Unanticipated Phenotypes Impacting Animal Health

This policy applies to situations that include but are not limited to cases in which the breeding of transgenic mice or crosses between strains of mice produce phenotypes for which the applicable protocol contains no provision for clinical care or experimental endpoints.

The Animal Research Protocol form should delineate all anticipated phenotype(s) that may be produced in the offspring of crosses or routine breeding of transgenic mice. Any phenotype produced that varies from that described in the protocol or that may cause significant morbidity or mortality must be reported to the IACUC and must be added to the protocol by amendment.

Animals enrolled in the experimental protocols may develop phenotypes and illness that have not been adequately anticipated by or described in the written protocol. As a consequence, these animals will not have the benefit of considered and IACUC-approved experimental aims and endpoints. However, animals with these phenotypes and illnesses may be valuable precisely because of the novel or unexpected nature of the phenotype.

It is the responsibility of the principal investigator (PI) to notify the veterinarian and IACUC of the unanticipated phenotype as soon as possible. This notification should include relevant scientific justification for continued study of the phenotype and a plan, including humane experimental endpoints, for insuring that the animals will be sufficiently monitored and cared for to ensure well-being.

In cases where the IACUC does not consider the justification appropriate or finds the monitoring and care plan inadequate, the IACUC will either convene a subcommittee to address the humane care and treatment of animals with the phenotype, or the IACUC will require that the investigator consult with a veterinarian to develop an appropriate monitoring and care plan and submit an amendment to the protocol for consideration by the IACUC based on that plan.

In the interval between discovery of the unanticipated phenotype and the decision of the IACUC regarding a covering amendment, the veterinarian will make an assessment of the health of the animal(s) and consult with the principal investigator to gather relevant information. During this interim period, the attending veterinarian is authorized to make final decisions regarding care and euthanasia of that animal (see IACUC policy on Authority of the Attending Veterinarian).

BU IACUC Approved March 2011, Revised January 2014