In response to the issues raised in this scenario, the Office of Laboratory Animal Welfare (OLAW) and the United States Department of Agriculture, Animal and Plant Health Inspection Service, Animal Care (USDA/APHIS/AC) offer the following clarification and guidance:

The primary questions posed in this scenario are when does a clinical evaluation become research, and does the IACUC need to be involved?

The Animal Welfare Act (AWA) requires registration of facilities using live animals in experiments. It is important that the Great Eastern IACUC definitively determine whether the procedures being done are for clinical purposes (for the medical benefit of the individual dog) or for experimental purposes (e.g., a systematic investigation evaluating a new procedure). If it is an experiment, then the IACUC must determine whether the facility is acquiring the animals, and whether it is receiving federal funds to carry out the work. In this scenario, the animals are privately owned and have not been acquired by the facility. Funding is provided by a foundation grant; if this is a federal source (such as the National Science Foundation), then the activity is covered by the USDA and there must be an IACUC-approved protocol for the activity1.

If the proposed work is supported by the Public Health Service (PHS), then either all of the work must be covered under the Great Eastern Animal Welfare Assurance or Southedge Hospital must obtain its own Assurance. If Great Eastern chooses to add Southedge to its Assurance, Southedge would need to agree to empower Great Eastern's Institutional Official and IACUC to oversee all aspects of the project and to implement provisions of the PHS Policy and recommendations of the Guide for the Care and Use of Laboratory Animals at Southedge2,3. In addition, OLAW would review and consider the inclusion of Southedge as a performance site under the Great Eastern Assurance prior to the commencement of any work. In similar circumstances, OLAW has observed that IACUCs often choose to add an appropriate staff member from the performance site to the IACUC, or otherwise as a consultant, to ensure that the proposed animal activities do not conflict with the primary use of the facilities for human patients.

If the proposed work is not PHS-supported, and if Great Eastern stated that all vertebrate animals were covered under its Assurance regardless of funding source, OLAW would expect Great Eastern to negotiate an agreement with Southedge as described above prior to the commencement of any work.

Concerning questions about ownership, the PHS Policy doesn't distinguish between the use of institutionally owned and privately owned animals. Although issues of consent are not mentioned in the PHS Policy or the AWA, OLAW and USDA recommend that institutions, in consultation with their legal counsel, devise appropriate consent agreements that fully explain the purpose and procedures involved in clinical trials, the potential benefits and risks to animal subjects and the responsibilities and rights of both owners and the institution.

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