This policy clarifies the requirements for submission of an Animal Care and Use (ACU) Protocol for studies in non-university owned animals.
The University is frequently involved in types of animal studies that do not fall under the traditional definition of laboratory research. For example an investigator might recommend a change in diet to a commercial dairy and record the influence of that diet on the performance of the cattle. This study could be conducted by any practicing veterinarian or by any dairyman; this could occur outside of the University, and would not be regulated by any laws, regulations, or guidelines.
A “study in non-University owned animals” with respect to this policy, refers to a study in which a treatment is applied to animals that is not actually experimental in the typical sense. The key factors that constitute a “study in non-University owned animals” are:
- The animals are not owned by the University of California, nor are they client-owned Veterinary Medical Teaching Hospital (VMTH) patients.
- No disease is being induced or health problem created for the animals on the study. If the study is focused on a particular disease, the disease is spontaneously occurring in the animals.
- The procedures performed on the animals are those that a practicing veterinarian, pet owner, or farmer/rancher would perform on their own animals or their clients’ animals and are being done for the health benefit of the animals.
- The project is not funded by a federal funding agency. Both USDA and OLAW require a protocol to be reviewed for animal research and teaching that is federally funded.
All of these conditions must be met for the study to be considered a study in non-University owned animals.
Studies in non-university owned animals are not regulated by the Animal Welfare Act. As such, these studies are exempt from the requirement for submission of an ACU Protocol. Submission of an ACU Protocol for such studies is optional. Some funding agencies and certain publishers of manuscripts or reports may require review of such a study by the Institutional Animal Care and Use Committee (IACUC). The IACUC will review such projects on request in order to satisfy the requirements of funding agencies or publishers.
For clinical research involving client-owned VMTH patients, an IACUC approved protocol is required. The veterinary Clinical Trial Review Board (CTRB) functions in an advisory fashion to the UC Davis IACUC and will pre-review all protocols involving client-owned VMTH patients. The primary responsibility of the CTRB is to determine whether clinical research projects place VMTH patients at increased risk. Protocols involving client-owned VMTH patients must also include an owner Informed Consent Form. Implementation of new technologies or procedures that are believed to be in the best interest of the patient, or that fall under compassionate use, do not constitute an investigation and thus do not fall under the definition of clinical research.
Date: August 11, 2016
Enabled by: PHS/AWA
Supersedes: September 19, 2013