Policy Statement on Trials in Non-University Owned Animals
Purpose
This statement clarifies the requirements for submission of a Protocol for Animal Use and Care for trials in non-university owned animals.
Background
The University is frequently involved in types of animal research that do not fall under the traditional definition of laboratory research. For example, a veterinarian might develop a new method for treating skin cancer and apply that technique to several of his/her patients presenting with skin cancer. An animal scientist might recommend a change in diet to a commercial dairy and record the influence of that diet on the performance of the cattle. Either of these projects could be conducted by any practicing veterinarian or by any dairyman; outside the University neither of these projects would be regulated by any laws, regulations, or guidelines; neither of these studies would be confined to USDA registered research facilities.
There are no laws governing such trials in animals. This is different from studies conducted in human beings, in which clinical trials are regulated. With respect to trials in non-university-owned animals, there is no equivalent to Human Subjects regulations.
Definition
A "trial in non-University owned animals" with respect to this policy, refers to a research project in which a treatment is applied to animals that are not actually experimental animals in the usual sense. The key factors that make a study a "trial in non-University owned animals" are:
1. The animals do not belong to the University of California, but to a private pet owner, farmer, or rancher.
2. No disease is being induced or problem being created for the animals by the study. If the study concerns disease, the disease is spontaneously occurring in the animals.
3. The procedures being performed on the animals are the sorts of procedures that a practicing veterinarian, pet owner, or farmer/rancher would perform on their own animals or their clients' animal.
All of these three conditions must apply for the study to be considered a trial in non-university-owned animals.
Policy
Trials in non-university-owned animals are not regulated by the Animal Welfare Act. As such, these trials are exempt from the requirement for submission of a Protocol for Animal Use and Care. Submission of a Protocols for Animal Use and Care for such studies is optional. Some funding agencies may request review of such a trial by the Institutional Animal Care and Use Committee. The IACUC will review such projects on request in order to satisfy the requirements of funding agencies.
Statement approved: 04/02/90
Revised: 8/12/99