In my opinion, the IACUC should withhold approval of the protocol until it is modified to meet the standards of USDA's animal care policy #14 on major survival surgery1. This policy references the Animal Welfare Act and Regulations2 and states that “[n]o animal is to be used in more than one major survival operative procedure except in cases of scientific necessity or veterinary care.”

As written, the protocol does not meet these standards for several reasons. First, each animal would be required to undergo four major survival operative procedures. Second, there is no need for these procedures that can be justified as veterinary care or for scientific necessity. Third, there are other, non-invasive, procedures that can be used to help evaluate kidney function.

Another study plan should be developed that can provide similar data. For example, the protocol could require only one biopsy from each dog at appropriate intervals: dog 1, right kidney at interval 1 (month 1); dog 2, left kidney at interval 1 (month 1); dog 3, right kidney at interval 2 (month 2); dog 4, left kidney at interval 2 (month 2); dog 5, right kidney at interval 3 (month 3); and dog 6, left kidney at interval 3 (month 3).

Return to Protocol Review