Departures from the Guide

The following resources are provided to assist Public Health Service (PHS) awardee institutions in meeting reporting requirements.

Introduction

OLAW oversees PHS-funded animal activities by the authority of the Health Research Extension Act of 1985 and the PHS Policy on Humane Care and Use of Laboratory Animals (Policy). The IACUC is responsible for oversight of the animal care and use program and its components as described in the PHS Policy and the Guide for the Care and Use of Laboratory Animals (Guide ).

The PHS Policy IV.B.3. requires that: The IACUC shall prepare reports of their semiannual program reviews and animal facility inspections and submit the reports to the Institutional Official (IO). The reports must contain a description of the nature and extent of the institution's adherence to the Guide and the PHS Policy and must identify specifically any departures from the provisions of the Guide and the PHS Policy, and must state the reasons for each departure.

The provisions of the Guide are stated in terms of standards that must be met, standards that should be met, and standards that may be met. In addition, the Guide establishes exceptions in specific situations. These exceptions are not departures from the Guide.

IACUC approval of departures from the Guide must be based on scientific, veterinary medical, or animal welfare issues.

Reporting Requirements

The Guide establishes exceptions in specific situations. These exceptions are not departures from the Guide and are not reported in the semiannual report to the IO. OLAW defines must as a minimum standard required of all Assured institutions. Deviation from these standards with IACUC approval is a departure from the Guide and must be reported in the semiannual report. Deviation from a must statement without IACUC approval is a noncompliance that must be reported to OLAW through the IO.

There are different reporting requirements for should statements in the Guide based on the situations listed below. IACUCs are responsible for determining the appropriate category for should statements as they apply to their institution's program of animal care and use and to report as described.

• Should statements often involve performance standards (OLAW FAQ G10, Guide pp 6-7). Well-established performance standards are not departures from the Guide and need not be reported in the semiannual report to the IO.
• Deviation from a should statement with IACUC approval is a departure from the Guide and must be reported in the semiannual report to the IO.
• Deviation from a should statement without IACUC approval is a noncompliance that must be reported to OLAW through the IO.

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

Comparison of Reporting Requirements

Comparison of reporting requirements for deviations from the provisions of the Guide:

• Download table of reporting requirements. (PDF - 74 KB)
• Download flow chart of reporting requirements. (PDF - 267 KB)
  (OLAW acknowledges the contributions of Patricia Foley, DVM and Alice Huang, PhD in developing this resource.)

Examples

Following are examples of reporting requirements. These scenarios may not be applicable or appropriate for every institution. The IACUC, animal program managers, and researchers working together must use professional judgment and carefully consider the specific circumstances at their institution.

A. Conduct of an activity according to a specifically described exception listed in the Guide.

1. Example: In an animal study protocol, the PI requests single housing for her mice so that she can measure individual fluid consumption. 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. It need not be reported to the IO in the semiannual report.
2. Example: Prior to implementing the Guide Eighth Edition, an institution had singly housed all rabbits. After trial attempts at social housing, the veterinarian determines that a current group of older male rabbits cannot be successfully socially housed. The facility manager and veterinarian prepare an SOP describing appropriate social housing of newly acquired rabbits which includes pairing of sibling does or neutered bucks. The IACUC approves an institution-wide SOP for social housing rabbits.
   • 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: The institution fulfilled the intent of the Guide should statement regarding social housing. Singly housing the older bucks is a deviation from a should statement according to a specifically established exception in the Guide (social incompatibility) and is not a departure from the Guide. It need not be reported to the IO in the semiannual report.
3. Example: The institution has previously housed all dogs in pairs. The veterinarian determines that one older dog can no longer be socially housed because of arthritis that requires specialized care and padded flooring. The veterinarian informs the IACUC of the circumstances for singly housing the dog based on veterinary-related concerns.
   • 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) Single housing of social species should be the exception and justified based on experimental requirements or veterinary-related concerns about animal well-being. (page 64)
   • Discussion: This is a deviation from a should statement according to a specifically established exception in the Guide (veterinary-related concern) and is not a departure from the Guide. It need not be reported to the IO in the semiannual report.

B. Comparison of reporting requirements when deviating from a Guide must statement.

1. Example: 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. 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.
2. 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 develop a plan and schedule to correct this unapproved deviation from a must statement in the Guide.

C. Comparison of reporting requirements when deviating from a Guide should statement.

1. Example: The PI proposes to trio breed transgenic and inbred mice in solid bottom cages with 71 in2 of floor space according to an SOP developed by animal facility personnel. The strains proposed are difficult to breed and generate small numbers of pups. The SOP addresses parameters of well-being and requires prompt weaning and separation of animals to avoid overcrowding. The SOP is based on local performance measures including growth rate, cage dimensions, and husbandry practices. The SOP has been reviewed and approved by the IACUC.
   • Guide: The space recommendations presented here are based on professional judgment and experience. They should be considered the minimum for animals housed under conditions commonly found in laboratory animal housing facilities. Recommended Minimum Space for Commonly Used Laboratory Rodents Housed in Groups. Female + litter, Floor Area/Animal in2 = 51 in2 Table 3.2. (pages 56-57)
   • Discussion: This is a deviation from a should statement that follows a well-established performance standard, is not a departure from the Guide, and not reported in the semiannual report to the IO.
2. Example: In describing a food-restricted animal study, the PI stated that animals have to be anesthetized before weighing and cited data demonstrating the adverse effect of anesthesia on the animal’s performance of behavioral tasks required in the proposed study. He cited other parameters of animal well-being that the research team will monitor and requested permission to weigh the animals monthly rather than weekly. 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 a 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.
3. Example: The PI’s approved protocol includes having the research team sanitize solid bottom rodent cages in a satellite facility. The PI goes on sabbatical and the research team decides that sanitation every three 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 develop a plan and schedule to correct this unapproved deviation from a should statement in the Guide.

Additional References

• NOT-OD-12-148: Guidance on Departures from the Provisions of the Guide for the Care and Use of Laboratory Animals
• OLAW FAQ C7: What are PHS Policy reporting requirements for departures from the Guide?
• Departures from the Guide: This OLAW Online Seminar discusses the PHS requirement to report departures from the Guide.

Questions or Suggestions?

Do you have questions or your own examples of deviations from the Guide that you’d like to share? Contact OLAW at 301-496-7163 or e-mail [email protected].