Term
|
Definition
Animal and Plant Health Inspection Service
(part of USDA) |
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Term
| Which regulatory body does NOT require that the IACUC have a scientific member? |
|
Definition
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|
Term
| Which organization confers CPIA certification? |
|
Definition
| The Council for CPIAs (CCPIA), an affiliate of PRIM&R. |
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Term
Which of the following offers a voluntary accreditation program of institutional animal care and use programs?
A. PHS
B. USDA
C. OLAW
D. AAALAC |
|
Definition
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|
Term
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 |
|
Definition
| C. Individual not otherwise affiliated with the institution |
|
|
Term
| USDA limit on how many IACUC members can be from the same administrative unit. |
|
Definition
| 3 (usually implemented at a departmental level) |
|
|
Term
| What limits the number of IACUC members from any one administrative unit to 3? |
|
Definition
USDA Regulations
(but also found in the Guide) |
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Term
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 |
|
Definition
| 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. |
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Term
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. |
|
Definition
| A. The IACUC may suspend an activity only after a majority vote of a convened meeting. |
|
|
Term
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 |
|
Definition
| D. Training and instruction of personnel must include guidance in research or testing methods that limit the use of animals. |
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Term
|
Definition
| Association for Assessment and Accreditation of Laboratory Animal Care International (voluntary, accreditation) |
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Term
|
Definition
| American Association for Laboratory Animal Science |
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Term
|
Definition
| Animal Care Section (USDA -> APHIS -> AC; enforces AWA through AWAR) |
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Term
|
Definition
| American College of Laboratory Animal Medicine |
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Term
|
Definition
| American Veterinary Medical Association (produce Guidelines for Euthanasia, current edition is 2013) |
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Term
|
Definition
| Animal Welfare Act (enforced by USDA-APHIS-AC; includes warm blooded animals aside from birds, Rattus, Mus, and farm animals) |
|
|
Term
| Which entity enforces the AWA? |
|
Definition
| USDA->APHIS->Animal Care Section |
|
|
Term
| Which animals are covered by USDA/AWA? |
|
Definition
| Most warm blooded animals. |
|
|
Term
| Which animals are specifically excluded from the AWA? |
|
Definition
| Birds, Rattus, Mus, farm animals, cold blooded animals |
|
|
Term
|
Definition
| Animal Welfare Act Regulations |
|
|
Term
|
Definition
Animal Welfare Information Center
(mandated by AWA to provide animal welfare info) |
|
|
Term
|
Definition
| Centers for Disease Control and Prevention |
|
|
Term
|
Definition
| Department of Health and Human Services |
|
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Term
|
Definition
|
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Term
|
Definition
| Environmental Protection Agency |
|
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Term
|
Definition
| Food and Drug Administration |
|
|
Term
|
Definition
|
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Term
|
Definition
| Institutional Animal Care and Use Committee |
|
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Term
|
Definition
| Institute for Laboratory Animal Research |
|
|
Term
|
Definition
|
|
Term
|
Definition
| Interagency Research Animal Committee |
|
|
Term
|
Definition
| National Institutes of Health |
|
|
Term
|
Definition
| National Research Council |
|
|
Term
|
Definition
| National Science Foundation |
|
|
Term
|
Definition
| Occupational Health and Safety Program |
|
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Term
|
Definition
| Office of Laboratory Animal Welfare (PHS->NIH; enforces Health Research Extension Act public law through PHS Policy) |
|
|
Term
| Which entity enforces the Health Research Extension Act? |
|
Definition
PHS->NIH->OLAW
(through PHS Policy) |
|
|
Term
|
Definition
| Occupational Safety and Health Administration |
|
|
Term
|
Definition
|
|
Term
|
Definition
|
|
Term
|
Definition
| Public Responsibility in Medicine and Research |
|
|
Term
|
Definition
| United States Department of Agriculture |
|
|
Term
|
Definition
| Department of Veterans Affairs |
|
|
Term
|
Definition
| Veterinary Medical Officer |
|
|
Term
| PHS Policy is enforced by |
|
Definition
|
|
Term
| AWA and AWAR are enforced by |
|
Definition
| Animal Care Section of APHIS (USDA) |
|
|
Term
| AWA is to AWAR as ______ is to _______ |
|
Definition
| Health Research Extension Act; PHS Policy |
|
|
Term
|
Definition
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) |
|
|
Term
| What are the three categories of regulatory documents used by USDA and PHS? |
|
Definition
1. Public law
2. The Regulations (carry force of law)
3. Guidance (interpretive rules)
Note: Institutions must comply with ALL of them. |
|
|
Term
| Where is most USDA Guidance published? |
|
Definition
| Animal Care Policy Manual (online and downloadable PDF) |
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|
Term
| List the five most important IACUC responsibilities |
|
Definition
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 |
|
|
Term
| How frequently must the IACUC review the animal program and facilities? |
|
Definition
|
|
Term
| List the five most important responsibilities of individual IACUC members |
|
Definition
1. Attend meetings
2. Be prepared
3. Understand animal issues affecting protocols
4. Attend semiannual review of program and facilities
5. Participate in discussions |
|
|
Term
| Who is responsible for the animal care and use program? |
|
Definition
1. the vet and their staff
2. the IACUC
3. the IO |
|
|
Term
| Which document provides fines for IACUC members who violate confidentiality regulations? |
|
Definition
| B: AWA (intended to protect institutions; AWAR states that reports of violations to regulatory agencies do NOT violate confidentiality) |
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Term
| True or False: The AWAR provide 'whistleblower' protections for people (including IACUC members) who report AWA or AWAR violations to regulatory agencies. |
|
Definition
|
|
Term
| 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. |
|
Definition
True
(with the exception that they may provide information requested by the IACUC) |
|
|
Term
| Which policy states that IACUC members may not contribute to a quorum for purposes of reviewing their own protocols? |
|
Definition
|
|
Term
| Which policy states that IACUC members may not vote on their own proposals? |
|
Definition
| USDA/APHIS Policy #15 in the Animal Care Policy Manual |
|
|
Term
| Which IACUC roles are specified by USDA AWAR? |
|
Definition
1. IO
2. Chairperson
3. Attending Vet
4. Nonaffiliated Member |
|
|
Term
| What is the best practice when discussing proposals for which IACUC members have conflicts of interest? |
|
Definition
| 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.) |
|
|
Term
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. |
|
Definition
| C. The IACUC does NOT typically review and and score the scientific value of submitted animal protocols. |
|
|
Term
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. |
|
Definition
| B. All members should feel encouraged to participate in discussions and voice differing opinions. |
|
|
Term
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. |
|
Definition
| C. Jargon should not get in the way of discussion or discourage any member from participating fully in the meeting. |
|
|
Term
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. |
|
Definition
| D. The AWAR specifically state that reporting violations to regulatory agencies is NOT a violation of the IACUC confidentiality provided by AWA. |
|
|
Term
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. |
|
Definition
| D. The AWAR provide 'whistleblower' protections for IACUC members who report violations to the USDA. |
|
|
Term
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. |
|
Definition
| C. The member should remove themselves from the room during BOTH deliberations AND voting. |
|
|
Term
| How many voting IACUC members are required, and who are they? |
|
Definition
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) |
|
|
Term
| True or False: The 2011 Guide does NOT list Chair as essential member. |
|
Definition
| 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) |
|
|
Term
|
Definition
| Guide for the Care and Use of Agricultural Animals in Research and Teaching (published by FASS) |
|
|
Term
|
Definition
| Federation of Animal Science Societies; publishes Ag Guide |
|
|
Term
| If institution uses agricultural animals, what additional requirements are there for the membership of the IACUC? |
|
Definition
| Must have 2 scientific members, one with ag animal research or teaching experience and one with ag animal management training and experience. |
|
|
Term
| Which regulatory body requires that the IACUC have a Chairperson? |
|
Definition
| USDA/APHIS (Policy #15 in AC Policy Manual) |
|
|
Term
| What are the required credentials and skills of the IACUC Chairperson? |
|
Definition
| 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. |
|
|
Term
| Can just any vet serve on the IACUC? |
|
Definition
| 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. |
|
|
Term
| Who is the only member that serves on the IACUC on the basis of employment (ex officio)? |
|
Definition
|
|
Term
| What are the best practice credentials for an Attending Vet? |
|
Definition
1. DVM or equivalent
2. Certification by ACLAM or equivalent (or equivalent training and experience)
3. Authority and responsibility for institutional animal activities. |
|
|
Term
| What additional authorities and responsibilities are given to the Attending Vet by AWAR? |
|
Definition
1. AV or designee must approve details of surgical proposals
2. Make recommendations (in health records) of activity level or restictions
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 |
|
|
Term
| For which animals must health records be kept? |
|
Definition
|
|
Term
| Can the non-affiliated member be a scientist? |
|
Definition
| Yes, but they should NOT utilize laboratory animals (Guide, p. 24). |
|
|
Term
| Can the non-affiliated member be compensated for participation on the IACUC? |
|
Definition
| Yes, as long as it is not a significant source of income, does not influence voting, and does not qualify them as an employee |
|
|
Term
| Can the non-affiliated member be a veterinarian? |
|
Definition
| Yes (but they CANNOT be the Attending Veterinarian). |
|
|
Term
| Can members of the IACUC fulfill more than one role (for example, an non-affiliated non-scientist)? |
|
Definition
| 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. |
|
|
Term
| Must the non-affiliated member attend in order for the IACUC to conduct business? |
|
Definition
| No. That is an IRB rule, and no equivalent rule exists for the IACUC. |
|
|
Term
| Must the Attending Vet attend in order for the IACUC to conduct business? |
|
Definition
| 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. |
|
|
Term
| How frequently must the IACUC meet? |
|
Definition
| 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. |
|
|
Term
| True or False: The required members of the IACUC must all be voting members. |
|
Definition
|
|
Term
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. |
|
Definition
| C. An IACUC cannot conduct official business unless it is properly constituted (must have all 5 required members appointed). |
|
|
Term
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. |
|
Definition
| D. 5 members–chair, veterinarian, scientist, non-scientific member, and non-affiliated member. |
|
|
Term
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. |
|
Definition
| A. Being the Attending Vet has nothing to do with being the Chair. |
|
|
Term
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. |
|
Definition
| B. Determine when emergency IACUC meetings must be scheduled. |
|
|
Term
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. |
|
Definition
| C. Non-affiliated members must not be affiliated with the institution, but they must also not utilize laboratory animals elsewhere. |
|
|
Term
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. |
|
Definition
| C. In fact, the IACUC han 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. |
|
|
Term
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. |
|
Definition
| 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. |
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|
Term
| Which two institutional administrators are specifically dealt with in the regulations? |
|
Definition
|
|
Term
|
Definition
| The highest operating official of the institution, such as the president of a university (PHS Policy). |
|
|
Term
| Who appoints members to serve on the IACUC? |
|
Definition
| The CEO, although they can delegate this responsibility in writing (HREA and PHS Policy). |
|
|
Term
| Can the CEO and the IO be the same person? |
|
Definition
| Yes (PHS Policy specifically allows) |
|
|
Term
|
Definition
| 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. |
|
|
Term
|
Definition
|
|
Term
| Who does the IACUC notify of deficiencies found during semiannual self-evaluation? |
|
Definition
|
|
Term
| Who does the IACUC inform is progress toward correcting significant program and facility deficiencies falls short? |
|
Definition
|
|
Term
| If the IACUC suspends an activity, what is the role of the IO? |
|
Definition
| The IO must in consultation with the IACUC review the reasons for supension 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. |
|
|
Term
| To whom does the IACUC make recommendations regarding the animal program, facilities, or personnel training? |
|
Definition
|
|
Term
| Who signs the USDA/APHIS Annual Report? |
|
Definition
|
|
Term
| What is best practice regarding institutional reporting practices? |
|
Definition
| 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. |
|
|
Term
| Can the IO (or other administrator) suspend IACUC approved activities? |
|
Definition
|
|
Term
| Can the IO (or other administrator) approve animal activities in the absence of IACUC approval or reverse and IACUC suspension? |
|
Definition
|
|
Term
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. |
|
Definition
| A. In fact, the CEO and the IO may or may not be the same person. |
|
|
Term
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. |
|
Definition
| A. The IO can NOT approve animal activities in the absence of IACUC approval, nor can he or she reverse an IACUC suspension. |
|
|
Term
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. |
|
Definition
| C. The IO can NOT approve an animal activity that the IACUC has witheld approval of. |
|
|
Term
| Aside from the IACUC, can any other body or official approve an animal protocol? |
|
Definition
| Not in the absence of IACUC approval. (AWAR and PHS Policy) |
|
|
Term
| True of False: The IACUC has no real authority to suspend animal activities. |
|
Definition
| False. The IACUC must have institutional authority to suspend any animal activities. (AWAR and PHS Policy) |
|
|
Term
| Can the IACUC suspend animal activities that it never reviewed in the first place? |
|
Definition
| 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.) |
|
|
Term
| Who can stop animal activities? |
|
Definition
| 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 quorom at a convened meeting, and this is a suspension. |
|
|
Term
| Is suspension synonymous with stopping animal activities? |
|
Definition
| 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. |
|
|
Term
| What steps are necessary for the IACUC to suspend an activity? |
|
Definition
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.) |
|
|
Term
| What are the criteria the IACUC should use in determining whether or not to suspend an animal activity? |
|
Definition
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? |
|
|
Term
| Do the individual members of the IACUC have authority to stop animal activities? |
|
Definition
| Only if specifically conferred by the institution (usually no). |
|
|
Term
| When should the IACUC and IO report a suspension? |
|
Definition
| As a best practice, immediately by phone and letting them know that written correspondence will be forthcoming. |
|
|
Term
| Under what circumstances does USDA/APHIS need to be informed of a suspension? |
|
Definition
| If the activity involves USDA covered species or if the PHS Assurance requires it. |
|
|
Term
| What has to be reported to AAALAC? |
|
Definition
| 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. |
|
|
Term
| Are even temporary holds considered suspensions? |
|
Definition
| Yes, according to OLAW, if they result from a majority vote of a convened quorum of the IACUC. |
|
|
Term
| Once the IO (or other individual with authority) has stopped an activity, can they reinstate the activity without IACUC action? |
|
Definition
| Yes, unless the IACUC voted to suspend--in that case, only the IACUC can lift the suspension. |
|
|
Term
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. |
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Definition
| 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. |
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Term
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. |
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Definition
| 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). |
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Term
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. |
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Definition
| C. Report to the IO right away, and then with the IO report right away to regulatory authorities. |
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Term
|
Definition
| More than 50% (50% plus one) of the voting members are present. |
|
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Term
| Can the IACUC conduct formal business without a quorum? |
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Definition
|
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Term
| If a quorum is present, then is lost when members have to leave or recuse themselves, can business continue? |
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Definition
| No. A quorum must be present for each issue that is before the committee. |
|
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Term
| Is it better for the IACUC to have an odd number of members or an even number of members? |
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Definition
| Odd is better, because it does not increase the quorum requirement. |
|
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Term
| Are alternate members discussed in AWAR or PHS Policy? |
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Definition
| No, but there is Guidance on the issue from OLAW and USDA. |
|
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Term
| Can a pool of alternates be used? |
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Definition
| No, they must be appointed in a one-to-one correspondence with regular members. |
|
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Term
| Do alternates need to be appointed by the CEO or his or her designee? |
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Definition
| Yes, just like regular members. |
|
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Term
| Should alternates be listed on IACUC rosters submitted to OLAW with Assurances and annual reports? |
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Definition
|
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Term
| Can a member and his or her alternate contribute to a quorum at the same time? |
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Definition
|
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Term
| What kind of training do IACUC alternates need? |
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Definition
| They should receive training similar or identical to that provided for regular members. |
|
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Term
| Are alternates supposed to represent the position of their regular members? |
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Definition
| No, they are supposed to vote their conscience. |
|
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Term
| Can alternate members attend meetings and participate in activities even when their regular members are present? |
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Definition
| Yes, at the discretion of the institution, but they cannot vote or contribute to a quorum at the same time as their regular member. |
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Term
| Can alternates serve for more than one regular member? |
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Definition
| Yes, but they can only stand in at the meeting for one absent member per issue. |
|
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Term
| Can one regular member have more than one alternate? |
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Definition
| Yes, but only one of them can stand in at the meeting for the regular member per issue. |
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Term
|
Definition
| 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. |
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Term
| Can teleconferencing (even phone) be used to convene a quorum? |
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Definition
| 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. |
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Term
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. |
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Definition
| 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. |
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Term
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. |
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Definition
| C. Alternates cannot vote on or contribute to a quorum for the same issue as their primary member(s). |
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Term
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. |
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Definition
| D. A quorum is 50% plus one of voting members. |
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Term
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. |
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Definition
| B. No official business can be conducted any time a quorum not present. |
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Term
| Which regulations require the use of prepared, fillable forms for animal protocols? |
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Definition
| None, it is just the most common practice. |
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Term
| Which regulations require pre-review? |
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Definition
| 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. |
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Term
| Do IACUC members have to be provided with actual protocols before the meeting? |
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Definition
| 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. |
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Term
| Should IACUC members have access to grant documents? |
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Definition
| It is not required, but it is best practice to make these available |
|
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Term
| What are the review methods allowed by USDA and PHS? |
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Definition
1. Full committee review (FCR)
2. Designated member review (DMR) |
|
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Term
| Can designated-member review be used for new submissions? |
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Definition
|
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Term
| Who assigns designated reviewers when DMR is used? |
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Definition
|
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Term
| What is the minimum number of designated reviewers for a protocol when DMR is used? |
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Definition
|
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Term
| What is the process for DMR of new submissions? |
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Definition
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. |
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Term
| What options do designated reviewers have? |
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Definition
1. Approve
2. Require modifications to secure approval
3. Request FCR. |
|
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Term
| Can designated members withhold approval? |
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Definition
| No (although they can require modifications or call for FCR). |
|
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Term
| What happens if there are more than one designated reviewer, and one of them calls for FCR? |
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Definition
| FCR, no matter what the other(s) want. |
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Term
| If 3 or more designated reviewers are used, does the majority decide the outcome. |
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Definition
| 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. |
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Term
| Which regulations call for the use of primary reviewers? |
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Definition
|
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Term
| True or False: Designated reviewers are the same thing as primary reviewers. |
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Definition
| 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. |
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Term
| Can the Chair initiate DMR during the waiting period for calling for FCR? |
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Definition
| 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.) |
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Term
| Who determines the time frame for when members must call for FCR before the DMR process can begin? |
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Definition
| The Committee (not the Chair). |
|
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Term
| What is expedited review? |
|
Definition
| 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. |
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Term
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. |
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Definition
| C. Send to all members -> no member calls for FCR within time frame -> initiate DMR. |
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Term
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. |
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Definition
| D. FCR and DMR are the only forms of review recognized by AWAR and PHS Policy. |
|
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Term
| What are the possible outcomes of FCR? |
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Definition
1. Approve
2. Require modifications to secure approval
3. Withhold approval |
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Term
| What is conditional approval? |
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Definition
| It does not exist. Protocols are either approved or not. A protocol that requires modifications is not yet approved. |
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Term
| How long is approval 'good' for? |
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Definition
| One year for USDA covered species, or up to three years for other species. |
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Term
| What are the conditions for DMR subsequent to FCR ("C&M DMR")? |
|
Definition
1. All members are present at meeting and there is a unanimous vote to review the protocol that way. -OR-
2. All member agree in advance in writing that a quorum of a convened meeting may decide by unanimous vote to proceed this way. In this case, any member may request to see the revised protocol and have the opportunity to call for FCR, and the Assurance should clearly spell out that this method is possible. -OR-
3. If all members not present, and there are no written SOPs as in (2), a majority can still vote for DMR, but in this case all members (including those not present) must have the revised protocol available and must have the opportunity to call for FCR. |
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Term
| Who must be notified of IACUC decisions to approve, withhold approval, or require modifications? |
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Definition
| The PI and the institution. |
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Term
| If the IACUC witholds approval, what must be included in the notification? |
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Definition
| The reasons for the decision, and an opportunity to respond in person or in writing. |
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Term
| If the IACUC votes to withold approval, can it reconsider its decision? |
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Definition
| Yes, in light of additional information provided by the PI, and their must be documentation in the minutes. |
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Term
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. |
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Definition
| A. Notifying the the PI in writing of protocol review outcomes is required. |
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Term
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. |
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Definition
| A. Designated reviewers can call for FCR, but they can NOT withhold approval. |
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Term
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. |
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Definition
| A. The only possible outcomes are Approve, Require modifications to secure approval, or Withhold approval. |
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Term
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. |
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Definition
| A. These terms have not codified meaning, and are best avoided. |
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Term
| What are the four categories of protocol reviews? |
|
Definition
1. Initial review
2. Annual review
3. Three-year review
4. Review of proposed significant changes to already approved protocols ("modifications" or "amendments") |
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Term
| Which regulatory body requires annual reviews? |
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Definition
| USDA (AWAR; continuing review, not less than annually) |
|
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Term
| How detailed should the USDA-required annual review be? |
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Definition
| It is not stipulated in the regs, but can be less detaile than initial review. |
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Term
| Which regulatory body requires detailed three-year (triennial) reviews? |
|
Definition
|
|
Term
| How detailed should the PHS-required three-year review be? |
|
Definition
| It is a de novo review, with the same level of detail as an initial review. |
|
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Term
| How frequently does the PI need to reconsider alternatives? |
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Definition
| 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. |
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Term
| How strict are the annual and triennial deadlines? |
|
Definition
| 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. |
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Term
| Do new forms have to be used for the triennial review? |
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Definition
| 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. |
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Term
| Does every project have to undergo both annual and triennial reviews? |
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Definition
| 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. |
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Term
| If a grant is for longer than 3 years, can the triennial review period be extended? |
|
Definition
| No, the activity must receive a de novo review at least once every three years (PHS), regardless of length of funding. |
|
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Term
| Can amendments just wait until the annual review? |
|
Definition
| No, the IACUC must review and approve significant changes to the approved protocol *before* they take effect. |
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Term
| What are considered "significant changes" in terms of requiring a review of an amendment? |
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Definition
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 |
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Term
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. |
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Definition
| B. But it is best practice for the IACUC to require new forms. |
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Term
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. |
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Definition
| B. Significant changes must be reviewed and approved by the IACUC before they are implemented. |
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Term
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. |
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Definition
| D. Perform an annual review prior to the first and second approval anniversaries, and perform a triennial review prior to the third anniversary. |
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Term
| 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. |
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Definition
|
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Term
| What level of detail must there be in the minutes? |
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Definition
| 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. |
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Term
| Do minority opinions have to be recorded? |
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Definition
| 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. |
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Term
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. |
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Definition
| C. Should allow an outside observer to verify that deliberations occurred and to understand the outcomes of those deliberations. |
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Term
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. |
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Definition
| 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. |
|
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Term
| Which body requires the semi-annual evaluation? |
|
Definition
|
|
Term
| What are the 3 main goals of the semi-annual evaluation? |
|
Definition
1. Monitor facilities and program to ensure they meet standards of AWAR and PHS Policy.
2. Identify deficiencies, create plan and schedule for corrections, make sure corrections are made.
3. Communicate results and suggestions to the IO. |
|
|
Term
| What are the two components of the semi-annual evaluation? |
|
Definition
1. Facility inspection
2. Program review |
|
|
Term
| What is to be used as the basis of the semi-annual evaluation? |
|
Definition
1. USDA requires use of AWAR
2. PHS requires use of PHS Policy (including Guide) |
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Term
| Is a quorum necessary to carry out the semi-annual evaluation? |
|
Definition
| 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. |
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Term
| Can any members be denied the ability to participate in the semi-annual evaluation? |
|
Definition
|
|
Term
| According to AWAR and PHS Policy, what 3 elements are required to be in the semi-annual report? |
|
Definition
1. description of facility's adherence to AWAR and PHS Policy
2. identification of departures, and the reason for each
3. any minority views |
|
|
Term
| Who must review and sign the semi-annual report? |
|
Definition
| A majority of all IACUC members (NOT just a quorum). (AWAR only) |
|
|
Term
| To whom is the semi-annual report submitted? |
|
Definition
| The IO (both AWAR and PHS Policy) |
|
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Term
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. |
|
Definition
| A. The two elements are facility inspection and program review. |
|
|
Term
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. |
|
Definition
| A. The USDA Animal Welfare Act Regulations (AWAR) and PHS Policy, which includes the Guide. |
|
|
Term
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. |
|
Definition
| C. With at least 2 IACUC members, and allow participation by any member who wishes to do so. |
|
|
Term
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. |
|
Definition
| 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. |
|
|
Term
| What animal areas have to be inspected? |
|
Definition
| 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). |
|
|
Term
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. |
|
Definition
| C. It is basically everything about IACUC and animal use other than the physical facility. |
|
|
Term
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. |
|
Definition
| D. All areas housing animals for more than 12 hours, and all investigator laboratory and study areas where animal procedures are performed. |
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Term
| What 2 categories are used for deficiencies described in the semi-annual report? |
|
Definition
1. Significant
2. Minor (non-significant) |
|
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Term
| What is a significant deficiency in the semi-annual report? |
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Definition
| One that in the view of the IACUC and IO is or may be a threat to the health or safety of the animals. |
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Term
| Do significant deficiencies found in the semi-annual evaluation have to be reported to regulatory bodies? |
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Definition
| 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. |
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Term
| 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? |
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Definition
| This must be reported within 15 days, through the IO, to the USDA and the federal funding agency. |
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Term
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. |
|
Definition
| A. A significant deficiency is one which is or may be a threat to the health or safety of the animals. |
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Term
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. |
|
Definition
| A. The IACUC and IO together. |
|
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Term
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. |
|
Definition
| B. A reasonable and specific plan for correcting significant and minor deficiencies and a schedule for completing the corrective actions. |
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Term
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. |
|
Definition
| B. Report the situation through the IO to USDA within 15 business days. |
|
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Term
| What are the responsibilities of the IACUC if a concern is raised from the public or a member of the institution regarding animal care? |
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Definition
| Review (both AWAR and PHS Policy) and if warranted investigate (AWAR) the concern. |
|
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Term
| What is the process for reviewing (and investigating) concerns about animal care? |
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Definition
| 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 with recommendations. Many IACUCs use a subcommittee. Best practice is to notify IO as soon as allegations are made. |
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Term
| Which regs make it illegal for an institution to take reprisal against an individual that reports a violation? |
|
Definition
|
|
Term
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. |
|
Definition
| A. In fact, it is the responsibility of the IACUC. |
|
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Term
| Which codes and policies call for animal research as a moral imperative? |
|
Definition
| Principle 3 of the Nuremburg Code, and PHS regulations. |
|
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Term
|
Definition
| American College of Laboratory Animal Medicine |
|
|
Term
| What official is responsible for the oversight of the DoD animal use program? |
|
Definition
| Director of Defense Research and Engineering (DDRE) |
|
|
Term
| Can DoD researchers inflict wounds with weapons to train in surgical or medical treatments for these wounds. |
|
Definition
| Yes, but they can't use dogs, cats, primates, or marine mammals. |
|
|
Term
| DoD rules apply to which animals? |
|
Definition
| Living or dead vertebrates, used on DoD facilities or in research supported by DoD. |
|
|
Term
| Which law/regs does DoD specifically require researchers to follow? |
|
Definition
|
|
Term
| Do DoD researchers have to follow foreign rules and regulations when working outside the US? |
|
Definition
|
|
Term
|
Definition
| Interagency Research Animal Committee. |
|
|
Term
| In DoD research, who reports infractions to DDR&E? |
|
Definition
|
|
Term
| How long does DoD require records be kept? |
|
Definition
| At least three years after the end of the activity. |
|
|
Term
| DoD Veterinary Services Program is under control of which military branch? |
|
Definition
|
|
Term
True or False?:
DoD requires its facilities to be AAALAC accredited. |
|
Definition
|
|
Term
| How many members does DoD require? |
|
Definition
| At least 5. Vet, non-affiliated (with mandatory alternate), non-scientist, plus enough others to make at least 5. |
|
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Term
| Which body requires that vet and non-affiliated member be present for IACUC to conduct business? |
|
Definition
|
|
Term
| According to DoD regs, what must be administratively reviewed & approved at the Component headquarters level? |
|
Definition
| 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). |
|
|
Term
| According to DoD regs, what events require an institution to notify the Component headquarters? |
|
Definition
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.) |
|
|
Term
True or False:
Under VA rules, the facility Director is the CEO, and can delegate IO responsibility to someone else. |
|
Definition
| False. VA rules mandate that the Director serve as the IO. |
|
|
Term
True or False:
Each VA with an animal program must have a PHS assurance. |
|
Definition
| False. A VA med center may be covered by an affiliate's Assurance. If so, the affiliate's IO must be appointed as IO for PHS correspondence. (Similar rule is in place for AAALAC accreditation.) |
|
|
Term
| Does the VA VMO have to be full-time? |
|
Definition
|
|
Term
| Does the AV have to *pre*-review protocols *before* IACUC submission? |
|
Definition
| 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). |
|
|
Term
| Does the AV have to participate in the semiannual review? |
|
Definition
|
|
Term
| Does the VA *require* AAALAC accreditation? |
|
Definition
|
|
Term
|
Definition
| 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. |
|
|
Term
| VA IACUC appointment process. |
|
Definition
| IACUC (in consultation with RDC) forwards names of nominees to director, who appoints. |
|
|
Term
| What are the VA IACUC membership requirements? |
|
Definition
| Must meet AWA and PHS Policy requirements. |
|
|
Term
| According to VA rules, who must take part in the semiannual review? |
|
Definition
| At least three members, two of whom must be voting members, and one of whom must the the Vet. |
|
|
Term
| To which animals do VA rules apply? |
|
Definition
|
|
Term
True or False:
VA rules require that vet pre-review occur for *all* animal protocols, and that it is done *before* IACUC review. |
|
Definition
True.
This is more strict than USDA/PHS rules. |
|
|
Term
True or False:
VA policy stipulates that when using DMR, all members must receive complete copies of all protocol forms. |
|
Definition
True.
This is more strict than USDA/PHS. |
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