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A Word from the USDA and OLAW

Lab Animal volume 51, page 2 (2022)Cite this article

Subjects

In this scenario, dogs that are client-owned were receiving an experimental drug as part of a veterinary clinical study to treat tumors that contain markers for a specific form of cancer. The investigator failed to obtain IACUC review of the preliminary research activities conducted in collaboration with the private practice veterinarian prior to receiving NIH funding for continuation of the research. There is concern that the early trial proceeded without IACUC oversight and without having a signed owner consent form.

Coverage under the Animal Welfare Act (AWA) depends on the species and purpose for the use of an animal1. In this scenario, the purpose for the client-owned dogs is to undergo treatment with an experimental drug for a tumor forming condition. This treatment is occurring under the oversight of their private practice veterinarian. In light of this, the dogs are not covered under the AWA because they are under treatment within the context of a veterinarian-client-patient relationship, as defined by the American Veterinary Medical Association2. Oversight by the IACUC is therefore not required under the AWA. Regarding owner consent, in the event there is evidence the veterinarian did not inform the owners of the work and consequently did not obtain consent, the issue would fall within the jurisdiction of the State Veterinary Medical Board.

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References

  1. 9 C.F.R. §1.1- Definitions: Animal.

  2. American Veterinary Medical Association - The Veterinarian-Client-Patient Relationship, online at: https://www.avma.org/resources-tools/pet-owners/petcare/veterinarian-client-patient-relationship-vcpr

  3. National Institutes of Health Grants Policy, Part I: NIH Grants – General Information, 2.3.6. Legal Implications of Applications. https://grants.nih.gov/grants/policy/nihgps/HTML5/section_2/2.3.6_legal_implications_of_applications.htm

  4. Public Health Service. Policy on Humane Care and Use of Laboratory Animals – Frequently Asked Questions. Applicability of the PHS Policy, Question No. A.1. (US Department of Health and Human Services, Bethesda, MD, USA). [online]. https://olaw.nih.gov/faqs#/guidance/faqs?anchor=question50285

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  8. National Institutes of Health Grants Policy Statement, Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities 15.2.1 Written Agreement. [online]. https://grants.nih.gov/grants/policy/nihgps/HTML5/section_15/15.2_administrative_and_other_requirements.htm

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Author information

Authors and Affiliations

  1. Director, Office of Laboratory Animal Welfare, OER, OD, NIH, HHS, Bethesda, MD, USA

    Patricia Brown

  2. Deputy Administrator, Animal Care, APHIS, USDA, Riverdale, MD, USA

    Betty Goldentyer

Authors
  1. Patricia Brown
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  2. Betty Goldentyer
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Correspondence to Patricia Brown or Betty Goldentyer.

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Brown, P., Goldentyer, B. A Word from the USDA and OLAW. Lab Anim 51, 2 (2022). https://doi.org/10.1038/s41684-021-00896-8

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