At a recent webinar hosted by the National Association for Biomedical Research, Drs. Elizabeth Meeks and William Stokes of the United States Department of Agriculture (USDA) answered approximately 50 questions submitted by participants. This article addresses several of those questions because they come up frequently, provide an opportunity to discuss a new issue, or are fundamental to the understanding of the regulatory process. This article has been reviewed by the USDA representatives and will attempt to provide additional clarification to the webinar responses.
Assuring a quorum
The AWA defines a quorum as “a majority of the members of the Committee” and requires a quorum for all formal actions of an IACUC. §2.31(d)(2) of the AWR provides additional guidance for when full committee review is requested and a member of the committee has a conflicting interest, such as personal involvement in the proposed activity. The conflicted member may not participate in the review and approval of the activity except to provide information, and specifically cannot contribute to the constitution of a quorum. Conflicts of interest that may arise during full committee review should be identified in advance of an IACUC meeting to ensure there will be a quorum to conduct business if conflicted members are not able to participate.
Oversight of the care and use of client-owned animals
Whether client-owned animals used in clinical trials or for teaching purposes are covered by the regulatory oversight of the AWR has become a frequently asked question. Client-owned animals used in clinical trials in the context of a veterinary-client-patient relationship are not regulated under the AWA; therefore a protocol or IACUC approval for these activities is not required. Animals owned by a shelter or pound that are receiving veterinary services, such as spays or neuters, are also considered to have a veterinary-client-patient relationship. How an institution provides internal oversight of client-owned animals is up to the institution, but if they elect to have the IACUC provide the oversight, the animals involved should not be included in the annual report (APHIS Form 7023) because they are not owned and maintained by the facility.