necessary). Departures require justification. Animals are euthanized as necessary to prevent severe/chronic pain 4. Animal situation represents appropriate housing directed by vet or scientist with animal experience + veterinary care 5. Appropriate training prior to animal use 6. Euthanasia consistent with AVMA guidelines (P13-14)

Which IACUC roles are specified by USDA AWAR?

1. IO 2. Chairperson 3. Attending Vet 4. Nonaffiliated Member

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")

What items are required in the PHS/OLAW Assurance program description?

1. Institutional and research program hierarchies 2. Qualifications, authority, responsibility of all vets 3. IACUC membership 4. Description of how IACUC fulfills PHS policy 5. Occ Health plan 6. Animal care and use trainings (summary) 7. Gross square footage of all animal facilities 8. Description of species and average census (p10)

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?

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 records are required to be kept under the PHS policy?

1. OLAW assurance 2. IACUC meeting minutes 3. Protocols and their changes, including denied and withdrawn ones 4. Semiannual inspection findings and reports, *including minority views* 5. Accrediting body determinations (p17)

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)

Describe the semiannual program review and inspection schedule/requirements for each of the following: 1. USDA 2. PHS Policy 3. The Guide 4. Ag Guide 5. DoD 6. VA

1. Program review and inspections due every 6 months 2. Program review and inspections due every 6 months, written report needed 3. Program review and inspections due at least annually, written report SHOULD be provided to IO 4. Inspections at least twice a year, provide written report to IO 5. No clue, but we were told every 6 mo by someone? 6. written report of semiannual inspections

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.

The three general categoris of aquatic life support systems

1. Recurculating 2. Flow Through 3. Static

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

Describe the allowed use of electronic communications for the IACUC meeting under each set of regulations? 1. USDA 2. PHS Policy 3. The Guide 4. Ag Guide 5. DoD 6. VA

1. Same as PHS 2. Ok as long as everyone is given notice, everyone has documents prior to meeting, everyone can fully participate in real time; only votes in real time count, need minutes 3. Not specified 4. Ok if in real time and interactive 5. no info 6. no info

What 2 categories are used for deficiencies described in the semi-annual report?

1. Significant 2. Minor (non-significant)

Who is the IO under each set of regulations? 1. USDA 2. PHS Policy 3. The Guide 4. VA

1. The individual authorized to legally commit on behalf of the research facility that requirements will be met. 2. The individual who has authority to and who signs the Assurance (legally committing on behalf of the institution that requirements will be met). 3. Representative of a senior administrator who bears ultimate responsibility for the program, including resource planning and aligning program goals with institution mission 4. VA official responsible for ensuring that the program has resources and support necessary to comply with all regs; point of contact for all regulatory correspondence. Typically the medical director of the VA.

Under the Health Research Extension Act of 1985, what information must each grant applicant provide in their proposal?

1. There is an IACUC 2. Adequate training is provided 3. Training includes 3Rs "use of research or testing methods that limit the use of animals or limit animal distress 4. Justification for animal use (P2)

What are the 10 US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training?

1. Transport, care, use complies with AWA and The Guide 2. Research activities are justified by benefits 3. Proper species, 3 Rs 4. Human pain= expect animal pain during research 5. Pain control or mitigation (anesthesia, etc) required 6. Euthanize to avoid severe or chronic pain 7. Appropriate care and housing, SHOULD be directed by vet or experienced scientist. Vet care SHALL be available. 8. Training required for researchers 9. Exceptions determined by IACUC only TRPHPEATE The right patient health practices ensure adequate treatments exceptionally (P4-5)

What are the registration/sign-ups required to comply with each? 1. USDA 2. OLAW 3. DoD/ONR 4. VA

1. USDA Registration every 3 years with annual inspection and annual report 2. Assurance at least every 5 years, with Annual Report 3.DFARS clause (i.e. will abide by DoD rules), USDA Registration, AAALACi Accreditation 32.16.01 3.2 4. MOU in place (can be standing MOU)

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)

USDA Regulations require the following IACUC members: 1. Veterinarian, chair, nonaffiliated 2. Veterinarian, chair, scientist 3. Veterinarian, nonaffiliated, scientist 4. Veterinarian, nonaffiliated, nonscientist

1. Veterinarian, chair, nonaffiliated

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

What are the required topics to be addressed by a grant application for animal use projects as described by PHS policy?

1. animal number and species 2. Scientific justification 3. Complete description of proposed animal use 4. Description of measures to decrease or eliminate pain/distress 5. Description of euthanasia methods (p16) 6. IACUC approval letter (p16)

What needs to be in the written annual report according to the USDA vs PHS?

1. assurance of acceptable animal care and use standards, that PI considered alternatives, that you comply with AWA, facility information, species and numbers 2. program or facility changes to category, changes to IACUC membership, semiannual dates and findings that were not corrected

What are the requirements of the semiannual IO report under the PHS policy?

1. available to OLAW upon request 2. Describe departures from the guide 3. Distinguish significant from minor deficiencies with corrective actions 4. list of AAALACi accredited facilities (P12)

What records must the institution have available for the USDA vs OLAW?

1. minutes, 2. protocol records, 3. semiannual IO reports 4. (USDA only) Animal records for dogs/cats (transport, sales, etc) 5 (PHS only) accreditation certificates 6. (PHS only) copy of Assurance

How often should the IACUC meet under each set of regulations? 1. USDA 2. PHS Policy 3. The Guide 4. Ag Guide 5. DoD 6. VA

1. shall conduct continuing reviews of activities regular intervals determined as appropriate by the IACUC but not less than annually (refers to protocols but by extension meetings) 2. shall conduct continuing review...at appropriate intervals as determined by the IACUC (refers to protocols but by extension meetings) 3. As often as necessary to fulfill responsibilities 4. at regular intervals as appropriate 5. Not stated 6. Not stated

What noncompliance needs to be reported according to the following: 1. USDA 2. PHS Policy 3. The Guide 4. Ag Guide 5. DoD 6. VA

1. suspensions 2. serious or continuing noncompliance, serious deviation from the guide, or suspension of activity 3. n/a 4. n/a 5. n/a

Who is responsible for the animal care and use program?

1. the vet and their staff 2. the IACUC 3. the IO

What are the training requirements under the AWA?

1. training is necessary 2. "sufficient to fulfill responsibilities" 3. must include handling, surgery, basic care, 3Rs, and reporting

Under the USDA regulations, how long to institutions have to report failure to correct significant deficiencies?

15 days- to APHIS and funding sources

Describe what should be in the semiannual report for the following: 1. USDA 2. PHS Policy 3. The Guide 4. Ag Guide 5. DoD 6. VA

1: Semiannual inspection findings with deficiency correction timetable, program review findings, departures from title 9 (?) 2. Semiannual deficiencies and correction schedule/plan, departures from the guide 3. Report of semiannual findings 4. Report regarding compliance with the guide 5. n/a 6. n/a

USDA limit on how many IACUC members can be from the same administrative unit.

3 (usually implemented at a departmental level)

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: 1) OLAW 2) USDA 3) The University's IO 4) All of the above

3) The University's IO

PHS Policy requires the following IACUC members: 1. Veterinarian, chair, nonscientist, nonaffiliated 2. Veterinarian, chair, nonaffiliated, scientist 3. Veterinarian, nonaffiliated, scientist, nonscientist 4. Veterinarian, nonaffiliated, nonscientist, statistician

3. Veterinarian, nonaffiliated, scientist, nonscientist

The guide incorporated two must to Diaster Planning and Emergency Prepardness which involved: a) triage plans for personnel and animals b) emergency contacts for all researchers and staff c) plans include satellite facilities d) corrdinated by the institutional official e) provisions on euthanasia The correct answer is: 1. a and e 2. a and d 3. c and e 4. All the above

3. c and e

What is the holding period prior to sale of a dog or cat under the AWA?

5 days minimum (p3), auctions excluded

Under PHS policy, what is the minimum composition of the IACUC?

5 members: 1 DVM in lab animal medicine who has delegated authority over animal activities, 1 scientist, 1 nonscientist, 1 unaffiliated member. Roles may be combined (for example, nonscientist and unaffiliated) but minimum number still stands (p11)

Which of the following is NOT a component of the IACUC responsibilities under the AWA? 1. review and investigate noncompliance 2. Make recommendations to the IO 3. Review and approve protocols 4. Suspend things if warranted 5. Ensure compliance with EPA regulations

5.

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.

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.

Who must review and sign the semi-annual report?

A majority of all IACUC members (NOT just a quorum). (AWAR only)

According to the PHS policy, what constitutes a quorum?

A majority of the members of the IACUC (P8)

According to USDA Regulations, an IACUC may have no more than how many members from any one administrative unit? A. 3 B. 4 C. 5 D. 6

A. 3 Source: CPIA Handbook Sample Examination Questions

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. B. A significant deficiency is one that is or may be a threat to the health and safety of larger mammals such as dogs. C. A significant deficiency is one that does not meet the criteria set for a minor deficiency. D. A significant deficiency is one that could cause harm to animals within 24 hours.

A. A significant deficiency is one which is or may be a threat to the health or safety of the animals.

The attending veterinarian must meet all of the criteria except which of the following? A. Must be qualified to serve as chair of the IACUC at the host institution. B. Must have training and/or have experience in the care and management of the species at the institution. C. Have direct or delegated authority for activities involving animals at the institution. D. Should be certified by the ACLAM or an equivalent organization or have received training and/or have experience in laboratory animal medicine.

A. Being the Attending Vet has nothing to do with being the Chair.

Which of the following activities would disqualify an animal from USDA category B? A. Blood collection. B. Being placed into new caging. C. Breeding. D. Being observed during quarantine.

A. Blood collection.

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. B. Chambers should be pre-filled to lessen animal anxiety when placed inside. C. Death must be verified before disposal of the carcass. D. Unintended recovery of animals after CO2 euthanasia must be reported to OLAW.

A. Carbon dioxide must be supplied only from compressed gas cylinders.

Which of the following statements is true regarding review outcomes in full committee review versus designated review of animal protocols? A. The "withhold approval" option is available in full committee review, but not designated review. B. The option of requiring modifications before approval is available in full committee review but not in designated review. C. The option of requiring modifications before approval is available in designated review but not in full committee review. D. The "approval" option is available in full committee review, but not designated review.

A. Designated reviewers can call for FCR, but they can NOT withhold approval.

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. The IO is responsible for reviewing, and if warranted, investigating such allegations. B. It is against the law for an institution to take any reprisal against any employee for reporting a violation of the USDA Animal Welfare Act Regulations. C. For the IACUC to suspend an activity following an investigation, a majority of a quorum must vote to do so at a convened meeting. D. The IACUC is responsible for reviewing, and if warranted, investigating such allegations.

A. In fact, it is the responsibility of the IACUC.

Which of the following statements about IACUC suspensions of an animal activity is *false*? A. Once notified of a suspension by the IACUC, the IO must convene an advisory committee to decide if it should be reported to regulatory authorities. B. OLAW considers a suspension to be a temporary or permanent interruption of an animal activity by the IACUC. C. Once the IACUC has suspended an activity, it must report to the IO, and the IO must report it to regulatory authorities. D. The IACUC may suspend an activity only after a majority vote of a quorum at a convened meeting.

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).

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. The USDA Animal Welfare Act Regulations require the CEO to also be the IO. B. The CEO must appoint IACUC members unless that responsibility is delegated in writing to someone else. C. The USDA Animal Welfare Act Regulations allow the CEO to appoint another official to act as the IO. D. The CEO may or may not also be the IO.

A. In fact, the CEO and the IO may or may not be the same person.

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. B. Observation studies of normal primate behavior. C. Blood collection from a superficial vessel of a dog. D. Major surgery in which anesthetics and postoperative analgesics are administered.

A. Lethal dose experiments in which animals are allowed to die without intervention.

With regard to conducting official IACUC business, the definition of a quorum is: A. More than fifty percent (a majority) of voting members. B. Fifty percent of voting and non-voting members combined. C. More than fifty percent (a majority) of voting and non-voting members combined. D. Fifty percent of the voting members.

A. More than fifty percent (a majority) of voting members

Notifying investigators of IACUC protocol review outcomes in writing is: A. Required by both the USDA Animal Welfare Act Regulations and PHS Policy. B. A common courtesy not required by regulatory authorities. C. Allowed by the USDA Animal Welfare Act Regulations and PHS Policy only after the IO is notified of the review outcome. D. Allowed by the USDA Animal Welfare Act Regulations and PHS Policy only after the minutes have been prepared and approved by the IACUC during a convened meeting.

A. Notifying the the PI in writing of protocol review outcomes is required.

Which of the following entities are required to release information per the Freedom of Information Act? A. OLAW B. AAALAC C. IACUC D. HSUS

A. OLAW

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. B. Review materials are sent to a quorum of designated reviewers, review results are solicited from designated reviewers, full committee approval of results is requested. C. Review materials are sent to all voting members, a majority of members do not request full committee review, the chairperson assigns one or more IACUC members as designated reviewers. D. Review materials are sent to a quorum of voting members, a majority of a quorum does not request full committee review, the chairperson assigns one or more IACUC members as designated reviewers.

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.

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. B. The designated member reviewer is authorized to approve, require modifications, or disapprove the proposal. C. All members receive information about the proposal and send their votes to the designated member reviewer for tallying. D. Designated member review may be utilized to review proposals when there is insufficient time to notify the full membership of the proposal details.

A. The IACUC Chair appoints one member to do the Designated Member Review.

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. B. The veterinarian and the IACUC together. C. Only the IACUC. D. Only the IO.

A. The IACUC and IO together.

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. B. Only the IACUC. C. The veterinarian and the IACUC together. D. Only the IO.

A. The IACUC and IO together.

The IACUC may suspend an activity only after A. a vote of a majority at a convened meeting. B. a discussion with the Principal Investigator takes place. C. the Institutional Official has been notified in writing of the event. D. all fact finding of the event has been conducted and documented.

A. The IACUC may suspend an activity only after a majority vote of a convened meeting.

Which of the following is NOT a duty assigned to the IO by the Animal Welfare Act Regulations or PHS Policy? A. Approve animal protocols in the absence of an IACUC. B. Sign the PHS Assurance and USDA Annual Report documents on behalf of the institution. C. Communicate with the IACUC when the IACUC has recommendations about the animal research program. D. Notify OLAW and affected federal funding agencies if the IACUC suspends a protocol.

A. The IO can NOT approve animal activities in the absence of IACUC approval, nor can he or she reverse an IACUC suspension.

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. B. The USDA Animal Welfare Act Regulations (AWAR) and PHS guidance in the form of published articles. C. PHS Policy and the Guide. D. The USDA Animal Welfare Act Regulations (AWAR) and the Guide.

A. The USDA Animal Welfare Act Regulations (AWAR) and PHS Policy, which includes the Guide.

Which of these IACUC protocol review outcomes is recognized in the USDA Animal Welfare Act Regulations and PHS Policy? A. Approve, require modifications in (to secure approval), and withhold approval. B. Approve, conditional approval, and approval pending modifications. C. Approve, require modifications in (to secure approval), and deferred approval. D. Approve, disapprove, and probationary approval.

A. The only possible outcomes are Approve, Require modifications to secure approval, or Withhold approval.

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. Facility inspection and program review. B. IACUC policy review and program review. C. Program review and animal care review. D. Facility inspection and IACUC policy review.

A. The two elements are facility inspection and program review.

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. B. The shared use of tissues by more than one investigator to minimize animal use. C. The use of improved assays that provide better data precision so that fewer animals are needed per group. D. The use of common control groups during simultaneous experiments to limit the number of control animals needed.

A. The use of a new anesthetic that provides better induction and a shorter recovery period.

Regarding IACUC use of review outcomes such as "approval pending," "conditional approval," or "deferred," which of the following is false? A. These terms are defined by the PHS Policy to be synonymous with "Requiring modifications in order to secure approval." B. These terms must be carefully defined so that IACUC members and research staff understand their meaning. C. These terms are often used to indicate that additional information or corrections are needed prior to receiving IACUC approval. OLAW does not approve of this. D. These terms are often incorrectly interpreted by investigators to mean that an animal activity is approved and work may begin immediately.

A. These terms have not codified meaning, and are best avoided.

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. B. Once the IACUC suspends an activity, it must report the suspension to the IO, who must report it to regulatory agencies. C. A majority of a quorum must vote at a convened meeting to suspend an activity. D. An institutional official can suspend an activity without agreement by the IACUC.

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.

The IACUC may suspend an activity only after A. a vote of a majority at a convened meeting. B. a discussion with the Principal Investigator takes place. C. the Institutional Official has been notified in writing of the event. D. all fact finding of the event has been conducted and documented.

A. a vote of a majority at a convened meeting. Source: CPIA Handbook Sample Examination Questions

What are the two categories of institutional status under the PHS policy?

AAALACi accredited with semiannual inspections or semiannual inspections only but sent to OLAW at time of renewal (P10-11)

Where do you send the USDA annual report?

APHIS AC Regional Director.

Which law/regs does DoD specifically require researchers to follow?

AWA/AWAR

What are the AWA requirements vs PHS for the AV?

AWA: AV (can be part time) with authority to do their job that sits on the IACUC. must have animal access, resources, oversee daily observation, provide guidance to PIs PHS: AV with authority, lab animal training

Which regs make it illegal for an institution to take reprisal against an individual that reports a violation?

AWAR

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.

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.

AALAS

American Association for Laboratory Animal Science

ACLAM

American College of Laboratory Animal Medicine

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.

Stress

An aversive state in which an animal fails to cope or adjust to various stressors with which it is presented.

Where is most USDA Guidance published?

Animal Care Policy Manual (online and downloadable PDF)

AC

Animal Care Section (USDA -APHIS - AC; enforces AWA through AWAR)

AWA and AWAR are enforced by

Animal Care Section of APHIS (USDA)

AWA

Animal Welfare Act (enforced by USDA-APHIS-AC; includes warm blooded animals aside from birds, Rattus, Mus, and farm animals)

AWAR/AWR

Animal Welfare Act Regulations

AWIC

Animal Welfare Information Center (mandated by AWA to provide animal welfare info)

APHIS

Animal and Plant Health Inspection Service (part of USDA)

Under what conditions may the NIH revoke a grant under the Health Research Extension Act of 1985?

Animal care dips below standards but lab does not provide corrective action despite NIH determination (P2-3)

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).

What animals are covered under PHS policy?

Any live, vertebrate animal used or intended for use in research, research training, experimentation, biological testing, or for related purposes (P8)

Who may sign an IACUC approval letter according to the PHS policy?

Anyone authorized by the institution (p16)

To who/ what locations does the PHS policy apply?

Anyone using PHS funds around the world (P7)

Who appoints members to an institution's animal care committee under the Health Research Extension Act of 1985?

Appointed by CEO (p1)

DoD Veterinary Services Program is under control of which military branch?

Army

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.

AAALAC (International)

Association for Assessment and Accreditation of Laboratory Animal Care International (voluntary, accreditation)

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.

How frequently must the IACUC review the animal program and facilities?

At least every 6 months.

How often must the IACUC review the care and treatment of animals in all animal study areas and facilities of the research entity under the Health Research Extension Act of 1985?

At least semiannually (p1)

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.

How long does DoD require records be kept?

At least three years after the end of the activity.

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

According to USDA Regulations, an IACUC may have no more than how many members from any one administrative unit? A. 2 B. 3 C. 4 D. 5

B. 3

To comply with the Animal Welfare Act Regulations (AWAR), after the IACUC semi-annual evaluation report has been written: A. A majority of all voting members must review and sign it, then it is submitted to the CEO. 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. C. A majority of the IACUC members who conducted the evaluation must review and sign it, then it is submitted to the CEO. D. A majority of the IACUC members who conducted the evaluation must review and sign it, then it is submitted to the IO.

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 information must be provided in the report for deficiencies identified during the IACUC semi-annual self-evaluation? A. A reasonable and specific plan and schedule for correcting significant deficiencies, and a description of minor deficiencies. B. A reasonable and specific plan for correcting significant and minor deficiencies and a schedule for completing the corrective actions. C. The name and title of the IACUC member who will perform the corrections and the institutional official in charge of verifying the corrections. D. The name and title of institutional support personnel who will provide the corrections and the IACUC members in charge of verifying the corrections.

B. A reasonable and specific plan for correcting significant and minor deficiencies and a schedule for completing the corrective actions.

What information must be provided in the report for deficiencies identified during the IACUC semi-annual self-evaluation? A. The name and title of institutional support personnel who will provide the corrections and the IACUC members in charge of verifying the corrections. B. A reasonable and specific plan for correcting significant and minor deficiencies and a schedule for completing the corrective actions. C. The name and title of the IACUC member who will perform the corrections and the institutional official in charge of verifying the corrections. D. A reasonable and specific plan and schedule for correcting significant deficiencies, and a description of minor deficiencies.

B. A reasonable and specific plan for correcting significant and minor deficiencies and a schedule for completing the corrective actions.

Which of the following does NOT facilitate an effective IACUC protocol review? A. Members who come prepared to discuss protocols under review. B. Members who are reluctant to express differing opinions. C. Members who consistently attend meetings. D. Members who participate in meeting discussions and other IACUC activities.

B. All members should feel encouraged to participate in discussions and voice differing opinions.

OLAW recommends which of the following reporting lines within an animal care and use program? A. IACUC reports to the Attending Veterinarian B. Attending Veterinarian reports to the Institutional Official C. Institutional Official reports to the IACUC D. Attending Veterinarian reports to the IACUC

B. Attending Veterinarian reports to the Institutional Official

All personnel performing animal procedures must be properly trained to do so when? A. By the end of the experiments. B. Before any procedures are performed. C. Before any procedures are performed unless they have doctoral level or medical degrees. D. Before any procedures are performed unless they receive a waiver from their supervisor.

B. Before any procedures are performed.

Which of the following statements is true regarding the IACUC-performed three-year (triennial) review of animal activities (protocols)? A. PHS Policy mandates the completion of new protocol forms by the investigator for IACUC review, unless given a waiver by the IACUC. B. PHS Policy mandates a review according to regulations and policies in place at the time of the triennial review, whether or not new protocol forms are completed. C. If an investigator will finish animal work prior to the fourth anniversary of receiving initial IACUC approval, the triennial review does not need to be performed. D. If an investigator has a grant that extends beyond three years, the triennial review can be postponed until the end of the granting period.

B. But it is best practice for the IACUC to require new forms.

All of the following are responsibilities of the attending veterinarian or designee except: A. Determine the frequency, method, and duration of dog exercise in consultation with and approval by the IACUC. B. Determine when emergency IACUC meetings must be scheduled. C. Provide consultations during the planning stages of proposed animal activities that involve more than momentary pain or distress. D. Direct the required environmental enrichment plan for primates.

B. Determine when emergency IACUC meetings must be scheduled.

Which of the following is false concerning prolonged restraint of animals? A. The restraint method used should be the least restrictive possible that will allow achievement of experimental objectives. B. It can be justified as a convenience for the research staff. C. The period of restraint should be the minimum required to achieve experimental objectives. D. It should not be considered a normal method of housing.

B. It can be justified as a convenience for the research staff.

In order to conduct official business throughout a convened meeting, a quorum of voting members must: A. Be present most of the meeting. B. Be present except when voting members have conflicts and must recuse themselves. C. Always be present. D. Be present at the beginning of the meeting.

B. No official business can be conducted any time a quorum not present.

What is a primary mission of the Animal Welfare Information Center (AWIC)? A. Publishes the Animal Welfare Act Regulations and Standards. B. Provides assistance with alternatives and database searches. C. Publishes the Guide for the Care and Use of Laboratory Animals. D. Provides assistance with identifying the best laboratory animal cage washing equipment.

B. Provides assistance with alternatives and database searches.

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? A. Report the situation through the IO to USDA within 3 months. B. Report the situation through the IO to USDA within 15 business days. C. Report the situation through the IO to USDA within 30 business days. D. Report the situation through the IO to USDA within 6 months.

B. Report the situation through the IO to USDA within 15 business days.

When reporting an IACUC suspension of an animal activity, the IACUC should: A. Limit disclosure of the facts to the absolute minimum necessary to prevent institutional embarrassment. B. Report the suspension as soon as possible to the regulatory authorities. C. Notify regulatory authorities no later than one year after the suspension. D. Notify regulatory authorities no earlier than 3 months after a suspension to ensure that a complete investigation has occurred.

B. Report the suspension as soon as possible to the regulatory authorities.

Although opinions vary about the level of detail needed in IACUC minutes, a typical standard is that IACUC minutes: A. Should provide as little information as possible to prevent outside observers from understanding how the IACUC operates. B. Should allow an outside observer to verify that deliberations occurred, and understand the outcomes of those deliberations. C. Must be no longer than three pages to satisfy federal paperwork reduction regulations. D. Must include an actual transcript of all conversations that occurred at the meeting, as a minimum.

B. Should allow an outside observer to verify that deliberations occurred, and understand the outcomes of those deliberations.

Which of the following statements is true about modifications or amendments to animal protocols after IACUC approval? A. The USDA Animal Welfare Act Regulations and PHS Policy allow any IACUC member to approve significant changes. B. Significant changes must be reviewed and approved by the IACUC before they are implemented. C. The USDA Animal Welfare Act Regulations and PHS Policy allow investigators to make significant changes without further IACUC action. D. Significant changes made in protocols are covered by the initial approval as long as the species does not change.

B. Significant changes must be reviewed and approved by the IACUC before they are implemented.

Which of the following is true of the dog exercise program mandated by the USDA Animal Welfare Act regulations? A. Dogs must be provided additional exercise regardless of the floor area of the cage. B. The IACUC can exempt an animal for scientific reasons. C. The veterinarian cannot exempt an animal, even for medical reasons. D. The veterinarian can exempt an animal for scientific reasons.

B. The IACUC can exempt an animal for scientific

Which of the following statements about attendance at IACUC meetings is false? A. Although an IACUC must be duly constituted and must have a quorum to conduct official business, members are not required to attend every meeting. B. Like the Institutional Review Board (IRB), the IACUC cannot conduct business unless the member with non-scientific interests is present. C. It is a responsibility for all IACUC members to attend as many meetings as possible. D. A meeting is valid if the attending veterinarian does not attend but a quorum of other members is in attendance.

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.

According to the Animal Welfare Act Regulations of the USDA, when conducting a semi-annual evaluation, the IACUC must conduct the evaluation: A. With at least 1 IACUC member and allow participation by any member who wishes to do so. B. With at least 2 IACUC members and allow participation by any member who wishes to do so. C. With a majority of IACUC members present, including the non-affiliated member. D. With all IACUC members present.

B. With at least 2 IACUC members and allow participation by any member who wishes to do so.

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)

Which animals are specifically excluded from the AWA?

Birds, Rattus, Mus, farm animals, cold blooded animals

Which body requires the semi-annual evaluation?

Both USDA and PHS.

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.

Which of the following statements about the use of "alternate" IACUC members is false? A. Alternates should receive IACUC training or orientation like regular IACUC members. B. Alternate members must be designated in advance and not simply as a matter of convenience on short notice. C. Alternate members may vote on an issue even when the regular member is present and votes on the same issue. D. Alternate members would be expected to vote their conscience rather than simply representing the views of the regular member.

C. Alternate members may vote on an issue even when the regular member is present and votes on the same issue.

Which of the following statements about the use of "alternate" IACUC members is *false*? A. Alternate members would be expected to vote their consciences rather than simply representing the views of the regular member. B. Alternate members must be designated in advance and not simply as a matter of convenience on short notice. C. Alternate members may vote on an issue even when the regular member is present and votes on the same issue. D. Alternates should receive IACUC training or orientation like regular IACUC members.

C. Alternates cannot vote on or contribute to a quorum for the same issue as their primary member(s).

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. To maintain harmony on the IACUC, it is best for the IACUC chairperson to strongly discourage minority opinions. B. There is no regulatory requirement for including minority opinions in other IACUC actions, so there is no precedent for including them in the minutes. C. It is a best practice to include them whenever an IACUC member requests that it be done. D. It is very damaging to IACUC harmony for minority opinions to be expressed, and they should be allowed only in exceptional circumstances.

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.

An IACUC that is not properly constituted: A. May conduct official business if in the judgment of the chair, a member not appointed is not critical to the review process. B. May conduct official business with approval of the Chief Executive Officer of the Institution. C. Does not have required members appointed and cannot conduct official business. D. Does not have required members appointed but may conduct official business with a quorum.

C. An IACUC cannot conduct official business unless it is properly constituted (must have all 5 required members appointed).

Which of these IACUC protocol review outcomes are recognized in the USDA Animal Welfare Act Regulations and PHS Policy? A. Approve, conditional approval, and approval pending modifications. B. Approve, require modifications in (to secure approval), and deferred approval. C. Approve, require modifications in (to secure approval), and withhold approval. D. Approve, disapprove, and probationary approval.

C. Approve, require modifications in (to secure approval), and withhold approval

Which of the following statements regarding the process of polling IACUC members is *true*? A. Polling can be used to obtain IACUC approval of a protocol during a convened meeting. B. Polling can be used to obtain IACUC suspension of an animal activity out of compliance. C. When using the designated reviewer system, polling can be used to allow the IACUC members to call for full committee review. D. Polling can be used to achieve a quorum if the IACUC does not have a quorum during a convened meeting.

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 IACUC membership is false? A. Consultants may be used to provide expert guidance to the IACUC, but may not approve or withhold approval of an activity or vote unless they are also members of the IACUC. B. A single member may fulfill more than one required IACUC role. C. The IACUC is not allowed to reimburse the non-affiliated member for expenses such as travel, parking, and meals. D. The required members must be voting members of the IACUC.

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 is a required member of the IACUC? A. Institutional Official B. Laboratory animal technician C. Individual not otherwise affiliated with the institution D. Representative from a local animal advocacy organization

C. Individual not otherwise affiliated with the institution Source: CPIA Handbook Sample Examination Questions

Which of the following is a required member of the IACUC? A. Institutional Official B. Laboratory animal technician C. Individual not otherwise affiliated with the institution D. Representative from a local animal advocacy organization

C. Individual not otherwise affiliated with the institution

Which of the following is a required member of the IACUC? A. Institutional Official B. Animal Facility Manager C. Individual not otherwise affiliated with the institution D. Representative from a local animal advocacy organization

C. Individual not otherwise affiliated with the institution

What do the Animal Welfare Act Regulations state about IACUC members who report violations to USDA? A. They may be subjected to reprisals if in violation of local IACUC policy. B. They may be subjected to reprisals if contact with USDA is not approved by IACUC Chair. C. It is against the law for anyone to discriminate against them or subject them to reprisals. D. Local institutional policy can discourage them from reporting violations of the regulations to USDA.

C. It is against the law for anyone to discriminate against them or subject them to reprisals.

The program review portion of the semi-annual IACUC evaluation includes all of the following except: A. Occupational health and safety and the institutional disaster plan. B. Procedures for reporting allegations of inappropriate animal care or use and the availability of veterinary care. C. The width of the animal facility hallways and adequacy of air flow in rooms housing animals. D.Training for IACUC members, researchers, and husbandry staff.

C. It is basically everything about IACUC and animal use other than the physical facility.

It is particularly important for IACUC members who are serving as the non-scientist member or the non-affiliated member to do what? A. Realize that science is difficult to understand unless you are a scientist. B. Accept the fact that science is complicated and refrain from asking questions about protocols during meetings. C. Ask questions if they do not understand so they can effectively fulfill their roles on the IACUC. D. Understand that technical and scientific jargon must inevitably be used during IACUC meetings.

C. Jargon should not get in the way of discussion or discourage any member from participating fully in the meeting.

Which of the following does NOT need to be maintained by the IACUC? A. Copy of Assurance B. Semiannual reports C. Logs of laboratory records D. Minutes from IACUC meetings

C. Logs of laboratory records Source: CPIA Handbook Sample Examination Questions

Which of the following statements about IACUC members is true? A. Non-affiliated members must not be employees of the institution, but may have an immediate family member employed at the institution. B. Each IACUC must have at least 2 scientists with animal research experience. C. Non-affiliated members must not utilize laboratory animals at any research facility. D. The non-scientific member may have "primary concerns" in a scientific area.

C. Non-affiliated members must not be affiliated with the institution, but they must also not utilize laboratory animals elsewhere.

The three Rs of Russell and Burch stand for what? A. Research, refinement, and recovery. B. Replace, recognize, and recover. C. Replacement, reduction, and refinement. D. Research, results, and review.

C. Replacement, reduction, and refinement.

When reporting an IACUC suspension of an animal activity, the IACUC should: A. Notify regulatory authorities no later than one year after the suspension. B. Limit disclosure of the facts to the absolute minimum necessary to prevent institutional embarrassment. C. Report the suspension as soon as possible to the IO, who must then notify regulatory authorities. D. Notify regulatory authorities no earlier than 3 months after a suspension to ensure that a complete investigation has occurred.

C. Report to the IO right away, and then with the IO report right away to regulatory authorities.

Notifying investigators of IACUC protocol review outcomes in writing is: A. A common courtesy not required by regulatory authorities. B. Allowed by the USDA Animal Welfare Act Regulations and PHS Policy only after the minutes have been prepared and approved by the IACUC during a convened meeting. C. Required by both the USDA Animal Welfare Act Regulations and PHS Policy. D. Allowed by the USDA Animal Welfare Act Regulations and PHS Policy only after the IO is notified of the review outcome.

C. Required by both the USDA Animal Welfare Act Regulations and PHS Policy.

Which of the following is not typically a function of the IACUC? A. Investigate allegations of animal mistreatment, and suspend approved research if conducted out of compliance. B. Communicate with the Institutional Official in matters pertaining to the animal care and use program. C. Review and score scientific value for animal protocols submitted. D. Review and approve proposed animal research.

C. Review and score scientific value for animal protocols submitted.

The best-practice sequence of events for a designated review by the IACUC is: A. Review materials are sent to a quorum of designated reviewers, review results are solicited from designated reviewers, full committee approval of results is requested. B. Review materials are sent to a quorum of voting members, a majority of a quorum does not request full committee review, the chairperson assigns one or more IACUC members as designated reviewers. C. 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. D. Review materials are sent to all voting members, a majority of members do not request full committee review, the chairperson assigns one or more IACUC members as designated reviewers.

C. Send to all members - no member calls for FCR within time frame - initiate DMR.

Although opinions vary about the level of detail needed in IACUC minutes, a typical standard is that IACUC minutes: A. Should provide as little information as possible to prevent outside observers from understanding how the IACUC operates. B. Must include, as a minimum, an actual transcript of all conversations that occurred at the meeting. C. Should allow an outside observer to verify that deliberations occurred and to understand the outcomes of those deliberations. D. Must be no longer than three pages to satisfy federal paperwork reduction regulations.

C. Should allow an outside observer to verify that deliberations occurred and to understand the outcomes of those deliberations.

Which of the following is not typically a function of the IACUC? A. Communicate with the Institutional Official in matters pertaining to the animal care and use program. B. Investigate allegations of animal mistreatment, and suspend approved research if conducted out of compliance. C. Review and score scientific value for animal protocols submitted. D. Review and approve proposed animal research.

C. The IACUC does NOT typically review and and score the scientific value of submitted animal protocols.

Which of the following does NOT need to be maintained by the IACUC? A. Copy of Assurance B. Semiannual reports C. Logs of laboratory records D. Minutes from IACUC meetings

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 USDA Animal Welfare Act Regulations and PHS Policy do NOT allow the IO to do which of the following? A. Administratively halt an animal-use project without IACUC approval of the halt. B. Conduct his or her own research involving animals. C. Approve an activity involving animals the IACUC has withheld approval of. D. Halt an activity involving animals because the institution does not want to support it any longer.

C. The IO can NOT approve an animal activity that the IACUC has witheld approval of.

Which of the statements below about the responsibility and authority of the Institutional Official (IO) is false? A. The IO must have authority to commit institutional resources in support of the animal care and use program. B. If the IO is not the institution's Chief Executive Officer, then the CEO must delegate IO authority to that person in writing. C. The IO may reinstate an animal activity that was previously suspended by the IACUC. D. The IO may suspend an animal activity that was previously approved by the IACUC.

C. The IO may reinstate an animal activity that was previously suspended by the IACUC.

Which of the statements below about the responsibility and authority of the Institutional Official (IO) is false? A. The IO must have authority to commit institutional resources in support of the animal care and use program. B. The IO must be the institution's Chief Executive Officer or some appointed by him with authority to fund resources. C. The IO may reinstate an animal activity that was previously suspended by the IACUC. D. The IO may suspend an animal activity that was previously approved by the IACUC.

C. The IO may reinstate an animal activity that was previously suspended by the IACUC.

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: A. Remove themselves completely during voting but participate in deliberations of the protocol. B. Remain in the room during deliberations but keep silent. C. Remove themselves completely from the IACUC meeting room during IACUC deliberations and voting on that protocol. D. Remain in the room to contribute to deliberations but not formally vote on the proposal.

C. The member should remove themselves from the room during BOTH deliberations AND voting.

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: A. The name of the databases searched B. The date the search was performed C. The specific field of study D. The search strategy (including scientifically relevant terminology) used

C. The specific field of study

Which of the following is not an example of replacement? A. The use of cell culture instead of animals to grow immortal cell lines. B. The use of a kit to assay hormone levels instead of a bioassay involving animals. C. The use of a new analgesic that provides better postoperative pain relief. D. The use of computer modeling software to replace the use of animals in pharmacologic studies.

C. The use of a new analgesic that provides better postoperative pain relief.

Which of the following is not an example of refinement? A. The use of newer surgical techniques that result in less tissue trauma. B. The use of a new analgesic that provides better postoperative pain relief. C. The use of computer modeling software to substitute for animal experiments. D. The use of a new bleeding technique that causes less pain and distress.

C. The use of computer modeling software to substitute for animal experiments.

What is the basis for the pain/distress classification system used by most institutions? A. AAALAC pain/distress categories. B. PHS pain/distress categories. C. USDA pain/distress categories. D. Guide pain/distress categories.

C. USDA pain/distress categories.

According to the Animal Welfare Act Regulations of the USDA, when conducting a semi-annual evaluation, the IACUC must conduct the evaluation: A. With at least 4 IACUC members, and allow participation by any member who wishes to do so. B. With a majority of IACUC members present, including the non-affiliated member. C. With at least 2 IACUC members, and allow participation by any member who wishes to do so. D. With all IACUC members present.

C. With at least 2 IACUC members, and allow participation by any member who wishes to do so.

Which statement about the Occupational Health and Safety Program is false? A. You should enroll in the local Occupational Health and Safety Program before you begin your work with laboratory animals. B. Typical services include rabies immunizations, TB testing, and tetanus immunizations. C. You may not decline medical treatments provided as part of the Occupational Health and Safety Program. D. Each institution must have an Occupational Health and Safety Program for personnel who have significant contact with laboratory animals.

C. You may not decline medical treatments provided as part of the Occupational Health and Safety Program.

Which of the following should be considered a significant change to an animal use proposal? A. change in departmental affiliation of the principal investigator B. change in start date of study C. change in anesthetic agent D. change in fluid administration

C. change in anesthetic agent

What agencies comprise the PHS (Public Health Service)?

CDC, FDA, NIH, Agency for Healthcare Research and Quality, Indian Health Service, Substance Abuse and Mental Health Services Administration (P8)

Under PHS policy, who is responsible for the creation of the IACUC and appointment of members?

CEO

Who is considered an animal exhibitor under the AWA?

Carnivals, circuses, zoos, animal owners who show animals NOT living on their property for more than "a substantial portion of their income." NOT pet stores, sponsors or organizations that put on things like fairs, rodeos, dog shows, etc (p2)

CDC

Centers for Disease Control and Prevention

Which of the following lists the required members of an IACUC constituted to comply with both USDA Animal Welfare Act Regulations and PHS Policy? A. 4 members-chair, veterinarian, and two scientists. B. 5 members-chair, veterinarian, scientist, non-scientific member, and recorder (or secretary). C. 4 members-chair, veterinarian, scientist, and non-scientific member. D. 5 members-chair, veterinarian, scientist, non-scientific member, and non-affiliated member.

D. 5 members-chair, veterinarian, scientist, non-scientific member, and non-affiliated member.

With regard to conducting IACUC business, the definition of a quorum is: A. Fifty percent of voting and non-voting members combined. B. More than fifty percent (a majority) of voting and non-voting members combined. C. Fifty percent of the voting members. D. More than fifty percent (a majority) of voting members.

D. A quorum is 50% plus one of voting members.

Which of the following offers a voluntary accreditation program of institutional animal care and use programs? A. PHS B. USDA C. OLAW D. AAALAC

D. AAALAC

Which of the following offers a voluntary accreditation program of institutional animal care and use programs? A. PHS B. USDA C. OLAW D. AAALAC

D. AAALAC Source: CPIA Handbook Sample Examination Questions

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: A. All areas housing animals for more than 24 hours, and all investigator laboratory and study areas where animal procedures are performed. B. All areas housing animals for more than 24 hours, and laboratories where animal procedures are performed with the exception of laboratories performing only non-survival surgical procedures. C. 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. D. All areas housing animals for more than 12 hours, and all investigator laboratory and study areas where animal procedures are performed.

D. All areas housing animals for more than 12 hours, and all investigator laboratory and study areas where animal procedures are performed.

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: A. All areas housing animals for more than 24 hours, and laboratories where animal procedures are performed with the exception of laboratories performing only non-survival surgical procedures. B. All areas housing animals for more than 12 hours, and all investigator laboratory and study areas where animal procedures are performed. C. All areas housing animals for more than 24 hours, and all investigator laboratory and study areas where animal procedures are performed. 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.

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.

Which of the following statements about IACUC suspensions (use the PHS definition) of animal activities is *false*? A. An institutional official can stop an animal-use activity without agreement by the IACUC. B. Once the IACUC suspends an activity, it must report the suspension to the IO, who must report it to regulatory agencies. C. A majority of a quorum must vote at a convened meeting to suspend an activity. D. 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.

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.

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? A. Categories B, C, and D. B. Category B. C. Category C. D. Category D.

D. Category D.

Which of the following statements concerning confidentiality of IACUC business is false? A. Trade secrets, processes, operations, and style of work may not usually be revealed to outsiders by IACUC members. B. It is against the law for an IACUC member to use information gained during IACUC meetings to his or her financial advantage. C. It is unlawful for any IACUC member to release certain confidential information about the research facility in some situations. D. Confidentiality requirements prohibit IACUC members from reporting violations of the Animal Welfare Act Regulations or PHS Policy.

D. Confidentiality requirements prohibit IACUC members from reporting violations of the Animal Welfare Act Regulations or PHS Policy.

What is required, of the IACUC, by the USDA AWA Regulations regarding alternatives? A. Ensure that the limit on animal use assigned to the institution by the USDA is not exceeded more than once every three years. B. Reduce animal usage by at least 10% per year over a five-year period. C. Reduce animal usage by at least 25% over a five-year period. D. Ensure that the principal investigator has considered alternatives to painful or distressing procedures, and review a written assurance that alternatives are not available.

D. Ensure that the principal investigator has considered alternatives to painful or distressing procedures, and review a written assurance that alternatives are not available.

The two IACUC review methods recognized by the USDA Animal Welfare Act Regulations and PHS Policy are: A. Subcommittee review and expedited review. B. Subcommittee review and designated review like that performed by an IRB. C. Full committee review and expedited review like that performed by an IRB. D. Full committee review and designated review.

D. FCR and DMR are the only forms of review recognized by AWAR and PHS Policy.

Which of the following institutions must follow the PHS Policy? A. Institutions that use any animals for research, teaching, or testing. B. Institutions that use vertebrate animals for research, teaching, or testing. C. Institutions that accept USDA research funds. D. Institutions that accept PHS funding.

D. Institutions that accept PHS funding.

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? A. Perform one annual review prior to the second approval anniversary, then perform a triennial review prior to the third anniversary. B. Perform only a triennial review prior to the third approval anniversary. C. Perform one annual and one triennial review prior to the third approval anniversary. D. Perform an annual review prior to the first and second approval anniversaries, and perform a triennial review prior to the third anniversary.

D. Perform an annual review prior to the first and second approval anniversaries, and perform a triennial review prior to the third anniversary.

Which of the following statements regarding the process of polling IACUC members via email is true? A. Polling via email can be used to achieve a quorum if the IACUC does not have a quorum during a convened meeting. B. Polling via email can be used to obtain IACUC suspension of an animal activity out of compliance. C. Polling via email can be used to obtain IACUC approval of a protocol during a convened meeting. D. Polling via email can be used to allow the IACUC members to call for full committee review when using the designated reviewer system.

D. Polling via email can be used to allow the IACUC members to call for full committee review when using the designated reviewer system.

U.S. Government Principles on the Use of Animals in Research state that: A. Relief of pain should be provided for vertebrate animals except for birds, mice and rats. B. Animals will show evidence of pain if a procedure causes them pain. C. Pain is perceived differently by animals than by humans. D. Procedures that are painful to humans should be assumed to cause pain in animals unless there is evidence to the contrary.

D. Procedures that are painful to humans should be assumed to cause pain in animals unless there is evidence to the contrary.

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? A. Report the situation through the IO to USDA within 6 months. B. Report the situation through the IO to USDA within 3 months. C. Report the situation through the IO to USDA within 30 business days. D. Report the situation through the IO to USDA within 15 business days.

D. Report the situation through the IO to USDA within 15 business days.

Training and instruction of personnel must include guidance in which of the following areas? A. Effective writing of animal use proposals B. Proper use of personal protective equipment C. Appropriate communication with animal activist groups D. Research or testing methods that limit the use of animals

D. Research or testing methods that limit the use of animals

Training and instruction of personnel must include guidance in which of the following areas? A. Effective writing of animal use proposals B. Proper use of personal protective equipment C. Appropriate communication with animal activist groups D. Research or testing methods that limit the use of animals

D. Research or testing methods that limit the use of animals Source: CPIA Handbook Sample Examination Questions

Which of the following activities would disqualify an animal from USDA category D? A. Retroorbital blood collection from a mouse performed under anesthesia. B. Collecting tail snips from adult rodents for genotyping under local or general anesthesia. C. Surgery performed under anesthesia. D. Studies in which animals are allowed to die without pain relief.

D. Studies in which animals are allowed to die without pain relief.

What do the Animal Welfare Act Regulations state about IACUC members who report violations to USDA? A. They may be subjected to reprisals if contact with USDA is not approved by IACUC Chair. B. Local institutional policy can discourage them from reporting violations of the regulations to USDA. C. They may be subjected to reprisals if in violation of local IACUC policy. D. It is against the law for anyone to discriminate against them or subject them to reprisals.

D. The AWAR provide 'whistleblower' protections for IACUC members who report violations to the USDA.

Which of the following statements concerning confidentiality of IACUC business is false? A. Trade secrets, processes, operations, and style of work may not usually be revealed by IACUC members. B. It is against the law for an IACUC member to use information gained during IACUC meetings to his or her financial advantage. C. It is unlawful for any IACUC member to release certain confidential information about the research facility in some situations. D. Confidentiality requirements prohibit IACUC members from reporting violations of the Animal Welfare Act Regulations or PHS Policy.

D. The AWAR specifically state that reporting violations to regulatory agencies is NOT a violation of the IACUC confidentiality provided by AWA.

Which of these statements is true concerning the USDA Animal Welfare Act? A. The USDA passed the Animal Welfare Act, and Congress has released regulations to enforce it. B. The USDA stands for United States Department of Assessments. C. The USDA is responsible for enforcing the Animal Withholding Action Act passed by Congress. D. The Animal Welfare Act regulations take precedence over guidelines produced by the Public Health Service, Department of Veterans Affairs, and other government agencies.

D. The Animal Welfare Act regulations take precedence over guidelines produced by the Public Health Service, Department of Veterans Affairs, and other government agencies.

In which of the following circumstances may animal work begin before receipt of IACUC approval? A. It is a continuing study awaiting three year renewal and for which the renewal protocol has been submitted to the IACUC. B. It is a small pilot study on non-AWAR species. C. It is a teaching activity that uses students' personally owned dogs and cats. D. There are no circumstances in which animal work may begin before IACUC approval.

D. There are no circumstances in which animal work may begin before IACUC approval.

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? A. They become less important. B. They become less stringent. C. They become more vague. D. They become more stringent.

D. They become more stringent.

Training and instruction of personnel must include guidance in which of the following areas? A. Effective writing of animal use proposals B. Proper use of personal protective equipment C. Appropriate communication with animal activist groups D. Research or testing methods that limit the use of animals

D. Training and instruction of personnel must include guidance in research or testing methods that limit the use of animals.

Which agency requires an annual report of the number of animals used by pain/distress category? A. American Association for Laboratory Animal Science B. Association for Assessment and Accreditation of Laboratory Animal Care C. Office of Laboratory Animal Welfare D. United States Department of Agriculture

D. United States Department of Agriculture

According to the PHS policy, what is the maximum lifespan of a protocol?

De novo required at least every 3 years (p15)

DOD

Department of Defense

DHHS

Department of Health and Human Services

VA

Department of Veterans Affairs

What official is responsible for the oversight of the DoD animal use program?

Director of Defense Research and Engineering (DDRE)

In DoD research, who reports infractions to DDR&E?

DoD Component heads.

What are the purposes of the AWA?

Ensure humane treatment of pets, show animals, and research animals, animals in transport, and protect against theft (p1)

EPA

Environmental Protection Agency

T/F The US Government Principles require that every biomedical research facility have an on-site veterinarian

F (P5)

T/F PHS policy supersedes state or local laws that are more stringent

F (P7) "This policy does not affect applicable state or local laws or regulations that impose more stringent standards for the care and use of laboratory animals"

T/F Animal courier services are considered animal dealers under the AWA

F (p1)

T/F PHS policy requires that protocols list the staff required for monitoring and animal sources

F (p16)

T/F the IO must sign all protocol notices under PHS policy

F (p16)

T/F the IO may approve a protocol in the event that the IACUC is unable to complete the review

F! "...officials at the institution...may not approve an activity involving the care and use of animals if it has nt been approved by the IACUC." (p15)

T/F IACUC approval must be granted only after the JIT stage

F! "...verification may be filed at any time prior to award unless specifically required earlier by the funding component." The most recent letter is required. (p16)

T/F: the IACUC may invite consultants for difficult decisions and the consultant's vote shall carry equal weight as that of a regular committee member under the PHS policy

F! While "the IACUC may invite consultants to assist with complex issues...Consultants may not approve or withhold approval of an activity or vote unless they are also members of the IACUC." (p15)

T/F FCR can be done via subcommittee according to the PHS policy

F* "If FCR is requested, approval...may be granted only after review at a convened meeting of a quorum" (p14)

T/F OLAW must be able to immediately access records when requested

F, "All records shall be accessible for inspection...at reasonable times and in a reasonable manner." (p17)

T/F A majority vote is required to call an item to FCR under the PHS policy

F. "...any member of the IACUC may obtain, upon request, full committee review" of research projects presented at committee polling (p14)

T/F OLAW approval or disapproval of an institution's assurance is final and reapplication is required every cycle until acceptance

F. "All assurances submitted...will be evaluated by OLAW... OLAW may approve or disapprove the assurance, or negotiate an acceptable assurance. (p9)

PHS policy covers rats and mice under NIH grants while the AWA applies to non-NIH projects

F. "All institutions are required to comply, as applicable, with the Animal Welfare Act" under the PHS policy" (P7)

T/F PHS funds for animal use may be awarded to independent researchers

F. "No PHS support for an activity involving animals will be provided to an individual unless that individual is affiliated with or sponsored by an institution which can and does assume responsibility for compliance with this policy, unless the individual makes other arrangements with the PHS" (p7)

T/F the IACUC chair may immediately suspend a protocol or activity if needed according to the PHS policy

F. "The IACUC may suspend an activity only after review of the matter at a convened meeting of a quorum of the IACUC and...vote of a majority of the quorum." (p15)

T/F Protocol review decisions may be communicated by letter, email, or verbally under the PHS policy

F. "The IACUC shall notify investigators and the institution in writing." Denials must be accompanied by reasons (p15) and investigators must be given the option to respond.

T/F The PHS policy supersedes the US Government Principles

F. "This policy is intended to implement and supplement those Principles" (P7)

T/F Research facilities may obtain dogs or cats from auctions, purpose-bred facilities, or internationally under the AWA

F. May NOT purchase from auctions (p3). Exception: US government research facilities may purchase from auction or USDA dealer (p3)

T/F OLAW must conduct site visits at least once every 3 years according to the PHS policy

F. No timeline is given. "OLAW... [will] conduct site visits to selected institutions" and "[e]ach awardee institution is subject to review at any time by PHS staff and advisors, which may include a site visit." (p19)

T/F semiannual IO reports must be sent to OLAW upon completion

F. Only if OLAW requests it (p12)

T/F The US Government Principles require a veterinarian to oversee the living conditions of animals

F. Should, not shall (P5)

T/F: The Health Research Extension Act of 1985 provides minimum guidelines for experimental design

F. Such guidelines (animal treatment guidelines) "shall not be construed to prescribe methods of research" (p1)

T/F The Health Research Act of 1985 allows the NIH to require full grant proposals for trade secrets in order to ensure animal welfare and make them available on grants.gov

F. The two are unrelated. The "NIH may not require a research entity to disclose publicly trade secrets or commercial or financial information which is privileged or confidential." (P3)

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.

True or False. DoD organizations/facilities are not required to apply for AAALAC accreditation.

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. Violation complaints within the DoD can only be reported to the Inspector General.

False

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

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.

T/F: The Health Research Extension Act of 1985 requires pre- and post- op veterinary care for USDA covered species but non mice of the genus mus and rats of the genus rattus

False. All animals must have access to veterinary care (p1)

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)

True or False: Under VA rules, the facility Director is the CEO, and can delegate IO responsibility to someone else.

False. VA rules mandate that the Director serve as the IO.

FASS

Federation of Animal Science Societies; publishes Ag Guide

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)

FDA

Food and Drug Administration

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.

GLP

Good Laboratory Practice

Ag Guide

Guide for the Care and Use of Agricultural Animals in Research and Teaching (published by FASS)

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.

AWA is to AWAR as ______ is to _______

Health Research Extension Act is to PHS Policy

VA IACUC appointment process.

IACUC (in consultation with RDC) forwards names of nominees to director, who appoints.

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.

ILAR

Institute for Laboratory Animal Research

IACUC

Institutional Animal Care and Use Committee

IO

Institutional Official

IRAC

Interagency Research Animal Committee

IRAC

Interagency Research Animal Committee.

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.

What is conditional approval?

It does not exist. Protocols are either approved or not. A protocol that requires modifications is not yet approved.

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.

Should IACUC members have access to grant documents?

It is not required, but it is best practice to make these available

How detailed should the USDA-required annual review be?

It is not stipulated in the regs, but can be less detailed than initial review.

What does the Guide say about IACUC records?

Keep meeting minutes

To which animals do VA rules apply?

Live vertebrates.

DoD rules apply to which animals?

Living or dead vertebrates, used on DoD facilities or in research supported by DoD.

How long is OLAW approval of an assurance good for?

Maximum 5 years (p9), though "OLAW may limit the period during which any particular approved assurance shall remain effective or otherwise condition, restrict, or withdraw approval."

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.)

The immediate physical environment surrounding the animal in the primary enclosure?

Microenvironment

The physical environment of the secondary enclosure i.e. room.

Microenvironment

How many IACUC members are required for DMR under the PHS policy?

Minimum 1 but must be qualified to conduct the review (p14)

Under the Health Research Extension Act of 1985, how many members must be on the IACUC, and in what roles?

Minimum 3 members, at least 1 unaffiliated and 1 DVM (p1)

How long must an institution keep records according to the AWA and PHS policy?

Minimum 3 years, then 3 years from cessation of related activity

What is a quorum?

More than 50% (50% plus one) of the voting members are present.

Which animals are covered by USDA/AWA?

Most warm blooded animals.

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.

What are the VA IACUC membership requirements?

Must meet AWA and PHS Policy requirements.

What details are required of IACUC members in the Assurance?

Name, position, credentials

NIH

National Institutes of Health

NRC

National Research Council

NSF

National Science Foundation

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.

Can a member and his or her alternate contribute to a quorum at the same time?

No

Can the IACUC conduct formal business without a quorum?

No

Can the IO (or other administrator) approve animal activities in the absence of IACUC approval or reverse and IACUC suspension?

No

Can any members be denied the ability to participate in the semi-annual evaluation?

No (AWAR)

Can designated members withhold approval?

No (although they can require modifications or call for FCR).

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.

Are alternate members discussed in AWAR or PHS Policy?

No, but there is Guidance on the issue from OLAW and USDA.

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.

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.

Are alternates supposed to represent the position of their regular members?

No, they are supposed to vote their conscience.

Can a pool of alternates be used?

No, they must be appointed in a one-to-one correspondence with regular members.

Does the VA VMO have to be full-time?

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 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.

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.

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.

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.

Which regulations call for the use of primary reviewers?

None

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.

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)

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.

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.

PHS Policy is enforced by

OLAW

What reports must the IACUC provide to the NIH under the Health Research Extension Act of 1985?

OLAW Annual Report (p2)= semiannual inspection reports (findings, corrective actions), noncompliance, etc, IACUC actions, and *minority views* (P2)

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.

OHSP

Occupational Health and Safety Program

OSHA

Occupational Safety and Health Administration

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.

OLAW

Office of Laboratory Animal Welfare (PHS-NIH; enforces Health Research Extension Act public law through PHS Policy)

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.

How long is approval 'good' for?

One year for USDA covered species, or up to three years for other species.

What is the minimum number of designated reviewers for a protocol when DMR is used?

One.

Which body requires that vet and non-affiliated member be present for IACUC to conduct business?

Only DoD.

Does the AV have to *pre*-review protocols *before* 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).

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.)

Do the individual members of the IACUC have authority to stop animal activities?

Only if specifically conferred by the institution (usually no).

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.

Does the AV have to participate in the semiannual review?

Only in the VA system.

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.

Which regulatory body requires detailed three-year (triennial) reviews?

PHS

Which policy states that IACUC members may not contribute to a quorum for purposes of reviewing their own protocols?

PHS Policy

Which entity enforces the Health Research Extension Act?

PHS-NIH-OLAW (through PHS Policy)

PI

Principal Investigator

Which codes and policies call for animal research as a moral imperative?

Principle 3 of the Nuremburg Code, and PHS regulations.

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).

PHS

Public Health Service

PRIM&R

Public Responsibility in Medicine and Research

What facilities are required to have an IACUC according to the Health Research Extension Act of 1985?

Required at every biomedical/behavioral research entity receiving PHS funds (including NIH, etc) (p1)

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 does the PHS policy say about the qualifications of the IACUC chair?

Shouldn't be anyone with a conflict of interest (AV, IO, etc)

Under PHS policy, what constitutes a Significant vs Minor deficiency?

Significant= is or may be a threat to the health or safety of the animals (P12)

T/F IACUC approval of the proposed projects is required before a grant may be awarded according to the PHS policy

T "PHS awarding units may not make an award for an activity involving animals...unless the awardee institution has provided verification of approval by the IACUC..." (p19)

T/F Buying, and selling even dead animals is considered "animal dealing" and subject to the AWA

T (p1). Exceptions: pet stores (unless they sell for research), personal transport of animals, and people who make less than $500 per year in animal dealing activities.

T/F According to PHS policy, an IACUC approval letter used for a grant must contain a description of the changes made

T (p16)

T/F persons who are not required to have a USDA license can still request one under the AWA

T (p2-3)

T/F All research facilities must register with the USDA under the AWA

T (p3)

T/F animal records must be available and viewable at all times under the AWA

T (p4)

T/F if OLAW restricts or withdraws approval for an assurance, all PHS funded work must cease

T until assurance is accepted again (p9)

T/F "code names" are acceptable to identify IACUC members in reports to OLAW

T* "Institutions may...represent the names of the members other than the chairperson and veterinarian with program authority by using numbers or other symbols." Caveat: you have to know who is who and be able to identify them if requested

T/F the AV must be a voting IACUC member even if there are other vets that can do it under the AWA

T, though that vet can also be a member

T/F the IO can revoke a protocol approval under the AWA and PHS policy

T- but only if research has not started. Otherwise it would be considered a suspension, which they can't do

T/F If an institution does NOT have an OLAW assurance but the PI submits an NIH grant, an assurance must be sent to OLAW

T. "... the signature of the official signing for the applicant organization [on the proposal] shall constitute a declaration that the institution will submit an assurance when requested by OLAW" (p17)

T/F Parts of the PHS policy may be waived upon special request

T. "Institutions may request a waiver of a provision or provisions of this Policy by submitting a request to OLAW... [and] sufficient justification is provided and the waiver is approved in writing..." (p19)

T/F committee polling is required under the PHS policy

T. While a time period for this is not specified, "...each IACUC member shall be provided with a list or proposed research projects to be reviewed [prior to protocol review]. (p14)

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.

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.

Who is the only member that serves on the IACUC on the basis of employment (ex officio)?

The Attending Vet.

Who signs the USDA/APHIS Annual Report?

The CEO or IO (AWAR).

Who appoints members to serve on the IACUC?

The CEO, although they can delegate this responsibility in writing (HREA and PHS Policy).

Who assigns designated reviewers when DMR is used?

The Chairperson.

Who determines the time frame for when members must call for FCR before the DMR process can begin?

The Committee (not the Chair).

Which organization confers CPIA certification?

The Council for CPIAs (CCPIA), an affiliate of PRIM&R.

What line of authority submits the annual report to OLAW?

The IO

To whom does the IACUC make recommendations regarding the animal program, facilities, or personnel training?

The IO (AWAR).

To whom is the semi-annual report submitted?

The IO (both AWAR and PHS Policy)

Who must sign the OLAW assurance?

The IO (p9)

Who must be notified of a suspension under the PHS policy?

The IO and OLAW (p15)

Which two institutional administrators are specifically dealt with in the regulations?

The IO and the CEO.

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.

Who does the IACUC inform its progress toward correcting significant program and facility deficiencies falls short?

The IO.

Who does the IACUC notify of deficiencies found during semiannual self-evaluation?

The IO.

Who signs the Assurance?

The IO.

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.

To whom is the OLAW assurance addressed?

The Office of the Director, NIH (p9)

Who must be notified of IACUC decisions to approve, withhold approval, or require modifications?

The PI and the institution.

Aquatic Life Support System

The Physical structure that contains the water and animals and the ancillary equipment to move or treat the water

What constitutional power does Congress invoke for the authority of the Animal Welfare Act?

The commerce clause

Who is the CEO?

The highest operating official of the institution, such as the president of a university (PHS Policy).

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.

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.

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.

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

What kind of training do IACUC alternates need?

They should receive training similar or identical to that provided for regular members.

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.

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.

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. 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 Joint Technical Working Group (JTWG) acts as a central advisory committee to the Armed Services Biomedical Research Evaluation and Management (ASBREM) Committee.

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. The non-affiliated member(s) on a DoD IACUC may be a federal employee with demonstrated commitment to the community.

True

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

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 required members of the IACUC must all be voting members.

True

True or False?: DoD requires its facilities to be AAALAC accredited.

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)

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)

T/F the PHS program description requires institutions to report the square footage of all animal facilities, including satellite facilities

True (p10)

T/F No activity involving animals may be conducted or supported by the PHS until the institution has provided their written OLAW Assurance

True (p9)

T/F: the Health Research Extension Act of 1985 establishes guidelines for the organization and operation of animal care committees

True! (p1)

True or False: VA policy stipulates that when using DMR, all members must receive complete copies of all protocol forms.

True. This is more strict than USDA

True or False: VA rules require that vet pre-review occur for *all* animal protocols, and that it is done *before* IACUC review.

True. This is more strict than USDA/PHS rules.

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 regulatory body requires annual reviews?

USDA (AWAR; continuing review, not less than annually)

Which regulatory body does NOT require that the IACUC have a scientific member?

USDA - APHIS

What limits the number of IACUC members from any one administrative unit to 3?

USDA Regulations (but also found in the Guide)

For which animals must health records be kept?

USDA covered species

Which entity enforces the AWA?

USDA-APHIS-Animal Care Section

Which regulatory body requires that the IACUC have a Chairperson?

USDA/APHIS (Policy #15 in AC Policy Manual)

Which policy states that IACUC members may not vote on their own proposals?

USDA/APHIS Policy #15 in the Animal Care Policy Manual

What is the difference between the guidance on suspensions in the AWA vs the PHS policy?

USDA: IACUC has authority to suspend- requires quorum PHS: IACUC has authority to suspend based on AWA, Guide, or Assurance, quorum required

What is the protocol review timeframe of the USDA vs OLAW?

USDA: annual OLAW: at appropriate intervals with de novo q 3 yrs

What are the AWA requirements vs PHS for veterinary care?

USDA: appropriate facilities, personnel, services to comply with animal welfare guidelines, including on weekends and holidays. Daily observation of animals. PI guidance. PHS: appropriate use of sedatives, euthanasia, etc, vet care required,

Describe the requirements of protocol approval letters according to the USDA vs PHS policy

USDA: written notice, if not approved need reasons PHS policy: same as above

USDA

United States Department of Agriculture

VMO

Veterinary Medical Officer

What are the USDA covered species?

Warm and fuzzies (so dogs, cats, rabbits, pigs, monkeys, hamsters, etc), livestock bred for research. NOT mice of the genus mus and rats of the genus rattus bred for research, birds, general livestock

When are breeders or pet stores NOT required to be USDA licensed?

When they do NOT "derive a significant portion of their income from breeding or raising of dogs or cats AND sells any such dog or cat to a dealer or research facility." (p2)

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.

Can designated-member review be used for new submissions?

Yes

Can the IO (or other administrator) suspend IACUC approved activities?

Yes

Do DoD researchers have to follow foreign rules and regulations when working outside the US?

Yes

Should alternates be listed on IACUC rosters submitted to OLAW with Assurances and annual reports?

Yes

Can the CEO and the IO be the same person?

Yes (PHS Policy specifically allows)

Can the non-affiliated member be a veterinarian?

Yes (but they CANNOT be the Attending Veterinarian).

Are even temporary holds considered suspensions?

Yes, according to OLAW, if they result from a majority vote of a convened quorum of the IACUC.

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 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.

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 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.

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 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.

Can the non-affiliated member be a scientist?

Yes, but they should NOT utilize laboratory animals (Guide, p. 24).

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.

Do alternates need to be appointed by the CEO or his or her designee?

Yes, just like regular members.

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.

Does the VA *require* AAALAC accreditation?

Yes.

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.)

To comply with the law, after the IACUC semi-annual self-evaluation report has been written, a majority of: a) A majority of all voting members must review and sign it, then it is submitted to the CEO. b) the IACUC members who conducted the evaluation must review and sign it, then it is submitted to the IO. c) all voting IACUC members must review and sign it, then it is submitted to the IO. d) the IACUC members who conducted the evaluation must review and sign it, then it is submitted to the CEO.

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

What area has the same level of standards and care as animal procedure rooms? a) Animal rooms b) Laboratories c) Corridors d) Storage 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

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 b) Realize that science is impossible to understand unless you are a scientist c) Accept the fact that science is complicated and never ask any questions about protocols during meetings d) Understand that technical and scientific jargon must always be used during IACUC meetings

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

What is one objective of the annual report to the USDA/APHIS? a) Assure that the facility complies with the AWA standards and regulations. b) Track and account for animal shipments received by the facility. c) Describe the animal use protocols in use at the research facility. d) List all personnel associated with animal care.

a) Assure that the facility complies with the AWA standards and regulations.

What is the mode of euthanasia action for an overdose of barbiturates? a) Depresses the CNS leading to cardiac arrest b) Over stimulates the CNS causing cardiac arrhythmia c) Causes hypoxia and brain activity ceases d) Paralyzes lungs and breathing ceases

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"

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. b) Although not required, cats should have an elevated resting surface. c) Breeding bitches and queens do not need additional floor space. d) All animals must have a minimum of six inches head room when in their normal standing position.

a) If clean and sanitized, the litter box can be counted as floor space.

Which disease is not readily transmitted to humans through animal bites? a) Measles b) Herpes B-virus c) Cat-scratch fever d) Rabies

a) Measles

What requirement does the Animal Welfare Act place on multiple survival surgery? a) Multiple survival surgeries are permitted when scientifically justified. b) All multiple survival surgeries require approval by the USDA on a case by case basis. c) A maximum of three multiple survival surgeries is permitted on each animal. d) Multiple survival surgeries are not ever permitted.

a) Multiple survival surgeries are permitted when scientifically justified.

How frequently does the USDA conduct inspections of research facilities? a) Once a year b)Quarterly c) Every six months d) Biannually

a) Once a year

The effectiveness of the autoclave can be monitored by using: a) Paper strips or vials containing bacterial spores b) Agar plates inoculated with viruses c) Agar plates inoculated with DNA fragments d) Vials of pH paper e) All of the above f) None of the above

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 statements concerning euthanasia is incorrect? a) Physical methods of euthanasia are most desirable when used on conscious animals. b) When used alone, non-physical methods of euthanasia are usually preferred over physical methods. c) Physical methods of euthanasia are most desirable when used on anesthetized animals. d) The investigator must provide a scientific justification to the IACUC if a physical method will be used alone.

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

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 b) Poses a threat to the successful completion of the project c) Poses a threat to the budget of the study d) Poses a threat to the integrity of the research project

a) Poses a threat to the health and safety of the animals

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. b) Use male sheep when possible. c) Wear PPE. d) Use respirators when working with pregnant sheep or their tissues.

a) Rely on serology in sheep to detect shedding of the organism.

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. b) Review materials are sent to a quorum of voting members; a majority of a quorum do not request full committee review; the Chairperson assigns one or more IACUC members as designated reviewers. c) Review materials are sent to a quorum of designated reviewers; review results are solicited from designated reviewers; full committee approval of results is requested. d) Review materials are sent to all voting members; a majority of members do not request full committee review; the Chairperson assigns one or more IACUC members as designated reviewers.

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 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. b) The Animal Welfare Regulations and PHS Policy allow investigators to make significant changes as necessary, so long as they are reported at the time of annual review. c) The Animal Welfare Regulations and PHS Policy allow any IACUC member to approve significant changes. d) Significant changes made in protocols are covered by the initial approval as long as the species does not change.

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

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. b) If your institution only uses mice you don't need PAM, because the USDA doesn't regulate laboratory mice. c) Since staff are not assigned to monitor protocols after they are approved, any compliance problems will be brought to the Chair by the person who finds them. d) The Animal Welfare Regulations require you to have one.

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

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. b) The use of non-pharmaceutical grade chemicals should be minimized whenever possible, but need not be specified in the protocol. c) Non-pharmaceutical grade chemicals may only be used on mice, rats, and birds. d) Non-pharmaceutical grade chemicals may never be used on animals.

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)

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. b) These are appropriate outcomes for Full Committee Review but not for Designated Review. c) These are appropriate outcomes for Designated Review but not for Full Committee Review. d) These terms correspond to the review outcome "require modifications in to secure approval" used by USDA and OLAW and may be used interchangeably.

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

Which is NOT a main objective of the Guide? a) To provide institutional policies b) To promote the advancement of science c) To enhance animal well-being d) To help institutions maintain high-quality research programs

a) To provide institutional policies

"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 b) False

a) True

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 b) False

a) True 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 b) False

a) True 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 b) False

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 b) False

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 b) False

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 b) False

a) True Source: AALAS Learning Library Regulatory and IACUC Compliance Track - Conflict of Interest

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 b) False

a) True Source: AALAS Learning Library Regulatory and IACUC Compliance Track - Conflict of Interest

Immersing aquatic species in a bath saturated with carbon dioxide is an acceptable euthanasia method. a) True b) False

a) True Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines"

The use of radioisotopes is regulated by what agency? a) US Nuclear Regulatory Commission b) Centers for Disease Control c) Nuclear Energy Protection Agency d) Food and Drug Administration

a) US Nuclear Regulatory Commission

Which of the following statements is false concerning shigellosis? a) Very large numbers of organisms are required to produce an infection. b) Transmission is fecal-oral. c) Clinical signs include acute bloody diarrhea. d) Nonhuman primates are the only important reservoir in an animal facility.

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"

Euthanasia agents that act by way of hypoxia are not recommended for which of the following groups of animals? a) Warm-blooded neonates b) Ruminants c) Older animals of most species d) Animals with respiratory problems

a) Warm-blooded neonates 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. b) cannot be easily restrained. c) will have an adjunctive method of euthanasia following the injection of chloral hydrate. d) None of the above

a) are already sedated. Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines"

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 b) should c) a and b d) none of the above

a) must

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. b) Report to US Department of Agriculture. c) Report to Office of Laboratory Animal Welfare. d) Retrain the investigator and staff.

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

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 b. Should c. May

a. Must

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 b. Should

a. Must

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 b. Should

a. Must

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 b. Should c. May

a. Must

Sheltered or Outdoor Housing Animals maintained in outdoor runs, pens, or other large enclosures ______ have protection from extremes in temperature or other harsh weather conditions and adequate opportunities for retreat. a. Must b. Should c. May

a. Must

The Attending Veterinarian The institution ______ provide the AV with sufficient authority, including access to all animals, and resources to manage the program of veterinary care. a. Must b. Should c. May

a. Must

The institution ______ develop methods for reporting and investigating animal welfare concerns. a. Must b. Should c. May

a. Must

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 b. Should c. May

a. Must

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 b. Should c. May

a. Must

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 b. Should c. May

a. Must

Agents designed to mask animal odors should not be used in animal housing facilities. a. True b. False

a. True

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 b. False

a. True

Antinociception occurs at a surgical plane of anes¬thesia and must be ascertained before surgery. a. True b. False

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 b. False

a. True

Room temperature settings for rodents are typically set below the animals' LCT (Lower Critical Temperature) a. True b. False

a. True

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 b. False

a. True

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 b. False

a. True

The biofilter must be of sufficient size (i.e., contain a sufficient quantity of bacteria) to be capable of processing the bioload a. True b. False

a. True

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 b. False

a. True

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 b. scientist with training or experience in agricultural animals c. a person whose primary concerns are in an area outside of science d. a person who is not affiliated with the institution

a. veterinarian with training or experience in laboratory animal science and medicine

What is a "research facility" under the AWA?

any higher education institution (not secondary school or elementary) using live animals or receives funds for animal research. Also, institutions may be exempted if they use only a few species as long as they are not dogs or cats, unless they have a large number of animals in general or primarily do research with those animals. Then they can't be exempted (p1)

What is an "intermediate handler" under the AWA?

anyone who is not a dealer, exhibitor, research facility, courier, or auctioneer who receives custody of animals as part of their business (so slaughterhouses would fall under this) (p2)

What is the main disadvantage of a passive PAM program? a) It requires more staff time. b) A whistleblower atmosphere may be created. c) It may be unclear to whom animal concerns should be reported. d) The institution must budget more funds with this type of program.

b) A whistleblower atmosphere may be created. Source: AALAS Learning Library Regulatory and IACUC Compliance Track - IACUC Members and Administration - Post-Approval Monitoring

What is the organization whose guidelines on euthanasia are required by the PHS Policy? a) American Medical Association b) American Veterinary Medical Association c) Federation of American Societies for Experimental Biology d) Animal Welfare Information Center e) Society for Neuroscience

b) American Veterinary Medical Association

What is not required by Animal Welfare Regulations for transport cages? a) Hand holds for easy lifting b) An elevated screened bottom to keep animals off the floor of the cage c) A mark with the letters "Live Animals" d) A design that allows no part of the animal's body to be outside the enclosure

b) An elevated screened bottom to keep animals off the floor of the cage

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 c) IACUC chairperson d) Research technicians

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"

According to the PHS Policy, the definition of animal includes which of the following? a) Only warm-blooded species b) Any live vertebrate animal c) Any animal d) Any vertebrate animal except laboratory strains of rats and mice, and birds

b) Any live vertebrate animal

Which of the following is NOT a role of the attending veterinarian? a) Providing for the veterinary treatment of all animals in the research program b) Approving animal use protocols c) Providing training on the use of sedatives, anesthetics, and analgesics d) Assessing the health status of animals in the research program

b) Approving animal use protocols

Which of the following viruses causes a disease similar to smallpox but much less severe? a) Measles b) Benign epidermal monkeypox c) Q fever d) Newcastle disease virus

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 term is defined in the Guide as "all measures to control known or unknown infections in laboratory animals." a) Biosafety b) Biosecurity c) Quarantine d) Stabilization

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)

What is included in Animal Welfare Regulations for housing guinea pigs and/or hamsters? a) Hamsters can be housed outside. b) Cages for hamsters must be at least 5 inches high. c) Cages for guinea pigs are required to be at least 7 inches high. d None of the above

b) Cages for hamsters must be at least 5 inches high.

Animal Welfare Regulations for rabbits require: a) Underlying pans/troughs to be cleaned every 2 weeks. b) Cages to be sanitized once every 30 days. c) Mechanical heating for rabbits housed inside. d) A minimum cage height of 16 inches.

b) Cages to be sanitized once every 30 days.

What is Post Approval Monitoring? a) Reviewing animal use protocols for compliance with federal regulations before they are approved by the IACUC b) Comparing the actual activities that are occurring against the written protocol document c) Comparing the animal use protocol with the institutions policies and procedures d Reviewing animal use protocols for scientific merit before they are approved by the IACUC e) None of the above

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

Which of the following statements about IACUC membership is FALSE? a) The required members must be voting members of the IACUC. 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. c) Although discouraged, a single member may fulfill more than one required IACUC role. d) Consultants may be used to provide expert guidance to the IACUC, but may not approve or withhold approval of an activity or vote unless they are also members of the IACUC.

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

Which is true about the effects of anesthetics? a) Perception of pain is lost but consciousness is never lost. b) Consciousness is lost before the perception of pain is lost. c) Consciousness and pain perception are lost at the same time. d) Perception of pain is lost before consciousness is lost.

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 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 c) Having environmental health and safety professionals tour the animal facility d) Relying on experiences from other institutions, professional associations, or societies

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

Which of the following serves as a biological filter in the life support systems of aquatic animals? a) Chlorine b) Denitrifying bacteria c) Water flow d) Dissolved oxygen

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)

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. c) A research technician is caring for genetically altered mice used in basic research. d) Janitorial staff is involved in cleaning operating room suites.

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"

Occupational health and safety programs intended to protect employees in animal facilities should be the same at all institutions where research animals are housed. a) True b) False

b) False

Federal employees may use their Government position or title to endorse a product or service. a) True b) False

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

b) False Source: AALAS Learning Library Regulatory and IACUC Compliance Track - Conflict of Interest

The PAM program is required by PHS Policy and the Animal Welfare Regulations to investigate any animal welfare concerns reported to them. a) True b) False

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

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

b) False 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

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. a) True b) False

b) False 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. a) True b) False

b) False Source: AALAS Learning Library Regulatory and IACUC Compliance Track - Conflict of Interest

A reflex movement during the euthanasia procedure indicates that the unconscious animal is still experiencing pain. a) True b) False

b) False Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines"

It is acceptable to hold excess equipment in a procedure room as long as the equipment is covered. a) True b) False

b) False Feedback: This is not a good practice. Source: AALAS Learning Library Regulatory and IACUC Compliance Track - Facilities, Supplies, and Materials

A person supplying dogs to research is exempted from licensing with the USDA under which of the following conditions? a) Less than $15,000 gross income is derived annually from the sale of dogs to research. b) Fewer than 25 dogs born on their premises are sold within a one-year period. c) Provided dogs are already dead. d) The primary business is as an animal exhibitor.

b) Fewer than 25 dogs born on their premises are sold within a one-year period.

Which of the following statements regarding floor drains is TRUE?? a) Floor drains are required in all animal rooms to minimize the danger of flooding from automatic watering systems. b) Floor drains are not necessary in all animal rooms; but if they are used, they should be at least 4 inches in diameter. c) While floor drains are not always required, they must be in place if an automatic watering system is used. d) Floor drains 6 inches in diameter are required in all animal rooms.

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)

What type of drug must be used with neuromuscular blocking agents? a) Antipyretic b) General anesthetic c) Anticonvulsant d) Sedative or tranquilizer

b) General anesthetic

Which of the following is not a hazardous property of a chemical? a) Toxicity b) Hardness c) Flammability d) Corrosiveness

b) Hardness

The AWA Regulations require that the attending veterinarian must: a) Approve animal use protocols. b) Have authority to ensure adequate veterinary care. c) Investigate public concerns over animal care and use. d) Appoint members to the IACUC

b) Have authority to ensure adequate veterinary care.

Which statement is TRUE regarding health requirements for shipping animals: a) Health certificates specify the health care needs of an animal while in transit. b) Health certificates must accompany any dog, cat or nonhuman primate transported by a research facility. c) Health certificates must be dated within two months of the date of shipment. d) Health certificates must accompany all covered species in transit.

b) Health certificates must accompany any dog, cat or nonhuman primate transported by a research facility.

What are allergic reactions seen within 10 to 15 minutes of exposure called? a) Rapid response reaction b) Immediate hypersensitivity c) Delayed hypersensitivity d) Quick sensitivity response

b) Immediate hypersensitivity

Under which circumstances is it acceptable to store food and chemicals in the same refrigerator? a) The food is in a sealed container and on a separate shelf. b) It is never acceptable. c) The storage period is less than one day. d) There is only one refrigerator available.

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

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? a) It recommends adherence to the Guide's standards. b) It requires that they use the Guide as a basis to develop and implement their animal care and use program. c) It suggests the Guide as a helpful reference. d) It overrides the Guide with other PHS mandates.

b) It requires that they use the Guide as a basis to develop and implement their animal care and use program.

Which hazard is addressed with the use of bite and scratch emergency kits? a) Tuberculosis b) Macacine herpesvirus 1 c) Laboratory animal allergy d) Radiation

b) Macacine herpesvirus 1

Which of the following is an example of a record that is NOT required by the IACUC to maintain? a) Letter of Accreditation by AAALAC b) Minutes of veterinary rounds meetings c) Records of semiannual reports to the IO d) Minutes of IACUC meetings

b) Minutes of veterinary rounds meetings

What is a quorum of a committee? a) Three quarters of the members b) More than half of the members c) Less than half of the members d) Half of the members

b) More than half of the members

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. c) Physical methods of euthanasia always cause more distress for the animal. d) Exsanguination, stunning, and pithing are acceptable physical methods of euthanasia for horses and cattle.

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"

Which of the following animals require the same minimum cage height recommendations in the Guide? a) Mice and hamsters b) Rats and guinea pigs c) Guinea pigs and rabbits d) Rabbits and cats

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)

Which person is primarily responsible for developing and sustaining a useful occupational health and safety program? a) IACUC chairperson b) Senior institutional official c) Attending veterinarian d) Vivarium manager

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 TRUE? a) A research institution can be either PHS-assured or registered with USDA, but not both. 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. c) Each PHS-assured institution must be inspected by OLAW at least annually, if the institution received federal funding for research. d) All mice bred for laboratory use are covered by the Animal Welfare Regulations.

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.

Which of the following statements is TRUE regarding review outcomes in full committee review versus designated review of animal protocols? a) The "approval" option is available in full committee review, but not designated review. b) The "withhold approval" option is available in full committee review, but not designated review. c) The option of requiring modifications before approval is available in designated review but not in full committee review. d) The option of requiring modifications before approval is available in full committee review but not in designated review.

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

Who has the legal authority to sign the USDA registration form of a research institution? a) The Animal Facility Director b) The Institutional Official c) The Animal Facility Manager d) The Attending Veterinarian

b) The Institutional Official

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 c) The act of reducing the emotional state of animals under distress d) The act of preparing animals for a surgical or otherwise invasive procedure

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

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 c) The decision of the IO d) Expediency of the method

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"

Who is responsible for monitoring the expiration date of drugs stored in a procedure room? a) The DEA b) The owner of the drug c) The USDA d) The IACUC

b) The owner of the drug Source: AALAS Learning Library Regulatory and IACUC Compliance Track - Facilities, Supplies, and Materials

Which of the following would occur if a PAM staff member finds a serious noncompliance? a) The staff member must develop a plan of correction. b) The staff member should report the issue to the IACUC. c) The staff member should report the issue to the USDA if an USDA-covered species is involved. d) The staff member would report the issue to OLAW.

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

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. c) Barbiturates break down quickly in the body so that carcasses of animals in which barbiturates were used for anesthesia do not represent a threat to predators which may eat them. d) Pentobarbital is a barbiturate that is not classified as a controlled substance.

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 infections is particularly hazardous to a human fetus? a) Dermatophytosis b) Toxoplasmosis c) Salmonellosis d) Orf

b) Toxoplasmosis

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: a) Formal orientation to the institution's program b) Training by a certified veterinarian on all procedures involving animals c) Training on how to review protocols as well as evaluate the program d) Training on how to inspect facilities and labs where animal use or housing occurs e) Training on legislation, regulations, guidelines, and policies

b) Training by a certified veterinarian on all procedures involving animals

According to the law, when conducting a semi-annual self-evaluation, the IACUC must conduct the evaluation with: a) all IACUC members present. b) at least 2 IACUC members, and allow participation by any member who wishes to do so. c) a majority of IACUC members present, including the non-affiliated member. d) at least 4 IACUC members, and allow participation by any member who wishes to do so.

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 two IACUC review methods recognized by the USDA Animal Welfare Act Regulations and PHS Policy are: a) subcommittee review and designated review like that performed by an IRB. b) full committee review and designated review. c) full committee review and expedited review like that performed by an IRB. d) subcommittee review and expedited review.

b) full committee review and designated review. Source: AALAS Learning Library Regulatory and IACUC Compliance Track - IACUC Members and Administration - Essentials for IACUC Members

Areas for quarantine, hazardous substance studies, and nonhuman primate rooms should be kept at ______________ pressure. a) positive b) negative c) neutral d) atmospheric

b) negative

Feed and bedding should be: a) maintained at a higher temperature than animal housing rooms. b) protected from vermin and toxic substances. c) stored in the corridors for easy access by technicians. d) stored under detergents and disinfectants.

b) protected from vermin and toxic substances.

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: a) remain in the room to contribute to deliberations, but keep silent during deliberations. b) remove themselves completely from the IACUC meeting room during IACUC deliberations on that protocol. c) remove themselves completely during voting, but participate in deliberations of the protocol. d) remain in the room to contribute to deliberations, but not formally vote on the proposal.

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

When reporting an IACUC suspension of an animal activity, the IACUC should: a) limit disclosure of the facts to the absolute minimum necessary to prevent institutional embarrassment. b) report the suspension as soon as possible to the IO, who must then notify regulatory authorities. c) notify regulatory authorities one week prior to the suspension. d) notify regulatory authorities no later than one year after the suspension.

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

PHS Policy ______________ an occupational health and safety program for PHS-assured institutions. a) outlines b) requires c) recommends d) urges

b) requires

PHS institutional Assurance is approve up to ___ years where as USDA registration is updated every ___ years: a) 3yrs PHS and 5 years USDA b) up to 5 years for PHS and 3 years FOR USDA c) up to 5 years for both d) 3 years for both

b) up to 5 years for PHS and 3 years FOR USDA

PHS policy states that the OLAW requires assurance renewal every: a) three years b) up to five years c) four years d) depends on the institution and program size

b) up to five years

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. c. Institutions using DOD funds to support the use of animals in research, product development, testing and education projects must provide electronic copies of IACUC-approved institutional protocol(s). d. Modifications or amendments must be reviewed and approved by ACURO PRIOR to implementation, even if already approve by an IACUC.

b. Animal work may be initiated once the awardee receives IACUC approval, but ACURO funds are only released upon ACURO approval.

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. a. True b. False

b. False

Areas for surgery or clean equipment storage should be kept under negative pressure? a. True b. False

b. False Areas for surgery or clean equipment storage should be kept under relative positive pressure.

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. a. True b. False

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.

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. a. True b. False

b. False Centralization provides a greater opportunity for exposure to disease.

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 a. True b. False

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

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. a. True b. False

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.

Animals can be maintained in a laboratory to satisfy the scientific aims of a protocol until the protocol expires or the animals are euthanized? a. True b. False

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.

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. a. True b. False

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.

Valves controlling reheat coils should fail in the open position? a. True b. False

b. False Valves controlling reheat coils should fail in the closed position.

Restraint devices should not be considered a normal method of housing, and should be justified in the animal use protocol. a. True b. False

b. False Restraint devices MUST not be considered a normal method of housing

Distress induces an immediate and observable pathologic or behavioral alteration. a. True b. False

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.

Emergency veterinary care should be available after work hours, on weekends, and on holidays. a. True b. False

b. False. Emergency, Weekend, and Holiday Care Emergency veterinary care must be available after work hours, on weekends, and on holidays.

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. a. Must b. Should c. May

b. Must

The Executive Agent for the Department of Defense Directive number 3216.1 is the _____ a. Director, Defense Research and Engineering b. Secretary of the Army c. Commander, US Army Veterinary Command d. Inspector General e. Under Secretary of Defense for Acquisition and Technology

b. Secretary of the Army

All Program personnel training _____ be documented. a. Must b. Should c. May

b. Should

Animals ______ have access to potable, uncontaminated drinking water according to their particular requirements. a. Must b. Should

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). a. Must b. Should c. May

b. Should

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. a. Must b. Should c. May

b. Should

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. a. Must b. Should c. May

b. Should

Single housing of social species ______ be the exception and justified based on experimental requirements or veterinary-related concerns about animal well-being. a. Must b. Should c. May

b. Should

The IACUC ______ have sufficient authority and resources (e.g., staff, training, comput¬ers and related equipment) to fulfill this responsibility. a. Must b. Should c. May

b. Should

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). a. Must b. Should c. May

b. Should

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. a. Must b. Should

b. Should

Use of pesticides ______ be recorded and coordinated with the animal care management staff and be in compliance with federal, state, or local regulations. a. Must b. Should

b. Should

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. a. Must b. Should c. May

b. Should

HVAC should be capable of adjustments in and ideally maintain dry-bulb temperatures of _____. a. 0.1°C b. ±1°C c. ±5°C

b. ±1°C (±2°F)

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: a) 24 hours, and laboratories where animal procedures are performed with the exception of laboratories performing only non-survival surgical procedures. b) 24 hours, and all investigator laboratory and study areas where surgery is performed. c) 12 hours, and all investigator laboratory and study areas where surgery is performed. d)12 hours, and laboratories where any animal procedures are performed.

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

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 b) 6 c) 24 d) 12

c) 24

PHS and AWRs state that all records should be kept for a minimum of: a) indefinate b) 1-2 years c) 3 years d) non of the above

c) 3 years

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? a) 5 years b) 2 years c) 3 years d) 1 year

c) 3 years

What does the term primary enclosure mean? a) An animal facility room b) A nest box c) A cage, pen, or stall d) An animal transport vehicle

c) A cage, pen, or stall

Record-keeping requirements of the Animal Welfare Regulations state that: a) IACUC records for meetings and protocols must be maintained but are not open to inspection by the USDA. b) Animal health records must be maintained for all vertebrate species. c) Acquisition records must be maintained for dogs and cats that are received by the facility. d) Disposition records must accompany the dog or cat when it leaves the research facility.

c) Acquisition records must be maintained for dogs and cats that are received by the facility.

Which of the following is not an IACUC activity? a) Investigating concerns about animal care or use b) Reviewing animal project activities c) Administering the employee health service d) Inspecting animal facilities e) Developing animal program reports to the Institutional Official

c) Administering the employee health service

Which of the following is not considered to be a major mode of transmission of the herpes B-virus? a) Needle stick b) Bite wound c) Aerosol d) Scratch

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"

What is the main problem caused by algae growth in an aquatic system? a) Entrapment of animals b) Increase of nitrogenous waste c) Blocks ability to easily observe animals d) Decrease in activity level of animals

c) Blocks ability to easily observe animals

What change was made to the Animal Welfare Act by the 1990 pet protection amendment? a) Cats and dogs cannot be obtained from pounds or shelters. b) Cats and dogs cannot be obtained for research from dealers. c) Cats and dogs must undergo a 5-day holding period before being acquired by a dealer. d) Dealers can only acquire cats and dogs from pounds and shelters.

c) Cats and dogs must undergo a 5-day holding period before being acquired by a dealer.

Confirmation of death is determined by: a) Lack of movement b) Duration of euthanasia procedure c) Cessation of vital signs d) Use of an adjunctive euthanasia method

c) Cessation of vital signs Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines"

Which of the following information need not be present on an official tag? a) Numbers identifying the animal b) The letters "USDA" c) Date of birth d) Numbers identifying the dealer

c) Date of birth

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. b) It is extremely stressful to the animal. c) Death occurs rapidly at concentrations of 4 to 6%. d) This agent is safe to use by human operators.

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

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"? a) Stressor b) Immobility c) Distress d) Pain

c) Distress

Which federal law mandates the PHS Policy? a) Animal Welfare Regulations b) Animal Welfare Act c) Health Research Extension Act (1985) d) Laboratory Animals Act

c) Health Research Extension Act (1985)

All of the following are good reasons to formalize a PAM program EXCEPT: a) It takes the subjectivity out of conducting an audit. b) It provides IACUC-approved documents which the PAM staff can refer to and enforce if necessary. c) It provides instructions for veterinary staff on the latest advances in veterinary care. d) It provides more guidance for both investigators and PAM staff.

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

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? a) Substrate b) Primary enclosure c) Life support system d) Microbial ecology

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 is not required when filing a PHS Institutional Assurance: a) dates of facility inspections b) IACUC member roster c) Number of covered species used annually d) Lines of authority e) species housed and average daily inventory by species

c) Number of covered species used annually

Which of the following statements about IACUC suspensions of an animal activity is FALSE? a) OLAW considers a suspension to be a temporary or permanent interruption of an animal activity. b) Once the IACUC has suspended an activity, it must report to the IO, and the IO must report it to regulatory authorities. 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. d) The IACUC may suspend an activity only after a majority vote of a quorum at a convened meeting.

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

If USDA-covered animals are involved in a compliance incident, what must the institution report to the USDA? a) Any noncompliances should be reported to the USDA. b) Report any noncompliances to the USDA in your annual report. c) Only suspensions of animal activity by the IACUC should be reported to the USDA. d) Only if there is a serious noncompliance that compromises animal welfare should it be reported 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

Which are used to standardize the method for performing specific institutional practices and procedures? a) Performance Standards b) Principles c) Procedures d) Policies

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)

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? a) Report the situation through the IO to USDA within 3 months. b) Report the situation through the IO to USDA within 30 business days. c) Report the situation through the IO to USDA within 15 business days. d) Report the situation through the IO to USDA within 6 months.

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

If the institution is PHS assured and is not AAALAC accredited, what must be included in the annual report to OLAW? a) The IACUC minutes b) The intituional officals assurance statement c) Semiannual IACUC report d) none of the above

c) Semiannual IACUC report

Which of the following statements is true? a) Female mice excrete four times as much allergen as males. b) Mouse urine contains less allergen than mouse serum. c) Sensitivity to mouse allergen is common. d) Urinary protein is not a major source of mouse allergen.

c) Sensitivity to mouse allergen is common

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 b) Amphibians c) Small rodents d) Nonhuman primates

c) Small rodents Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines"

Who appoints the IACUC members? a) The Attending Veterinarian b) The IACUC Chair c) The CEO of the institution d) The Director of Research Compliance

c) The CEO of the institution

How does one know there is a hazard in a room? a) Only specific people are allowed to enter the room. b) People in the room will be wearing radiation detection badges. c) The appropriate signage is posted on the outside door. d) There will be radiation labeling tape on all instruments used with radioactive material.

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

Which US agency requires placing animals used in research into pain/distress categories? a) AVMA b) OLAW c) USDA d) NIH

c) USDA

What determines cage space requirements for nonhuman primates as outlined in the Animal Welfare Regulations? a) Nutritional needs of the nonhuman primates b) Length of the nonhuman primates c) Weight group of the nonhuman primates d) None of the above

c) Weight group of the nonhuman primates

According to the PHS Policy, can the non-affiliated member and the nonscientific member of the IACUC be the same person? a) Yes, but only if special permission is received from OLAW. b) Yes, but only for one two-year term of participation. c) Yes, but the committee still must consist of no less than five members. d) No, one person cannot fulfill two roles.

c) Yes, but the committee still must consist of no less than five members.

What best describes the required composition of a 5-member IACUC? a) a veterinarian, a nonscientist, and a public member not affiliated with the institution b) a veterinarian, a scientist, and a public member not affiliated with the institution c) a veterinarian, a scientist, a nonscientist, and a public member not affiliated with the institution d) a veterinarian, a chairman, and a member from the public

c) a veterinarian, a scientist, a nonscientist, and a public member not affiliated with the institution

In general, enclosures and accessories, such as tops, should be sanitized at least once every ______. a. day b. week c. 2 weeks d. month

c. 2 weeks

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. b. IV administration produces the slowest loss of consciousness. c. IC injection is acceptable when the animal is either heavily sedated, anesthetized, or comatose. d. IP administration is optimal for irritating euthanasia agents.

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

For the VA semiannual program review and facility inspection report, which of the following need not be included: a. Date of the review/isnpection b. Names of individuals responsible for corrective actions c. The signatures of the majority of the voting members d. The timeline for the corrective actions e. The reason for the deficiency

c. The signatures of the majority of the voting members

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. b) $20,000. c) $40,000. d) $50,000. e) $30,000.

d) $50,000

Cervical dislocation should not be performed in rabbits weighing more than: a) 500 g. b) 2 kg. c) 800 g. d) 1 kg.

d) 1 kg. Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines

What is the shelf life for feed that is fortified with non-stabilized vitamin C? a) 1 month b) 9 months c) 6 months d) 3 months

d) 3 months

What is the recommended concentration of carbon monoxide used for euthanasia of small mammals? a) Over 10% b) 8-10% c) 2-3% d) 4-6%

d) 4-6% Source: AALAS Learning Library Regulatory and IACUC Compliance Track > US Mandates and Guidelines > Euthanasia of Research Animals: AVMA Guidelines

Which of the following lists the required members of an IACUC constituted to comply with both Animal Welfare Regulations and PHS Policy? a) 4 members- Chair, veterinarian, scientist, and non-scientific member b) 5 members- Chair, veterinarian, scientist, non-scientific member, and recorder (or secretary) c) 4 members- Chair, veterinarian, and two scientists d) 5 members- Chair, veterinarian, scientist, non-scientific member, and non-affiliated member

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

How often should the people who use the procedure room clean it? a) Monthly b) Daily c) Weekly d) After each use

d) After each use Source: AALAS Learning Library Regulatory and IACUC Compliance Track - Facilities, Supplies, and Materials

Dogs obtained from a Class B dealer may originate from what source? a) Animal pound b) Animal broker c) Hobby breeder d) All of the above

d) All of the above

Which group monitors the conditions of procedure rooms? a) IACUC b) USDA c) AAALAC d) All of the above d) None of the above

d) All of the above Source: AALAS Learning Library Regulatory and IACUC Compliance Track - Facilities, Supplies, and Materials

To protect yourself from potentially severe penalties, you should discuss and fully disclose potential outside payment and royalty opportunities with whom? a) Legal counsel representing a company that will be paying you royalties. b) Your personal lawyer. c) A banker or credit union official. d) An agency ethics official.

d) An agency ethics official. Source: AALAS Learning Library Regulatory and IACUC Compliance Track - Conflict of Interest

Which of the following types of drugs relieve pain? a) Anxiolytics b) Sedatives c) Neuromuscular blocking drugs d) Analgesics

d) Analgesics

What are three components that must be described in the Animal Welfare Assurance? a) Environmental Health and Safety Program description, IACUC membership, and FDA status b) Radiation Safety Program description, Animal Care and Use Program description, and Biological Hazards Program description c) IACUC membership, USDA status, and Institutional status d) Animal Care and Use Program description, Institutional Status, and IACUC membership

d) Animal Care and Use Program description, Institutional Status, and IACUC membership

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. b) Due to their small size, inhalants provide a quick euthanasia method for neonatal animals. c) Using a low concentration of inhalation agent is the preferred method to conduct euthanasia procedures. d) Animals should be protected from contact with the liquid form of the anesthetic agent.

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 is the best definition of a laboratory animal as defined by the Guide? a) Any invertebrate animal produced for or used in research, testing, or teaching. b) Any animal produced for or used in research, testing, or teaching. c) Any warm-blooded animal produced for or used in research, testing, or teaching. d) Any vertebrate animal produced for or used in research, testing, or teaching.

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)

The Animal Welfare Regulations and PHS policy do NOT allow the IO to do which of the following? a) Suspend an activity involving animals before IACUC approval b) Suspend an activity involving animals after IACUC approval c) Administratively suspend an investigator project without IACUC approval d) Approve an activity involving animals

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 these IACUC protocol review outcomes are recognized in the Animal Welfare Regulations and PHS Policy? a) Approve, require modifications (to secure approval), and deferred approval. b) Approve, conditional approval, and approval pending modifications. c) Approve, disapprove, and probationary approval. d) Approve, require modifications (to secure approval), and withhold approval.

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

How often should biological safety cabinets be certified? a) At the time of the IACUC inspection b) When installed c) At least monthly d) At least once a year

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

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: a) After the study is conducted on VA patients but before the results of the study are submitted for publishing. b) After the VA patients have been recruited but before the study begins. c) After consulting with a scientific colleague to make sure other people have recruited VA patients for similar private studies. d) Before proceeding with VA patient recruitment.

d) Before proceeding with VA patient recruitment. 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? a) Before any scientific work resulting from that activity is published. b) Before a potentially problematic activity is completed. c) Before you file taxes declaring payments made to you as part of royalty agreements. d) Before you engage in that activity.

d) Before you engage in that activity. Source: AALAS Learning Library Regulatory and IACUC Compliance Track - Conflict of Interest

What type of identification is not acceptable for dogs or cats at acquisition? a) Tattoo on the hairless area of the ear b) Tag on a collar around the animal's neck c) Tag on a collar affixed to a cat's primary enclosure d) Distinctive color markings

d) Distinctive color markings

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. b) The HVAC system should maintain the relative humidity in the 30-70% range. c) Temperature is best regulated by having a separate thermostat control in each animal holding room. d) Each institution's HVAC system should maintain each room's temperature by +/- 5° C.

d) Each institution's HVAC system should maintain each room's temperature by +/- 5° C.

How much extra caging can be stored in the procedure room at one time? a) One cart load b) A one week supply c) Enough for one room change d) Enough for short term use (less than 2 days)

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

Which statement is TRUE about exercise plans for dogs? a) Exercise plans do not need approval by the attending veterinarian. b) Exercise plans are not required if dogs are walked or allowed out of their cages daily. c) Exercise plans require an animal to be released from its primary enclosure. d) Exercise plans are required for all facilities housing dogs.

d) Exercise plans are required for all facilities housing dogs.

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? a) IACUC policy review and program review b) Program review and animal use protocol review c) Facility review and IACUC policy review d) Facility inspection and program review

d) Facility inspection and program review Source: AALAS Learning Library Regulatory and IACUC Compliance Track - IACUC Members and Administration - Essentials for IACUC Members

Which of the following statements is true when using CO2 for euthanasia? a) It is best to combine carbon dioxide with oxygen for euthanasia. b) Pulmonary lesions may occur if the carbon dioxide concentration reaches 40%. c) The optimal flow rate is one that displaces 10% of the chamber volume every minute. d) Gas flow should be maintained for at least 1 minute after apparent death to make sure the animal does not recover.

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

Who has the responsibility to ensure that all personnel working with live animals have been properly and appropriately trained? a) Attending Veterinarian b) Institutional Official c) Management d) IACUC

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)

Record-keeping requirements of the Animal Welfare Regulations state that: a) Mandated facility records must be kept for a minimum period of six months. b) Documentation is not required for the disposition of dogs, cats and nonhuman primates. c) Documentation of breeding pedigrees records are open to inspection by the USDA. d) IACUC records for meeting minutes, protocols and semiannual reports must be available to USDA inspection.

d) IACUC records for meeting minutes, protocols and semiannual reports must be available to USDA inspection.

Under what circumstance is the IV or IC injection of potassium chloride an acceptable euthanasia method? a) When other methods have failed b) When used in combination with a barbiturate c) If a catheter is used d) If the animal is anesthetized

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

Why are inspections, or assessments of animal use areas, an important part of a PAM program? a) You need to catch investigators red-handed doing things incorrectly so they can be punished. b) Inspections can scare investigators into complying with the PAM programs requests. c) Inspections by PAM personnel are mandated by the Animal Welfare Act. 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.

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

On behalf of an institution, which individual is ultimately responsible for compliance with PHS Policy? a) The IACUC b) Attending Veterinarian c) IACUC Chair d) Institutional Official

d) Institutional Official

Which of the following statements is FALSE? a) If animals are taken to the laboratory for behavioral testing, the area should be inspected. b) Dirty cages should be removed from the laboratory daily. c) If there is a dedicated animal use space in the laboratory, it should be kept clean, tidy, and free of bedding, animal debris, etc. d) Investigators are usually allowed to house animals in the laboratory if it is only for a couple of days.

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

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. b) There is no regulatory requirement for including minority opinions in other IACUC actions, so there is no precedent for including them in the minutes. c) Minority opinions should be encouraged, but need not be formally documented. d) It is a best practice to include them whenever an IACUC member requests to do so.

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

Which of the following should not be a consideration when selecting proper equipment for facilities? a) Ease of maintenance b) Operational integrity c) Reliability d) Least expensive e) All of the above f) None of the above

d) Lease expensive

Which of the following do NOT facilitate an effective IACUC protocol review? a) Members who participate in meeting discussions and other IACUC activities b) Members who come prepared to discuss protocols under review c) Members who consistently attend meetings d) Members who are reluctant to express differing opinions

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

Which of the following statements is true concerning dermatomycosis? a) Infected animals usually have several obvious lesions. b) One species of dermatophyte is common in animal facilities. c) Spores readily degrade in the environment. d) None of the above

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 mandates require the provision of occupational health services for employees who work in animal facilities? a) Occupational Health and Safety Act b) GLPS c) Animal Welfare Act d) PHS Policy

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"

Which of the following is FALSE regarding performance standards? a) Performance standards provide flexibility for achieving an outcome. b) Performance standards should be balanced with engineering standards. c) Performance standards require input from a team of qualified professionals. d) Performance standards define the methods in detail to be used to achieve the outcome.

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)

Which of the following statements regarding the process of polling IACUC members is TRUE? a) Polling can be used to achieve a quorum if the IACUC does not have a quorum during a convened meeting. b) Polling can be used to obtain IACUC suspension of an animal activity out of compliance. c) Polling can be used to obtain IACUC approval of a protocol during a convened meeting. d) Polling can be used to allow the IACUC members to call for full committee review before using the designated reviewer system.

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 is an example of appropriate enrichment for a guinea pig? a) Manipulable toy b) Foraging device c) Resting board d) Shelter

d) Shelter

Which of the following is NOT a responsibility of the IACUC? a) Reviewing and approving animal use protocols b) Performing a semi-annual review of the animal care program and inspection of all animal facility areas c) Reviewing and investigating staff reports about noncompliance with AWA regulations and standards d) Specifying veterinary treatments to be administered to facility animals

d) Specifying veterinary treatments to be administered to facility animals.

What is the procedure for removing soiled cages from a procedure room? a) Set them inside the nearest animal room for pick up. b) Place them on the counter near the door. c) Tape a note to the cages that says "Please remove" and leave them in the room. d) Take them to the cagewash room yourself at the end of the day.

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

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) The CEO may or may not also be the IO. b) The CEO may appoint another official to be the IO. c) The CEO must appoint IACUC members unless that responsibility is delegated in writing to someone else. d) The CEO must also be the IO.

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

Regarding investigations of complaints, which of the following statements is TRUE? a) The AWA Regulations mandate a specific process for the IACUC to investigate allegations about animal care, but the PHS Policy has no such requirements. b) There is a specific, required process for the IACUC to investigate concerns about animal care and use as mandated by the AWA Regulations and PHS Policy. c) The IACUC is not required to investigate complaints about improper animal care and use as this is a USDA responsibility. d) There is no required process for investigating concerns expressed about animal care and use; however, investigations must be quick and complete.

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

The regulatory entities that enforce the Animal Welfare Act and Regulations and PHS Policy, respectively, are: a) OHRP and USDA/APHIS/Animal Care. b) USDA/APHIS/Animal Care and OMB. c) OPRR and OLAW. d) USDA/APHIS/Animal Care and OLAW.

d) USDA/APHIS/Animal Care and OLAW. Source: AALAS Learning Library Regulatory and IACUC Compliance Track - IACUC Members and Administration - Essentials for IACUC Members

When should you stop using a sharps container? a) When it is filled to the top b) When it is overflowing c) When it is half full d) When it is 2/3 full

d) When it is 2/3 full Source: AALAS Learning Library Regulatory and IACUC Compliance Track - Facilities, Supplies, and Materials

Physical methods of euthanasia cause death through destruction of: a) muscular activity in the body. b) afferent pathways from the periphery to the brain. c) chemical pathways in the heart muscle. d) midbrain centers controlling respiratory and cardiac activity

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

There are three main circumstances for prompt report to PHS, which one of the three circumstances below must be reported promptly to USDA: a) Suspension of an activity by the IACUC b) serious deviation from the Guide (unless previously approved by the IACUC) c) Serious continuing non compliance with PHS Policy d) none of the above

d) none of the above

Although opinions vary about the level of detail needed in IACUC minutes, a typical standard is that IACUC minutes: a) must include an actual transcript of all conversations that occurred at the meeting, as a minimum. b) should provide as little information as possible to prevent outside observers from understanding how the IACUC operates. c) must be no longer than three pages to satisfy federal paperwork reduction regulations. d) should allow an outside observer to verify that deliberations occurred, and understand the outcomes of those deliberations.

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

Life support systems are usually one of three types: re-circulating, flow-through, or ____________________. a) aeration b) ionized c) neutralized d) static

d) static

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: a. The Chair of the Joint Technical Working Group (JTWG) b. A veterinarian to the Interagency Research Animal Committee c. The office that will perform headquarters-level administrative review of the use of non-human primates. d. None of the above e. All of the above

d. None of the above

The institution's program for the care and use of animals should include which of the following information? a) Description of the training provided to personnel b) Membership of the IACUC and its established procedures c) Description of the occupational health and safety program available to personnel d) Qualifications of the veterinarian participating in the program e) All of the above

e) All of the above

What factors should you consider when designing a PAM program for your institution? a) The compliance history of your program b) The level of invasiveness of the studies performed at your institution c) The technical level of the people performing animal work at your institution d) The size of your animal program, including how many USDA-covered species you have e) All of the above f) None of the above

e) All of the above Source: AALAS Learning Library Regulatory and IACUC Compliance Track - IACUC Members and Administration - Post-Approval Monitoring

Which federal agency decides if an employee has violated conflict of interest statutes? a) Department of Veterans Affairs. b) Department of Defense. c) Department of Health and Human Services. d) Whichever agency pays the employee. e) Department of Justice.

e) Department of Justice

Which of the following is NOT a component of the veterinary care program? a) Animal procurement and transportation b) Euthanasia c) Treatment of diseases and injuries d) Presurgical planning, training, monitoring, and postsurgical care e) Training of husbandry personnel on changing cages

e) Training of husbandry personnel on changing cages

According to the Guide, who can conduct Post-Approval Monitoring (PAM)? a) IACUC b) veterinarians c) animal care personnel d) compliance staff e) all the above

e) all the above

When there are allegations of concerns on animal care and use, what are recommended steps for the IACUC when investigating the concern: a) the chair convene a meeting of the IACUC b)IO should be notified b) the AV should be involved in the investigation d) suspend research activity e) all the above

e) all the above

According to PHS, awardee institutions shall maintain good recordkeeping. Which one is not a recordkeeping requirement? a) a copy of the Assurance approved by PHS b) minutes of IACUC meetings c) records of accrediting body determinations d) records and proposals and applications and propose significant changes, IACUC reports and recommendations e) records of semiannual IACUC reports to IO (including minority views) d) all the above e) none of the above

e) none of the above

Which of the following are applicable to the Department of Defense: a. Animal Welfare Act; Animal Welfare Regulations b. The Guide for the Care and Use of Laboratory Animals; The Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching c. The Lacey Act; Marine Mammal Protection Act; Endangered Species Act; Convention on International Trade in Endangered Species of Wild Fauna and Flora d. A & C e. All of the above

e. All of the above

Programs for medical evaluation preventative medicine include all the following except: a) pre-employment evaluation b) health history c) procedures for reporting and treating injuries and allergies, including bites and accidents d) Zoonosis surveillance e) Institutions must consider confidentiality and other legal factors f) Pre-employment serum samples g) None of the above

g) Nove of the above

What "activities" are covered by PHS policy?

research, research training, and biological testing (P7)

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

According to the Health Research Extension Act of 1985, the animal care "Guidelines...shall require" what?

the appropriate use of tranquilizers, analgesics, anesthetics, paralytics, and euthanasia; appropriate pre- and post- surgical veterinary medical and nursing care for animals in research (p1)