Departures from the Guide

May statements in the Guide are suggestions that institutions can choose to implement if suitable for their program. These deviations are not included in the semiannual report to the IO.

Example: A PI requests single housing for her rats to measure individual urine output post-treatment with a test article. After considering the specific details of the proposed experiment, the IACUC approves the protocol. 

Guide: "Social animals should be housed in stable pairs or groups of compatible individuals unless they must be housed alone for experimental reasons or because of social incompatibility" (page 51).

Discussion: This is a deviation from a should statement according to a specifically established exception in the Guide (experimental reasons). Exceptions are not departures from the Guide and need not be reported in the semiannual report to the IO. 

Example 1: A PI proposes to forgo cage sanitization for a 5-week study because animals are exposed to a biohazardous infectious agent. An SOP was developed based on data collected at the institution addressing cage density, parameters for sanitary conditions, regular ammonia level testing, and use of specialized bedding that facilitates cleanliness. Both the SOP and protocol were reviewed and approved by the IACUC. 

Guide: "In general, enclosures and accessories, such as tops, should be sanitized at least once every 2 weeks" (page 70).

Discussion: This is a deviation from a should statement that follows a performance standard using data established at the institution. It is not a departure from the Guide and is not reported in the semiannual report to the IO.

Example 2:  All mouse wire bar lids are sanitized once every 4 weeks according to performance standards established by the institution. The SOP was reviewed and approved by the IACUC.

Guide: "In general, enclosures and accessories, such as tops, should be sanitized at least once every 2 weeks" (page 70).

Discussion: This is a program-wide institutional, rather than a study-specific deviation from a should statement that follows a performance standard using data established by the institution. It is not a departure from the Guide and is not reported in the semiannual report to the IO. 

Example: The PI proposes to confine dogs for 3 days in small cages to limit the dogs' ability to stand as part of a scientifically justified research requirement. The IACUC reviews and approves the scientific justification and the protocol. 

Guide: "At a minimum, animals must have enough space to express their natural postures..." (page 56).

Discussion: This is a deviation from a must statement of the Guide that has been scientifically justified by the PI and reviewed and approved by the IACUC. It is an approved departure and must be reported in the semiannual report to the IO. 

Example: In describing a food-restricted animal study, the PI stated that animals must be anesthetized before weighing and cited data demonstrating the adverse effect of anesthesia on the animals' performance of behavioral tasks required in the proposed study. The research team will monitor and weigh the animals and requested permission to weigh monthly rather than weekly. The IACUC reviewed and approved the request. 

Guide: Regarding food-restricted diets, the Guide states: "Body weights should be recorded at least weekly" (page 31).

Discussion: This is a deviation from a should statement based on scientific justification that has been reviewed and approved by the IACUC. It is an approved departure from the Guide and must be reported in the semiannual report to the IO. 

Example: The IACUC learns that one of the satellite facilities has inadvertently been omitted from the disaster plan. 

Guide: "Facilities must therefore have a disaster plan" (page 35).

Discussion: This is a noncompliance. The IACUC must report to OLAW through the IO and develop a plan and schedule to correct this unapproved deviation from a must statement in the Guide. 

Example 1:  The IACUC approved a PI's protocol allowing the research team to sanitize solid-bottom rodent cages weekly in a satellite facility. The PI goes on sabbatical and the research team decides that sanitation every 3 weeks is sufficient. A post-approval monitor discovers the discrepancy and informs the IACUC. 

Guide: "In general, enclosures and accessories...should...be sanitized at least once every 2 weeks. Solid-bottom caging...usually require[s] sanitation at least once a week" (page 70).

Discussion:  This is a noncompliance. The IACUC must report to OLAW through the IO and develop a plan and schedule to correct this unapproved deviation from a should statement in the Guide. 

Example 2: An institution has begun a breeding program for Siberian hamsters, a new species at the institution. The visiting investigator who was charged with setting up a breeding program assured the IACUC members that the species does well with trio breeding. The IACUC approved the protocol without considering that the facility's cages have 20 inches² of floor space, without consulting the investigator, veterinarian, or the literature regarding space requirements.

Guide: "The space recommendations presented here are based on professional judgement and experience. They should be considered the minimum for animals housed under conditions found in laboratory animal housing facilities" (page 56 and Table 3.2).

Discussion:  This is a noncompliance. Breeding in space that did not meet Guide standards was permitted without appropriate justification or use of a well-established performance standard regarding space requirements. The IACUC must report to OLAW through the IO and develop a plan and schedule to correct this unapproved deviation from a should statement in the Guide. 

Example 3: The PI for a guinea pig study is trying to cut costs and instructed his laboratory manager to order non-pharmaceutical-grade euthanasia drugs for his study. The original animal activity approved by the IACUC specified pharmaceutical grade drugs and the PI did not submit an amendment to the IACUC requesting the change. 

Guide: "The use of pharmaceutical-grade chemicals and other substances ensures that toxic or unwanted side effects are not introduced into studies conducted with the experimental animals. They should therefore be used, when available, for all animal-related procedures. The use of non-pharmaceutical-grade chemicals or substances should be described and justified in the animal use protocol and be approved by the IACUC" (page 31). 

Discussion: This is a noncompliance because it is a change that was not approved by the IACUC in advance of implementation, and therefore constitutes a deviation from an IACUC-approved protocol. The IACUC must report to OLAW through the IO and develop a plan and schedule to correct this unapproved deviation from a should statement in the Guide.