At Great Eastern University, investigators using animals were required to list on the IACUC protocol form the number of animals, by species, being requested. Although this requirement was well-established at Great Eastern and many other institutions, it was questioned by the school's IACUC administrator, who believed it would be more appropriate to list on the IACUC protocol form the number of animals requested by strain and species, rather than by species alone. Her rationale was simple: many research protocols at Great Eastern required one or more specific strains of mice, and she felt that failure to list the number of animals needed for each strain could lead to the acquisition of more animals than needed, animals that could be potentially unusable. For example, she said, “If 100 mice were required for a study, and 50 of them had to be C57Bl/6, how would the IACUC know whether the investigator used only the approved 50 rather than 100 C57Bl/6 mice, if only the species was indicated on the protocol? And, if 100 C57BL/6 were obtained, what were the extra 50 used for?”

Of course, not everybody agreed with that reasoning, particularly the researchers on the committee. They presented four points of view against having to list specific strains on the protocol form. First, researchers would never spend their precious research grant dollars purchasing animals they did not need. Second, the Animal Welfare Act regulations1 and the Public Health Service Policy on Humane Care and Use of Laboratory Animals2 indicate a need to justify the approximate number of animals required by species, not by any additional descriptions. Third, research needs change and researchers would not want to waste time submitting protocol amendments to change the number of animals of a particular strain requested. And fourth, noncompliance is noncompliance, no matter which species, strain or stock is being used. Nevertheless, some other members of the IACUC took up the administrator's cause, reminding the investigators that when multiple strains were to be used in a protocol, the information about the strains was already included in the descriptive parts of the protocol form in order for the reviewers to understand the component parts of the planned study. They also noted that when animals were eventually ordered, the needed strain had to be indicated. Therefore, they wanted to know why it would be a problem to list strain information on the protocol form where the species and total number of animals requested was shown. That way, they claimed, there would be less chance for ordering errors and less chance for noncompliance.

What is your opinion? Do you think Great Eastern University should change the protocol form along the lines suggested by the IACUC administrator or leave it as it is, as favored by the researchers?

Response to Protocol Review Scenario: Right info, wrong place

Response to Protocol Review Scenario: Change to ensure compliance

Response to Protocol Review Scenario: When strain matters