Policy Statement on Clinical Trials

Purpose:
The purpose of this statement is to clarify the requirements for submission of an IACUC Protocol form for clinical trials using client-owned animals with the owner’s informed consent, to the Institutional Animal Care and Use Committee (IACUC). This statement interprets, to the best of our understanding, the use of client-owned animals in research use at the University.   
Background:
The University of Tennessee Animal Care and Use Program is responsible for compliance with two agencies:

1. OLAW (Office of Laboratory Animal Welfare)
2. USDA (United States Department of Agriculture)

The IACUC has reviewed projects involving client-owned animals for a number of years.
Definition:
A "clinical trial", 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 essential factors that make a study a "clinical trial" are:

1. The animals do not belong to The University of Tennessee, but to a private owner.
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.

Policy:
 USDA and OLAW require IACUC approval and oversight of all vertebrate animal research.  
Approved 10/2/2007