In response to the questions posed in this scenario, the Office of Laboratory Animal Welfare (OLAW) offers the following clarification and guidance:

The key issues raised in the scenario are: 1) whether the experimental design is consistent with the strategic aims of the research; 2) concerns for animal welfare in considering two of the three “Rs”, reduction versus refinement; and 3) if the statistical power of the animal numbers in the control group is appropriate for the study.

Although an IACUC's primary focus is on animal welfare, often it must include consideration of the soundness of the research design in its review of protocols. The Guide states that “While the responsibility for scientific merit review normally lies outside the IACUC, the committee members should evaluate scientific elements of the protocol as they relate to the welfare and use of the animals”1. If a rationale for the experimental design is unclear to the IACUC then the committee should request further clarification from the investigator.

Minimizing the number of animals is a worthwhile consideration, but it must allow for valid results and be balanced by the discomfort, distress and pain experienced by each individual animal2. The Guide states that “reduction involves strategies for obtaining comparable levels of information from the use of fewer animals or for maximizing the information obtained from a given number of animals (without increasing pain or distress) so that in the long run fewer animals are needed to acquire the same scientific information” and that the goals of refinement versus reduction “should be balanced on a case by case basis”1.

Whenever an IACUC is faced with complex issues, including the statistical justification for control and experimental groups, it should consider using consultants to provide expert counsel3.

Return to Protocol Review