CPIA Flashcards
IACUC Monitoring Responsibilities
From the USDA Animal Welfare Act Regulations and Standards, Section 2.31-
c. “IACUC Functions. With respect to activities involving animals, the IACUC, as an agent of the research facility, shall:
1. Review, at least once every six months, the research facility’s program for humane care and use of animals, using title 9, chapter I, subchapter A–Animal Welfare, as a basis for evaluation;
2. Inspect, at least once every six months, all of the research facility’s animal facilities, including animal study areas, using title 9, chapter I, subchapter A-Animal Welfare, as a basis for evaluation; provided, however, that animal areas containing free-living wild animals in their natural habitat need not be included in such inspection;”
http://www.access.gpo.gov/nara/cfr/waisidx/9cfr2.html
From PHS Policy, Section IV.B.1-
“As an agent of the institution, the IACUC shall with respect to PHS - conducted or supported activities:
- review at least once every six months the institution’s program for humane care and use of animals, using the Guide as a basis for evaluation;
- inspect at least once every six months all of the institution’s animal facilities (including satellite facilities) using the Guide as a basis for evaluation;
- prepare reports of the IACUC evaluations conducted as required by IV.B.1. and 2. of this Policy, and submit the reports to the Institutional Official. (NOTE: the reports shall be updated at least once every six months upon completion of the required semiannual evaluations and shall be maintained by the institution and made available to OLAW upon request. The reports must contain a description of the nature and extent of the institution’s adherence to the Guide and this Policy and must identify specifically any departures from the provisions of the Guide and this Policy, and must state the reasons for each departure. The reports must distinguish significant deficiencies from minor deficiencies. A significant deficiency is one which, consistent with this Policy, and, in the judgment of the IACUC and the Institutional Official, is or may be a threat to the health or safety of the animals. If program or facility deficiencies are noted, the reports must contain a reasonable and specific plan and schedule for correcting each deficiency. If some or all of the institution’s facilities are accredited by AAALAC or another accrediting body recognized by PHS, the report should identify those facilities as such.);”
http://grants.nih.gov/grants/olaw/references/phspol.htm
IACUC Review Responsibilities
From the USDA Animal Welfare Act Regulations and Standards, Section 2.31-
- “Review and approve, require modifications in (to secure approval), or withhold approval of those components of proposed activities related to the care and use of animals, as specified in paragraph (d) of this section;
- Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities; and
- Be authorized to suspend an activity involving animals in accordance with the specifications set forth in paragraph (d)(6) of this section. d. IACUC review of activities involving animals. (1) In order to approve proposed activities or proposed significant changes in ongoing activities, the IACUC shall conduct a review of those components of the activities related to the care and use of animals and determine that the proposed activities are in accordance with this subchapter unless acceptable justification for a departure is presented in writing; Provided, however, That field studies as defined in part 1 of this subchapter are exempt from this requirement. …”
www.access.gpo.gov/nara/cfr/waisidx/9cfr2.html
From PHS Policy, Section IV.C.1-
“In order to approve proposed research projects or proposed significant changes in ongoing research projects, the IACUC shall conduct a review of those components related to the care and use of animals and determine that the proposed research projects are in accordance with this Policy. In making this determination, the IACUC shall confirm that the research project will be conducted in accordance with the Animal Welfare Act insofar as it applies to the research project, and that the research project is consistent with the Guide unless acceptable justification for a departure is presented. Further, the IACUC shall determine that the research project conforms with the institution’s Assurance and meets the following requirements:…”
http://grants.nih.gov/grants/olaw/references/phspol.htm
What institutions are covered by the USDA Animal Welfare Act Regulations?
Uses live animals in teaching, research, tests, or experiments, and
2.Purchases or transports live animals in (interstate) commerce OR receives funds under a grant, award, loan, or contract from a department, agency, or instrumentality of the United States for the purpose of carrying out research, tests, or experiments.
Thus, the scope of the Animal Welfare Act is based upon the authority of the federal government to regulate interstate commerce, and its responsibility to make sure funds provided for animal research and testing are used appropriately. Dealers who sell animals are covered by the Animal Welfare Act Regulations, as are exhibitors such as traveling exhibits, carnivals, and zoos.
To what animals do the USDA Animal Welfare Act Regulations apply
Animal means any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warm blooded animal, which is being used, or is intended for use for research, teaching, testing, experimentation, or exhibition purposes, or as a pet. This term excludes: Birds, rats of the genus Rattus and mice of the genus Mus bred for use in research, and horses not used for research purposes and other farm animals, such as, but not limited to livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber. With respect to a dog, the term means all dogs, including those used for hunting, security, or breeding purposes.”
What year was the Health Research Extension Act passed by congress? What did it do?
- Directed Public Health Service to provide guidelines for animal research
Which agency is the Public Health Service in?
Department of Health and Human Services
What does OLAW do
The Office of Laboratory Animal Welfare (OLAW) is responsible for monitoring institutional compliance with PHS policy and guidelines.
What documents does OLAW use to asses compliance?
PHS Policy on Humane Care and Use of Laboratory Animals. It incorporates nine U.S. Government Principles For The Utilization And Care Of Vertebrate Animals Used In Testing, Research, and Training that must be considered when institutions receive support from U.S. Government agencies.
The second, lengthier document is the Guide for the Care and Use of Laboratory Animals (usually called the Guide). These two documents together provide important information sometimes collectively called “PHS Policy.” Compliance with PHS Policy is a required condition for receiving PHS support for activities involving vertebrate animals
What is the PHS Policy
nine U.S. Government Principles For The Utilization And Care Of Vertebrate Animals Used In Testing, Research, and Training that must be considered when institutions receive support from U.S. Government agencies.
Who must follow PHS Policy?
Any institutions that receive funding from PHS agencies
What are PHS agencies
NIH, CDC, FDA, NSF
What animals does the PHS policy cover?
PHS Policy covers all vertebrate species used for research, teaching, and testing in PHS-funded activities.
What animals does the Animal Welfare Act cover?
USDA AWA Regulations and Standards are not currently applied to laboratory mice and rats, birds, and animals used for agricultural research.
What is the Ag Guide
Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching,
In what case will the USDA accept Ag Guide standards for research animals?
The USDA also accepts the standards in the Ag Guide for research animals housed in agricultural settings but only when the animals are used for food and fiber research; for medical research they follow The Guide.
Which of these statements is true concerning the USDA Animal Welfare Act?
1) The USDA passed the Animal Welfare Act, and Congress has released regulations to enforce it.
2) The USDA stands for United States Department of Assessments.
3) The USDA is responsible for enforcing the Animal Withholding Action Act passed by Congress.
4) The Animal Welfare Act regulations take precedence over guidelines produced by the Public Health Service, Department of Veterans Affairs, and other government agencies.
4) The Animal Welfare Act regulations take precedence over guidelines produced by the Public Health Service, Department of Veterans Affairs, and other government agencies.
The Animal Welfare Act is federal law, whereas the other documents are requirements developed by those agencies for internal and external use.
Do the AWAR apply to
Non-vertebrates, laboratory mice, and laboratory rats.
No
The Animal Welfare Act definition of animal pertains to warm-blooded animals and explicitly excludes laboratory mice and rats, birds bred for research, and farm animals not used in biomedical research and teaching.
What are the two principal animal research regulatory documents used by the Public Health Service?
The PHS Policy on Humane Care and Use of Laboratory Animals and the Guide for the Care and Use of Laboratory Animals.
What did two British scientists, William Russell and Rex Burch, do?
3-R’s 1959
Refinement, Replacement, and Reduction
In the 1959 publication, The Principles of Humane Experimental Technique, Russell and Burch “classified humane techniques under the headings of replacement, reduction, and refinement.”
Purpose of the 3-rs
minimize animal use and pain or distress while still achieving the critical scientific objectives that lead to advances in health and medicine.
What does the USDA Animal Welfare Act Regulations require the IACUC to do regarding alternatives:
The first is to ensure that the principal investigator has considered alternatives if painful or distressing procedures are proposed.
The second is to evaluate a written narrative provided by the principal investigator that describes which source or sources were used to determine that alternatives were not available.
What details does the USDA Animal Welfare Act Regulations require for the search for alternatives
- The databases searched (Index Medicus, Medline, Current Contents, etc) or other sources used, such as colleagues at scientific meetings, journal articles read, and presentations attended.
- The date that any database searches were performed.
- The years of citations covered by database searches.
- The key words and/or search strategy used when searching a database.
- A search for reduction and refinement, not just replacement of animals.
What is a primary mission of the Animal Welfare Information Center (AWIC), a part of USDA?
Provides assistance with alternatives and database searches.
USDA AC Policy 12
“Alternatives or alternative methods are generally regarded as those that incorporate some aspect of replacement, reduction, or refinement of animal use in pursuit of the minimization of animal pain and distress consistent with the goals of the research. These include methods that use non-animal systems or less sentient animal species to partially or fully replace animals (for example, the use of an in vitro or insect model to replace a mammalian model), methods that reduce the number of animals to the minimum required to obtain scientifically valid data, and methods that refine animal use by lessening or eliminating pain or distress and, thereby, enhancing animal well-being.” USDA AC Policy 12
According to USDA AC Policy 12 “the regulations state that any proposed animal activity, or significant changes to an ongoing animal activity, must include: 1. a rationale for involving animals, the appropriateness of the species, and the number of animals to be used; 2. a description of procedures or methods designed to assure that discomfort and pain to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals; 3. a written narrative description of the methods and sources used to consider alternatives to procedures that may cause more than momentary or slight pain or distress to the animals; and 4. the written assurance that the activities do not unnecessarily duplicate previous experiments.” If alternatives are found as a result of a search, then those alternatives must be used or a scientific justification must be provided for not doing so.
Does the USDA AWAR or AWA require written documentation of assurance that animal studies are not unnecessarily duplicating previous studies?
The USDA Animal Welfare Act Regulations state that IACUCs must evaluate a written assurance that the proposed animal studies do not unnecessarily duplicate previous studies
The form of the written documentation is not specified by the Animal Welfare Act, but typically the same types of documentation used for the alternatives mandate do double duty here. Although not mandated by the AWA, experience has shown that database searches are effective ways to document that work proposed is not unnecessarily duplicative. For this reason, many institutions require that a database search of the scientific literature be completed to help document a lack of unnecessary duplication, even though such a search is not required by the AWA.
What species should not be fasted prior to surgeries?
However, rodents and rabbits are unable to vomit because of their esophageal physiology, and thus they should not be fasted prior to surgery unless there are other medical or scientific reasons for doing so.
If an animal undergoes non-survival surgery as part of a biomedical research activity, is sterile technique required?
If an animal undergoes non-survival surgery as part of a biomedical research activity, sterile technique may not be required. Even though the animal will not survive beyond the end of surgery, at a minimum, the surgeon should wear gloves, the surgical site should be clipped, and the instruments and work area should be clean.
What is the difference between major and minor surgery
Major surgery is defined as surgery that penetrates and exposes a body cavity such as the chest or abdomen, or surgery that produces substantial physical or physiological impairment. Examples of major surgeries include laparotomy, thoracotomy, craniotomy, joint replacement, and limb amputation.
Minor surgery is less invasive surgery that does not meet the criteria for major surgery above.
What factors are important in determining if a room can be used for surgery?
The rooms that can be used for surgery vary depending on:
- The species.
- Whether a surgery is major or minor.
- Whether the surgery is survival or non-survival.
When is a dedicated surgical suite required?
A dedicated surgical suite is required for major survival surgery on all non-rodent mammals (this includes rabbits).
When is a clean area/portion of a room acceptable for surgeries?
In contrast, a clean area or portion of a room (along with the use of aseptic technique) is acceptable for:
- Major survival surgeries on rodents and lower vertebrates.
- All non-survival surgeries.
- All minor survival surgeries.
Are health records required? how long must they be kept?
The USDA requires that health care records be maintained in a manner consistent with prevailing professional veterinary practice standards. The records should be maintained at least a year after the death of the animal to meet USDA policy.
Which of the following is not allowed by USDA policy, unless the IACUC approves
Entries on postoperative care records by multiple individuals.
Entries on postoperative care records by non-veterinarians.
Changes in animal ownership and movement of animals between facilities during the postoperative period.
Actions taken to ensure continuity of postoperative care.
The USDA does not allow changes in animal ownership during the postoperative recovery period, and does not allow movement of the animal between facilities during recovery from anesthesia unless the IACUC approves it. These prohibitions are meant to help ensure continuity of care during the postoperative period. Appropriate health records must be maintained regardless of the animal’s location.
