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Response to Protocol Review Scenario: Follow the Rules of the Game

The details of this situation are somewhat unclear, making it difficult to draw a fair and sound decision. Was this project funded by a peer-reviewed granting agency? If yes, the IACUC is not responsible for reviewing the protocol's scientific merit. The use of the term “failure” to describe McNulty's experiments is ambiguous and unclear. If they “failed” because McNulty was unable to generate data that support an experimental hypothesis, she should remember that unexpected results are not necessarily meaningless. On the other hand, if the term “failure” alludes to increased rates of morbidity and/or mortality within the experimental animal population, consultation with the Attending Veterinarian (AV) is in order. Are technically competent individuals using standard and published methods? A complete protocol review, ranging from the laboratory methods employed to the technical proficiency of the research personnel, may shed additional light on the situation. Rodent health surveillance and animal husbandry programs vary considerably among institutions, and even within a single organization. To what extent does Great Eastern screen for pathogens capable of causing subclinical infections? Subclinical disease, which often goes undetected or is simply overlooked, can be a potentially important confounding experimental variable. Similarly, there is a wide variation of both the implementation and execution of husbandry practices among facilities. Therefore, given the paucity of information, a comparison of rodent health between Great Eastern and other institutions is inconclusive at best.

McNulty should not suffer penalties for her pre-sabbatical actions. Investigators are not obliged to give advance notice for an impending colony depopulation. Not only are the animals often unique to a single study, but experimental manipulations may also make them of little use to others. She is currently requesting a reasonable number of animals. Although the facility supervisor's concerns are understandable in light of the historical problems with this protocol, given the nature of the work and the specific candidate criteria, culling of unsuitable animals remains inevitable.

Before resuming the work, McNulty should consult with the AV and facility supervisor to clarify information concerning the University's rodent health monitoring and animal care programs. The IACUC might recommend that an objective third party assist McNulty in reviewing the entire experimental protocol. If unresolved problems surface, implementation of necessary changes can commence immediately. If McNulty initiates any new measures, these should be highlighted in a report to the IACUC. Following resumption of the work, the IACUC can request regular updates until such time that the Committee is fully satisfied with the implemented amendments and current status of the protocol.

Most importantly, at no time did the investigator ever violate her protocol. Given that she will act cooperatively with the IACUC to strive for optimal animal care and use, the approval should be neither revisited nor rescinded.

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Matsumiya, L. Response to Protocol Review Scenario: Follow the Rules of the Game. Lab Anim 32, 23 (2003).

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